In our previous note, we had taken a rather optimistic view of the post-Myriad patentability of patents directed towards purified non-genomic DNA biological products, such as, for example, stem cells, peptides, antibodies, industrial enzymes, vaccines and diagnostic assays, among others. We had hoped that the courts and the USPTO would not extend the Myriad ruling to these other types of patentable molecules. Currently this view appears to have been somewhat over-optimistic.
On March 4, 2014, the United States Patent and Trademark Office (PTO) issued guidelines to its examiners (the Guidelines) following the Supreme Court’s 2013 Myriad decision (Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)).
Based on the Guidelines, it appears that the new 35 U.S.C. 101 rejections will extend well beyond the DNA gene claims that were invalidated in Myriad. The Guidelines apparently will apply to several technologies besides nucleotide probes and primers, and include peptides, stem cells and isolated or purified biological products (e.g., cytokines, peptide hormones, etc.). The USPTO will also apparently apply 35 U.S.C. 101 rejections to combinations of components such as vaccines, and nucleotide and antibody multiplex diagnostic claims.
Currently the USPTO is reviewing public comment and is considering whether the Guidelines need to be revised. A number of commenters have taken stances disagreeing with the USPTO’s current extension of the natural products doctrine into other types of molecules besides DNA. We are hopeful that perhaps that the Guidelines may be revised in the wake of these comments.
However, for clients, as of right now, it appears that the scope of claims obtainable in biotechnology and chemistry inventions has been narrowed significantly by Myriad as interpreted by the USPTO. According to the USPTO, any type of natural product requires a substantial structural change in the natural product itself. But what is that “substantial structural change”? For example, is a “pharmaceutically acceptable composition” claim limitation a sufficient ground for overcoming a natural product-based rejection? Will a fusion protein or an antibody be considered a new structure?