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Supreme Court Reviewing Drug Patents

Interesting related read. Blue

Wednesday April 20, 12:09 pm ET
By Hope Yen, Associated Press Writer
Supreme Court Reviews How Far a Patent Can Go to Thwart Rival's Efforts to Conduct Drug Research


WASHINGTON (AP) -- Pharmaceutical companies must have flexibility to conduct research into potentially ground-breaking new medicines, the Supreme Court was told Wednesday, as it heard arguments on how far a patent can go to thwart a rival firm's efforts to develop new drugs.

The court considered the case of Integra LifeSciences Holdings Corp., which accuses Germany's Merck KGaA of infringing a patent it holds on certain molecules Merck is using for research. Merck, which isn't related to the U.S. company, says a federal law gives it leeway to experiment.

"You don't spend millions on toxicity studies unless you have a safe drug candidate," said Joshua Rosenkranz, an attorney for Merck, arguing that companies need room for trial and error without overly burdensome restrictions.

But Mauricio Flores, Integra's attorney, argued that a jury properly found that Merck researchers had overstepped their bounds since Integra held a patent. "Chicken embryos have nothing to do with safety," he said, suggesting that most of the company's work was a fishing expedition.

Most justices appeared ready to ask the lower court to take a second look at its ruling, expressing concern that patent protections that are too strong will stifle valid research. All nine justices participated in the argument, suggesting the full court would rule on the case.

In January, Justices Sandra Day O'Connor and Stephen Breyer had removed themselves in the vote to hear the case. The two own shares in the U.S.-based Merck & Co., which was affiliated with Merck KGaA in the 1800s, but the companies are now separate.

The dispute pits large drug companies such as Eli Lilly & Co., Wyeth and Pfizer Inc., which seek greater flexibility to produce innovative new medicines, against smaller biotech firms who say they are entitled to strong legal protection in the highly competitive industry.

A ruling for Integra would "restrict significantly the development of new drugs," argues the Bush administration, which filed a brief backing Merck. "A researcher aware of a promising new cure involving a patented invention could not undertake the research necessary to develop the drug."

The case centers on a patent held by Integra, which is based in Plainsboro, N.J., that was set to expire by 2006. Integra sued for patent infringement after Merck set up animal trials for a promising cancer therapy as a first step in a decade-long plan toward possible approval.

The peptides, or biological molecules, contain a specific amino acid sequence that researchers hope could inhibit tumors.

At issue is whether Integra's patent prohibits Merck's from beginning research into a potential new anticancer drug, even if the drug could not feasibly be marketed until after the patent expired.

Merck contends it was entitled to the "head-start" research under a Food and Drug Administration exemption for studies "reasonably related" to a future drug application, saying it would promote the innovation of cutting-edge treatments while respecting the rights of patent holders.

The Washington-based U.S. Court of Appeals for the Federal Circuit, however, ruled that the FDA exemption did not extend to exploratory research -- only later-phase, human trials typically involving generic drugs. It reasoned that Congress intended only to promote the growth of generics when it passed the exemption in 1984.

AARP, the advocacy group for people 50 and over, argues in filings that the case has important implications for older Americans amid skyrocketing prescription drug costs.

"If this decision stands, the inevitable effect will be that the costs of drug development will be driven up even further and it will serve to delay the development of new medicines," the group states.

But smaller firms such as Invitrogen Corp., which develops scientific tools for use in drug research, counter that their $26 billion industry would go bankrupt if larger companies are given freedom to poke around their patented work without paying a licensing fee first.

"The patent system, as it presently operates, provides the incentive necessary to fuel the development of innovative and beneficial research tools by granting an inventor the exclusive right to control the use of his invention for a limited time," Invitrogen, based in Carlsbad, Calif., writes in its friend-of-the-court filing.

The case is Merck v. Integra Lifesciences, 03-1237.

Supreme Court: http://www.supremecourtus.gov/