Posts Tagged: "written description"

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?

Novartis is currently involved in a multi-district patent litigation campaign to block generic entrants for Entresto®, which is Novartis’ blockbuster heart medication. In the fall of 2022, Novartis went to trial on the validity of one of the asserted patents, U.S. Patent No. 8,101,659 (“the ‘659 patent”). On July 7, 2023, the district court invalidated the patent for lack of written description despite rejecting an enablement defense based upon the same evidence. The district court’s decision highlights a clear tension between claim construction and enablement that, if left to stand, could permit pharmaceutical companies to block lower-cost generic medications with patents they did not actually invent.

Yesterday, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Medytox, Inc. v. Galderma S.A. affirming a final written decision by the Patent Trial and Appeal Board (PTAB) invalidating Medytox’s patent claims covering methods for treating patients with botulinum toxin and denying a revised motion to amend patent claims. On appeal, the Federal Circuit rebuffed several challenges, including an Administrative Procedures Act (APA) challenge to the PTAB’s motion to amend pilot program, holding that the PTAB’s change in claim construction was not arbitrary or capricious, nor did it prevent Medytox from litigating construction issues.

In two separate precedential decisions authored by Chief Judge Moore today, the U.S. Court of Appeals for the Federal Circuit (CAFC) delivered victory for Teleflex Innovations, S.À.R.L. when it upheld Patent Trial and Appeal Board (PTAB) rulings that found Medtronic, Inc. had failed to prove Teleflex’s patent claims for catheter technology used in interventional cardiology procedures unpatentable. The court issued a related decision last month, authored by Judge Lourie, also finding for Teleflex. Chief Judge Moore joined Lourie’s opinion, while Judge Dyk dissented.

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 set to hear opening arguments in Amgen Inc. v. Sanofi on March 27. This is a case that could have profound impacts both on the invention enablement issues that have been plaguing life science patenting, but also more broadly on defining the contemporary role that the patent system will play in our innovation economy going forward. Specifically at issue will be the question of what genus claims require from an enablement perspective. Will the enablement standard be governed by the black and white, codified Section 112 statutory requirement that the specification must only teach those skilled in the art how to “make and use” the claimed invention? Or will the Supreme Court lean on lower court-based additions to the standard that the specification must enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation?

A number of amici weighed in this week on Novartis Pharmaceuticals’ petition to the U.S. Supreme Court asking the Justices to consider whether the U.S. Court of Appeals for the Federal Circuit (CAFC) should have been allowed to vacate the decision of a previous three-judge panel composed of different judges, thus invalidating Novartis’ patent for a dosing regimen for its multiple sclerosis drug, Gilenya. In January of this year, Novartis followed through on its September 2022 promise that it would appeal the CAFC’s June 2022 decision invalidating its U.S. Patent No. 9,187,405 to the Supreme Court, after the CAFC denied its request to rehear the case.

The Federal Circuit’s decision in Juno v. Kite undermines effective prosecution practice and ultimately patent enforcement. The Juno panel held that to satisfy the written description requirement, a patent needs to demonstrate to a skilled artisan that the inventors possessed and disclosed in their filing the full scope of every genus being claimed. By denying rehearing to the Federal Circuit’s 2021 decision on the scope of the written description requirement, Juno v. Kite demonstrates how once again, the courts never consider anything from a prosecutor’s point of view. Here’s why Juno v. Kite is bad for patent prosecution practice.

Last week, Novartis Pharmaceuticals followed through on its  September 2022 promise that it would appeal the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) June 2022 decision invalidating its patent for a dosing regimen for its multiple sclerosis drug Gilenya to the U.S. Supreme Court, after the CAFC denied its request to rehear the case.

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.

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.

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.

Earlier today, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. granting a petition for rehearing from appellant HEC Pharm Co., Ltd. In granting HEC’s petition, the panel majority of Chief Judge Kimberly Moore, who authored the decision, and Circuit Judge Todd Hughes vacated a previous January ruling by the Federal Circuit, which had affirmed the District of Delaware’s final judgment that Novartis patent claims covering its Gilenya treatment for multiple sclerosis were not invalid for failing to satisfy the written description requirement under 35 U.S.C. § 112. Senior Circuit Judge Richard Linn authored a dissent arguing that the panel majority had improperly adopted a heightened written description standard and failed to take into account expert testimony from Novartis regarding a negative claim limitation that the district court found was supported by ample evidence.