Gene patents (and by extension biotech patents) have received quite a bit of attention lately from the ongoing Myriad Genetics case, which challenges the appropriateness of genetic material for patents. However, patentable subject matter is only one hurdle would-be patentees must face in order to obtain a coveted patent. The invention must also be novel and not obvious over what is known in the field of art at the time of invention. This last point recently caused one patentee to lose his battle for a patent, and due to his own publication at that.
In a unanimous decision, the Court of Appeals for the Federal Circuit affirmed the U.S. Patent and Trademark Office’s decision that Patent Application 10/082,772 to Droge was obvious, and therefore unpatentable, in view of a previous patent (US 6,143,530 to Crouzet) and Droge’s own prior publication. In re Droge, (Fed. Cir. September 21, 2012). The invention at issue is a method of recombining DNA in eukaryotic cells in a site-specific manner using certain mutated versions of the enzyme Int. The Crouzet patent teaches using wild-type Int to facilitate site-specific recombination in eukaryotic cells, but does not mention mutated forms of Int. Droge’s own prior publication, however, discusses the efficacy of using mutated Int (Int-h and Int-h/218 – the same mutations claimed in the application at issue) to facilitate site-specific recombination in prokaryotic cells. Droge argued that it would not have been expected that these mutant Int variants would be effective in eukaryotic cells as well, being different cell types with different characteristics, co-factors, and DNA structure. The Federal Circuit, however, was not swayed. Citing another article that one of the mutant variants Int-h recombines identically with DNA structured as in prokaryotic and eukaryotic cells, the Federal Circuit held that this created a “reasonable expectation of success” – the hallmark for obviousness. They remind us that “[o]bviousness does not require absolute predictability of success…all that is required is a reasonable expectation of success.” citing In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009). Accordingly, the claims are unpatentable.
This ruling is a reminder of two important aspects of patent law, particularly in the biotechnology areas. First, an applicant’s own publications can be used against them as prior art, depending on the dates of the patent application, so journal publications and presentations should be timed carefully. Second, it is not enough to have patentable subject matter – the invention also cannot be obvious.
A link to the decision can be found here.