Takeaway:  If a patent owner presents evidence of secondary considerations of non-obviousness, a petition asserting obviousness should address the evidence substantively.

In its Decision, the Board found that Petitioner had not established a reasonable likelihood that it would prevail in showing unpatentability of any of the challenged claims (1-10) of the ’522 Patent, and denied institution of inter partes review. The ’522 Patent is directed in part to polynucleotides encoding the extracellular region of an insoluble human TNF receptor (“TNF-R”).

The Board began with claim construction, stating that the claim terms are given their broadest reasonable construction in light of the specification. The first term discussed was “TNF receptor.” The Board agreed with Patent Owner that this term should be given its ordinary meaning and does not require a construction. The next term that the Board reviewed was “all of the domains of the constant region of a human IgG/IgG₁ immunoglobulin heavy chain other than the first domain of said constant region.” Patent Owner agreed with Petitioner’s construction with two caveats: (1) that the reference to IgG should refer to claims 1 and 7, and the reference to IgG₁ should refer to claim 1; and (2) that IgG and IgG₁ be limited to human origin. The Board noted that the parties did not dispute no. 2. The Board then adopted Petitioner’s construction. Regarding the last proposed construction of “about,” the Board agreed with Patent Owner that no construction was necessary.

The Board then turned to the single ground of unpatentability – whether the challenged claims are obvious over Smith, Capon, and Seed. Petitioner asserted three reasons that this combination fails: (1) the Petition presents no new art that was not considered previously by the Office; (2) the Petition did not explain adequately why one of skill in the art would combine teachings of the references to arrive at the claimed invention; and (3) Petitioner failed to address Patent Owner’s evidence of unexpected results presented in the prosecution history of the ’522 Patent.

The Board agreed with Patent Owner that Petitioner failed to show an articulated reason with a rational underpinning as to why one of ordinary skill would have combined Smith, Capon, and Seed to arrive at the claimed invention. Specifically, the Board agreed with Patent Owner that the generalized guidance in Seed and Capon would not have led one of ordinary skill in the art to produce a p75 TNFR-based fusion protein having a structure that corresponds to the expression products of the challenged claims or the protein encoded by the polynucleotides described in the challenged claims. The Board found Petitioner’s offer of a rationale to combine the references unavailing because Petitioner failed to offer persuasive evidence to explain why one of skill in the art would choose the Fc portion of the immunoglobulin heavy chain from the choices taught in Seed or Capon, and Petitioner only offered generalized teachings from the references to show a rationale to combine. The Board also found that Petitioner did not adequately address the objective indicia of nonobviousness presented to the Office during prosecution of the ’522 Patent.

Coalition for Affordable Drugs V LLC v. Hoffman-LaRoche Inc., IPR2015-01792 Paper 14: Decision Denying Institution of Inter Partes Review
Dated: March 11, 2016
Patent 8,163,522 B1
Before: Susan C. Mitchell, Brian P. Murphy, and Tina E. Hulse
Written by: Mitchell
Related Proceedings: Sandoz Inc. v. Amgen Inc., 773 F.3d 1274 (Fed. Cir. 2014); Immunex Corp. v. Sandoz Inc., No. 2:16-cv-01118-CCC-JBC (D.N.J.)