Without comment, the Supreme Court has declined to review a Federal Circuit decision on a University of Rochester patent involving the discovery of a separate cox-2 gene and related biological processes. The University had petitioned the Court to hear the case after a three-judge panel of the federal appeals court, in February, upheld a lower court ruling that declared the University’s patent invalid on the grounds that it did not provide sufficient information to meet what the court described as a "written description" requirement. In July, the federal appeals court had denied, on a 7 to 5 vote, a request by the University for an en banc hearing.
While the fact was uncontested that the University’s discovery of a gene and biological process enabled companies to create new drugs, the federal appeals court in effect imposed a second hurdle for such patents by saying that the Rochester patent was invalid because it did not include the precise chemical formula for such a compound.
The school committed more than $10 million in legal costs to defend the patent for a new cyclo-oxygenase enzyme that causes inflammation. Pharmaceutical companies later codeveloped lucrative cox-2 inhibitor drugs, such as Celebrex, and the school hoped to recoup royalties and fees ranging from $3 billion to $30 billion. The University is not anticipating any further legal steps at this time.
The Rochester decision, and other recent precedent, is sending a message that the Federal Circuit does not intend to limit the written description requirement solely to cases involving issues of priority or DNA structure. Rather, Rochester holds that the written description requirement applies when a patentee seeks to claim an aspect of an invention in terms of functionality rather than structure.