[author: Donald Zuhn]

Last week, a group of 23 industrial, environmental, food, and agricultural biotechnology companies sent a letter to Attorney General Eric H. Holder, Jr. and Solicitor General Donald Verrilli, Jr., expressing their concerns over Association for Molecular Pathology v. Myriad, which was remanded back to the Federal Circuit in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc. in March (see "Supreme Court Remands Myriad Case").  The group states that "it is essential that it be understood that this case could potentially adversely impact ours and other industries whose activities are far removed from the clinical diagnostic testing context in which this case is commonly discussed."

Noting that their products -- which include renewable fuels and chemicals, industrial enzymes, fermentates, pigments, dyes, fragrances, flavorants, food additives, bio-based specialty chemicals, cosmetics, biological fungicides and pesticides for farm and garden use, pest- and disease-tolerant crops, higher-yield plant varieties, drought-resistant crops, nutritionally improved plants, and genetically modified trees -- "were originally, in some way, modified or derived from natural sources," the companies indicate a "concern[] that the AMP case invites, potentially, a broad reinterpretation of the judge-made exclusion from patentability for 'manifestations of nature' that would create significant uncertainty about the patentability of technologies unique to the areas in which we conduct our businesses."  The group argues that "[v]isceral and unsubstantiated objections to human 'gene patents' should not be grounds for wholesale revision of an area of patent law that has long been settled," and contends that "[s]ubjecting [their] inventions to a new and uncertain patentability analysis under a broadened 'laws of nature' or 'natural phenomena' exclusion that is nowhere to be found in the Patent Act draws into question tens of thousands of issued U.S. patents and upsets longstanding, settled, investment-backed reliance interests."

The companies suggest that because Myriad and Prometheus were developed in the context of human diagnostics without a discussion of the broader implications of these cases, "many in our industry are concerned that unless some wider context is added, the very essence of what is patentable in our field of biotechnology will be jeopardized."  While noting that biotech companies had continued to pursue innovation despite recent economic tumult, the group indicated that "the patentability of their innovations was never as uncertain as it is in light of the AMP and Mayo cases."  The companies conclude by asking the Attorney General and Solicitor General to "carefully consider the[] implications as you develop the position of the US Government in the pending remand of the AMP case to the U.S. Court of Appeals for the Federal Circuit."

The 23 signatories to the letter are:  AgraQuest, Inc., Agrivida, Inc., ArborGen, Inc., AquaBounty Technologies, Inc., BASF Plant Science, Bayer Crop Science LP, Dow Agrosciences, LLC, DuPont, EPYGEN, Genomatica, Inc., Hematech, Inc., Mendel Biotechnology, Inc., Monsanto Company, Modular Genetics, Inc., Recombinetics, Inc., Renmatix, Inc., Senomyx, Inc., Sweetwater Energy, Inc., Syngenta Corporation, Targeted Growth Inc., Tate & Lyle, Yorktown Technologies L.P., and ZeaChem, Inc.