Posts Tagged: "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.”

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.

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.

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.

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 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.

On June 21, the United States Court of Appeals for the Federal Circuit (CAFC) denied a petition for rehearing and rehearing en banc filed by Amgen Inc., Amgen Manufacturing, Limited, and Amgen USA, Inc. (Amgen) in their case against Sanofi, Aventisub LLC, FKA Aventis Pharmaceuticals Inc., Regeneron Pharmaceuticals Inc., and Sanofi-Aventis U.S. LLC (Sanofi). Judge Lourie was joined by Judges Prost and Hughes in a separate opinion on the denial of the petition for panel rehearing. A group of intellectual property professors; GlaxoSmithKline plc; and Biogen Inc., Bristol-Myers Squibb Company, Corning Incorporated, and Merck Sharp & Dohme Corp. filed amicus briefs.

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Thursday upheld the District of Delaware’s grant of judgment as a matter of law (JMOL) that Amgen’s patent claims covering its Repatha cholesterol treatment were invalid for lack of enablement. The court found that Amgen’s composition claims were defined by meeting functional limitations, rather than by structure, and that the patent specifications didn’t enable the preparation of the full scope of the claims without undue experimentation. Judge Lourie authored the opinion.  Amgen v. Sanofi (CAFC, Feb. 11, 2020)

On July 1, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a holding of the U.S. District Court for the District of New Jersey in Immunex Corporation, Amgen Manufacturing, Limited, Hoffman-La Roche Inc. v. Sandoz, Inc., Sandoz International GMBH, Sandoz GMBH, holding that Sandoz failed to prove that the asserted claims were invalid for obviousness-type double patenting (ODP), failure to meet the written description requirement, and obviousness for lack of motivation to combine the prior art references. The ruling for now blocks Sandoz from marketing its biosimilar version (Erelzi) of the popular rheumatoid arthritis drug, Enbrel. Judge Reyna dissented, arguing that certain clauses of the licensing agreement were illusory, thereby rendering the agreement an effective assignment for purposes of ODP.

Yesterday, in an opinion authored by Judge Moore, the Court of Appeals for the Federal Circuit (CAFC) affirmed the District of Delaware’s decision that: 1) U.S. Patent No. 5,856,298 (the ‘298 patent) belonging to Amgen was infringed by Hospira and not invalid; 2) 14 batches of drug substance for Hospira’s erythropoietin biosimilar drug product were not covered by the Safe Harbor provision of 35 USC § 271(e)(1); and 3) Amgen had proven that it was entitled to a jury verdict of $70 million in damages. Additionally, the CAFC affirmed the jury’s verdict of noninfringement of U.S. Patent No. 5,756,349 (the ‘349 patent).

The Federal Circuit issued an opinion on July 29 affirming the District Court for the District of Delaware’s dismissal of Amgen Inc. and Amgen Manufacturing Ltd.’s (collectively, “Amgen”) complaint alleging infringement of U.S. Patent 8,273,707 (the “’707 Patent”) for failure to state a claim.  The district court held that prosecution history estoppel barred Amgen from succeeding on its infringement claim under the doctrine of equivalents.  Amgen Inc. v. Coherus BioSciences, Inc., No. 18-1993 (Fed Cir. July 29, 2019) (Before Reyna, Hughes, and Stoll, Circuit Judges) (Opinion for the Court, Stoll, Circuit Judge). 

This week in Other Barks and Bites: the Senate Judiciary Committee plans to go after drug patents to promote access to generic medications; Apple faces another patent suit in the Eastern District of Texas in the midst of attempts to remove its business presence from the district; China enacts a code of conduct for patent agents; Samsung and Huawei enter into an agreement to terminate their multi-year legal battle in the Android sector; the makers of Fortnite face yet another copyright suit over dance moves; Warner Bros. strikes down a Kickstarter campaign intending to distribute edited versions of The Departed; and a Delaware jury upholds cholesterol treatment patents owned by Amgen.

Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. State law claims are preempted by the BPCIA on both field and conflict grounds, which means only remedy available against biosimilar applicants refusing to engage in the patent dance is filing for a declaration of infringement, validity, or enforceability of a patent that claims the biological product or its use. Notably, this must be done before receiving manufacturing information from the biosimilar company. Patent lawsuits are notoriously costly so, in the short term, the decision will have the greatest impact on innovator start-ups with limited financial resources. In the long term, relying on costly litigations to keep biosimilar drugs off the market will likely increase the consumer price for any biologic drug.

In the case, Amgen v. Sanofi, the Court vacated an injunction Amgen obtained against a competing drug to its new PCSK9-inhibitor.  The Court’s decision turned on a finding that the jury was improperly instructed on the criteria for invalidating a patent directed to an antibody for lack of written description.  Thus, will the precedent recently established in Amgen’s PCSK9 case doom the validity of its patents covering Enbrel®?  There are likely two ways that the decision in Amgen v. Sanofi made a validity challenge to Enbrel®’s patents easier.