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Intellectual Property & Technology

Reach-Through Claims Declared Invalid

by Ranjana Kadle

A recent case (University of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004)) decided by a three-judge panel of the Court of Appeals for the Federal Circuit (CAFC), which the CAFC refused to review en banc (University of Rochester v. G.D. Searle & Co., Inc., No. 03-1304 (Fed. Cir. July 2, 2004) Order)), delivered a blow against the so called “reach-through” claims in U.S. Patent No. 6,048,850 (the ‘850 patent). “Reach-through” claims refer to claims for products or uses for products when experimental data is provided for screening methods or tools for the identification of such products.

The ‘850 patent is directed to cyclooxygenases (COX) inhibitors. The COX enzymes (COX-1 and COX-2) catalyze the synthesis of prostaglandins, which are implicated in inflammation. Traditional anti-inflammatory drugs (such as ibuprofen) ameliorate inflammation by inhibiting harmful COX-1 but also cause gastric problems by inhibiting the helpful COX-2. The ‘850 patent provided a method for screening compounds that specifically inhibited COX-2 (implicated in inflammation) but not COX-1 (thereby reducing gastric side effects). The claims of this patent were directed to a method of selectively inhibiting COX-2 in a human by administering an inhibitor of the gene for Protaglandin H synthase 2 (PGHS2—another name for COX-2). Upon the issuance of a patent, the assignee of the ‘850 patent, University of Rochester, sued G.D. Searle (and related companies including Pfizer), the makers of Celebrex, a COX-2 inhibitor.

Upholding a lower court’s decision, the CAFC noted that while a screening method was provided in the ‘850 patent for identification of COX-2 inhibitors, no COX-2 inhibitors had been identified and no treatment demonstrated. Therefore, the court upheld the invalidation of claims directed to methods of selectively inhibiting PGHS2 activity in humans for failure to meet the written description requirement. The University of Rochester has indicated it will file a request for an en-banc hearing of this case by the CAFC.

This case emphasizes the hurdles faced by academic and research institutions in their quest to obtain protection for early-stage discoveries. In amici briefs filed by the University of California and the University of Texas, the academia cautioned that invalidating this patent would have an adverse effect on technology transfer programs and thereby undermine the Bayh-Dole Act. The court, however, rejected their argument and noted that the Bayh-Dole Act was intended to enable universities to profit from their federally funded research and not to relax the statutory requirements of patentability.

This case emphasizes the importance of drafting claims that conform not only to the enablement requirement (which explains how to make and use the invention) but also to the written description requirement (which allows one skilled in the art to recognize the invention).