Posts Tagged: "genus claims"

The Supreme Court’s decision in Amgen Inc. v. Sanofi, 143 S. Ct. 1243, 1248 (2023), found that antibody claims defined by their binding and blocking function lacked enablement…. The Supreme Court’s decision relied highly on the unpredictability of the art—scientists cannot always predict how substitutions of even single amino acids will affect the binding and/or blocking function of an antibody. The disclosed methods of identifying species within the scope of the claim were little more than “trial and error.”… The consensus seems to be that Amgen generally forecloses broad genus claims in the biotechnology field. The remaining questions are: Are patent applicants limited to claiming species (e., sequence listings)? What steps may a patent applicant take to obtain broader coverage?

Earlier today, the United States Supreme Court issued its decision in Amgen, Inc. v. Sanofi et al. The Court held, as many feared they would, that the 26 antibody examples and detailed instructions for generating additional antibodies within the genus—which covered some 400 pages and included a CD Rom of the x-ray crystallography coordinates of Amgen’s “anchor” (or lead) antibodies 21B12 (Repatha) and 31H4—was insufficient to satisfy the enablement requirement. Unfortunately, the Supreme Court did not explain what level of detail would have been sufficient, nor did the Court provide direction to the industry on what more is expected to satisfy the enablement requirement. So, we simply learned today that the extraordinary disclosure and detail provided by Amgen was not enough.

The U.S. Supreme Court heard three separate arguments today in Amgen v. Sanofi, a case that even Sanofi’s counsel agreed could effectively wipe out patents involving genus claims if the Court sides with Sanofi, or—as counsel for Sanofi and the Solicitor General’s Office suggested the Court could do—if it were to dismiss the case as improvidently granted.

On March 6, biotechnology developer Amgen filed a reply brief  with the U.S. Supreme Court in its appeal of the invalidation of its patent claims covering antibodies effective at blocking low-density lipoprotein (LDL) cholesterol receptors. The brief responds to arguments raised both by rival pharmaceutical firm Sanofi and the U.S. federal government in Amgen’s appeal of the invalidation of its patent claims as a matter of law under 35 U.S.C. § 112, which the district court entered on judgment as a matter of law (JMOL) after a jury verdict upheld the validity of Amgen’s patent claims.

In a precedential decision published Monday, the United States Court of Appeals for the Federal Circuit (CAFC) affirmed the Patent Trial and Appeal Board’s (PTAB) decision to invalidate a pharmaceutical patent owned by the University of Minnesota. Gilead Sciences filed an inter partes review (IPR) in 2017 challenging the claims of the university’s  U.S. Patent 8,815,830 as unpatentable. The ‘830 patent covers chemical compounds that prevent the reproduction of viruses or the growth of cancerous tumors. The PTAB found that the University of Minnesota failed to provide a sufficient written description that supported the patent’s priority claim. The Board thus concluded that the patent would not guide a skilled artisan to the patent’s claims. The CAFC agreed with the PTAB’s decision and with the ruling that a 2010 patent application publication filed by Gilead was “prior art” over the university’s patent.

The United States Supreme Court is soon poised to decide the fate of the enablement requirement, and the patent community is collectively holding its breath, wondering if the Court will strike a deathblow to the biopharmaceutical industry—simultaneously making all patents harder to get and even easier to challenge than they already are. The Supreme Court does not have a strong track record of objectively getting patent issues correct, at least not from a pro-innovation standpoint, although the Justices and their supporters likely would disagree. The undeniable truth, however, is that since the Supreme Court issued its decision in eBay v. MercExchange, virtually every decision of consequence to the patent system has made patent rights weaker and patents themselves easier to successfully challenge.

On November 4, the U.S. Supreme Court granted Amgen’s petition for certiorari against the advice of the U.S. government – taking up Amgen’s challenge to the Federal Circuit’s enablement review of its PCSK9 antibody patents covering evolocumab (Repatha®). In its petition, Amgen asserts that the Federal Circuit has gone too far in invalidating its PCSK9 antibody patents by imposing a disclosure burden beyond the requirements of 35 U.S.C. § 112. Notably, the Supreme Court, albeit with a different composition, recently declined to hear several other similar cases raising issues with the Federal Circuit’s enablement precedent.

The United States Solicitor General (SG) on Wednesday accepted the U.S. Supreme Court’s invitation to file an amicus brief regarding Amgen’s petition for certiorari in its case against Sanofi. Amgen is seeking review of the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) decision invalidating antibody patent claims based on a lack of enablement for genus claims. The High Court invited the SG to file a brief in April and, on September 21, the SG recommended that the Court deny the petition and said Amgen’s argument that the CAFC “erred by treating enablement as a question of law and by examining the full scope of the claims in assessing whether they are fully enabled…. lack merit.”

The issue was whether the PCT, which disclosed a “connection to fibre optics bundle which provides for lighting” was a sufficient written description to support the “light guide” “permanently affixed” in the “first channel” of the patented claims. The Board reversed the Examiner and concluded that the earlier application had sufficient written description to qualify as a priority document… The Federal Circuit affirmed. The disclosure of a species, here a “fibre optics bundle,” was sufficient support for a priority claim by a later-filed patent application utilizing genus claims, here a “light guide,” because the patent-in-suit was in a predictable art field and the genus claims covered well-known limitations.