MinTankesmie

- Legemiddelfirmaer står foran milliardtap i 2011 idet patenter utløper

Drug Firms Face Billions in Losses in ’11 as Patents End (Legemiddelfirmaer står foran milliardtap i 2011 idet patenter utløper)
Sandy Huffaker for The New York Times
nytimes.com 6.3.2011
Pfizer’s multimillion-dollar gamble on a replacement for the popular drug Lipitor, which lowers cholesterol, failed in clinical trials.

At the end of November, Pfizer stands to lose a $10-billion-a-year revenue stream when the patent on its blockbuster cholesterol drug Lipitor expires and cheaper generics begin to cut into the company’s huge sales. (...)

Morgan Stanley recently downgraded the entire group of multinational pharmaceutical companies based in Europe — AstraZeneca, Bayer, GlaxoSmithKline, Novartis, Novo Nordisk and Roche — in a report titled “An Avalanche of Risk? Downgrading to Cautious.” The analysts wrote, “The operating environment for pharma is worsening rapidly.” (...)

- Legemiddelfirmaer angriper amerikanske patentplaner

Drug Firms Attack U.S. Patent Plans (Legemiddelfirmaer angriper amerikanske patentplaner)
online.wsj.com 16.2.2011
ZURICH—A U.S. government proposal to bring cheaper generic drugs to the market more quickly and help curb health-care costs has triggered criticism from the European pharmaceutical sector.

Many drug makers fear that cutting the patent protection for biologic drugs to seven years from 12 years will upend their business models and curtail their ability to develop new drugs and generate profits.

Fears are also lingering that, should the U.S. plan be pushed through, the European Union could follow up with similar steps in a bid to help strained government budgets and rein in health-care costs. (...)

Drug Industry: Pharmaceutical Companies Find Ways To Cope As Patents Expire; FDA Criticized For Consulting Contracts
kaiserhealthnews.org 12.11.2010
The Philadelphia Inquirer: "There is a simple explanation for most of the mergers and acquisitions in the pharmaceutical world these days: the so-called Patent Cliff. Simply put, many of the drug industry's biggest earners — blockbuster medications that have paid the bills for the last decade — are about to lose their patent protections." (...)

The Wall Street Journal: "The Food and Drug Administration has been paying consultants millions of dollars for management help — including leadership classes held at a Civil War battlefield — amid concerns in Congress that the contracts aren't helping the agency to clear long backlogs." (...)

- Legemiddelindustrien kan betale for å holde generiske legemidler utenfor markedet, ifølge Høyesterett

Pharma Can Pay for No Play, Supreme Court Says (Legemiddelindustrien kan betale for å holde generiske legemidler utenfor markedet, ifølge Høyesterett)
Medpagetoday.com 7.3.2011
Without providing comment, the Supreme Court decided not to review a federal appeals court ruling that allows pharmaceutical companies to pay competitors to delay the production of generic drugs.

Last year, the a New York-based federal appeals court dismissed a legal challenge to a 1997 deal in which Bayer AG paid Teva Pharmaceutical's Barr Laboratories not to develop a generic version of the antibiotic ciprofloxacin, saying that such an action does not violate antitrust laws.

The legal challenge was raised by several pharmacy chains, which appealed the ruling to the Supreme Court. (...)

(Anm: Generiske legemidler (generika) (mintankesmie.no).)

- Legemiddelfirmaer endrer "aggressivt" måten de utfører R&D (forskning og utvikling) på

Drugmakers “aggressively changing the way they do R&D” (Legemiddelfirmaer endrer "aggressivt" måten de utfører R&D (forskning og utvikling) på)
pharmatimes.com 6.1.2011
With dozens of prescription medicines due to lose patent protection over the next few years, and company pipelines currently containing few likely blockbusters with the potential to replace declining revenues, developers are aggressively changing the way they do R&D, says a new study.

“The research-based drug industry, in the United States and globally, is not sitting still, but the question remains whether developers can bring enough new drugs to market at the pace needed to remain financially viable,” according to Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development (CSDD). (...)

- USA mener at gener ikke bør være gjenstand for patenter

U.S. Says Genes Should Not Be Eligible for Patents (USA mener at gener ikke bør være gjenstand for patenter)
nytimes.com 30.10.2010
Reversing a longstanding policy, the federal government said on Friday that human and other genes should not be eligible for patents because they are part of nature. The new position could have a huge impact on medicine and on the biotechnology industry. (...)

- Legemidler, profitt og handelsavtaler

Bill Daley's Big Pharma History: Drugs, Profits And Trade Deals (Bill Daleys Big Pharma-historie: Legemidler, profitt og handelsavtaler)
huffingtonpost.com 28.9.2011
This piece is a continuation of The Huffington Post's collaboration on trade issues with The Dylan Ratigan Show, called Trading Our Future.

WASHINGTON -- As commerce secretary under Bill Clinton, William Daley worked with U.S. pharmaceutical giants to curb the use of cheaper generic drugs abroad. As a board member for Abbott Laboratories, he had a front-row seat on a brutal clash between a major drug company and a developing nation over access to life-saving medication. And as White House chief of staff today, Daley has President Barack Obama’s ear.

Add up Daley’s power and experience, and experts who follow public health policy suspect his influence in the U.S. stance in negotiations over a major international trade deal -- a stance with hugely profitable implications for giant American drugmakers.

The United States is in talks with eight other Pacific nations to establish the Trans-Pacific Partnership, which the administration hopes will serve as a template for other trade pacts. According to leaked documents from the negotiations, the Obama administration is using the deal to push hard-line intellectual property standards that could drive up medicine prices overseas, boosting the bottom line for U.S. drugmakers like Abbott Labs at the expense of public health. (...)

- Hvordan FDA glemte bevisene

How the FDA forgot the evidence: the case of donepezil 23 mg (Hvordan FDA glemte bevisene: tilfellet med donepezil 23 mg)
BMJ 2012;344:e1086 (22 March)
In the first of a new occasional series highlighting the exaggerations, distortions, and selective reporting that make some news stories, advertising, and medical journal articles “not so,” Lisa M Schwartz and Steven Woloshin challenge the claims made for the new 23 mg dose of donepezil

What is the difference between 20 and 23? If you said three, you are off by millions—of dollars in sales, that is—at least from the perspective of Eisai, the manufacturer of donepezil (marketed as Aricept by Pfizer).

A little context helps make the maths clearer. Donepezil, the biggest player in the lucrative market for Alzheimer’s disease treatments, was a blockbuster, with over $2bn in annual sales in the United States alone. But the drug, first approved in 1996, had reached the end of the road: the patent expired in November 2010. Investors call this “going over the cliff,” an anxious reference to plummeting sales as market share is lost to generic competitors. Necessity, however, is the mother of invention. Just four months before the expiry of the patent, the US Food and Drug Administration (FDA) approved a new dose for moderate to severe Alzheimer’s disease: donepezil 23 mg. Is 23 an odd number? Not really, when you consider that you cannot get to 23 mg using the 5 mg and 10 mg doses that were going generic. The “new” 23 mg product would be patent protected for three more years. (...)

Diverse artikler

Hvis patenter er våpen, så er dette verdens supermakter
dagensit.no 16.3.2012
Makt- og pengefordelingen innen mobil og it handler ikke bare om hvem som selger best.

Etter at Apple og Google gikk inn i mobilverdenen har det oppstått en rekke konflikter knyttet til patenter. Apple har vært svært aktive med å sende søksmål, særlig mot Samsung, men de andre produsentene har heller ikke ligget på latsiden. (...)

Brukte 12,5 milliarder på "ammunisjon"
Viktigheten av patenter vises ikke minst av at Google kjøpet selveste Motorola for 12,5 milliarder dollar, et kjøp som hovedsaklig skal ha vært motivert av Motorolas patenter. Som et gammel mobilselskap har Motorola svært mange patenter, og det tok ikke mange ukene før disse patentene ble overført til en av Googles partnere, og brukt mot Apple.

Les også: Saksøker Apple med "lånte" patenter (...)

EMA klar med retningslinjer for biologisk kopimedicin
dagenspharma.dk 24.1.2012
Det europæiske lægemiddelagentur EMA udsendte i fredags et udkast til en ny vejledning inden for biosimilære lægemidler, som er ’kopier’ af biologiske lægemidler, hvor patentet er udløbet, f.eks. insulin, EPO og væksthormon. EMA gør med detaljeringen af kravene for de biosimilære lægemidler klar til øget konkurrence på et marked, der forventes at eksplodere i de kommende år. I en ny prognose forudsiger farmaanalyse- og rådgivningsfirmaet IMS Health, at det globale marked vil vokse fra 310 mio. dollars i 2010 til 2-2,5 mia. dollars i 2015.

Et biosimilært lægemiddel er et lægemiddel, der svarer til et biologisk lægemiddel, som allerede er godkendt. Det aktive stof i et biosimilært lægemiddel svarer ligeledes til det aktive stof i det biologiske referencelægemiddel. (...)

EMA’s udkast er i høring frem til maj. Agenturet forventes at fremlægge sin endelige vejledning til biosimilære monoklonale antistoffer i marts eller april. Udkast til retningslinjer om godkendelsesprocessen for kopier af andre lægemidler vil følge i maj eller juni. Disse vil bl.a. indeholde lavmolekylært heparin, enoxaparin og moderne analoger af insulin.

Det har været muligt at få godkendt biosimilære lægemidler siden 2004, og de hidtidige retningslinjer har været gældende siden 2006. (...)

Should Patents on Pharmaceuticals Be Extended to Encourage Innovation?
online.wsj.com 23.1.2012
Pharmaceuticals have improved and extended the lives of millions of people. But the many advances over the past couple of decades haven't come without controversy, much of it centering on the massive profits the industry makes on blockbuster drugs.

The drug makers say those profits fund the research that produces breakthrough treatments. They warn that with patents expiring on several big-money drugs, their ability to develop new drugs will be severely hampered. Longer-lasting patents, they say, would protect the profits that they need to keep innovative products moving through the pipeline. (...)

• Yes: Innovation Demands It, says Josh Bloom.
• No: It's more of a bad thing, says Els Torreele.
• Read the complete Big Issues: Health Care report. (...)

A Whitewash? Trade Talks And Access To Meds
pharmalot.com 13.9.2011
Amid increasingly controversial trade talks, the Obama administration has released a white paper that emphasizes a commitment to providing access to needed medicines as part of its goals for the current TransPacific negotiations. But the five-page missive was met with derision by patient advocates who maintain the White House has become a stalking horse for the pharmaceutical industry. (...)

Microsoft og Google fortsætter mudderkastning
business.dk 6.8.2011
Det fyger frem og tilbage med beskyldninger i patent-slagsmålet mellem Microsoft og Google.

Som ComON kunne fortælle i går, er der udbrudt et åbent skænderi mellem de to giganter Microsoft og Google om patentkrav mod Android. Den slags diskussioner bliver normalt ført bag lukkede døre. Men de to selskabers jurister har helt usædvanligt valgt at fremføre deres argumenter mod hinanden på Twitter og i offentlige blogs.

Det er blevet til en omgang mudderkastning – og den fortsætter nu. Google anklager Microsoft for at samle patenter der kan bruges mod Android. Microsoft og Apple har betalt 23 mia. kroner for Nortels gamle patentsamling – disse patenter skal nu bruges til at opkræve licens fra producenter af Android-telefoner, mener Google. (...)

– Android utsatt for en fiendtlig kampanje
digi.no 4.8.2011
Google mener at Microsoft, Oracle og Apple samarbeider om å hemme konkurransen.

Ifølge de nyeste rapportene har Googles smartmobilplattform oppnådd en global markedsandel på nærmere 50 prosent i andre kvartal i år. Men nå frykter Google at dette ikke vil vare lenge.

Mengden av patentsøksmål mot selskapet, Android-fellesskapet og enkelte produktleverandører som benytter systemet, kan i verste fall føre til at kostnadene ved å benytte Android i produkter, som i utgangspunktet tilbys gratis, langt vil overstige kostnadene ved å utstyre produktene med for eksempel Windows Phone.

– En smartmobil kan involvere så mange som 250 000 i stor utstrekning tvilsomme patentkrav, og våre konkurrenter ønsker å påtvinge en «skatt» for disse tvilsomme patentene, noe som vil gjøre Android-enheter dyrere for forbrukere. De ønsker å gjøre det vanskeligere for fabrikanter å selge Android-enheter. I stedet for å konkurrere ved å lage ny funksjonalitet eller nye enheter, forsøker de å slåss gjennom rettstvister, skriver David Drummond, juridisk sjef i Google i et blogginnlegg. (...)

Microsoft svarer
Ifølge Bloomberg avviser Microsoft påstandene fra Google.

– Google sier at vi kjøpte Novell-patentene for å holde dem unna Google. Virkelig? Vi spurte dem om å by sammen med oss. De sa nei, skriver Brad Smith, juridisk direktør i Microsoft, i en Twitter-melding. (...)

Some doctors insist on brand-name drugs even when cheaper generics are available (- Noen leger insisterer på originallegemidler selv om generiske er tilgjengelige)
washingtonpost.com 11.7.2011
Three words to watch out for next time you get a new prescription: “Dispense as Written.” Scrawled across the prescription form in your doctor’s hand — or, more likely, ticked off on a check box — the words may seem innocuous enough. But they’re costing you.

In fact, a recent article in the American Journal of Medicine says they’re costing all of us $7.7 billion a year. Because what this note from your doctor to your pharmacist means is: “I won’t let you fill this prescription with a generic.” (...)

The great billion dollar drug scam: part two
daylife.com 3.7.2011
The pharmaceutical industry uses dirty tricks to maximise profits at any cost, hurting sick people and taxpayers.

This is the second of a two-part series examining the methods by which multinational drug corporations inflate their expenses and justify their pricing strategies. The first part revealed how, far from costing the reported (and widely accepted) $1bn to... Full Article at Al Jazeera (...)

