Immunex Corporation, Amgen Manuf., Ltd., Hoffman La-Roche Inc. v. Sandoz Inc., et al.
Docket No. 2020-1037
O’MALLEY, REYNA (D), CHEN
July 1, 2020
Update (May 17, 2021): SCOTUS denied Sandoz’s petition for writ of certiorari.
Brief Summary: DC finding of no invalidity for obviousness-type double-patenting (no common ownership), written description or obviousness affirmed.
Summary: Sandoz appealed abbreviated Biological License Application (“eBLA”)-related DC judgment that Sandoz has failed to prove the Enbrel® (an anti-TNF antibody) patents-in-suit (US 8,063,182 and 8,163,522) were invalid for obviousness-type double patenting, lack of written description, or obviousness. Immunex (which was acquired by non-party Amgen and was the original licensee) is Roche’s exclusive licensee of the patents-in-suit. Sandoz argued for invalidity under obviousness-type double patenting based on “several patents filed by Immunex Corp. in the years leading up to and shortly after the approval of Enbrel®” but the DC concluded “(1) that Sandoz’s proposed test for common-ownership does not apply; (2) even that test applies, the patents-in-suit and the asserted double-patenting reference patents are not commonly owner; (3) even if they are commonly owned, the two-way, rather than the one-way test…applies as to come of the double-patenting references; and (4) the patents-in-suit are patentably distinct from each of the asserted double patenting references.” The FC panel determined that the Roche-Immunex exclusive license “did not transfer all substantial rights” from Roche to Immunex, and therefore there was no common ownership of the patents cited by Sandoz. In reaching its decision, the FC panel rejected Immunex’s “time of invention” arguments (i.e., issue “arises only where the relevant inventions were owned by the same entity at the time of the invention”) since, e.g., it could “lead to the absurd result where, even if originally applied for by inventors working under an obligation of future assignment to an employer, patents may not be considered ‘commonly owned’ because, at the ‘time of invention,’ the assignment had not been effectuated” (In re Longi, FC 1985; Geneva Pharm., FC 2003; Ex Parte Maurice, BPAI 2005). And it found “Roche did not transfer all substantial rights in the patents to Immunex” because “although Immunex obtained the first right to sue, Roche retained the secondary right to sue” (Alfred E. Mann, FC 2010; Lone Star, FC 2019; Speedplay, FC 2000 (“a licensee’s right to grant royalty-free sublicenses to defendants sued by the licensor rendered illusory the licensor’s right to sue”, “precisely what Immunex cannot do here”)). It therefore concluded that “obviousness-type double patenting does not apply”. Judge Reyna disagreed, writing in the dissent that “Roche’s retained rights are illusory”. The FC panel affirmed the DC’s finding that the patents were adequately described (e.g., “[i]t is well-established that a patent specification need not re-describe known prior art concepts” (Capon, FC 2005; Zoltex, FC 2016; e.g., prior art referenced in priority application “shows that a POSA would have known the entire p75 sequence at the time of the invention”, “POSA would have followed [Example 11] to create” the antibody). The FC panel also affirmed the DC’s finding of no invalidity for obviousness (e.g., no error in finding “a POSA would be dissuaded from selecting or combining the components as claimed”, no persuasive secondary considerations evidence).