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

BIO filed an amicus brief in Acorda Therapeutics, Inc., Alkermes Pharma Ireland Limited v. Roxane Laboratories, Inc., Mylan Pharmaceuticals Inc., Teva Pharmaceuticals USA, Inc., at the U.S. Court of Appeals for the Federal Circuit.

BIO members create products and services that have long lead times from invention to market. Because of the long lead time, patents on foundational innovations are often issued before all possible uses or variations of a disclosed medical invention have been explored. Improvements often 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 with increasingly narrow scope. Thus, a patent covering an improved therapy, or a new use of a known drug, often 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 is often used to demonstrate non-obviousness 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 is concerned 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.