On September 8, 2008, the United States Court of Appeals for the Federal Circuit ruled that certain claims of a patent owned by Carnegie Mellon University were invalid as lacking adequate written description. Carnegie Mellon University v. Hoffmann-La Roche, Inc., Nos. 2007-1266; 2007-1267 (Fed. Cir. September 8, 2008). Despite arguments that the claims were directed to a biotechnology tool combining well-known elements and that one of the claimed elements had been a subject of scientific study since at least the 1970s, the court affirmed a lower court summary judgment holding of invalidity.
The claims at issue cover plasmids containing bacterial DNA polymerase I genes. Plasmids are DNA constructs that can be engineered to manipulate genes of interest and to grow the gene of interest in a host cell. The invention of the patents at issue stemmed from a discovery that the DNA polymerase I gene (polA) of an E. coli bacteria could be grown successfully in a host cell if the gene’s internal regulation mechanism was removed (if the natural promoter of the polA gene was deleted). Consistent with this discovery, the patent specification only described this single gene (and its single natural promoter). In contrast to this disclosure, Roche argued that the claims at issue covered a broad bacterial genus containing thousands of bacteria species and that the sequence of the polA gene would differ among bacteria species. Based on these set of facts, the court sided with Roche and affirmed the holding of the lower court that the claims were invalid as covering a genus not supported by a sufficient number of DNA species.
The court refuses to distinguish Regents v. Eli Lilly as limited to novel DNA sequences.
In the decision, Carnegie Mellon unsuccessfully argued that the courts prior decision in Regents of University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), should be limited to claims directed to novel DNA sequences because the patent claims at issue in Eli Lilly covered novel insulin DNA sequences. The court, however, rebuffed this argument, holding that nothing in Eli Lilly limited the decision to novel DNA sequences.
The court finds that three is not enough to support a DNA genus claim.
Under the Eli Lilly decision, a claim covering a DNA sequence must be supported in the specification by a “representative number of species.” How many species is enough to support a nucleotide claim is a question that has beleaguered patent practitioners since the day the court handed down the Eli Lilly decision. In the instant Carnegie Mellon decision, the court held that a single species in the patent specification and evidence of two additional species known in the art at the time of filing was not sufficient. In other words, three species was not enough. The future impact of this “three is not enough” holding, however, remains to be seen. As stated in the Carnegie Mellon decision, the doctrine under Eli Lilly is fact specific and requires an inquiry into, among other things, the knowledge in the art, the prior art, and the maturity and predictability of the technology.
The fate of biotechnology tool claims is still to be determined
Carnegie Mellon argued to the court that its invention was a biotechnology tool and therefore outside the scope of the Eli Lilly decision. As discussed above, the court rejected this distinction. The Carnegie Mellon decision leaves unanswered, however, how the doctrine of the Eli Lilly decision impacts inventions that include DNA but where the DNA is a marginal aspect of the invention.
If you have any questions about the information in this alert or the ramifications of the coort’s decision in Carnegie Mellon University v. Hoffmann-La Roche, Inc please contact:
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