Absurde bud fra Google på milliard-auktion
business.dk 2.7.2011
"De må have været overordentligt selvsikre, eller også har de kedet sig," lyder kommentaren til talgymnastik med milliarder af dollar på spil.

Beløbene var i sig selv næsten uvirkelige, da softwarevirksomheden Nortels patenter blev sat på auktion. Og kigger man nærmere på buddene fra Google, og det har Reuters gjort, viser der sig at ligge en højst mærkværdig logik bag tallene: Søgemaskine-giganten brugte både Pi, afstanden mellem Jorden og Solen og andre matematiske begreber, mens byderne smed om sig med bud i multimilliard-klassen.

Først bød Google 1.902.160.540 dollar - rundt regnet 10 milliarder kroner. Er man matematik-nørd genkender man måske tallet som Bruns konstant - en teori om primtal fremsat af den norske matematiker Viggo Brun i 1919. (...)

Generics seen slashing global drug sales growth
reuters.com 18.5.2011
(Reuters) - Global sales growth of prescription drugs could be cut in half over the next five years as lucrative brands lose patent protection and cheaper generics and emerging markets become the only significant growth drivers, according to IMS Health

"Past patterns of spending offer few clues about the level of expected growth through 2015," said Murray Aitken, an IMS Health executive whose division conducted the study.

"There are unprecedented dynamics at play, which are driving rapid shifts in the mix of spending by patients and payers between branded products and generics," said Aitken, whose company tracks prescription drug sales and trends.

Average annual sales are expected to grow 3 to 6 percent during the period, reaching nearly $1.1 trillion by 2015. But the trend reflects a slowdown from annual growth of 6.2 percent seen during the past five years, the report said.

U.S. sales will grow only 0 to 3 percent a year over the period, while sales in Europe will rise 1 to 4 percent. Spending on branded drugs is expected to be little changed in such developed markets in 2015, with growth coming instead from higher demand for cheaper generics. (...)

Google vil kjøpe seg et patentforsvar
digi.no 5.4.2011
Men beklager at milliardbudet på Nortels portefølje er nødvendig.

Etter hvert som Google utvider produktporteføljen til stadig nye områder, opplever selskapet i økende grad å bli utsatt for patentsøksmål. Ikke minst gjelder dette på mobilsiden. Google er kanskje mer utsatt enn en del av selskapets største konkurrenter. Selskapet er fortsatt relativt ungt og har i mindre grad enn konkurrentene rukket å bygge opp en stor patentportefølje.

I et blogginnlegg skriver Kent Walker, juridisk sjef i Google, at selskapet stadig kjemper for en patentreform som i større grad belønner de som skaper de nyttigste innovasjonene for samfunnet, i stedet for dem som kommer med falske krav i tvilsomme rettssaker.

– Teknologiverdenen har nylig sett en eksplosjon i patentrettstvister, som ofte involverer programvarepatenter av lav kvalitet, og som truer med å kvele innovasjonen, skriver Walker. (...)

Peering Into Pfizer’s Future
blogs.forbes.com 31.3.2011
In November, Pfizer, the world’s largest drug company, will face the biggest ever patent expiration of a drug, as the first generic copycats of its top seller Lipitor hit the market. This is just one in a wave of big patent expiries for the drug giant, which has already seen revenue from one-time top sellers like Norvasc and Zoloft disappear due to cheap, commodity-priced generics in the U.S.

This is what drug company analysts refer to as the “patent cliff” – because sales can literally fall off a cliff. Patent expirations of today’s blockbusters are what drove big mergers for Pfizer, Merck and, most recently, Sanofi-Aventis. They are also leading to industry-wide layoffs that have hit everyone from the aforementioned giants to Eli Lilly and GlaxoSmithKline. (...)

Trade talks on patent protection violate right to health, allege advocacy groups
BMJ 2011; 342:d1993 (29 March)
Eleven advocacy groups have filed a complaint with the United Nations’ independent expert on the right to health, alleging that a regional free trade accord being discussed in secret talks by nine countries violates human rights because it threatens to restrict access to cheap generic drugs.

The talks have “clearly ignored” right to health and access to drugs, the groups say, and “threaten to violate the right of hundreds of millions of persons to the enjoyment of the highest attainable standard of health.”

Last month aid agencies and patients’ groups from India and several Asian countries urged the Indian government to reject a free trade agreement it is negotiating with the European Union that they said may undermine India’s capacity to produce generic drugs (BMJ 2011;342:d1480, doi:10.1136/bmj.d1480). (...)

New European online clinical trials register is launched
BMJ 2011; 342:d1994 (29 March)
Health professionals and the wider public will soon have access to information on every clinical trial taking place in 30 European countries. The online system, which is being managed by the London based European Medicines Agency, was launched on 22 March.

The new EU clinical trials register already contains details of 3452 trials, of which 763 involve participants under 18 years of age. The European Commission expects it to eventually hold data on around 10 000 ongoing trials on the basis that each lasts two to three years and some 4000 trials are authorised each year. (...)

The EU clinical trials register is at https://www.clinicaltrialsregister.eu/. (...)

How Eli Lilly Will Face Patent Expirations
seekingalpha.com 14.3.2011
Eli Lilly (LLY) appears perilously perched on the precipice of a patent cliff. A plummet could result in revenue falling for at least the next two years, and loss of more than 75% of sales within the next 7 years. Worse yet, there’s no parachute of freshly approved drugs to replace this revenue. Lilly’s perch is perhaps the best example of the crisis faced by much of the pharmaceutical industry faces. However, it’s not the end of the world. Even acrophobic investors should take a closer look at patent expiration dates before abandoning hope of possible replacements for this revenue. (...)

The Patent Cliff: What Big Pharma Investors Need to Know
seekingalpha.com 11.3.2011
"For most of the postwar era, the pharmaceutical industry has been the most profitable sector of the U.S. economy by virtually any performance measure (return on equity, return on sales, etc.). This superior performance was based on four structural pillars: (1) latitude to charge relatively high prices, (2) long product life cycles, (3) 'blockbuster' drugs, and (4) relatively high R&D productivity."

The above quote from Prof. Gary Pisano’s book "Science Business" concisely sums up the sector and dives straight into the fundamental issues of the pharmaceutical business. (...)

Nytt förslag om EU-patent
lakemedelsvarlden.se 17.12.2010
Efter mer än tio års diskussion om att införa ett gemensamt patent för alla EU-länder har ingen lösning nåtts. Men nu väcks hoppet med ett nytt förslag. (...)

Om förslaget går igenom ska det bli möjligt för de länder som vill, kunna gå före i snabbare takt och att andra kan ansluta sig senare.

Nästa steg är att kommissionen under 2011 lägger fram ett mer detaljerat förslag och att detta sedan diskuteras och eventuellt godkännas av ministerrådet. (...)

Protests in Delhi as EU defends Big Pharma (Protester i Dehli idet EU forsvarer Big Pharma)
presseurop.eu 3.3.2011
“Thousands march in India against EU trade deal,” headlines the EUobserver. With the EU on the verge of concluding a Free Trade Agreement (FTA) with India, its largest trading partner, HIV-positive protesters took to the streets of New Delhi on 2 March concerned that the union is seeking to put an end to the production of affordable life-prolonging drugs. Since negotiations opened in 2007, the EU has pushed for a “data-exclusivity” clause which would protect intellectual property rights with respect to drugs. “European drug manufacturers complain that many of their patented products are frequently undercut by generics produced in India,” the Brussels website notes. Data exclusivity would mean that “clinical trial data filed by one company could not be relied upon by other companies,” critics argues. “As a result, the need for each firm to produce its own clinical trial tests would dramatically increase the price of medicines.” According to Anand Grover, the UN Special Rapporteur on the Right to Health, "It would be a colossal mistake to introduce data exclusivity in India, when millions of people across the globe depend on the country as the pharmacy of the developing world.” (...)

EU's pharma trade hoax (EUs svindel innen legemiddelhandel)
thehindubusinessline.com 25.2.2011
The proposed India-EU trade pact is riddled with intellectual property provisions that would harm India's 2005 Patent Act.

Last month, the global health community cheered when India's patent office ruled that Abbott Laboratories, a major US-based pharmaceutical firm, could not block Indian generic drug makers from producing low-cost versions of Aluvia, a critical AIDS drug. Now, however, the European Union and multinational firms are launching a back-door campaign — disguised as a “free trade” pact — to undo this momentous victory.

This EU deception must stop. India's Aluvia ruling is likely to dramatically reduce the cost of treating HIV throughout the world. Currently, 33 million patients worldwide are living with HIV/AIDS, and only 5 million receive treatment. Aluvia is a critical, second-line anti-retroviral (ARV) drug, which attacks new HIV-virus mutations that have grown resistant to earlier ARV drugs. Prior to India's ruling, Abbott priced Aluvia at roughly $1,000-$3,800 per patient per year in many developing countries. (...)

Patents Ending, Eli Lilly Chases New Drugs
nytimes.com 30.9.2010
INDIANAPOLIS — John C. Lechleiter walks a mile to work every morning to think about the day ahead. He walks home in the evening, he says, “to try to forget about it.”

These are challenging times for Eli Lilly, the company he leads. It is losing patent protection in the next seven years on drugs that accounted for 74 percent of its sales in 2009, a decline considered to be the worst patent cliff facing major companies in the industry. (...)

Patentdatabase åpnet for alle
vg.no 9.9.2010
Har du funnet opp noe nytt? Nå kan du sjekke på nett om noen allerede har tatt patent på oppfinnelsen. Du kan også sjekke hva et firma som Apple har søkt patent på.

Patentstyret administrerer patenter, varemerker og kopibeskyttet design her til lands.

Nå åpner de databasene for folk flest, med en ny søketjeneste på nettet. (...)

Hva legemiddelindustrien faktisk gjør
Tidsskr Nor Lægeforen 2007; 127:1806 (28.6.2010)
Legemiddelselskapet Novartis har nylig gått til søksmål mot den indiske stat. Selskapet aksepterer ikke avslaget de fikk på en patentsøknad. Dersom selskapet vinner saken ved at indisk patentlovgivning kjennes ugyldig, vil apoteket for de fattige, som India ofte kalles, tørke inn. (...)

Vil ha patent på egg og bacon
handelsbladet.no 30.4.2010
Frøselskapet Monsanto prøver å få patent på egg og bacon i Europa. Utviklingsfondet frykter økte priser og dårligere utvalg.

Monsanto, som er et av verdens største jordbruksselskaper, gjør i en patentsøknad til Det europeiske patentkontoret (EPO) krav på kjøttprodukt som bacon, skinke og ribbe fra griser som er fôret med selskapets genmodifiserte planter, skriver ANB.

Hvis søknaden går gjennom blir dette også norsk lov, ifølge Utviklingsfondet, som krever stopp i patentering av matkjeden.

– Monsanto og andre multinasjonale selskaper bruker patentsystemet til å få stadig sterkere kontroll over hele matkjeden, sier programkoordinator Bell Batta Torheim i Utviklingsfondet.

– Multinasjonale selskapers økte kontroll over matkjeden går ut over forbrukere, bønder og planteforedlere. Monsanto påstår i realiteten at de har funnet opp bacon og ribbe. Dette er et uakseptabelt forsøk på å utnytte patentlovgivingen til å få kommersiell enerett på fellesskapets goder, sier Batta Torheim til ANB. (...)

Gene Patenting — Is the Pendulum Swinging Back?
NEJM 2010 (Published at www.nejm.org April 7)
Are human genes and the process of comparing DNA sequences patentable? These questions were raised by a group of researchers, pathologists, patients with cancer, and medical professional organizations challenging some of Myriad Genetics' patents covering the BRCA1 and BRCA2 genes and their use in screening for elevated risks of breast and ovarian cancer. On March 29, in a startling decision, a federal district court judge invalidated many of Myriad's patent claims,¹ reigniting a long-simmering debate about the patentability of genes. (...)

How Gene Patents Harm Innovation (Hvordan patenter skader innovasjon)
forbes.com 1.4.2010
A New York judge's opinion to toss out the patents on two breast cancer genes paves the way for high-tech gene sequencing to begin having a real impact on medicine.

The ruling by federal judge Robert Sweet earlier this week invalidated long-standing patents on two breast cancer genes held by Myriad Genetics. (MYGN - news - people). His basic argument is one that many researchers have been making for years: You can’t patent genes because genes are natural. But thousands of patents on human genes have been granted anyway. (...)

Avviser patent på gener
aftenposten.no 31.3.2010
For første gang har en domstol i USA erklært at patenter på gener er i strid med grunnloven. Men i Norge er det fortsatt lov. (...)

– Ingen oppfant gener. Oppfinnelser er spesifikke tester eller medikamenter, som det kan tas patent på. Men gener er ikke oppfinnelser, sier Daniel B. Ravicher, direktør for organisasjonen PUBPAT, som også deltok i søksmålet og arbeider for å begrense det den ser som misbruk av patentsystemet. (...)

Antibiotics don't cure colds, so why do patients think they do? (Antibiotika kurerer ikke forkjølelse, så hvorfor tror pasienter at de gjør det?)
guardian.co.uk 20.3.2010
Leger som nører opp under pasientpress skaper etterspørsel (Doctors who cave into patient pressure create demand)

Sist måned forslo regjeringen å tillate farmasøyter å erstatte forskrivninger av originallegemidler med generiske alternativer. Et protestbrev ble publisert i The Times, signert av en rekke pasientgrupper og eksperter, med positiv dekning i flyveblader. The Times rapporterte at "eksperter sier at plan om å bytte til billigere legemidler vil skade pasienter". De viste til og med til en case studie: "Pasienter som fikk Seroxat-kopier i stedet for originalen følte seg uvel innen to dager." (Last month the government proposed allowing pharmacists to substitute prescriptions for branded medicines with generic alternatives. A letter of protest appeared in the Times, signed by various patient groups and experts, with positive coverage in the broadsheets. "Plan to switch to cheaper medicines will harm patients, say experts," reported the Times. They even had a case study: "Patient given Seroxat substitute felt unwell within two days.")

