Recently, the USPTO rejected claims in a pending patent application directed to the cDNA encoding the human natural killer cell activation inducing ligand (NAIL) protein. The patent examiner took the position that the claimed invention was obvious because the protein was known in the prior art and there were also known, reliable methods for identifying the gene sequence that codes for NAIL.
The patent applicants appealed to the Patent Office Board of Appeals, which affirmed the rejection. Undaunted, the applicants appealed that decision to the CAFC.
As might be expected, the biotech community took a dim view of the Patent Office position. A total of five (5) amicus curiae (literal meaning “friend of the court;” actual meaning “friend of one of the parties”) briefs were filed in support of the applicants. The brief of BIO – the Biotechnology Industry Organization (how cute) – argued that such DNA inventions should not be considered obvious “where the structure of the invention was not predictable as a combination of known structural elements, even if the route taken by the inventors to make their discovery was known in the art.” The BIO people went on to devote six (6) pages of their brief to a description of the dire consequences sure to result if the CAFC were to affirm the Board of Appeals.
Apparently, the CAFC was not impressed by either the legal arguments or the economic prognostications, as they did affirm the Board of Appeals. (In Re Marek Z. Kubin and Raymond G. Goodwin) The court had previously held that an obviousness finding was appropriate where the prior art “contained detailed enabling methodology for practicing the claimed invention, a suggestion to modify the prior art to practice the claimed invention, and evidence suggesting that it would be successful.” The BIO folks had argued that biotechnology was “unpredictable” and, hence, the success achieved by the inventors could not have been foreseen. The CAFC specifically rejected this argument and went on to opine that the science had developed to the point that cloning and sequencing techniques were no longer “unpredictable.” The court went on to state that “granting patent protection to advances that would occur in the ordinary course without real innovation retards progress.”