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Patent Law Update

July 3, 2004

An important university biotech case that could significantly impact patent law may be headed to the Supreme Court - if the University of Rochester has its way. At issue is whether a patent can be held invalid if it fails to provide a "written description" of the invention. The University of Rochester obtained a patent on a method to identify drugs that can block the so-called COX-2 enzyme that produces pain and inflammation without inhibiting the enzyme that coats the stomach lining. It then sued several pharmaceutical companies, including Pfizer Inc., alleging that Pfizer's sale of the COX-2 inhibitor drugs Celebrex and Bextra infringed its patent.

In February, the Federal Circuit ruled that the university had failed to comply with patent law's written description requirement since the university did not identify a specific compound in its patent. Legal analysts believe that the matter is ripe for the Supreme Court since the several judges said that the courts have issued conflicting opinions on the subject. Some analysts feel that the patent law's enablement requirement -- holding that an invention must enable any person skilled in the art to make it -- is sufficient. The impact on research universities - where most of the inventions are early stage - could be significant.

While it is unclear whether the University of Rochester will petition the Supreme Court to hear the case, patent lawyers, as well as universities and the pharmaceutical and biotech industries, are closely following the case.