Men lege Margaret McCartney, som har gjort en gravejobb, skriver i British Medical Journal: i virkeligheten er brevet koordinert og skrevet av PR-firmaet Burson-Marsteller, betalt av legemiddelfirmaet Norgine. Til tross for at det var Norgines virksomhetsleder Peter Martin, som hadde størst innflytelse på kampanjen, signerte han ikke brevet selv. På spørsmål om hvorfor, svarte han: "Der var ingen konspirasjon. Den oppriktige sannhet, den redelige sannhet, er at jeg tenkte at det å blande inn et legemiddelfirma på en måte ville gjøre budskapet litt mindre troverdig. (...) (But Margaret McCartney GP, writing in the British Medical Journal, has been digging: in fact the letter was coordinated and written by the PR company Burson-Marsteller, paid by the drug company Norgine. Norgine's chief operating officer, Peter Martin, , despite being the major influence behind the campaign, did not sign the letter himself. Asked why not, he said: "There was no conspiracy. The frank truth, the honest truth, is that I thought that having a pharmaceutical company in there would sully the message somewhat.")

(Anm: Generic drugs: protest group was not quite what it seemed. BMJ 2010;340:c1514 (17 March).)

Time for drug giants to jump into the patent pool?
guardian.co.uk 12.3.2010
While drugmaking giant GlaxoSmithKline has picked up a load of good press for CEO Andrew Witty's developing world initiatives - from ploughing back some of the (tiny) profits made in Africa to the more interesting patent pool it announced for neglected tropical diseases - it is Californian rival Gilead that gets a higher approval rating at the moment from Aids campaigners. (...)

EC will keep pressure on pharma sector, say lawyers
pharmatimes.com 27.1.2010
Drugmakers need to review their patent settlement agreements as a form of due diligence as the European Commission maintains its scrutiny of the pharmaceuticals sector, according to a leading law firm. (...)

Biotech's Latest Failed Trials, Mishaps and Missed Targets
seekingalpha.com 18.1.2010
The European Commission has contacted Pfizer (PFE) as part of its antitrust investigation into patent settlements between pharmaceutical firms and generic drugmakers, according to various press accounts. Pfizer acknowledged it was among the companies involved in the probe and said it was cooperating and confident it complied with applicable laws. AstraZeneca (AZN), GlaxoSmithKline (GSK), Sanofi-aventis (SNY), Novartis (NVS), Roche (RHHBY.PK), and Boehringer Ingelheim have also said they have been contacted by the Commission about drug patent settlements. The investigation is part of an effort by the EU to fight anticompetitive actions by drugmakers that it says cost healthcare providers $4.4 billion between 2007 and 2008, according to Reuters. (...)

European Commission targets drug firms over illegal patent protection (EU-kommisjonen ser nærmere på legemiddelfirmaers ulovlige beskyttelse av patenter)
BMJ 2010;340:c268 (15 January)
The European Commission is stepping up pressure on drug companies it suspects of using illegal sweetener deals to protect their patents and prevent cheaper generic drugs from entering the market.

Just three weeks before she is due to stand down as European Union Competition Commissioner, Neelie Kroes has asked several European companies to supply her staff with copies of their patent settlement agreements.

The commission did not divulge the identities of the companies it had targeted. But several confirmed they had been contacted and asked to provide documentation, including annexes, of all agreements with generic drug producers concluded between 1 July 2008 and 31 December 2009. These included AstraZeneca plc, GlaxoSmithKline, Sanofi-Aventis, Novartis, and Roche. (...)

Genombrott för EU-patent
lakemedelsvarlden.se 9.12.2009
EU:s ministerråd anser sig nu vara på god väg att få ett gemensamt EU-patent och gemensam patentdomstol. Om planerna går i lås blir det billigare för företagen och tvister blir behandlade på samma sätt i hela Europa, menar kommissionen. (...)

Schweizer tredobler erstatningskrav mod Lundbeck
business.dk 13.11.2009
Det danske medicinalselskab Lundbeck og dets amerikanske partner Forest Laboratories kan se frem til et forhøjet erstatningskrav fra det schweiziske selskab Infosint.

Schweizerne har tidligere af en jury under retskreds i New York delvis fået ret i sin påstand om, at Lundbeck skulle have forbrudt sig imod et af Infosints patenter i forbindelse med en fremstillingsproces i forhold til antidepressivet Lexapro.

Ved den lejlighed besluttede en jury, at Lundbeck som kompensation skal betale 15 mio. dollar til Infosint. Nu forhøjer Infosint kravet mod Lundbeck til 43 mio. dollar. (...)

(Anm: Cipralex (Lexapro) (escitalopram) - Cipramil (Celexa) (citalopram)- H. Lundbeck A/S (mintankesmie.no).)

Gir forskning og innovasjon økonomisk vekst?
forskningsradet.no 24.9.2009
Tre forskningsprosjekter legger grunnlaget for norsk forsknings- og innovasjonspolitikk ved å se på sammenhengen mellom økonomisk vekst, forskning og innovasjon. Nå foreligger foreløpige resultater. (...)

Patentsystemer som flaskehals for innovasjon
- Såkalte blokkerende patenter kan bremse utvikling og kommersialisering av teknologi, sa Christian Riis ved Handelshøgskolen BI i sin presentasjon. - Patenter sikrer aktører rettigheter til teknologi og ofte må man kjøpe rettighetene eller vente til perioden som rettighetene er bundet opp er over før man kan utvikle teknologien videre. (...)

Generics versus Brands: Are They Really Equivalent?
medpagetoday.com 25.8.2009
(...) "There will always be a slight, but not medically important, level of natural variability" in drug absorption, according to a review of concerns about generic drugs posted on the FDA's Web site. (See Facts and Myths about Generic Drugs)

"Much of the criticism we get really centers around anecdotes from patients," said Buehler in an interview. (...)

EU vil stoppe medicinalvirksomheders krumspring
epn.dk 18.8.2009
Årelange retssager, bagvaskelse af kopiproducenter og op til 1.300 patentansøgninger i flere europæiske lande på ét medicinsk præparat.

Kreativiteten er stor, når medicinalvirksomheder kæmper for holde kopiproducenterne ude af markedet. (...)

Our view on generic medications: Drugmakers seek excessive monopolies on ‘biologics’
blogs.usatoday.com 13.8.2009
Twelve years of exclusivity is too many for pricey pharmaceuticals. (...)

Samfundet taber milliarder på patent-krumspring
business.dk 10.8.2009
Når patentet på et bestemt præparat udløber, forsøger medicinalvirksomhederne ved hjælp af forskellige manøvrer at holde de billige kopiprodukter væk fra markedet så længe som muligt.

'Patent-krumspring'. Det lyder som en joke, men det er ikke desto mindre et begreb, som er vidt udbredt i medicinalindustrien. Når patentet på et bestemt præparat udløber, forsøger medicinalvirksomhederne ved hjælp af forskellige manøvrer at holde de billige kopiprodukter væk fra markedet så længe som muligt.

Og disse krumspring koster hvert år forbrugerne og samfundet dyrt, fortæller Jens P. Kampmann, der er institutleder på Institut for Farmakoterapi, der hører under Sundhedsministeriet:

»Det er helt klassisk for medicinalindustrien at finde måder at forlænge patenter på. Dermed bliver medicinen dyrere for både patienten og samfundet,« siger han til Dagbladet Information. (...)

THE INFLUENCE GAME: Biotech drug lobbying war (Påvirkningsspillet: Lobbykrigen om biologiske legemidler)
forbes.com 3.8.2009 (Associated Press)
WASHINGTON -- With the nation's $46 billion biological drug market at stake, the war between makers of the pricey biotech medicines and their would-be generic competitors has involved millions of dollars in lobbying, thousands in campaign contributions and uncounted visits to members of Congress. And one noteworthy letter.

The note from the private National Health Council, sent to House leaders drafting health overhaul legislation, said the plea was on behalf of "the more than 133 million Americans living with chronic diseases and disabilities and their family caregivers." It urged lawmakers to protect the makers of high-technology biological medicines against early competition from lower-cost generic copycats. (...)

(Anm: Lobbyisme (lobbying – lobbyregister - interessekonflikter - korrupsjon) (mintankesmie.no).)

Big pharma likely to push authorised generics more
pharmatimes.com 29.7.2009
Given the pressure being put upon pay-for-delay agreements, the number of authorised generics hitting the market is set to increase, claims a new study.

The analysis, from Datamonitor, says that the number of authorised generics agreements will grow, “in tandem with the increasing convergence” between branded and copycat companies. It adds that the growing trend for big pharma – notably GlaxoSmithKline, Sanofi-Aventis and Pfizer – to bolster their non-branded presence also means that “the strategy of fielding own-generics will gain traction”. (...)

Lobbyists battle over drug sales (Lobbyister kjemper om legemiddelsalg)
usatoday.com 28.7.2009
WASHINGTON — As Congress struggles with a massive health care overhaul, several lobbying powerhouses — including the pharmaceutical industry and the nation's largest advocacy group for retirees — are locked in a contentious fight over the future of biotechnology drugs.

Both sides have spent heavily to sway lawmakers in the debate over how long to keep the expensive drugs exempt from generic competition. President Obama is pushing for seven years of exclusivity as he looks to trim costs to help pay for his health care plan — five years less than what the industry wants. (...)

Industry donates to drug plan foes (Industrien donerer til fiender av legemiddelplan)
usatoday.com 28.7.2009
WASHINGTON — Lawmakers who count pharmaceutical companies among their biggest contributors lead the opposition to a health care proposal that would cut costs by allowing generic drugs to compete sooner with pricey biotechnology drugs, campaign-finance records show.

Sen. Orrin Hatch, R-Utah, has helped lead Senate efforts to give drug companies 12 years of exclusive rights to sell biotech drugs, rather than seven as proposed by President Obama. Hatch has received nearly $1.3 million from the employees and political action committees of drug and health products companies since 1989, making the industry his largest contributor, according to data compiled by the non-partisan Center for Responsive Politics.

HEALTH CARE OVERHAUL: Lobbyists battle over drug sales (Lobbyister kjemper om legemiddelsalg)

In the House, Rep. Anna Eshoo, D-Calif., whose district is home to dozens of biotech companies, is sponsoring a similar measure. Drug company employees and political action committees have donated $645,000 since 1992 to Eshoo — second only to the computer and Internet industry.

This year, she is the biggest recipient of pharmaceutical money in the House, the data show. (...)

Lobbyists battle over drug sales (Lobbyister kjemper om legemiddelsalg)
usatoday.com 28.7.2009
WASHINGTON — As Congress struggles with a massive health care overhaul, several lobbying powerhouses — including the pharmaceutical industry and the nation's largest advocacy group for retirees — are locked in a contentious fight over the future of biotechnology drugs.
Both sides have spent heavily to sway lawmakers in the debate over how long to keep the expensive drugs exempt from generic competition. President Obama is pushing for seven years of exclusivity as he looks to trim costs to help pay for his health care plan — five years less than what the industry wants.

PHARMACEUTICALS: Industry donates to drug plan foes (Industrien donerer til fiender av legemiddelplan)

"If you extend that 12 years, obviously it's better for (drugmakers') bottom line," Obama said Friday. "But it also means you're keeping important drugs off the market and driving up those costs further."

The pharmaceutical industry counters that a longer period of exclusivity is needed to recover its investments in "biologic drugs," which are made from living organisms and used to treat cancer, multiple sclerosis and other serious diseases. (...)

Novo Nordisk hives i retten i Australien
business.dk 20.7.2009
Novo Nordisk bliver beskyldt for at overtræde et patent på human væksthormonformulering og hives nu i retten i Australien. (...)

Dangerous Side Effects
washingtonpost.com 16.7.2009
A law meant to spur prescription drug competition has instead delayed it. Congress could change that.

EVERY YEAR, American consumers pay an estimated $3.5 billion too much for health care because of a loophole in a law regarding the marketing of prescription drugs. (...)

EU kræver fair play i medicinalindustrien
business.dk 8.7.2009
Det skal være slut med patentfifleri og endeløse retssager for at holde billig kopimedicin ude af markedet. Det fastslår EU-kommissionen i sin endelige redegørelse om konkurrencesituationen i medicinalindustrien.

Konkurrencen halter kraftigt på det europæiske lægemiddelmarked, og den er især gal, når det gælder hurtig introduktion af billig kopimedicin. Det konstaterer EU-kommissionen i en konkurrenceredegørelse, som blev offentliggjort onsdag. (...)

EU “will act” against drugmakers over generic delays (EU "vil handle" mot legemiddelfirmaer som forsinker generiske legemidler)
pharmatimes.com 9.7.2009
The European Commission says it will not hesitate to act against “anticompetitive practices” by drugmakers which delay the market entry of generics, but has also called on member states to do more to boost generic uptake.

The entry of generics onto the European market is being delayed and there is also a decline in the number of novel medicines coming to market, the Commission concludes, in its final report on competition in the drug sector. EU officials are already investigating possible anticompetitive activities by drugmakers, but “regulatory adjustments” are also expected, said Competition Commissioner Neelie Kroes, announcing the investigation’s findings yesterday. (...)

EU pharma competition report “creates uncertainty,” say experts
pharmatimes.com 9.7.2009
Legal experts have criticised the final report of the European Commission’s inquiry into pharma sector competition for failing to tell drugmakers whether the strategies they use to protect their patents are lawful or not.

The suggestion that the Commission will now increase scrutiny of the sector is likely to have “a chilling effect and could lead to real uncertainty over normal commercial practices the industry considers legitimate,” says Nicola Holmes, senior associate at international law firm Eversheds. (...)

