By Jason Rantanen
Genetics Institute, LLC v. Novartis Vaccines and Diagnostics, Inc. (Fed. Cir. 2011)
Panel: Lourie (author), Plager, Dyk (dissenting in part)
The Science: In the 1980's, scientists raced to develop a truncated version of Factor VIII, an essential blood-clotting protein. Two companies, Genetics and Novartis, successfully developed and patented truncated versions of this 2,332 amino acid protein. Genetics' patent, with a 1985 priority date, included claims directed at a version of the protein that removed between 581 and 949 amino acids in the region between amino acid 740 and 1690, while Novartis's patents, with a 1986 priority date, retained amino acids 1 to 740 and 1649 to 2332. The retention of amino acids 1649 to 1689 later turned out to be significant because this range binds to von Willebrand factor ("vWF"), an association that is critical for the optimal regulation of the blood coagulation.
Procedural Background: In 2008, Genetics sued Novartis to determine priority of invention under 35 U.S.C. § 291. Novartis argued that the district court lacked subject matter jurisdiction because the PTO's extension of the patent term from 2006 to 2010 under 35 U.S.C. § 156 applied to fewer than all of the patent claims, and that there was no interference-in-fact. The district court rejected Novartis's jurisdictional challenge but agreed there was no interference.
Appellate jurisdiction: Seeking to terminate the appeal at the outset, Novartis contended that the CAFC itself lacked subject matter jurisdiction because the Genetics patent expired three days after the district court's entry of judgment. None of the judges were persuaded. Distinguishing an earlier case in which the court held that it lacked subject matter jurisdiction because of a claim disclaimer, the CAFC held that the expiration of Genetics' patent "following the district court's final decision does not strip our court of jurisdiction over the present appeal."
Section 156 extension applies to the entire patent: The panel likewise affirmed the district court's finding of subject matter jurisdiction, rejecting Novartis's argument regarding the scope of the patent term extension. Although Section 156(b) limits the effect of the extension, it does not limit the extension to specific claims. "A patent as a whole is extended even though its effect may be limited to certain of its claims." Slip Op. at 17 (emphasis added).
No prima facie case of obviousness: To determine whether an interference-in-fact exists, courts apply a two-way validity test, i.e.: whether the claims of one patent invalidate the claims of the other and vice-versa. Both directions must be established. In this case, the court focused on whether the claims of Genetics' patent rendered obvious the claims of Novartis's patents.
Judge Lourie, joined by Judge Plager, concluded that they did not, as the lack of any reason to create a truncated protein that incorporated the 1649-1689 region supported the district court's finding of no prima facie case of obviousness. Any motivation, they reasoned, would have been in the opposite direction - to create a shorter protein and eliminate more amino acids, not to create a longer protein. Nor was the mere existence of a cleavage site (a natural point for cutting proteins) sufficient to provide the requisite reason to cut the protein at that point to make the claimed truncated protein.
Judge Dyk disagreed, pointing to cases holding that structural relationships may provide the requisite reason to modify compounds and can give rise to a case of prima facie obviousness. "[T]he truncated Factor VIII proteins of the Novartis patents are not merely homologs, analogs, or isomers - they are all variants of the exact same protein, exhibiting the exact same procoagulant functions." Dissent at 5 (emphasis in original).
The use of post-invention "unexpected results": The majority further supported their conclusion by citing to the unexpected result of the 1649-1689 region binding to vWF. The problem, however, lay in the lack of appreciation of this role until well after the priority date of Novartis's patents. Undisuaded, the majority pressed on, holding that such evidence was nonetheless relevant to nonobviousness: "[E]very property of a claimed compound need not be fully recognized as of hte filing date of a patent application to be relevant to nonobviousness." Slip Op. at 29. In other words, "evidence of unexpected results may be used to rebut a case of prima facie obviousness even if that evidence was obtained after the patent's filing or issue date." Id.
Again, Judge Dyk disagreed. "The majority's finding of nonobviousness is based entirely on hindsight and happenstance, and not on what the inventors knew at the time the Novartis patents were filed. See 35 U.S.C. § 103(a) (stating that an invention cannot be patented if 'the subject matter as a whole would have been obvious at the time the invention was made')." Dissent at 10 (emphasis in quotation). In Judge Dyk's view, the "unexpected properties must either be set forth in the specification or contemporaneously known to the inventors, rather than being discovered long after the fact." Id. at 12.
Judge Dyk's citation of Section 103 notwithstanding, it seems reasonable to look to post-filing or issuance evidence with respect to at least some secondary indicia of nonobviousness. Commercial success, for instance, would be difficult to establish if only pre-filing evidence were able to be considered. But I think he's right on the question of unexpected results. In my mind, a valid distinction can be drawn between discoveries of unexpected results - which really go to the fundamental question of obviousness - and commercial success, which must necessarily rely on the invention's post-filing success in the marketplace.
Practice note: Infringement defense attorneys writing discovery requests may want to take note of the majority's holding on unexpected results to press for either post-filing/issuance discovery on this point or a stipulation that such evidence will not be relied upon by the patent holder.