BIO files Amicus Brief in Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., U.S. Court of Appeals for the Federal Circuit

BIO’s members create products and services that have long lead times from invention to market. Among the longest time-to-market technologies are radiopharmaceutical diagnostics (7-9 years), agricultural chemicals (9 years), medical devices (first-in-class) (5-10 years), genetically modified crops (6 to 13 years), in vitro diagnostics based on new diagnostic correlations (7 to 10 years), and pharmaceuticals (12-16 years). Only oil and gas drilling (16 years) and fuel cells (7-25 years) are technologies with similar or longer times to market.

Because of the long lead time, patents on foundational innovations often issue before all possible uses or variations of a disclosed medical invention have been explored, and improvements often—and desirably—occur while products and services are being developed and regulated, and such improvements in medicine can generate substantial health benefits.

Patenting of improvements over time leads to a cascade of overlapping patent terms of increasingly narrow scope. Thus, a patent covering an improved therapy or a new use of a known drug often issues in an intellectual property landscape that includes an earlier patent which may dominate the improvement. In obviousness challenges to such improvement patents, such as those at issue in this appeal, evidence of secondary considerations (e.g., commercial success, failure of others, long-felt but unmet need) is often used to demonstrate nonobviousness of the improvement invention.

The district court and others have relied on Merck & Co. v. Teva Pharm. USA, Inc., 395 F.3d 1364 (Fed. Cir. 2005), rehearing en banc denied, 405 F.3d 1338 (Fed. Cir. 2005), to discount to the point of irrelevance the probative value of such objective evidence when a patentee also held dominating patent rights. BIO and its members are concerned that the development and commercialization of important therapeutic improvements will be disincentivized if a party’s dominating patent rights are permitted automatically to eliminate the probative value of objective evidence of non-obviousness.