EU actively pursuing some drugmakers, official says (EU vil aktivt forfølge enkelte legemiddelfirmaer, ifølge ledere)
reuters.com 7.7.2009
BRUSSELS, July 7 (Reuters) - EU regulators are probing some drug firms over suspected anti-competitive practices that include deals with makers of cheap generics to delay medicines' market entry, a European Commission official said on Tuesday.

European Union Competition Commissioner Neelie Kroes will say in a report on the pharmaceutical industry on Wednesday that "we are actively pursuing a number of individual cases", the official, who has seen the 600-page document, said.

"The report will say that there are no final conclusions at this stage to those cases being pursued," the official said, adding that the document did not identify any companies. (...)

In its preliminary report last November, the EU's executive arm estimated that delays in getting generics on the market had cost healthcare providers 3 billion euros ($4.2 billion), based on a sample of medicines that lost patent protection in 17 EU states between 2000 and 2007.

The European Commission's final report will pave the way for increased regulatory scrutiny of settlement agreements in which brand-name companies pay generics makers for not competing with them or set restrictions on competition, the official said. (...)

Kroes kicked off her investigation in January 2008 with a series of raids on makers of brand-name drugs, including AstraZeneca (AZN.L), GlaxoSmithKline (GSK.L), Pfizer (PFE.N), Merck (MRK.N) and Sanofi-Aventis (SASY.PA). (...)

Sector Snap: Pharma stocks flat in wake of probe
forbes.com 7.7.2009 (Associated Press)NEW YORK -- Shares of major drug makers were mostly flat Wednesday after European regulators announced they plan to step up investigations of whether the companies are delaying the launch of cheaper generic drugs.

The European Union said it plans to monitor settlement deals between major and generic pharmaceutical companies, including some that include payments to delay drug launches. It launched its investigation in January 2008. (...)

Generikaavtal kostar samhället miljarder
lakemedelsvarlden.se 2.4.2009
Avtal mellan olika läkemedelsföretag som försenar introduktionen av generiska läkemedel kostar de amerikanska konsumenter 12 miljarder dollar årligen. I amerikanska kongressen pågår nu ett arbete för att förbjuda avtalen.

När ett patent håller på att gå ut sluter originalföretagen avtal med generikaföretagen som gör att läkemedlet inte blir konkurrensutsatt förrän långt senare. Mellan åren 1993 och 2008 lyckades läkemedelsindustrin på det sättet skydda 20 olika läkemedel från billiga alternativ, vilket har kostat de amerikanska konsumenterna 12 miljarder per år. Det framkommer i en hearing i den amerikanska kongressen, skriver tidningen Pharmatimes. För att motverka liknande avtal arbetar flera amerikanska politiker nu med att få fram en ny lag.

I Europa arbetar EU-kommissionen också med att motverka liknande avtal. Enligt en delrapport från kommissionen som kom i höstas har företagens förseningsstrategier kostat de europeiska konsumenterna 30 miljarder kronor. (...)

Former Bristol exec pleads guilty in patent case
forbes.com 6.4.2009 (Associated Press)
The federal government said Monday a former executive for Bristol-Myers Squibb Co. has pleaded guilty to his role in a deal in which the drugmaker intended to pay a rival to keep a generic version of the anti-clotting drug Plavix off the market.

The Justice Department said Andrew Bodnar pleaded guilty to lying to the Federal Trade Commission about his discussions with Apotex, which made the generic. According to the agreement, Bodnar promised a rival, Apotex Inc., that Bristol-Myers would not launch its own generic version of Plavix if Apotex agreed to accept a $40 million payment in return for delaying its generic until 2011. (...)

Experts Disagree on How Long Biologic Drugs Should Have Market Exclusivity
kaisernetwork.org 19.3.2009
Settling the "debate over how long biotechnology drugmakers should retain exclusive rights to their patents" if done right "will save patients' lives and cut costs; if done incorrectly, however, it could cripple investment in products that cost billions to develop," Roll Call reports. (...)

EU Patent Court drug rulings “must consider public interest”
pharmatimes.com 18.3.2009
The European Union Patent Court proposed by the European Commission must, crucially, take “due care of the public interest” in its considerations regarding pharmaceutical patents, say generic drugmakers.

Greg Perry, director-general of the European Generics Medicine Association (EGA), welcomed the proposal for a central EU Patent Court, put forward by the Commission’s DG Internal Market, as a “very positive initiative.” However, the Court should also take account of the interest of “other affected parties such as the public or the administration, not party in the litigation…when deciding on provisional measures,” he told the EGA’s legal affairs forum on March 13. (...)

Medicinalindustrien fifler med patenter
business.dk 13.3.2009
Den forskende del af medicinalindustrien forsøger i stigende grad at forlænge levetiden for de mest populære lægemidler ved hjælp af patentfifleri og andre krumspring, viser en EU-rapport.

Den forskende del af medicinalindustrien er presset af mangel på nye storsælgende lægemidler og af myndighedernes voksende ønske om at fremme brugen af billig kopimedicin.

Derfor forsøger medicinalvirksomheder i stigende grad at holde deres lægemidler kunstigt i live ved hjælp af patentsystemet og med andre krumspring, når det løber af patent.

Det viser en foreløbig rapport om konkurrencevilkårene for udvikling af nye lægemidler. Rapporten, som er meget kritisk over for industriens forretningsmetoder, uden dog at kunne påvise direkte ulovligheder, har netop har været i høring hos såvel myndigheder som lægemiddelindustri i Europa.

Ifølge rapporten bruger den forskende del af lægemiddelindustrien, originalproducenterne, bevidst patentsystemet til at lægge hindringer ud for såvel andre originalproducenter som kopiproducenter.

Resultatet er, at kopimedicin introduceres langsommere på markedet end forventet. (...)

Generic Biologics Face 'Long, Tough Road to Realization,' Wall Street Journal Reports
kaisernetwork.org 4.3.2009
The development of new generic versions of expensive biologic drugs "faces a long, tough road to realization" because the complex generics "will likely face tough regulatory scrutiny, as well as high development and marketing costs," the Wall Street Journal reports. According to the Journal, President Obama's legislative agenda is expected to include a proposal to allow generic versions of biologic drugs, also known as "biosimilars." (...)

GSK promises to cap price of its drugs in poorest countries
BMJ 2009;338:b686 (18 February)
GlaxoSmithKline, the United Kingdom based pharmaceutical group, has unveiled a series of policies to boost access to its drugs in poorer and richer countries alike (www.gsk.com/media/Witty-Harvard-Speech-Summary.pdf).

In a speech at Harvard Medical School last week, Andrew Witty laid out his approach for the first time since taking over as the company’s chief executive last spring, saying: "Society expects us to do more . . . To be frank, I agree. We have the capacity to do more and we can do more." (...)

Billigere medicin er politik
business.dk 17.2.2009
Den britiske medicinalkoncern Glaxo Smith Kline har vakt opsigt med et løfte om at skære medicinpriserne ned med 75 pct. i de fattigste lande i verden. Men det er mere end en politisk udmelding end en reel hjælp til de fattigste, lyder kritikken. (...)

»Der er positive signaler i udmeldingerne fra Glaxo Smith Kline, men langt hen ad vejen er der tale om politik. Skal adgangen til medicin i de fattige lande virkelig udvides, må medicinalindustrien tage et meget større skridt,« siger Michelle Childs, leder for Læger Uden Grænsers internationale kampagne for øget adgang til medicin, til Berlingske Business.

Samme holdning har Mikkel Wakefield, der er salgsdirektør i danske MissionPharma, som specialiserer sig i at sælge kopimedicin til de fattigste lande.

»Det lyder flot, men er ren politik. For dem handler det om deres offentlige image. De store medicinalkoncerner er ikke særlig velsete i de fattige lande på grund af patenter og høje priser,« siger Mikkel Wakefield. (...)

Billig fornøjelse
Prisnedsættelserne og investeringerne i infrastruktur kommer da heller ikke til at koste Glaxo Smith Kline de store beløb. Det erkender Andrew Witty selv ifølge Wall Street Journal. I dag omsætter Glaxo Smith Kline for i cirka 250 millioner kr. i de 50 fattigste lande i verden. 20 pct. af overskuddet på salget i disse lande vil udgøre et sted mellem otte og 16 millioner kr. (...)

The Value Of New Drugs Is Dropping
forbes.com 8.1.2009
Yes, the FDA approved more medicines in 2008 than the year before. But in terms of sales, a new drug ain't what it used to be. (...)

New drugs approved in the first half of 2008 generated less than $40 million, one of the lowest numbers for any six-month period going back to the beginning of 1998. The average new drug generated only a few million in the first six months of 2008, a tenth as much as in a banner period like the first half of 1999. New medicines contributed much less than 0.5% to the growth of the global market, another way in which the first half of 2008 constituted six of the weakest months in a decade. (...)

EU accuses pharma companies of adopting anti-competitive practices (EU anklager legemiddelfirmaer for innføring av antikonkurransepraksis)
pharmaceutical-business-review.com 2.12.2008
The European Union has blamed the drug makers for their role in the escalating healthcare costs. It has accused the pharma companies of indulging in anti-competitive practices that blocked the sales of low-cost generic medicines, reported The New York times. (...)

Legal tactics to delay launch of generic drugs cost Europe €3bn, report says (Rettslig taktikk for å forsinke generiske legemidler koster Europe 3 milliarder euro, ifølge rapport)
BMJ 2008;337:a2817 (1 December 2008)
Drug companies are bracing themselves for the launch of a series of antitrust investigations in Europe after the European Commission published a highly critical report on industry practices.

The 426 page preliminary report by the commission’s Competition Directorate, which is to be followed by a final version next spring, highlights widespread legal tactics by drug companies to defend their patents. The commission says that such tactics have delayed the entry of cheaper generic drugs, at a cost of 3bn (£2.5bn; $3.8bn) since the start of the decade. (...)

Pharmaceutical Sector Inquiry: Preliminary Report is at http://ec.europa.eu/comm/competition/sectors/pharmaceuticals/inquiry/preliminary_report.pdf. (...)

Drugmakers abuse patents to block generics, says EU, EFPIA objects (Legemiddelprodusenter misbruker patenter til å blokkere generika, ifølge EU, EFPIA tilbakeviser)
pharmatimes.com 28.11.2008
Tactics used by pharmaceutical manufacturers to delay or block the entry onto the market of cheaper generics mean that European Union member states spent around 3 billion euros more during 2000-2007 than they would have if the generics had been available without delay, according to the preliminary findings of an investigation by the European Commission.

On average, it takes about seven months for generics to reach the market, and four months for even the top-selling products to arrive, according to the report, which was presented this morning by Competition Commissioner Neelie Kroes. (...)

(Anm: EU-kommisjonen (Den europeiske unions høyeste organ) (mintankesmie.no).)

(Anm: Generiske legemidler (generika) (mintankesmie.no).)

EU-kommissionen till attack mot läkemedelsföretag
lakemedelsvarlden.se 28.11.2008
Originalföretagens strategier för att försena försäljningen av generika har kostat konsumenterna i Europa runt 30 miljarder kronor. Det hävdas i en rapport från EU idag.

Anklagelserna bygger på bevis som EU-kommissionen samlade in under oannonserade inspektioner under januari månad. Då fick Astrazeneca, Glaxosmitkline och åtminstone sju bolag till oväntade besök från kommissionens kontrollanter. (...)

”Jag förmodar att vi alla haft diskussioner om hur vi ska kunna hindra generikaföretagen”, är ett citat från dokumentation som kommissionens kontrollanter fann vid sin raid. ”Vänta inte för länge med att patentera nya salter, generikaföretagen startar allt tidigare” ett annat citat. (...)

Pharmaceuticals
Sector Inquiry
ec.europa.eu 28.11.2008
"Individuals and governments want a strong pharmaceuticals sector that delivers better products and value for money. But if innovative products are not being produced, and cheaper generic alternatives to existing products are being delayed, then we need to find out why and, if necessary, take action."

Neelie Kroes, European Commissioner for competition

Public presentation of preliminary findings on 28 November 2008
The Commission is presenting the preliminary findings at a conference on 28th November 2008 in Brussels. (...)

(Anm: Preliminary Report (28 November 2008) Executive Summary en - Preliminary Report.)

Krass kritikk av legemiddelbransjen
dn.no 28.11.2008
EU-kommisjonen anklager legemiddelbransjen for bevisst å blokkere billige medisiner.

Dermed bidrar bransjen til unødvendig høye priser for forbrukerne i Europa, mener EU . (...)

– Betaler konkurrenter
Blant papirene som Kommisjonen fikk se, fant man blant annet bevis for at de store selskapene i enkelte tilfeller har betalt kopiselskapene for ikke å lansere billige kopipreparater. Over 200 millioner euro, om lag 1,8 milliarder kroner, skal ha blitt brukt på slike avtaler.

I et annet tilfelle hadde et storselskap lagt inn ikke mindre enn 1.300 patentsøknader for ett enkelt preparat, for å hindre kopier å komme på markedet. (...)

Drugmaker Delay on Generics Cost EU 3 Billion, EU Says (Update2) (Legemiddelprodusenters forsinkelse av generika koster EU 3 milliarder, ifølge EU)
bloomberg.com 28.11.2008
Nov. 28 (Bloomberg) -- European Union regulators accused drugmakers of costing consumers in 17 countries as much as 3 billion euros ($3.9 billion) by using patent lawsuits and other tactics to keep cheaper generic medicines off the market.

The claim, part of an interim report by the European Commission today, was based on evidence collected during January raids at GlaxoSmithKline Plc, AstraZeneca Plc and at least seven other competitors. EU Competition Commissioner Neelie Kroes in Brussels said she “would not hesitate” to open antitrust cases when there’s evidence of restrictive business practices. (...)

Europe Accuses Drug Makers of Padding Health Care Costs
nytimes.com 28.11.2008
BRUSSELS — The European Union accused drug companies on Friday of adding billions of dollars to health care costs by delaying or blocking the sale of less expensive generic medicines. (...)

