4 Key Takeaways | Updates in Standard Essential Patent Licensing and Litigation
Mosaic Brands, Inc. v. Ridge Wallet LLC, Appeal Nos. 2022-1001, -1002 (Fed. Cir. Dec. 20, 2022) - In our Case of the Week, the Federal Circuit discussed the corroboration requirement concerning the amount of evidence...more
We have previously reported on AbbVie’s first and second wave suits against Alvotech hf (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar. In the first wave suit, on October 5, 2021 AbbVie...more
Arguments to the Patent Office That Contradict Information Submitted to the FDA Support an Inference of Deceptive Intent In Belcher Pharmaceuticals v. Hospira, Inc., Appeal No. 20-1799, the Federal Circuit held that a...more
Inequitable conduct is an affirmative defense to patent infringement, but the bar for proving it is a high one. A defendant must prove by clear and convincing evidence that the patentee intentionally deceived the Patent...more
The US Court of Appeals for the Federal Circuit found prior art submitted to the US Food and Drug Administration (FDA), yet withheld from the US Patent & Trademark Office (PTO) during prosecution of an asserted patent,...more
Imposition of liability under the equitable doctrine of inequitable conduct (as it has been variously defined) can result in a patent being held unenforceable; for this reason, former Chief Judge Rader called it the "atomic...more
The Federal Circuit published a precedential decision on September 1, 2021 regarding the unenforceability of a pharmaceutical patent due to inequitable conduct. In Belcher Pharmaceuticals LLC v. Hospira, Inc., the Court...more
Belcher Pharmaceuticals, LLC v. Hospira, Inc., Appeal No. 2020-1799 (Fed. Cir. Sept. 1, 2021) - In an appeal from the United States District Court for the District of Delaware, the Federal Circuit affirmed the district...more
BELCHER PHARMACEUTICALS v. HOSPIRA, INC. Before Reyna, Taranto, and Stoll. Appeal from the District of Delaware. Summary: A patentee committed inequitable conduct by advancing an argument during patent prosecution...more
In the most recent of a series of litigations by AbbVie against manufacturers seeking to market biosimilar versions of Humira®, the world’s most profitable drug, AbbVie initiated an action against Alvotech in the district...more
Below is an update on recent developments in several litigations involving biosimilar products. Amgen v. Sandoz (filgrastim, pegfilgrastim): As we previously reported, the district court granted summary judgment of...more
PATENT CASE THIS WEEK - In an appeal from a bench trial finding patents unenforceable, the Federal Circuit issued a rare decision on the doctrine of unclean hands. The doctrine of unclean hands in patent law arises from...more
As we previously reported, Immunex sued Sanofi and Regeneron earlier this year in the Central District of California alleging that the sale of Sanofi and Regeneron’s FDA-approved Dupixent® (dupilumab) product would infringe...more
In a decision clarifying the analysis for inequitable conduct, a split panel of the US Court of Appeals for the Federal Circuit affirmed a district court finding of specific intent to deceive the US Patent and Trademark...more
In March 2014, Regeneron Pharmaceuticals, Inc. sued Merus B.V. for allegedly infringing U.S. Patent No. 8,502,018 (“the ’018 Patent"). The ’018 Patent generally relates to using vectors to modify genes and chromosomal loci...more
In Regeneron Pharmaceuticals, Inc. v. Merus N.V., No. 2016-1346, slip op. (Fed. Cir. July 27, 2017) (hereafter, “Slip Op.”), the Federal Circuit seems to have loosened the standards for finding a patentee culpable of...more
In a 38 page decision with a 19 page dissent by Judge Newman, the Federal Circuit determined that Regeneron’s transgenic mouse patent is unenforceable due to inequitable conduct. The decision was rendered in Regeneron...more
In Regeneron v. Merus, a divided panel affirms a determination of unenforceability for violation of the duty of disclosure. What is interesting about the case is that neither the district court nor the majority reviewed...more
Last week, the Federal Circuit affirmed a finding of inequitable conduct in Apotex v. USB, a relatively rare occurrence in the years after the Federal Circuit's decision in Therasense v. Becton, Dickenson. In the Therasense...more