To: Biomaven who wrote (17056 ) 6/13/2005 4:33:12 PM From: keokalani'nui Respond to of 52153 Drug Patents Don't Bar Rival Research Monday June 13, 4:19 pm ET By Hope Yen, Associated Press Writer High Court Rules Drug Patents Don't Bar Rivals From Starting Research on Competing Medications WASHINGTON (AP) -- The Supreme Court gave drug companies more freedom to develop new disease-fighting therapies, ruling Monday that rival firms' patents do not bar them from starting research on competing medications. The unanimous ruling set aside a lower-court ruling for patent holder Integra LifeSciences Holdings Corp. It means that major pharmaceutical companies such as Eli Lilly & Co. and Pfizer Inc. can start experiments sooner, leading to faster drug development, perhaps billions in savings and lower costs for consumers. "It's a big win," said Sarah Lock, a senior attorney for AARP, which filed a friend-of-the-court brief on behalf of Americans age 50 and over. "With rising prescription drug costs, consumers are feeling pinched. Consumers are going to end up saving money." Justice Antonin Scalia, writing for the court, said a lower court was wrong to bar automatically early stage research conducted to identify new drugs. Such experiments are OK so long as the drug could not be feasibly be marketed until after a rival's patent expired, he said. "The use of patented compounds in preclinical studies is protected," Scalia wrote, in sending the case back to lower court to determine the exact scope of drug companies' rights under federal law. Mauricio Flores, an attorney representing Integra, said he was disappointed that justices overturned the $6 million jury verdict for Integra. "We're satisfied we'll have an opportunity to go back to lower court to prove our claims," he said. Integra's lawsuit accused Germany's Merck KGaA of infringing on a patent that Integra holds on certain molecules Merck is using for research. The peptides, which are biological molecules, contain a specific amino acid sequence that researchers hope could inhibit tumors. Integra, based in Plainsboro, N.J., sued for patent infringement after Merck set up animal trials for a cancer therapy as a first step in a decade-long effort to win federal approval for use in humans. The experimental cancer drug included the peptides that Integra says are patented until 2006. The U.S. Court of Appeals for the Federal Circuit ruled last year 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. But in its opinion Monday, the Supreme Court disagreed. It said drug companies should have more leeway under the FDA exemption to investigate new drugs, not just generics, so long as the studies are "reasonably related" to a future drug application. Legal experts said the ruling is a boon for big drug companies, who will save millions in licensing costs when conducting startup research. It also will promote more drug development in the U.S. rather than being outsourced to foreign countries, which historically have had looser patent protections. In the last decade, consumer spending on prescription drugs has quadrupled from $40.3 billion to $162.4 billion. "Less money will be spent on patent infringement threats and battles and more on unencumbered research, development and testing," said Janice Mueller, a patent law expert at the University of Pittsburgh law school. Added E. Joshua Rosenkranz, an attorney representing Merck, "It means that researchers will not have to sit on their hands for a decade when they have discovered a promising new drug, but rather, without skipping a beat, can conduct the experiments they need to conduct." Justices Sandra Day O'Connor and Stephen G. Breyer, who own shares in U.S.-based Merck & Co., had initially recused themselves when the court considered whether to hear the case. But after attorneys made clear in January that the German-based Merck split from the U.S. company in the early 1900s and wasn't affiliated, O'Connor and Breyer opted to participate in the decision. The case is Merck v. Integra Lifesciences, 03-1237. Supreme Court: supremecourtus.gov