EU says drug makers blocked cheaper medicines
forbes.com 28.11.2008
European patients had to pay some euro3 billion ($3.87 billion) more for medicines in 2000-2007 because pharmaceutical companies deliberately stalled the sale of cheaper generic versions, EU antitrust regulators said Friday.

An investigation of major pharmaceutical companies - including Pfizer Inc., GlaxoSmithKline and Sanofi-Aventis - showed they had blocked or delayed generic drugs from entering the market to prevent losing revenue on their more profitable drugs, the European Commission said. (...)

European Regulators Widen Inquiry Into Drug Makers
nytimes.com 26.11.2008
BRUSSELS — European Union regulators led a second round of raids on pharmaceutical companies this week, just days before the release of the findings of an earlier antitrust investigation.

The competition commissioner, Neelie Kroes, began the initial investigation in January with a series of raids on major drug companies, including GlaxoSmithKline, Pfizer and Sanofi-Aventis, searching for evidence that they were slowing the release of generic drugs and new medicines. (...)

Analyst expects aggressive M&A in big pharma
forbes.com 26.11.2008
Large mergers and buyouts may be on the way in the pharmaceutical sector, a Deutsche Bank analyst said, because drug makers can't keep up their current level of spending in the face of expiring patents and conservative regulators.

In a note late Tuesday, analyst Barbara Ryan envisioned scenarios where Pfizer Inc. might buy Amgen Inc., Bristol-Myers Squibb Co. or Wyeth, and either Pfizer or Merck & Co. could buy Gilead Sciences Inc. She said big pharma's hand may be forced by the upcoming industry "patent cliff," a period between 2010 and 2013 when the patent protection on many top-selling drugs will expire, and lower-cost generic drugs may reach the market. (...)

EU report slams drug industry practices –source
reuters.com 25.11.2008
BRUSSELS/LONDON, Nov 25 (Reuters) - A European report on competition in the pharmaceuticals sector will criticise drug companies for the way they prolong drug patents and conduct litigation, an EU source familiar with the investigation said on Tuesday.

Competition Commissioner Neelie Kroes is to publish interim findings of her department's broad probe of the sector on Friday.

So-called "strategic patenting", whereby drugmakers use minor product changes to win extra patent life for their medicines, plus the process of litigation used to block cheap generic rivals, will both come under fire. (...)

Styrtrik etter patent-tyveri
aftenposten.no 18.10.2008
Stjal patent – må betale 192 millioner dollar. (...)

Expert Says Eshoo-Barton Bill Stifles Drug Innovation
marketwatch.com 17.9.2008
Boston University Economist Finds Excessive Market Protection Threatens Development of New Biologics

WASHINGTON, Sep 17, 2008 (BUSINESS WIRE) -- Pending legislative proposals in Congress to create a follow-on biologics (FOBs) pathway risk overextending monopoly protection and undermining innovation, according to a comprehensive analysis released today by Boston University Economics Professor Laurence J. Kotlikoff and commissioned by Teva Pharmaceuticals USA. (...)

En realistisk plan
Thomas Pogge, Professor Yale University, Aidan Hollis, University of Calgary
dagbladet.no 25.8.2008
Professor Thomas Pogge vil ha en realistisk plan for å få en slutt på det.

Utviklingen av nye medisiner styres i dag av utsikten til inntekter basert på monopoltilgang til markedet gjennom patentbeskyttelse. Når en ny medisin blir beskyttet fra allmenn konkurranse, får medisinen en pris som gjør at en stor del av verdens befolkning forhindres fra å få tilgang til den. Dette inkluderer også mange i velstående land. Resultatet er (1) at mange mennesker helt unødig lider og dør, og (2) at forskningen fokuseres på de medisinene som oppfinnerne kan tjene mest penger på, snarere enn på de medisinene som kan føre til de største helsegevinstene. (...)

NEDTUR FOR LEGEMIDDELINDUSTRIEN
e24.no 19.8.2008
Billige medisiner gir svake resultater

Det kan bety færre medisiner og mindre forskning i Norge. (...)

It's a relief for the HIV-infected
deccanherald.com 4.7.2008
If patents are granted to a company, the price of the drug would be beyond the reach of the masses. (...)

- Kan bli sykere av kopimedisiner
nrk.no 31.7.2008
Bruken av kopimedisiner kan føre til feilmedisinering som gjør folk sykere. Det mener Allmennlegeforeningen. (...)

Leder i Allmennlegeforeningen Jan Emil Kristoffersen mener at bytte av navn og utseende fører til feilmedisinering.

- Pasientene slutter å ta et viktig legemiddel fordi de får en pille med nytt navn. Eller så tar de begge deler og får dobbel dose fordi de ikke forstod at de fikk en ny versjon av det samme, sier Kristoffersen. (...)

Kristoffersen mener at problemene rundt nye navn og nytt utseende på medisiner har vært kjent lenge.

- Stortinget har med helt åpne øyne vedtatt en ordning som sparer penger, men som har en risiko ved seg for enkelte pasienter, sier han. (...)

(Anm: Generiske legemidler (generika) (mintankesmie.no).)

Brøt patent – reddet 80 prosent flere liv
abcnyheter.no 29.7.2008
I november 2006 bestemte Thailand seg for å bryte patentene på to ulike aidsmedisiner.

Medisinene, som skal forelenge livene til aidssyke, selges dyrt av legemiddelindustrien, og koster ofte altfor mye for fattige folk, skriver Bangkok Post.

WTOs medlemsland har imidlertid lov til å bryte panten på legemidler, og lage sine egne billigversjoner, dersom landet står ovenfor en krisesituasjon. Med utgangspunkt i denne klausulen, bestemte altså Thailandske myndigheter seg for å bryte patentene på aidsmedisinene.

Legemiddelindustrien frykter at flere land ville følge Thailands eksempel, og i 2007 gjorde Brasil nettopp det. Det er ventet at enkelte utviklingsland vil følge etter i løpet av noen år. (...)

Depakote. Pharmacy blog.
melmccally.blogspot.com 14.6.2008
Seven Toxic Effects of Drug Companies

I'm the first to admire the strengths and virtues of the free-enterprise model as it applies to drug development and sales. This model encourages drug companies to employ talented people and to take risks in developing new drugs for serious medical problems. But let's face it, current practices also produce undesirable effects. (...)

US branded drug makers pay to prevent generic competition (Amerikanske legemiddelfirmaer, som produserer originalpreparater, betaler for å hindre generisk konkurranse)
BMJ 2008;336:1266-1267 (7 June)
Companies that make branded drugs make payments or beneficial agreements called "side deals" to prevent or restrict marketing of a generic form of a patented drug, the US Federal Trade Commission (FTC) reported last month.

The commission reported that there were 33 final settlements in the fiscal year 2007. Fourteen included payment to the aspiring generic manufacturer and a restriction on the generic company’s ability to market the generic drug, a number similar to the previous year. The report did not name the companies involved. (...)

Positiva tongångar efter WHO-möte
lakemedelsvarlden.se 28.5.2008
I lördags avslutades WHO:s världsmöte där det bland annat fördes intensiva diskussioner om hur fattiga länder ska få tillgång till läkemedel. Trots stora oenigheter inför mötet enades länderna om ett dokument som ska förändra drivkrafterna för att ta fram nya läkemedel. (...)

Den viktigaste slutsatsen anser Ellen t´Hoen är den att WHO fått mandat att jobba fram alternativa sätt att finansiera nya innovationer inom läkemedelsområdet. Dagens modell, där en innovation betalar sig genom patent som ger dyra läkemedel, innebär ofta ett hinder för fattiga länder. (...)

Patent Law Battle a Boon to Lobbyists (Kamp om patentlover nyttig for lobbyister)
nytimes.com 29.4.2008
WASHINGTON — A fight has erupted in Congress over the question of whether drug makers and other companies should be allowed to keep patents they obtained by misrepresentation or cheating. (...)

Patents can protect an invention for up to 20 years. But federal judges can void patents after finding that companies engaged in “inequitable conduct,” meaning that they misrepresented or concealed information with an intent to deceive the patent office. In such cases, judges can declare the patents unenforceable.

Robert A. Armitage, a senior vice president and general counsel of Eli Lilly & Company, said, “This is like imposing the death penalty for relatively minor acts of misconduct.”

Brand-name drug companies are urging Congress to eliminate the penalty — or to curtail it as proposed under a bill passed by the House. (...)

Uenige om patentvern
dn.no 5.5.2008
Nærings- og handelsdepartementet avviser at Norge bryter sine forpliktelser når det gjelder patentrettigheter på medisiner.

Fredag i forrige uke ble det kjent at Norge er havnet på USAs liste over land som overvåkes for brudd på patentrettigheter. Denne listen utarbeides årlig av USAs kontor for handelspolitikk (USTR).

– Vi merker oss selvsagt USAs syn i denne saken, men er uenige i deres påstander, sier statssekretær Annelene Svingen i Nærings- og handelsdepartementet til NTB.

Hun avviser norske brudd på patentrettigheter og presiserer at det i omtalen av Norge på USTRs liste heller ikke slås fast at Norge bryter slike forpliktelser. (...)

Pinlig for Norge å stå på amerikansk svarteliste
vg.no 2.5.2008
- Det er pinlig at Norge står på USAs overvåkingsliste over land med dårlig patentvern, sier administrerende direktør Pål Christian Roland i Legemiddelindustriforeningen (LMI). (...)

Norge svartelistet av USA
nrk.no 26.4.2008
Norges bruk av kopimedisiner har sikret landet en plass på USAs liste over land som overvåkes for brudd på patentrettigheter.

Fredag offentliggjorde USAs kontor for handelspolitikk (US Trade Representatives) listen over land de vil overvåke i 2008 for brudd på patentreglene. (...)

Bill Gates on Pharmaceuticals: The System Isn't Working
blog.wired.com 22.4.2008
(...) He also pointed to one specific problem that he'd like to take a shot at: getting pharmaceutical companies to develop drugs for the infectious diseases that plague billions of people in the developing world. The track record is horrible, and familiar. While billions of dollars have yielded treatments for baldness and erectile dysfunction, Gates said, there's comparatively little on the shelf for malaria, tuberculosis or HIV. (...)

Pfizer patent chief charged with distributing child pornography
iht.com 28.3.2008 (International Herald Tribune)
Federal agents have charged the global patent director of Pfizer Inc. with receiving, distributing and possessing child pornography (...)

Patentsystemen stoppar läkemedel till fattiga
lakemedelsvarlden.se 13.3.2008
Två år efter att de flesta länder i tredje världen införde det internationella patentsystemet TRIPS växer kritiken. De undantag i regelverket som skulle garantera att fattiga länder fortfarande fick tillgång till dyra patenterade läkemedel fungerar inte. I en rapport till regeringen belyser nu Kommerskollegium problematiken. (...)

Company accused of exploiting unique features of drug to retain market share (Firma anklaget for å utnytte unike legemiddelegenskaper for å beholde markedsandel)
BMJ 2008;336:576 (15 March)
Doctors, governments, and drug regulators must watch the way drug companies operate because the dearth of new medicines is taking profit chasing to new heights, an expert has warned. (...)

Professor Collier warned that whatever efforts were made to tighten the law or industry codes of conduct, drug companies would find a way to push their boundaries to the limit.

"Doctors, governments, and regulators of medicines have got to recognise that the industry may not have the best interests of patients or the NHS at heart. They should . . . try to force the industry to behave in a way that is socially responsible," Professor Collier told the BMJ. "But of course social responsibility does not bring profitability." (...)

The practice of switching patients is widely used in the drug industry. GlaxoSmithKline and Wyeth were forced to abandon schemes for paying a third party or practice staff to switch patients to new formulations of salmeterol (Serevent) and lansoprazole (Zoton) (BMJ 2004;329:875; doi: 10.1136/bmj.329.7471.875-a).

A spokesperson for the Office of Fair Trading said that it is aware of the case and is considering whether Reckitt Benckiser has breached competition laws. The health select committee is also expected to investigate the case.

In June 2005 the European Commission fined AstraZeneca €60m for supplying regulatory agencies throughout Europe with misleading information about when the patent of its drug omeprazole (Losec) was issued, in a bid to delay development of a generic version. The company is appealing. (...)

Gir alle tilgang til viktige miljøpatenter
digi.no 14.1.2008
Selskaper som IBM, Nokia og Sony går sammen om en «Eco-Patent Commons».

IBM og World Business Council for Sustainable Development (WBCSD) melder at de i samarbeid med Nokia, Pitney Bowes og Sony har etablert en ordning der patenter som er viktige for miljøet skal gjøres gratis og fritt tilgjengelig for alle. (...)

Pfizer, Glaxo Drug Research Success Fails to Impress Investors
bloomberg.com 11.1.2008
Jan. 11 (Bloomberg) -- Pfizer Inc., GlaxoSmithKline Plc and Sanofi-Aventis SA are testing a record number of experimental drugs, and so far shareholders are unimpressed.

There are about 1,425 potential therapies in the drug industry's research pipeline, 50 percent more than a decade ago, according to Cowen & Co., the New York securities firm. The treatments, for diabetes, cancer and brain disorders, may help offset an industrywide revenue decline commencing in 2011, when drugs generating $150 billion annually face generic competition. (...)

Drug companies are ignoring health crisis in poor countries, Oxfam says
BMJ 2007;335:1111 (1 December)
The drug industry is "burying its head in the sand" when dealing with health in developing countries and denying poorer people access to life saving drugs, a report claims this week.

A critical report by the international agency Oxfam says that the drug industry is refusing to change the way it does business in poor countries, despite promising that it would, and is undermining its own future. (...)

