Genentech recently submitted two opening appellate briefs to the Federal Circuit in connection with its appeals from the Board’s final written decisions in Hospira’s IPRs, IPR2016-01771 and IPR2016-01837, which found that the challenged claims of U.S. Patent Nos. 7,622,115 and 7,807,799, respectively, were unpatentable in view of the prior art.
The ’115 patent is directed to a method of treatment of cancer by administering an effective amount of bevacizumab and additionally assessing the patient for gastrointestinal perforation, a potential adverse event, during treatment. The ’799 patent is directed to a protein purification method using protein A chromatography at a temperature in the range from about 10 °C to about 18 °C. In March of this year, the Board found that all claims of the ’115 patent were obvious over the prior art, and that all challenged claims of the ’799 patent (claims 1-3 and 5-11) were anticipated by and/or obvious over the prior art.
Genentech is asserting both of these patents in its BPCIA litigation against Amgen regarding Mvasi (bevacizumab-awwb), a biosimilar of Avastin®. Pfizer is developing a bevacizumab biosimilar of its own, PF-06439535. The ’799 patent, whose claims are not limited to a single antibody, has also been asserted in Genentech’s BPCIA litigations against Pfizer, Celltrion and Teva, and Samsung Bioepis regarding their respective proposed biosimilars of Herceptin® (trastuzumab), and against Sandoz and Celltrion and Teva regarding their respective proposed biosimilars of Rituxan® (rituximab).
In both opening appellate briefs, Genentech challenges the merits of the Board’s final written decisions, including the Board’s claim construction and patentability analyses, as well as the constitutionality of subjecting patents that issued before the America Invents Act (AIA) was enacted in 2011 to inter partes review. According to Genentech, the AIA established the IPR procedure, and “the retroactive application of inter partes review to a patent issued before that procedure existed is unconstitutional, a taking without just compensation and a denial of due process,” in violation of the Fifth Amendment to the U.S. Constitution.
In Genentech’s opening brief in the ’115 patent appeal, it outlines the following issues on appeal:
- May the Board base its Final Written Decision on a construction different from that proposed by either party, where no basis is provided for the construction, where the Board does not explain in any reasonably clear way what its construction means, and where Genentech was provided no opportunity to argue the patentability of the claims as the Board construed them?
- May the Board enter a Final Written Decision determining that the challenged claims are obvious, without any analysis or discussion of the contrary evidence and without considering the objective indicia of nonobviousness the patentee presented?
- May the Board, consistent with the U.S. Constitution, conduct inter partes review of a patent issued prior to enactment of the Leahy-Smith America Invents Act, Pub. L. 112-29, 125 Stat. 284 (2011)?
In its opening brief in the ’799 patent appeal, Genentech raises the following issues on appeal:
- Whether the Board erred in construing the claim language “about 18° C.”
- Whether the Board erred in applying the law of anticipation and made findings not supported by substantial evidence.
- Whether the Board erred in applying the law governing obviousness and in its ultimate obviousness conclusion.
- Whether it violates the U.S. Constitution to subject patents issued prior to the America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011), to inter partes review.
The Court has certified Genentech’s constitutional challenges to the U.S. Attorney General, who has been directed to inform the Court whether the United States intends to intervene in the appeals within 30 days: by September 24 for the ’115 patent appeal, and by September 27 for the ’799 patent appeal. Both appeals are stayed pending the resolution of the Attorney General’s feedback.
Stay tuned to Big Molecule Watch for further developments.