On Monday, March 27, the Supreme Court will hear oral argument in Amgen v. Sanofi, a case with the parties and 27 Amici, including the United States, weighing in on whether and how the Court should address the enablement requirement of Section 112 in the context of genus claims, and in particular, genus claims to antibodies in the pharmaceutical sciences. Depending on how the court focuses its analysis, the opinion could be as narrow as how the jury instruction should read for pharmaceutical antibody claims written in the form of “a binding site plus a function.” But some of the briefs invite the court to loosen the constraints of Section 112 by eliminating the requirement of enablement of the “full scope” of the claimed embodiments in favor of a test focused on the “make and use the invention” language in the statute without the “full scope of the claimed embodiments” language the courts have used for years, with implications not just for pharma but for any art that uses functional or genus claiming.
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.
Late last week, a slew of additional amicus briefs were filed with the U.S. Supreme Court in Amgen v. Sanofi, a closely-watched case that will consider the scope of the enablement inquiry under 35 U.S.C. § 112. More than 30 amici in total have now weighed in on the case. The Court granted certiorari in November 2022 over the U.S. Solicitor General’s recommendation to deny the petition. The justices granted cert on one of the two questions presented.
On January 3, a total of 14 amicus briefs and one motion for leave to participate in oral argument were filed with the U.S. Supreme Court on the question presented by Amgen Inc. v. Sanofi, on which the Supreme Court granted certiorari this past November. While organizations representing the most powerful interests in the technology industry supported the Federal Circuit’s holding that Amgen’s patent claims were invalid for lack of enablement, a wide swath of patent stakeholders are urging the Supreme Court to correct the enablement standard to continue the encouragement of genus patent claims. Below is a collection of arguments raised by several of the recent amicus filings from earlier this week.
The patent world is trained on the upcoming Supreme Court Amgen v. Sanofi case. That case is the first time in over 75 years that the Supreme Court is evaluating the meaning and scope of the enablement requirement of 35 U.S.C. § 112. The case offers the Court an opportunity to correct a negative trend in enablement law that has made it more difficult to protect groundbreaking, pioneering inventions. Waiting in the wings, however, is an equally important Section 112 case: . There, the petitioner sought review on whether “the ‘written description of the invention’ [is] to be measured by the statutory standard of ‘in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the same.’” As is apparent, Juno’s written description issue is highly intertwined with the Section 112 enablement issue in Amgen v. Sanofi.
Following the denial of Juno Therapeutics’ petition to the U.S. Supreme Court earlier this month, Juno last week petitioned the High Court for rehearing, arguing that the grant of certiorari in Amgen v. Sanofi warrants reconsideration. Juno explained that the issues presented in the Amgen case “are tightly related, and the outcome in Amgen is likely to at least affect, if not be outcome-determinative of, this case.” Juno is asking that the Court grant the petition for rehearing, vacate the denial of certiorari, and hold the case pending the outcome in Amgen.
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.
On November 7, the U.S. Supreme Court issued an order list showing that it had denied the petition for writ of certiorari filed in Juno Therapeutics, Inc. v. Kite Pharma, Inc. In denying the petition, the Court refused yet again to clarify the Federal Circuit’s questionable interpretation of U.S. patent code, this time within the context of the written description requirement of 35 U.S.C. § 112, and leaves in place an appellate court ruling that many believe will be very damaging to the United States’ life sciences innovation sector.
On October 5, American biopharmaceutical firm Amgen filed a supplemental brief at the U.S. Supreme Court, which comes about two weeks after the U.S. Solicitor General’s office filed a brief urging the Court to deny certiorari on Amgen’s petition for writ. Amgen’s petition seeks Supreme Court review of rulings in the lower courts invalidating Amgen’s patent claims for lack of enablement. Amgen’s latest brief argues that Solicitor General’s own arguments further support Supreme Court review to clarify the proper standard for reviewing questions of enablement under 35 U.S.C. § 112.
Last week, the U.S. Supreme Court received several amicus briefs filed in support of the petition for writ of certiorari filed in Biogen International GmbH v. Mylan Pharmaceuticals Inc. If cert is granted, this case will ask the nation’s highest court to clarify the written description requirement under 35 U.S.C. § 112. The appeal follows a contentious decision this March from the U.S. Court of Appeals for the Federal Circuit to deny panel rehearing and rehearing en banc of an earlier ruling affirming the Northern District of West Virginia’s invalidation of Biogen’s patent claims covering a method of treating multiple sclerosis (MS) under Section 112.
Interactive Wearables, the petitioner in yet another patent eligibility case that the U.S. Supreme Court is being asked to review, filed a reply brief on July 11 distancing its petition from that of American Axle & Manufacturing, Inc.’s, which was denied certiorari on June 30, 2022. The brief characterizes U.S. patent eligibility doctrine as being “perilously fractured” and narrows its arguments to focus on the third question presented in its petition, since the first two were addressed, and have now been rejected by the Court, in the American Axle case.
On April 11, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Niazi Licensing Corp. v. St. Jude Medical S.C., Inc. in which the court affirmed most of a ruling from the District of Minnesota, including sanctions against Niazi for improper use of expert testimony, as well as a finding of no induced infringement by St. Jude on one of Niazi’s asserted patent claims. However, the Federal Circuit’s decision reversed the Minnesota district court’s ruling invalidating most patent claims asserted by Niazi for indefiniteness under Section 112. The CAFC found that Niazi’s asserted claims were not invalid simply for including descriptive words or terms of degree, as long as the intrinsic record and extrinsic evidence enable a skilled artisan to identify the boundaries of a claim’s scope.
The U.S. Court of Appeals for the Federal Circuit (CAFC) earlier today affirmed a district court ruling that Biogen International’s patent for a method of treating multiple sclerosis (MS) was invalid for lack of written description. Judge O’Malley dissented, arguing that the district court clearly erred in its finding that Biogen was judicially estopped from drawing a distinction between clinical and therapeutic effect, and that the entire analysis “might well change” if the case was remanded “for reconsideration of the record with the understanding that the patent is not about clinical efficacy” but therapeutic effect.
On the final day of IPWatchdog LIVE last week, a panel titled “Jurassic Patents: Genetic Engineering and the Future of Life Science Innovation,” moderated by president and CEO of the PCT learning center and founding partner of Berenato & White, John White, examined the challenges of patenting discoveries in the life sciences in light of recent legal developments. The panel included patent litigator and partner at Akin Gump, Dr. Rachel Elsby, patent prosecutor and shareholder with Volpe Koenig, Dr. Douglas Bucklin, and food and drug lawyer and counsel at McGuire Woods, Kae Gruner.
Senators Thom Tillis (R-NC) and Tom Cotton (R-AR) sent a letter on Monday to the acting Director of the United States Patent and Trademark Office (USPTO), Drew Hirshfeld, asking him to “initiate a pilot program directing examiners to apply a sequenced approach to patent examination,” rather than the traditional “compact approach.” This proposed pilot program would require a select group of examiners and applicants who elected to participate in the program “to engage in a full examination of the grounds of patentability and then, once that process is complete, a full examination of the grounds of eligibility.”