Pasienter, patenter og profitt
Charlotte Haug
Tidsskr Nor Lægeforen 2007; 127: 2921 (15.11.2007)
Det er forståelig at legemidler og medisinsk utstyr trenger patentbeskyttelse, men kostnaden er svært høy for pasienter og samfunn
Hvorfor skulle et legemiddelselskap nekte å selge sin egen medisin, et medikament de har arbeidet i årevis for å få frem? Eller hvorfor skulle et firma insistere på at deres eget produkt er farligere for pasientene enn konkurrentens? Sett fra pasientens og helsetjenestens perspektiv høres dette underlig ut. Men så er det heller ikke pasientbehandling dette dreier seg om. Det dreier seg om penger og patentrettigheter. (...)

Patent pools: should pharma share IP with the developing world?
bulletin.sciencebusiness.net 8.11.2007
A proposal to change patent protection rules to speed the development of affordable drugs for the developing world is under debate this week at the World Health Organisation (WHO) in Geneva. The suggestion is being put to the second meeting of the intergovernmental working group on Public Health, Innovation and Intellectual Property, set up in September 2006 to prepare a global strategy and plan of action to bring the benefits of modern medicines to developing countries. (...)

Pharma Links of NGOs in the WHO IGWG process
essentialaction.org 7.11.2007
Essential Action today released a report detailing the brand-name pharmaceutical industry ties of NGOs submitting comments to the second public hearing of the World Health Organization's Intergovernmental Working Group on Public Health, Innovation and Intellectual Property.

The full report is available here: igwg.contributorlinks.rtf

A pdf version of the report is available here: igwg.contributorlinks.pdf

The report finds that, even excluding pharmaceutical trade associations that described themselves as NGOs, NGO submissions from groups with links to the pharmaceutical industry outnumbered those from independent groups by a margin of 2 to 1.

Understanding an organization's ties to affected industries is helpful in assessing the merits of comments submitted. Essential Action urges the WHO in the future to request that all authors disclose their financial ties to corporations, including funding sources and whether the author is a consultant, lobbyist or other representative of private industry. (...)

GSK blocks new patent rules
in-pharmatechnologist.com 1.11.2007
By staff reporter
- Just a day before they were due to come into force, GlaxoSmithKline has won a court case to block controversial changes to patent rules.

The new rules were due to come into effect today but that was before the US District Court for the Eastern District Court of Virginia issued a Preliminary Injunction preventing the US Patent and Trademark Office (PTO) from implementing them yesterday.

The last minute reprieve will undoubtedly have left GSK delighted - at least for the moment. Whether or not this will lead to a permanent scrapping of the changes is unclear. (...)

Masters of Invention
portfolio.com (November 2007 Issue)
For the first time, Condé Nast Portfolio has identified the world's most prolific inventors alive—three of them have more patents than Thomas Edison—and asked them the big question: Where do the big ideas come from? (...)

Medicin-industrien finder smuthuller til patentforlængelse
business.dk 24.10.2007
De store medicinalindustrier er så pressede, at de finder nye veje til at forlænge deres patent. I USA bliver det mere og mere udbredt at kombinere et gammelt patent med ny service og dermed få forlænget patentet.

De store medicinalselskaber har i mange år haft svært ved at finde nye stoffer, men nu har de ramt en ny guldåre, der gør det muligt at sælge gammel vin på helt nye flasker. (...)

Glaxo Sues to Block New Patent Rules
forbes.com 12.10.2007
WASHINGTON - British pharmaceutical maker GlaxoSmithKline PLC has sued to block new patent rules that the company says will harm about 100 of its pending applications for new products.

The rules were issued in August by the U.S. Patent and Trademark Office and are scheduled to take effect Nov. 1. They are intended to streamline the application process by limiting the number of times patent applicants can change existing applications. (...)

Drama om Lundbecks fremtid - køb eller bliv købt
business.dk 7.9.2007
Næppe er rygter om et opkøb af medicinalselskabet Lundbeck manet til jorden, før nye rygter opstår. Lundbeck har vist interessere for den amerikanske virksomhed Endo Pharmaceuticals, der er førende i USA inden for smertemedicin. (...)

Flere analytikere vurderer i stedet, at Lundbeck nærmer sig den sidste nødudgang: et frasalg af hele medicinalselskabet.

Det skyldes, at Lundbeck står med en vaklende pipeline, da de inden for det seneste halve år har opgivet to vigtige stoffer, søvnmidlet Gaboxadol og Desmoteplase-studiet.

Samtidig udløber patentet på depressionsmidlet Lexapro, der i Europa sælges under navnet Cipralex, i 2012. (...)

Hos Lundbeckfonden, der ejer knap 70 pct. af selskabet, afviser man endnu engang et salg af Lundbeck.

»Jeg er sikker på, at Lundbeck enten vil udvikle noget selv eller finde noget at købe. Med andre ord: Lundbeck er ikke til salg,« siger Arne V. Jensen, formand for Lundbeckfonden. (...)

Innovasjon, men uten respekt for patenter
Andreas Moan, forsknings- og utdanningsdirektør ved Ullevål Universitetssykehus
dagensmedisin.no 30.8.2007
- Det er forstemmende at norske myndigheter benytter et hull i patentlovgivingen til å hente ut kortsiktig fortjeneste. Det har klar negativ konsekvens for innovativ industri i Norge, og er et alvorlig signal fra en nasjon som vil bli ledende innen medisinsk nyskaping og bioteknologi, skriver Andreas Moan. (...)

Dette skjedde første gang for om lag to år siden. Da fikk ett av Norges største legemidler, alendronate, sin patenttid avkortet med fire-fem år - og med et beregnet tap for legemiddelprodusenten på over 100 millioner kroner pr. år. (...)

Bad science
Spectacularly expensive cost of trial and error
guardian.co.uk 11.8.2007
(...) It costs £500m to bring a drug to market. Much of that is spent on randomised trials. We have made these trials so spectacularly complicated and expensive that they are beyond the reach of governments, academia, and even small companies: only huge international pharmaceutical corporations can afford to run drugs trials now, and so corporations are in complete control of the information. This is bad, as the problems with Vioxx, SSRIs, and other drugs have shown. (...)

Imagine there are two drugs called Sixofone and Halfadozen. Nobody knows which one is better for treating sickitis. The drug companies periodically do trials, but funnily their own drug always seems to come out the best. (...)

Bad science
Evil ways of the drug companies
guardian.co.uk 4.8.2007
(...) In the UK, the pharmaceutical trade is the third most profitable activity after finance and - this will surprise you if you live here - tourism. We spend £7bn a year on pharmaceutical drugs, and 80% of that goes on patented drugs - medicines released in the last 10 years. In 2002, the 10 US drug companies on the Fortune 500 list had combined international sales of $217bn (£106.6bn).

They spent only 14% of that money on research and development, but 31% on marketing and administration. They are very careful not to let anyone see how much goes on marketing and on administration. (...)

Drug Patents in India
online.wsj.com 14.8.2007
The war on drug patents has now moved to India, where a court last week denied Novartis a patent for its cancer drug, Gleevec. Indian patients will be the losers, as will Indian drug makers, whose incentive to innovate will be stunted by weaker patent laws. (...)

Legemiddelfirma tapte patentstrid i India
vg.no 6.8.2007
Det sveitsiske legemiddelkonsernet Novartis tapte mandag saken om å få India til å endre sin patentlovgivning. At India fortsatt kan være «de fattige lands apotek», er en viktig seier, mener Leger Uten Grenser. (...)

(Anm: The Madras High Court judgment dismissing Novartis' challenge to the Indian patent law (lawyerscollective.org.)

Skræddersyet medicin giver giganter dødsstødet
business.dk 3.8.2007
Skræddersyet medicin til den enkelte patient kan blive dødsstødet for medicinalgiganterne, der har nydt godt af milliardsælgende lægemidler til en bred gruppe patienter. Danmark skal være ”hotspot” for området, mener to investeringsfremmeforeninger. (...)

A Patent Is Worth Having, Right? Well, Maybe Not
nytimes.com 16.7.2007
PATENTS are supposed to give inventors an incentive to create things that spur economic growth. For some companies, especially in the pharmaceutical business, patents do just that by allowing them to pull in billions in profits from brand-name, blockbuster drugs. But for most public companies, patents don’t pay off, say a couple of researchers who have crunched the numbers. (...)

Calls mount for rethink of "Big Pharma" model
By Ben Hirschler, European Pharmaceuticals Correspondent
reuters.co.uk 20.6.2007
LONDON (Reuters) - Is the "Big Pharma" model broken? An increasing number of people seem to think so.

Institutional investors with more than $1 trillion (500 billion pounds) of assets under management were the latest to call on drugmakers to offer better value to both customers and shareholders in a report on Tuesday. (...)

PwC to pharma: Adapt and invest or die
fiercebiotech.com 13.6.2007
In a remarkably critical report, PricewaterhouseCoopers analysts are urging pharma companies to shift money from marketing into research and tie drug prices to efficacy or face a collapse of an unsustainable business model. PwC's "Pharma 2020: The Vision" says the pharma business model is "economically unsustainable and operationally incapable of acting quickly enough to produce the types of innovative treatments demanded by global markets." (...)

Drugs industry economics not sustainable' – report (Legemiddelindustriøkonomi ikke "bærekraftig" ifølge rapport)
business.guardian.co.uk 13.6.2007
The pharmaceutical industry business model is "economically unsustainable", according to a report by accountants PricewaterhouseCoopers. The study suggested drug companies' reliance on heavy marketing of a few drugs in the hope of huge sales meant they were "operationally incapable" of acting quickly enough to produce innovative treatments demanded by global markets.

According to Steve Arlington, the main author, drug companies spend twice as much on research and development than 10 years ago, yet produce half as many drugs: 40 to 45% of medicines in phase 3 clinical trials, the last stage, now failed.

Shares in pharmaceutical companies have not performed well, sales and marketing costs have increased, as have legal and regulatory constraints and the reputation of the industry has been tarnished by high-profile cases such as Vioxx, Merck's painkiller that has provoked thousands of lawsuits. (...)

Analysis: Pharma swimming against IP tide?
upi.com 23.5.2007
WASHINGTON, May 23 (UPI) -- In an effort to head off a potential worldwide flood of so-called compulsory drug licenses -- where foreign countries skirt intellectual-property laws and make generic versions of a patented drug -- the head of the U.S. pharmaceutical manufacturers' trade group met with Thai officials this week, but activists say those efforts might not prove successful. (...)

Drug sales worth 140 bln usd will lose patent protection by 2016 – report
forbes.com2.5.2007
LONDON (Thomson Financial) - Drug makers face a decade of 'unrelenting generic competition' with medicines worth nearly 140 bln usd in sales due to lose patent protection by 2016, according to a report from market analysts Datamonitor.

Globalt legemiddelsalg beløp seg til 643 milliarder dollar sist år, ifølge IMS Health data. (Global pharmaceutical sales reached 643 bln usd last year, according to IMS Health data.) (...)

Rekordsummor för lobbying i USA
Läkemedelsvärlden 2007(4) (April)
Förra året spenderade den amerikanska läkemedelsindustrin rekordsummor på politisk lobbying. Under perioden januari 2005 till juni 2006 satsade företagen 182 miljoner dollar för att påverka lagstiftningen.

LOBBYING Den amerikanska branchorganisationen Pharmaceutical Research and Manufactures of America (PhRMA) spenderade 18 miljoner dollar förra året på lobbying, det är den högsta siffran hittills sedan mätningarna startade 1998. Det visar en rapport som organisationen Center for Public Integrity nyligen presenterade. Det enskilda företag som satsade mest var Pfizer som betalade 12 miljoner dollar för olika lobbyingprojekt.

Totalt arbetar drygt 1100 lobbyister med att påverka politikers beslut som rör läkemedel. Bland annat är det frågan om import av billiga generika från Kanada som varit föremål för lobbying samt olika patentfrågor.

Som Läkemedelsvärlden skrivit tidigare går även den svenska trenden allt mer mot politisk lobbying, se länk till artiklar här bredvid. (...)

Europe "must deliver urgently" on patents
pharmatimes.com 9.4.2007
There is an urgent need for action to provide a simple, cost-effective and high-quality patent system for the European Union says a European Commission Communication issued this month. (...)

Bruk pris og ikke patent
Av Joseph E. Stiglitz, professor i økonomi ved Columbia-universitetet i USA og nobelprisvinner i økonomi.
aftenposten.no 23.3.2007
EN HØY PRIS. Legemiddelindustrien bruker mye mer på livsstilsmedisiner enn på medisiner som redder liv. Og de bruker nesten ikke noe på sykdommer som rammer hundrevis av millioner fattige mennesker, for eksempel malaria. (...)

Bruk av kunnskap.
Men er patentene nok til å påvirke industrien slik at pengene brukes fornuftig og går til å helbrede sykdommene som burde bekymre oss mest?

Beklager, men svaret er et høyt "nei".

Det grunnleggende problemet med patenter er enkelt, det bygger på at man begrenser bruken av kunnskap. Det er ingen ekstra kostnad ved at en person til har glede av å bruke kunnskap. Å legge bånd på kunnskap er ineffektivt.

Men patentene begrenser ikke bare bruken av kunnskap. Ved å gi et midlertidig monopol blir ofte medisinene for dyre, slik at mange ikke har råd til dem. I den fattigste delen av verden kan dette bli et spørsmål om liv og død, for mennesker som ikke har råd til merkevaremedisiner, men kanskje kan klare å kjøpe generiske medisiner. (...)

Kopimedisiner. (...)
Til tross for at de betaler en høy pris, får utviklingslandene lite igjen. Medisinindustrien bruker langt mer på markedsføring og reklame enn på utvikling. De bruker mye mer på livsstilsmedisiner (mot problemer som impotens og skallethet) enn på medisiner som redder liv. Og de bruker nesten ikke noe på sykdommer som rammer hundrevis av millioner fattige mennesker, for eksempel malaria. (...)

