In an American Antitrust Institute (AAI) White Paper issued today, AAI Vice President Diana Moss sets out the major issues involving the development of generic competition in a genetic trait for soybean tolerance to the herbicide glyphosate. One of the many competitive issues in the agriculture industry today is the intersection of competition law and intellectual property (IP) protection, particularly in the transgenic seed industry for crops such as soybeans, corn, and cotton. The debate has been triggered by the impending expiration of the patent on a major trait – Roundup Ready® – in 2014, leaving a short time for generic rivals to bring new seed products containing a generic trait to market at the time of patent expiration.
Moss’s paper, “Generic Competition in Transgenic Soybeans,” covers five major points concerning the transition to generic competition: the benefits of generic transgenic soybeans; the likely effect on generic competition of competitive problems in the genetic traits markets; the importance of securing a path to market for generic traits; what is missing from the current industry approach; and policy priorities.
Moss states that an independent process, backstopped by a legislative agenda, is needed to develop transparent and enforceable terms and conditions governing access to IP. Such IP is necessary to perform on-patent and post-patent R&D in order to bring new seed products containing the generic trait to market. Given the cramped time frame and unlikelihood that Congress can act quickly, however, a second priority is antitrust enforcement. An antitrust remedy under Section 2 of the Sherman Act would clarify critical IP access issues that are central to promoting generic competition.
Diana Moss 720-233-5971