Tuesday, November 30, 2004

End of the line for URochester COX-2 patent

from the AP:

-->The University of Rochester's costly legal battle to reap billions of dollars in royalties from a new class of "super aspirin" appeared to be over November 29, 2004, after the U.S. Supreme Court refused to hear its claims. The high court denied the school's request for a review of lower court rulings that dismissed its patent infringement claims against the makers of lucrative painkillers known as cox-2 inhibitors, which include Pfizer Inc.'s Celebrex and Merck & Co.'s Vioxx.<--

[The use of the term "super aspirin" is a bit misdescriptive, because COX-2 drugs offer no more pain relief than do conventional NSAIDs.]

I had written in the May 2003 issue of Intellectual Property Today:

-->In University of Rochester v. G. D. Searle, et al., 2003 U.S. Dist. LEXIS 3030, the Federal Circuit will have the opportunity to tackle so-called "reach-through" claims, claims which attempt to reach-through from one discovery to obtain patent protection on a different discovery not yet made. In the area of non-steroidal anti-inflammatory pain relievers (for example, aspirin, RELAFEN), researchers at the University of Rochester had a theory that two enzymes were implicated in inflammatory pain, and that inhibition of one of them (COX-2) but not the other (COX-1) would be beneficial in treating humans. They identified the portion of the genome coding for COX-1 and COX-2, and were able to make these two enzymes. However, they did not make, or suggest how to make, a drug which was capable of selectively inhibiting the COX-2 enzyme. The University of Rochester obtained a patent claim for a method of treating humans with a drug capable of selectively inhibiting the COX-2 enzyme, and they asserted the patent the day it issued. However, in the litigation, this claim was invalidated because of the failure of the patent to describe such a drug or a way to make such a drug. The defendants in that litigation had made a drug capable of selectively inhibiting the COX-2 enzyme, and were selling it to the public (CELEBREX). One suspects that the decision will be affirmed by the Federal Circuit. [IT WAS.] From a patent law standpoint, 35 U.S.C. section 112 requires that the patent applicant provide a written description of the invention to show what it is that the inventor possesses and that the applicant show that the invention actually works. Patent law expresses the requirements of a deal between the inventor and the public. The public, in return for the grant of a right to exclude others for a limited period, is entitled to receive an invention which can be put into practice without undue experimentation. In the case of the University of Rochester patent, the public did not receive knowledge of how to obtain a drug to selectively inhibit the COX-2 enzyme, and thus could not use the invention as claimed. The public cannot live on promises of what could have been if some third party did significant work. Of Chairman Greenspan's issues, one notes that a determination that reach-through claims were valid would discourage the innovative effort of those who would actually bring a tangible, working product to the public. Economic growth, in the form of patients buying newly developed, viable drugs to foster better health, would be thwarted. <--

[In passing, with the issues with Merck's VIOXX, there is a whole new discussion about COX-2 inhibitors in regard to stroke and heart attack.]


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