Premiefond.
Det finnes en alternativ måte å betale for og stimulere til forskning. På noen områder kan alternativene være bedre enn patenter, både for å styre forskningen og sørge for at fordelene ved den nye kunnskapen kommer flest mulig til gode. Jeg tenker på et premiefond, for å belønne dem som finner kurer og vaksiner. I og med at regjeringer allerede betaler for mye av medisinforskningen, enten direkte eller indirekte, kan de betale for premiefondet. Pengene skal gå til dem som forebygger eller utvikler behandling av sykdommer som rammer mange millioner mennesker. (...)

Midlertidig monopol.
Selvsagt er patentsystem også en ordning som premierer oppfinnere. Men det er et merkelig system, premien er et midlertidig monopol, som igjen fører til høye priser og begrenset tilgang til fordelene den nye kunnskapen gir.

Premieringen jeg tenker på vil stole på at konkurransen i markedet vil gi lavere priser og spre fruktene av den nye kunnskapen så vidt som mulig.

Dersom belønningen gjør at man bruker mer forskningspenger på de viktigste sykdommene, og mindre penger på bortkastet og skadelig markedsføring, kan vi få bedre helse til en lavere pris.

Allikevel, premiefondet vil ikke erstatte patenter. Det vil være ett av flere tiltak for å oppmuntre til forskning. (...)

Skjevt marked.
Markedsøkonomien og ønsketom profitt har gitt ekstremt høy levestandard mange steder. Men helsemarkedet er ikke noe vanlig marked. De færreste betaler for det de bruker. De stoler på andres vurdering av hva de skal bruke. Og prisen spiller ingen stor rolle i denne vurderingen, i motsetning til i de fleste markeder.

Derfor er dette markedet fullt av skjevheter. Da er det ikke overraskende at patentsystemet har sviktet på så mange måter i helsemarkedet. Et premiefond vil ikke være en mirakelkur. Men det vil være et skritt i riktig retning. (...)

Teknologi mot legemidler i USA:
Sterke krefter strides om nytt patentsystem
digi.no 14.3.2007
IT-bransjen støter mot produsenter av legemidler i sin kamp for å overhale USAs patentsystem.

To sentrale medlemmer av den amerikanske kongressen, representanten Howard Bermen (demokrat fra California) og senatoren Patrick Leahy (demokrat fra Vermont) varslet i februar at de vil fremme omfattende forslag for å overhale USAs patentsystem. (...)

Hovedårsaken til at republikanernes forslag ikke for lengst er vedtatt, skal være press fra legemiddelbransjen.

Presset fikk partiet til å legge forslagene på is mens de kjempet den innbitte valgkampen i fjor høst. For å unngå at saken preget valgkampen, sørget de for å hindre at forslag fra Berman og en annen demokrat, Rick Boucher fra Virginia, ble behandlet. (...)

Big Pharma's Black Hole
forbes.com
Big Pharma is heading "off a cliff" and into "a black hole," according to Wall Street.

Analysts are already using such big scary metaphors to describe the challenges facing the drug industry in five years, when drug makers will face the worst series of patent expirations ever. (...)

Lovforslag gør det nemmere at gå patenter i bedene
business.dk 20.11.2006
Det skal være lettere for medicinalvirksomheder at kopiere og videreudvikle konkurrenternes patenterede produkter - uden at blive anklaget for at krænke patentet. (...)

Børneforsøg skal sikre bedre medicin
berlingske.dk 29.10.2006
(...) Halvdelen af den medicin, danske og europæiske læger skriver ud til Europas godt 100 mio. børn, er aldrig blevet testet på børn. (...)

Den praksis skal der nu sættes en effektiv stopper for. EU-Parlamentet ventes sidst i november at vedtage en beslutning, der vil pålægge medicinselskaberne at gennemføre kontrollerede forsøg med børn som forsøgspersoner. (...)

Guleroden for medicinselskaberne bliver, at de får forlænget deres patentperiode for nye produkter med et halvt år, hvis de kan dokumentere, at et middel også er afprøvet på børn. (...)

Legemiddelfirma bestrider Indias patentlov
hegnar.no 26.9.2006
Den sveitsiske legemiddelgiganten Novartis har gått til sak i India for å bestride landets patentlov som gir adgang til å produsere billige medisiner.

Dersom selskapet vinner fram, vil det få alvorlige konsekvenser for tilgangen til livsviktige medisiner, især for fattige land, advarer Leger uten grenser. (...)

Europeisk samarbeid for å stimulere utvikling av innovative medisiner
lmi.no 19.9.2006
Legemiddelfirmaer, universiteter, pasientorganisasjoner og myndighetene med en felles strategi. (...)

Patent Fight Bounces Bristol-Myers CEO
businessweek.com 12.9.2006
Peter Dolan's missteps in trying to secure an anticlotting drug's profitability led to his dismissal from the drugmaker's top post

The test of a drug company isn't just how good it is at developing new medicines, it's also how well its executives fight the patent wars.

Patents ensure that successful drugs reap monopoly profits, but those monopolies are often fragile and open to challenge. That plunges pharmaceutical companies into an enormously high-stakes game of chicken. Right choices can bring extra billions in revenues. Wrong decisions can send stocks plunging—and cost CEOs their jobs. That's what just happened to Bristol-Myers Squibb's Peter Dolan, who was ousted from his post on Sept. 12. (...)

GSK hails judgment as blow to parallel trading
timesonline.co.uk 6.9.2006
GLAXOSMITHKLINE (GSK), Europe’s biggest pharmaceutical company, claimed victory yesterday in a six-year legal battle against wholesalers that had bought its drugs cheaply in Greece and then resold them for profit in richer European countries. (...)

Legemiddelindustrien
Sverre A. Danbolt Sentralstyremedlem i Changemaker
dagbladet.no 4.9.2006
PATENTER: I et lite leserbrev den 29. august synes Robert Rustad å hevde at legemiddelindustrien er hevet over enhver kritikk fordi det er «en bransje som faktisk gir livsviktige bidrag til folkehelsen». Beskrivelsen av bransjen er god; avvisningen av kritikk er skremmende. Hvem hadde brydd seg om at vellykkethet synes å være omvendt proporsjonal med antallet mennesker som dør av kurerbare sykdommer? (...)

Like kynisk som pornoindustrien?
Robert Rustad Direktør Regulatory Affairs, AstraZeneca AS
dagbladet.no 29.8.2006
PATENTER: I en lederkommentar i Dagbladet nylig uttaler redaktøren at legemiddelbransjen er like kynisk som den internasjonale våpenindustrien fordi bransjen forsøker å ivareta egne opphavsrettigheter (patenter). Dette er vel omtrent like søkt (og like ufint) som å si at avisen Dagbladet er like kynisk som den internasjonale pornoindustrien fordi avisen «i ytringsfrihetens navn» publiserer sexannonser og annonser for sexprodukter og tjener penger på dette.

Når lederskribenter kommenterer en bransje som faktisk gir livsviktige bidrag til folkehelsen, må det kunne forventes en viss grad av edruelighet - selv fra Dagbladets side. Det burde være mulig med en beklagelse for redaktørens overtramp.

Patentpress
dagbladet.no 20.8.2006
Pål Christian Roland Adm. dir. i Legemiddelindustriforeningen (LMI)
PATENTER: Torsdag 17. august har Dagbladet en kortleder som ikke kan stå ukommentert. Her sauses udokumenterte påstander om legemiddelindustrien sammen med synsing om patentrettigheter. (...)

DET ER AVGJØRENDE for utvikling av nye og bedre legemidler at patentbeskyttelsen for originallegemidlene blir respektert. LMI arbeider derfor for at originallegemidler skal ha samme beskyttelse i Norge som i andre land. Verken mer eller mindre. I dag får myndighetenes virkemidler for å fremme bruk av generiske legemidler/kopimedisiner i enkelte tilfeller anvendelse også før originallegemidlenes patenttid har løpt ut. Norge har en historisk svak patentbeskyttelse, og er i så måte i en særstilling internasjonalt. Det er i strid med uttrykte intensjoner fra Storting og departement. (...)

Risks and benefits of the profit motive in the pharmaceutical industry
by Joel Lexchin MD
agoravox.com 11.7.2006
Is the profit motive the best way to encourage the development of new drugs? Do the benefits of the new therapies outweigh the problems associated with the profit motive/ This article looks at the price we pay for new drugs. (...)

Norden samarbeider om patentinstitutt
dn.no 4.7.2006
Norge, Danmark og Island går sammen om å danne et felles nordisk patentinstitutt som kommer til å ligge i Taastrup ved København.

Det nye instituttet betyr at danske selskaper slipper å henvende seg til et utenlandsk institutt når de ønsker å søke patenter i flere land gjennom det internasjonale systemet PCT.

Ifølge direktør Jesper Kongstad ved patent- og varemerkemyndighetene i Danmark er samarbeidet unikt.

– Med dette instituttet vil Norden komme til å spille en viktig rolle i fremtidens europeiske og globale patentsystem. Det blir enklere, mer effektivt og billigere for nordiske selskaper å få utført patentarbeid. Saksbehandlingen blir av høyeste internasjonale standard, sier Kongstad. (©NTB)

Patents medicines and lobbies
latimes.com 24.6.2006
According to a recent Asia Times Online report (World health: A lethal dose of US politics, June 17), the World Health Organization's country representative to Thailand, William Aldis, was removed for expressing views contrary to Western corporate interests. Such arm-twisting is neither new to international organizations nor unbelievable - nor even unexpected.

Many global organizations, including the United Nations, offer "freedom of speech" without guaranteeing "freedom after the speech". If the report is correct, Aldis I salute you. Poor people in the Third World need more advocates like you. I wholeheartedly endorse the view that corporate interests have obstructed the global poor's access to medicines. The mechanism that works against the poor and in favor of the rich multinationals is more of an invisible arm-twisting rather than a problem of reaching an agreement at the negotiating table. (...)

On an intellectual plane, rich countries argue that protection of the patents is necessary to enable them to continue research and development to produce better medicines. On a "situation on ground" basis, however, the interests of millions of patients suffering from lethal epidemics cannot just be ignored. (...)

Medicinalgiganter tryner parallelimportører
berlingske.dk 5.6.2006
Medicinalgiganternes kvoteordninger og dobbeltpriser presser nu de danske parallelimportører af medicin hårdt på omsætning og indtjening. Parallelimportørerne anklager medicingiganterne for at sætte konkurrencen ud af kraft.

De har længe advaret om det. Nu kan man se det på tallene. Den største danske parallelimportør af lægemidler, Carefarm koncernen, presses så hårdt af globale medicinalgiganters benspænd, at omsætningen er ved at gå i stå. Væksten stagnerer også hos Paranova Gruppen, der dog præsterede solid omsætningsfremgang i 2005. (...)

EU adopts new rules on children's medicine
usatoday.com 6.6.2006
BRUSSELS (AP) — The European Union is offering drug makers extended patents as an incentive to produce children's versions of drugs for diseases such as cancer, AIDS or psychiatric disorders.

New regulations approved by the EU Parliament Thursday encourage pharmaceutical companies to develop pediatric drugs that don't have the undesirable side-effects of medicines for adults and which can be administered in smaller doses. (...)

Enighet om patentrett og åpne standarder
digi.no 29.5.2006
Et plenumsmøte i UN/Cefact har blant annet løst spørsmålet om patentrettigheter og åpne standarder.

Plenumsmøtet til UN/Cefact i Genève har gitt oppmuntrende resultater:

• UBL («Universal Business Language») vil utvikles i nært samarbeid mellom Oasis og UN/Cefact.
• Spørsmålet om patentrettigheter i forhold til åpne standarder ble løst
• De nordiske landene lovet ytterligere støtte til UN/Cefact

Det er et stadig sterkere behov i markedet for elektronisk samhandling mellom bedrifter, samtidig som utviklingen av nye, åpne standarder nesten har stoppet opp. Hvordan skal vi endre på dette? Det var temaet for et FN-møte i regi av standardiseringsorganisasjonen UN/Cefact i Geneve i forrige uke. Nær 100 land var representert i det som viste seg å bli en meget konstruktiv og god dialog mellom delegatene og UN/Cefacts ledelse. (...)

WHO to see if patent system keeps drugs from poor
reuters.com 27.5.2006
GENEVA (Reuters) - The World Health Organization said on Saturday it would examine whether the international drug patent system prevents developing countries from obtaining needed medicines, vaccines and diagnostic tests.
Spurred on by Brazil and Kenya, the 192 WHO members agreed at an annual meeting in Geneva to launch an intergovernmental group to look for gaps in medical research and development, and draw up a global strategy to ensure the health needs of poor people are met.

The WHO said the group would integrate the findings of an April report by former Swiss President Ruth Dreifuss, which criticized the existing drug development, marketing and pricing system, saying it largely neglected the poor.

The report, commissioned by the WHO in 2003, did not call for a weakening of patent rights but urged big companies to reduce the price of medicines sold to developing countries and to avoid filing for patent protection there. (...)

Drug makers delay generics hitting market
dfw.com 26.5.2006
NEW YORK - The marketers of the world's second-largest selling drug dodged a major threat to their revenues two months ago by reaching a deal to keep a generic competitor at bay until at least 2011.

Now, 10 lawsuits have been filed over the settlement Sanofi-Aventis SA and Bristol-Myers Squibb Co reached with Apotex Inc., a generic manufacturer challenging blood thinner Plavix's patent. The suits, filed by businesses, unions and health plans, allege the deal violates antitrust laws by denying access to cheap, generic versions of Plavix.

"We want to have a high level of (health) benefits for our members but to do that we need access to cheap, generic drugs," said Wendell W. Young IV, president of United Food and Commercial Workers Union Local 1776.

Experts say drug makers are delaying the introduction of cheaper rivals with deals like the Plavix settlement, in which Apotex agreed to drop its patent challenge and launch its product at a time approved by the patent holders in exchange for a payment of at least $40 million.

