COX-2 Patent Ruling Hinges on Important Principle of Patent Specification

In a split, 7-5 decision en banc (University of Rochester v G D Searle & Co Inc et al), the US Court of Appeals for the Federal Court has refused to review a lower court ruling against the University of Rochester in a patent dispute which raises an important principle. The contentious issue is what precisely is required in a patent specification under US law. Some courts have held that if a person skilled in the art can reproduce the invention from the information in the patent specification, that is sufficient. However, other decisions have suggested that the precise nature of the invention itself, and not just how to produce it, must be disclosed in the specification. In this case, the University of Rochester owned a patent on methods to treat inflammation, which included administering a substance that acts to inhibit COX-2 activity (US Patent No 6,048,850). (COX-2 is the particular substance that causes inflammation, and so substances that inhibit it are generally desirable). However, the patent in question does not identify any COX-2 inhibiting substance, or specify how to make one. The defendants are drug companies that claim have marketed substances that inhibit COX-2 activity. Affirming the District Court decision below, the Court of Appeals, by a narrow majority, held that the patent did not cover the COX-2 inhibiting substances themselves because the patent specification did not include a separate "written description" of the invention as claimed. As such, since the claimed invention could not be practiced based on the patent's specification, the patent was therefore invalid. In the words of one of the majority concurring decisions, "The fact, if it is a fact, that written description has only been relied upon in recent years as a ground of invalidity does not remove that requirement from the statute." The decision has raised concerns among patent holders, as their rights may be in jeopardy if this rule were to be applied to their patents. Moreover, the split decision suggests that there is no judicial consensus about exactly what is required in a patent specification, and that an authoritative decision by the US Supreme Court may be needed to settle the issue. For a news report, see: http://makeashorterlink.com/?V20B128D8. For copies of two decisions in the Court of Appeals, see: http://fedcir.gov/opinions/03-1304o.doc (Order); and http://fedcir.gov/opinions/03-1304.doc (Earlier Decision by Court of Appeal). Summary by: James Kosa