Federal Circuit Aligns Part of Patent Law With Realities of Biotechnology; Will the Court Go All the Way?

In a recent decision (In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009)) the Federal Circuit has done an end around the principle established in In re Deuel, holding that a method of cloning a gene makes obvious a claim to the gene.

In Deuel (51 F.3d 1552 (Fed. Cir. 1995)) the Federal Circuit reversed a Board of Patent Appeals Interferences decision holding a claim to a specific cDNA sequence obvious over the sequence of the protein encoded by the cDNA and known methods of cloning cDNA molecules using the sequence of the encoded protein. The decision in Deuel was clearly based on the priciple that the cDNA claimed was a chemical compound with a specific structure. The Federal Circuit reasoned there that because the cited prior art taught a method of obtaining a cDNA but (according to the court) did not provide any suggestion of the structure of the claimed cDNA, the claimed cDNA could not be obvious. The court in Deuel clearly focused on the lack of teaching in the prior art of any structure of the claimed cDNA. Although the court also mentioned that the prior art method of obtaining the cDNA was "obvious to try" and that "obvious to try" art was insufficient render a claim obvious, this was not the basis of the decision in Deuel, nor was it the legal principle thereafter applied from Deuel. The lasting legal principle from Deuel was that the structure of a claimed chemical compound could not be described by a mere method of obtaining that chemical (in the absence of a teaching suggesting the structure of the compound).

With amnesiatic sleight of hand, the Federal Circuit in In re Kubin recast In re Deuel as a case about the “obvious to try” principle in obviousness analysis. In Kubin the court affirmed a Board of Patent Appeals and Interferences decision holding a claim to a polynucleotide encoding a protein structurally and functionally related to a cell surface receptor protein obvious over prior art teaching the same receptor protein and a general method of obtaining the gene encoding the receptor protein.

The court first highlighted how obvious the art made it to isolate the gene encoding the receptor protein based on the protein and emphasizing that it was undisputed that the prior art method would almost surely result in obtaining the gene. Thus, the court agreed that there would have been a reasonable expectation of success in obtaining the gene using the method. The court then recognized that affirming the Board decision in Kubin would require the court to address the contrary decision of In re Deuel. To do so, the court noted that the Supreme Court decision in KSR v. Teleflex (550 U.S. 398 (2007)) had changed the landscape for obviousness determinations. In particular, the court spent some effort highlighting how KSR weakened the status of the “obvious to try” principle in assessing obviousness. The court even suggested that the Supreme Court in KSR was repudiating the obvious to try principle of In re Deuel (“Insofar as Deuel implies the obviousness inquiry cannot consider that the combination of the claim’s constituent elements was “obvious to try,” the Supreme Court in KSR unambiguously discredited that holding.”). The court also noted that the Supreme Court cited In re Deuel as supporting the “obvious to try” principle. However, as noted above, the holding in Deuel does not depend on the “obvious to try” principle. In any case, this repudiation of the holding in Deuel (now apparently based on application of the “obvious to try” principle) allowed the court to hold that the prior art method of obtaining the gene for the receptor protein made the claim to the gene itself obvious, noting that the proper application of the “obvious to try” principle supported a conclusion of obviousness.

In a sense, the decision in In re Kubin brings obviousness of biotechnology inventions back to more rational ground. Even in 1995 (and in the 1980s, the era of the invention in Deuel), biotechnologists considered cloning of a gene based on a protein sequence to be routine, with success given a high probability. Thus, the decision in In re Deuel was greeted with some disbelief by those knowledgeable in biotechnology. The Deuel decision was pro-patent and so might not have had clear negative consequences on the development and funding of the biotechnology industry except for one significant anti-patent decision that followed directly from the true principle of the Deuel holding.

In Regents of the University of California v. Eli Lilly (119 F.3d 1559 (Fed. Cir. 1997)) the Federal Circuit addressed the question of whether a method of obtaining a gene provided a sufficient written description of the gene to satisfy the requirements of 35 U.S.C. § 112, first paragraph. A specific human cDNA was claimed in patent at issue in Eli Lilly but the patent specification provided only the sequence of the rat version of the cDNA and a method of using the rat cDNA sequence to obtain the human cDNA sequence. It was agreed by the court and the parties that the method of obtaining the human cDNA was enabling and would (and did) result in the human cDNA when it was performed. However, neither the rat cDNA nor the method suggested the precise structure of the human cDNA. Citing the reasoning in Deuel, the court held that an enabled method of obtaining a gene did not provide an adequate written description of the gene because it did not provide sufficient information about the structure of the gene. There was no doubt that the method/structure aspect of Deuel was the basis for the holding in Eli Lilly:

"We had previously held that a claim to a specific DNA is not made obvious by mere knowledge of a desired protein sequence and methods for generating the DNA that encodes that protein. See, e.g., In re Deuel, 51 F.3d 1552, 1558, 34 USPQ2d 1210, 1215 (1995) ("A prior art disclosure of the amino acid sequence of a protein does not necessarily render particular DNA molecules encoding the protein obvious because the redundancy of the genetic code permits one to hypothesize an enormous number of DNA sequences coding for the protein."); In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed.Cir.1993). Thus, a fortiori, a description that does not render a claimed invention obvious does not sufficiently describe that invention for purposes of § 112, ¶ 1. Because the '525 specification provides only a general method of producing human insulin cDNA and a description of the human insulin A and B chain amino acid sequences that cDNA encodes, it does not provide a written description of human insulin cDNA. Accordingly, the district court did not err in concluding that claim 5 is invalid for failure to provide an adequate written description.

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A written description of an invention involving a chemical genus, like a description of a chemical species, "requires a precise definition, such as by structure, formula, [or] chemical name," of the claimed subject matter sufficient to distinguish it from other materials."

Eli Lilly, 119 F.3d at 1567-68 (emphasis in original).

The decision by the Federal Circuit in Ariad Pharmaceuticals v. Eli Lilly, 2008-1248 (Fed. Cir. 2009), issued the same day as In re Kubin, is just the latest written description case holding that a method of obtaining a compound does not provide an adequate written description of the compound.

I would hope that the more scientifically rational decision in In re Kubin would filter into the Federal Circuit’s written description jurisprudence, but I have serious doubts that it will.