Posts Tagged: "amgen"

Amgen is the Answer to Alice

The Supreme Court decided Amgen Inc. v. Sanofi on May 18, 2023, nearly nine years after its decision in Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014). Amgen was concerned with the enablement statute of the patent law, 35 U.S.C. § 112. In comparison, Alice was concerned with the eligibility statute of the patent law, 35 U.S.C. § 101, and has been highly criticized for creating a mess of patent eligibility. At first glance, these cases are distinguishable from one another, since they deal with different aspects of the patent laws. However, statutory interpretation and analysis should be the same in both instances.

Federal Circuit Axes Antibody Claims for Hemophilia Treatment Under Amgen

The U.S. Court of Appeals for the Federal Circuit (CAFC) today affirmed a district court’s grant of summary judgment that Baxalta, Inc. and Baxalta GmbH’s Hemophilia patent claims are invalid for a lack of enablement. The court said the facts of the case are “materially indistinguishable from those in Amgen.”… While Baxalta tried to argue its screening process does not require the type of trial and error described in Amgen and instead “predictably and reliably generates new claimed antibodies every time it is performed,” the court said “this does not take the process out of the realm of the trial-and-error approaches rejected in Amgen.”

Federal Circuit Nixes APA Challenge to PTAB Pilot, Cites Amgen in Enablement Analysis

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.

After Amgen: What SCOTUS Said—and Didn’t Say—About Enabling a Claim’s Full Scope

The Supreme Court’s reasoning in Amgen v. Sanofi upholds the Federal Circuit’s longstanding requirement to enable the full scope of a claimed invention. Since the Patent Act of 1790, patent law has required describing inventions with such clarity and specificity as to enable one skilled in the art to make and use the claimed invention. Moreover, the Court has consistently held that a patent fails to satisfy the enablement requirement if a person having ordinary skill must engage in undue experimentation to practice the claimed invention. The Federal Circuit has gone a step further, requiring that patents enable the full scope of a claimed invention. Amgen is a ratification of this aspect of the Federal Circuit’s enablement jurisprudence.

CAFC Affirms Ruling that Blocks Generic Version of Amgen’s Psoriasis Drug Until 2028

Yesterday, in a precedential decision, the United States Court of Appeals for the Federal Circuit (CAFC) affirmed a district court ruling that upheld the validity of several claims in two Amgen patents and barred Sandoz and Zydus from producing generic versions of Amgen’s psoriasis drug Otezla until 2028. The CAFC ruling also upheld the district court’s ruling that three claims in Amgen’s U.S. Patent 10,092,541 were invalid. However, that did not stop Amgen from declaring victory in the case in a press release.