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Wednesday, April 20, 2005
Law - More on Merck v. Integra arguments today
Updating yesterday's ILB entry, How Appealing has links here to several stories about today's oral arguments before the U.S. Supreme Court in Merch v. Integra. Here are some quotes from an LA Times story:
The case has split the biotechnology industry, which includes a handful of drug giants and hundreds of smaller, research-focused companies.Siding with Integra are small biotech companies that produce and sell equipment and other products used in drug research, including Applera Corp. and Invitrogen Corp. They worry that big drug companies could run all over their patents if the lower court ruling is overturned.
Two of the largest biotechs, Genentech Inc. and Biogen Idec Inc., are aligned with Merck.
At the center of the dispute is a federal law known as Hatch-Waxman, which was passed in 1984 to foster drug development. The law granted a "federal exemption" from patent laws for research needed to obtain FDA approval of a drug. The law has been used to shield generic drug companies from patent infringement suits while they prepare to bring knock-off drugs to market.
Merck claims that the Hatch-Waxman exemption should also apply to its research, but a federal jury disagreed, awarding $15 million in damages to Integra, which an appeals court reduced to $6.4 million in 2003.
In upholding the verdict, the appeals court said that Merck and Scripps used the peptide in experiments that weren't needed to obtain FDA approval of the brain-cancer drug. The court said the exemption applied only to drugs in clinical trials, while Merck was using the peptide in laboratory studies.
Posted by Marcia Oddi on April 20, 2005 08:55 AM
Posted to Biotech | General Law Related