The Supreme Court gave drug companies more freedom to develop new disease-fighting therapies, ruling yesterday that rival firms' patents...
WASHINGTON — The Supreme Court gave drug companies more freedom to develop new disease-fighting therapies, ruling yesterday 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. It means that major pharmaceutical companies such as Eli Lilly and Pfizer 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 marketed until after a rival’s patent expired, he said.
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“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 Merck 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 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 yesterday, 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.