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Monday, April 18, 2005

Law - Merck v. Integra to be argued before the Supreme Court this Wednesday

This ILB entry from June 20, 2003 is titled "Construction of the "safe harbor" of 35 U.S.C. ยง 271(e)(1).," and discusses the U.S. Court of Appeals for the Federal Circuit ruling 6/6/03 in the case of Integra LifeSciences v. Merck.

Nearly two years later, on this Wednesday, the U.S. Supreme Court will hear oral arguments in the case. The UK's Financial Times writes today:

The US Supreme Court could be about to rewrite the rules of innovation in America. A patent case this week could profoundly affect not only those who take or make American drugs but also the innovation economy.

Those are the claims made by drug and biotechnology companies lobbying hard to influence the outcome of Merck v Integra. The case tests the basic legal compromise that has fostered 20 years of drug creation in the US: that drug companies should be allowed to use other companies' patents for free when their goal is to bring new drugs to market.

But the justices are also being urged to examine a more fundamental bargain, one that supports creativity in fields well beyond pharmaceuticals: the notion that society benefits when scientific knowledge is freely shared with those who use it to invent something new. * * *

Last month, it was copyright and file-sharing. This month the issue is patent law and drug research. But the challenge is broadly the same: how to ensure that creators enjoy enough legal protection to encourage them to create without stifling those who want to build on their inventions.

The case Merck v Integra poses the question this way. Should Merck KGaA, a German drug company, be allowed to use the patents of tiny Integra LifeSciences, a medical technology company, to look for drugs that could help fight cancer?

A 20-year-old federal law says Merck can use the material for free as long as the use is "reasonably related" to getting a drug approved by the Food and Drug Administration. But does the right to infringe patents stretch back to the earliest explorations or just to final clinical testing?

A federal jury sided with Integra and awarded $15m in damages against Merck. A federal appeals court agreed, ruling that the main point of the research exemption was to give generic drug makers time to get their products ready to introduce right after a patent expires on a proprietary drug - not to immunise every drug maker for all experimental activity.

Big pharma was outraged and drug makers predict dire consequences if the ruling is upheld. A brief from Eli Lilly, Wyeth and Pfizer, which support Merck, said "Patients will be deprived of timely access to new, safer, more effective drugs; promising drugs to treat unmet medical needs will never be developed; and drug development activities along with valuable American jobs will be exported to countries having more favourable legal environments".

The US government, also on Merck's side, says there is "no question" the ruling would "restrict significantly the development of new drugs". And the AARP, the lobby group for older Americans, says favouring patent protection in this case is against the public interest.

But the patent owners - biotech companies that develop the tools used to discover new drugs - say the pharmaceutical companies are just trying to cheat them out of their fair share of the reward for bringing new drugs to market. Professor Martin Adelman, patent expert at George Washington University law school, agrees. "This case is just about money: it's about the pharmaceutical developers having to share some money with the developers of research tools," he says. * * *

You can read useful reviews of, and download, all the briefs in this case via the Patently-O: Patent Law Blog's entry from earlier this year.

Here is the link to the Medill School of Journalism - On the Docket's resources in the case.

Posted by Marcia Oddi on April 18, 2005 04:38 PM
Posted to Biotech | General Law Related