Other tactics include filing petitions with the U.S. Food and Drug Administration that express concern about a generic version of one of their products, and arranging to manufacture an "authorized" generic to cut into the challenger's profits.

Evidence suggests such activities are becoming more common and regulators - fearing consumers' access to cheaper medications is being stalled by legal loopholes - are examining the issue. (...)

Drug companies 'failing to meet health needs of world's poorest'
independent.co.uk 23.5.2006
The dominance of the global pharmaceutical firms in providing medicine to the world's poor faces its strongest challenge yet at a meeting of World Health Organisation (WHO) in Geneva this week

The existing system of drug patenting and pricing is fundamentally flawed and does not meet health needs, according to report released to health experts last month.

Delegates at this year's World Health Assembly, which opened yesterday, will vote on proposals that would dramatically increase pressure on the companies, governments and the WHO to reform the system for producing and distributing drugs in the developing world.

However, campaigners fear the report is being undermined after it was not given prime position in the assembly's agenda.

The way in which multinational drug companies protect their patents in order to reap profits was highlighted by the pricing of Aids drugs a decade ago at $10,000 (£5,300) to $15,000 a year, beyond the means of countries such as South Africa where the need was greatest.

An international outcry led to a court challenge which resulted in the price of Aids drugs being slashed to $150 a year. (...)

Drug Firms' Deals Allowing Exclusivity
washingtonpost.com 25.4.2006
Makers of Generics Being Paid to Drop Patent Challenges, FTC Review Finds

Brand-name drug companies have resumed the practice of slowing the sale of cheaper generic competitors by cutting deals that result in paying millions of dollars to makers of generic drugs while consumers continue to pay brand-name prices.

The agreements follow two federal appeals court rulings last year that rejected Federal Trade Commission actions that since the late 1990s had prevented brand-name companies from paying their rivals to drop patent challenges.
An FTC analysis found at least seven such agreements so far in fiscal 2006, with three in 2005. Before that, no generic companies had been paid to drop their patent challenges for years.

Speaking yesterday in Philadelphia, FTC Commissioner Jon Leibowitz said that if the appeals court decisions remain in force, rival drugmakers will have "carte blanche to avoid competition and share resulting profits." He said the commission had agreed to ask the Supreme Court to overturn one of the lower-court decisions.

"Until recently, payments by brand-name companies to generics were the exception, but now they're the rule," he said in an interview after his speech. "They appear to be a new way to do business, and that's very troubling. Hopefully the Supreme Court will take our case and reverse." (...)

The White House. The Drug Industry. Genocide.
huffingtonpost.com 24.4.2006
I'll start off giving you some background. A few years ago I attended a closed meeting with consultants for Ernst & Young. They told the gathered drug executives that the industry was in trouble. Ernst & Young had added together the sales forecasts the drug industry had given to Wall Street and they told us, "if you are going to meet those numbers, you need twice as many drugs as you have in your pipeline. Your stock is going to tank during the next ten years." Of course, no drug executive ever told Wall Street and their investors about this data.

Today, the prediction has come true. Drug company stocks have tumbled. The biggest drug company, Pfizer, has lost 40% of its value in the last five years. Revenue for the first quarter in 2006 came in at $12.7 billion, down 3% from the first quarter of 2005. Growth suddenly went "poof."

IMS Health, an industry research firm, estimates prescription drugs worth $121.5 billion will come off patent between 2006 and 2011. That's half of U.S. drug sales.

So the drug industry is in a panic, because they don't have enough new drugs to fill the gap. The CEO's are trying to sound optimistic, to pump up their stock options, but they know that the "perfect storm" is coming. The good news for consumers is that drug prices will drop and many more generics will be available at low cost.

So what's going on here, could the drug industry really be in for a rough ride?
And, what is the drug industry doing about this?

Simple: Just like a bad student might contemplate cheating, the drug industry plans on big scale cheating.

Number one on the cheat sheet is to stop generics from coming onto the market. (...)

Blank Slate
A Heartburning Recipe
forbes.com 18.4.2006
Five years ago, AstraZeneca found an ingenious solution to a looming financial catastrophe. With the patent on its best-selling heartburn medicine, Prilosec, about to expire, AstraZeneca scientists decided to see what would happen if they split the Prilosec molecule in half. (...)

Is the Patent System Broken?
time.blogs.com 18.4.2006
You know something extraordinary is going on when The Wall Street Journal and Doctors Without Borders agree on anything. But lately, both the fervent champion of free markets and the equally impassioned humanitarian organization have come out blazing against the current patent system. (...)

Prizes Not Patents
forbes.com 18.4.2006
What is the most idiotic feature of America’s current system for patenting drugs?

A hard question, since there are so many good answers. The U.S. patent system sticks American consumers and taxpayers with eye-popping bills even as it lets foreign countries shirk their share of research costs by simply outlawing high drug prices. A mindless, one-size-fits-all incentive system, patents offer no special reward to scientists who tackle truly groundbreaking research while lavishing huge profits on easy-to-discover “me-too” drugs such as AstraZeneca’s Nexium. (see: “A Heartburning Recipe”). Today’s system makes drugs unaffordable for many of the sickest Americans, while simultaneously convincing the not-so-sick to take more and more pills to stay healthy. (Drug ads persuade people to exercise less, smoke more and rely on pill-popping to save them, according to a new National Bureau of Economic Research study.) (...)

Gjør skituren helt patent
aftenposten.no 11.4.2006
Slik sikrer du deg:
Patent: Gir deg enerett til å utnytte din oppfinnelse kommersielt for et begrenset tidsrom. I denne perioden har du et konkurransefortrinn, som kan sikre inntjening, skaffe samarbeidspartnere, investorer. Oppfinnelsen må være ny og skille seg vesentlig fra tidligere kjent teknikk på området.
Varemerke: Et særpreget kjennetegn for dine varer og/eller tjenester. Varemerkeregistrering gir deg enerett til å bruke varemerket som kjennetegn for dine varer og/eller tjenester.

Design: Designregistrering dokumenterer din rett til en bestemt design i et begrenset tidsrom, og du kan lettere hindre andre i å utnytte samme designen. Som hovedregel må en design som registreres være ny og ikke tidligere offentliggjort innenfor EØS-området.
Kilde: Patentstyret

Virker mot sin hensikt
Patenter skal fremme kunnskapsdeling
digi.no 22.3.2006
Det finnes ikke et eneste eksempel fra virkeligheten hvor et patent på programvare har fremmet nyskaping.

Patent er et ord som kommer fra det latinske språket og det betyr åpent. Ordet ble valgt som en beskrivelse av hva hensikten med patenter egentlig er.

Et patent er en kontrakt mellom samfunnet og en oppfinner. Kontrakten gir sistnevnte en tidsbegrenset enerett i bytte mot at vedkommende deler kunnskapen sin med andre gjennom publisering. Derfor må patentsøknader inneholde en teknisk beskrivelse av hva slags problem som løses og hvordan det løses.

Desverre har det båret galt av sted med patentsystemet etter at det i USA ble vanlig med programvarepatenter.

Istedenfor å være et middel for å fremme innovasjon og nyskaping, har det i mange tilfeller blitt en ekstra kostnadsbyrde for små selskaper og et effektivt utpressingsmiddel for mafia-lignende bedriftsutpressere.

Tilhengerne av programvarepatenter trekker gjerne frem at patenter gir de små en sjanse i konkurransen mot de store aktørene. Dette er et vikarierende argument som er galt og dessuten irrelevant. Patenter er ikke til for å hjelpe de små, det er et middel for å fremme innovasjon og nyskaping. (...)

Ser på patentreglene
dagensmedisin.no 24.2.2006
Etter press fra legemiddelindustrien vurderer myndighetene å endre patentreglene slik at originalpreparater får bedre beskyttelse. (...)

- Det er nødvendig at departementet tar nødvendige grep slik at Norge får en reell patentbeskyttelse av legemidler, sier administrerende direktør Pål Christian Roland i Legemiddelindustriforeningen (LMI).

Property rights and danger of a new form of colonialism
The Financial Times 21.11.2005
By Alfred B Engelberg
Sir, A failure to strike the appropriate balance between intellectual property rights and open access to knowledge can harm innovation, competition and economic growth in both developed and developing countries. Put simply, patents of poor quality and overly restrictive access to copyrighted materials containing important knowledge are bad for the global economy.

Recently, important policymaking bodies in the US, the Federal Trade Commission and The National Academies, have concluded that the quality of patents being granted has deteriorated; that the standard for determining whether a patent claims a meaningful advance has become too low; and that a comprehensive evaluation of the patent system's impact on innovation is needed.

In the pharmaceutical area, for example, there have been patent challenges involving the majority of important drugs and the challenger has won more than 70 per cent of the decided cases and been paid to drop the challenge in many other cases. Yet, global pharmaceutical patents impede the ability of poor nations to gain access to medicines at affordable prices.

Similarly, there are rising complaints from the biomedical research community that patents claiming research tools are impeding the quest for important new knowledge. Other industries complain that their ability to make rational investment decisions is hampered by organisations that accumulate large patent portfolios solely for the purpose of bringing complex patent infringement litigations that create years of uncertainty. These examples illustrate the deteriorating balance between intellectual property rights and free competition.

Ny lov vil få medicinpriser til at stige endnu mere
Ugeskr Læger 2005;167(45):4246-4248
Kort tid efter, at Folketinget har indført nye regler, som skulle sænke udgifterne til medicin, lægger indenrigs- og sundhedsminister Lars Løkke Rasmussen (V) op til det stik modsatte i en reform af hele lægemiddelområdet. Fremover skal medicinalselskaberne kunne beskytte deres patenter i ti år mod seks år i dag. Det vil føre til store ekstraudgifter for Sygesikringen og patienterne, og forslaget møder skarp kritik. Men samlet set er reformen udtryk for et fremskridt, mener de fleste.

Intellectual property
An initiative to reverse the proliferation of patents and copyrights
The Economist 13.10.2005
PATENTS and copyright laws are meant to be the friends of innovation and are a foundation of the modern business world. But there is a growing risk that intellectual-property laws are now so stringent that they are actually inhibiting innovation, rather than protecting it.

PATENTS and copyright laws are meant to be the friends of innovation and are a foundation of the modern business world. But there is a growing risk that intellectual-property laws are now so stringent that they are actually inhibiting innovation, rather than protecting it.

The call for a new approach was made forcefully this week in a statement called the Adelphi Charter, issued by a group of prominent legal scholars, artists, scientists and experts from around the world. The Adelphi group are a varied crew ranging from Gilberto Gil, the Brazilian culture minister (and pop star) to Sir John Sulston, a Nobel-winning scientist who helped decode the human genome, and James Boyle, a law professor at Duke University. They believe that the intellectual-property system is starting to lean so far in favour of private enrichment that it no longer serves the public interest. For example, two hundred years ago, copyright lasted 28 years. It then began to increase and, in the 20th century, lawmakers roughly doubled its length in America and many other countries with little public debate or economic rationale. Organised by Britain's Royal Society for the encouragement of Arts, Manufactures & Commerce, the group hopes the 453-word charter will help restore balance.

The charter lays out a "public-interest test" for policymakers to use before changing intellectual property laws: an automatic presumption against expanding rights, placing the burden of proof on those who seek this, as well as requiring rigorous analysis to justify changes, along with broad public consultation.

Mulig å revidere patentavtale
Aftenposten 20.9.2005
U-land. Nobelprisvinner Joseph Stiglitz kritiserer patentavtalen, TRIPS, i Verdens handelsorganisasjon, WTO (Aftenposten, økonomidebatt 19. august). Stiglitz peker på at TRIPS kan hindre utvikling i u-landene. Løsningen er ifølge Stiglitz å avvikle TRIPS, og flytte forhandlingene til Verdensorganisasjonen for immaterialrett, WIPO.

Medisiner for verdens fattige
Aftenposten 18.9.2005
Aas-Hansen Jens
Patent på WTO-forhandlinger. I Aftenposten 28. august tar Inge Lønning imot vår utfordring om å jobbe for en mer rettferdig patentavtale i Verdens Handelsorganisasjon WTO.

Lønning fortjener honnør for at han tør kritisere Norges egoistiske og lite helhetlige posisjon i forhandlingene. En slik holdning legger til rette for en konstruktiv debatt.

Selv om Lønning er opptatt av helheten må ikke dette skygge for den lille ukjente, men svært viktige avtaleteksten om patenter. Patentavtalen er blitt bagatellisert og glemt lenge nok.

Avtalen er tilpasset de rike landenes behov, og er hverken rettferdig eller bidrar til å utrydde fattigdom. Vår intensjon med patentdebatten er ikke å diskutere oss i mellom hvordan man best legger til rette for effektiv forskning, men å sikre at alle dem som omfattes av patentavtalen skal være med å bestemme innholdet. Vi ønsker at de fattige landene skal få den reforhandlingen av patentavtalen de ble lovet for elleve år siden, og at målsettingen for den nye patentavtalen ikke må være å trygge vestlige legemiddelselskapers stadig større overskudd. Det må være mulig å lage en avtale som ikke tvinger afrikanske regjeringsledere til å la sine innbyggere dø av sykdommer det finnes medisiner mot.

Lønning etterlyser konkrete alternativer til den eksisterende patentavtalen i WTO. Vi tar utgangspunkt i forslag fra grupper av utviklingsland om at en nyforhandlet avtale må sikre at opphavslandet blir informert og godkjenner patentering av ressurser funnet i deres land, og at verdien av patentet må bli rettferdig fordelt. Vi er også opptatt av lands rett til å motsette seg patentering av celler og gener. Fattige land ønsker en reforhandling av patentavtalen, men uten støtte fra et rikt land som Norge, er dette i realiteten umulig. Lønning, du er en innflytelsesrik utenrikspolitiker. Vil du arbeide for en rettferdig reforhandling av patentavtalen på toppmøtet i Hongkong?