Tuesday, June 14, 2005

AP on Merck v. Integra decision

from the Boston Globe (AP):

The Supreme Court gave drug companies more freedom to develop 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 Holdings Corp. It means major pharmaceutical firms like 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." [As smaller companies cease patenting their work, it will remain to be seen if consumers have benefitted.]

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 all right so long as the drug could not feasibly be marketed until after a rival's patent expired, he said.

In another case, the justices declined to hear the appeals of newspaper and television groups to restore federal rules easing local media ownership limits.

Without comment, the justices let stand a lower court ruling that threw out the new Federal Communications Commission rules as unjustified.

The proposed changes would have allowed a single company to own TV stations and a newspaper in the same area, and to own more TV and radio stations in a single market.


The Chronicle of Higher Education had a different take:

The U.S. Supreme Court ruled unanimously on Monday that pharmaceutical
makers have broad rights to use another party's patented material in
the course of developing new drugs without infringing the patent.
The case did not involve academe directly but was being keenly watched
by a number of universities that are active in patenting.
Several universities and academic organizations, led by the patenting
arm of the University of Wisconsin at Madison, had submitted a
friend-of-the-court brief that urged the Supreme Court not to broaden those rights. They had contended that the value of many university patents would be diminished
if the court expanded the rights of companies to use patented research

The case, Merck KGaA v. Integra LifeSciences I, Ltd. et al. No. 03-123,
arose because of a dispute over how much latitude drug makers were
entitled to under an exemption, enacted by Congress in 1984, that allows a party
to use patented materials and techniques as long as it was doing so as
part of an application for approval of a new drug before the Food and Drug

While the unanimous ruling went against the interests of Integra
LifeSciences, which the group of universities had supported, a
spokesman for the Wisconsin patenting organization, the Wisconsin Alumni Research
Foundation, said the decision was not a defeat. That's because, he
said, the justices included an important footnote in the 15-page ruling that
appears to limit the scope of the decision to things like patented compounds,
and not all sorts of research patents. The footnote states that the court was not expressing a view "about whether or to what extent" the exemption should apply to patented research tools that might be used in the course of evaluating and developing a drug for approval by the FDA. Justice Antonin Scalia wrote the opinion, which reflected many of the same points raised by several of the justices
during the April 20 oral argument on the case.

Andy Cohn, spokesman for the Wisconsin foundation, said the footnote means that the Supreme Court has not declared that any patented research inventions used in the course of developing a new drug will now be covered by the exemption. "They made
the distinction that we asked them to make," he said on Monday.
Merck KGaA is a German company that is not affiliated with the American
drug company with a similar name. Integra LifeSciences is based in Plainsboro,

The full text of the ruling is available on the court's Web site
v/opinions/04pdf/03-1237.pdf> (requires Adobe Reader,
available free).


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