The Court of Appeals for the Federal Circuit has its hands full with biotechnology patent matters lately. Particularly, the Court will analyze patentable subject matter under 35 U.S.C. §101 regarding biotechnology patents in their consideration of the following three cases: (1)Prometheus Laboratories, Inc. v . Mayo Collaborative Services, (2) Classen Immunotherapies, Inc. v. Biogen Idec, and (3) Association for Molecular Pathology v. U.S. Patent and Trademark Office et al. (also known as “Myriad”). The first of these cases, Prometheus, concerns a method of treatment involving the steps of administering an amount of a drug to a subject and determining levels of 6-thioguinine (6-TG) and 6-methylmercaptopurine (6-MMP) in the subject. In Classen, patent claims are directed to a method of evaluating whether an immunization schedule affects a chronic immune-mediated disorder. These cases will be decided in light of the recent U.S. Supreme Court decision of Bilski v. Kappos, No. 08-964 slip op. (U.S. June 28, 2010). The Federal Circuit will also decide the highly publicized Myriad case on appeal, which involves patents claiming isolated DNA molecules that code for a polypeptide of BRCA1 or BRCA2, as well as various diagnostic methods relating to these sequences.
The Federal Circuit recently decided another biotechnology case, Intervet, Inc. v. Merial Limited, on a separate issue. In that case, the court construed several claim terms (such as “porcine circovirus type II” and “ORFs 1-13”) and one full claim, which was directed to an isolated DNA molecule of a particular sequence. Although the issue of patentable subject matter was not before the Court, one judge nevertheless wrote at length in the dissent about whether the term “isolated DNA” is patentable subject matter. Ostensibly, these comments are in the wake of theMyriad case and the buzz it has created.
Importantly, the Federal Circuit has not yet ruled on patentable subject matter as it pertains to biotechnology. Until it does, biotechnology methods and even “isolated DNA” claims remain patentable in the view of the U.S. Patent and Trademark Office, as long as they meet statutory requirements. See 66 Fed. Reg. at 1093.