Amicus Briefs

The Biotechnology Industry Organization (BIO) is the country’s largest biotechnology trade organization, representing over 1100 companies, academic institutions, and biotechnology centers in all 50 States and countries around the world.
INTRODUCTION BIO and CLA submit this brief in support of the decision below, and also to counter the troubling and unsubstantiated assertions of the amici in support of the Appellants. BIO and CLA reject the proposition that this Court’s recent declaratory judgment standing cases have departed from guiding Supreme Court precedent. Equally important, BIO and CLA reject the proposition of amicus Intellectual Property Professors (“IPP”) that patent validity issues warrant a departure from, and essentially a dilution of, traditional standing requirements.
The Federal Circuit Court previously concluded that the claimed isolated genomic DNA and cDNA molecules in this case are patentable compositions of matter. Nothing in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), changes the framework for that analysis or the principles that informed this Court’s decision. The composition of matter claims therefore remain patent eligible under 35 U.S.C. § 101. Method claim 20 also easily survives review, because it involves the use of a transformed cell that itself would be patent eligible.
The Federal Circuit's majority panel decision in this case upsets the delicately balanced, congressionally created incentive system for reexamination.  It is inconsistent with the relevant statutes and imposes a rule that would create massive implementation challenges in the USPTO.  At bottom, the decision conflates the separate and distince concepts of argument estoppel and claim amendment, thereby creating uncertainty for amici, investors, customers, and the general public, which benefits greatly from innovation in the life sciences industries.  
In this brief filed jointly with the Association of University Technology Managers and CropLife International, BIO explains that the current high burden of proof for invalidating a patent in court has deep historic roots in Supreme Court law, and has been consistently applied by the lower courts for many decades.
In the brief filed in support of neither party, BIO asserts that the existing Federal Circuit standard of liability for infringing a process patent when the steps of the patented process are practiced by multiple different entities is too inflexible, and should be replaced with the kind of fact-intensive inquiry that allows for fair allocation of liability in other areas of the law.