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United States Patent and Trademark Office › Inequitable Conduct › Pharmaceutical Patents

The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.... more +
The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.    less -
Wilson Sonsini Goodrich & Rosati

Inventor’s Failure to Provide Material Information to the USPTO Results in an Unenforceable Patent

Wilson Sonsini Goodrich & Rosati on

On August 20, 2025, the U.S. District Court for the District of Delaware (court) found inequitable conduct when Applicant, Lindis Biotech, GMBH (Lindis), relied on data from hastily performed experiments to obtain a patent...more

Knobbe Martens

Federal Circuit Review - September 2021

Knobbe Martens on

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

Buckingham, Doolittle & Burroughs, LLC

Belcher Patent Unenforceable for Inequitable Conduct

Buckingham, Doolittle & Burroughs, LLC on

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

McDermott Will & Schulte

Material Information Submitted to FDA but Withheld from PTO Gives Rise to Inequitable Conduct

McDermott Will & Schulte on

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

Haug Partners LLP

Belcher Pharmaceuticals’ Patent Held Unenforceable by the Federal Circuit

Haug Partners LLP on

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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - September 2021

Schwabe, Williamson & Wyatt PC on

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

Rothwell, Figg, Ernst & Manbeck, P.C.

Getting Lost in the Thicket: AbbVie Wields Its Expansive Humira® Patent Portfolio Against Alvotech’s Adalimumab Biosimilar

Rothwell, Figg, Ernst & Manbeck, P.C. on

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

McDermott Will & Schulte

Counsel’s Actions Support Inference of Intent to Deceive PTO

McDermott Will & Schulte on

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

Knobbe Martens

Litigation Misconduct Helps Render a Patent Unenforceable

Knobbe Martens on

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

BakerHostetler

Regeneron Pharmaceuticals, Inc. v. Merus N.V.: The Federal Circuit Revisits the Defense of Inequitable Conduct

BakerHostetler on

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

Foley & Lardner LLP

Federal Circuit Finds Regeneron Transgenic Mouse Patent Invalid For Inequitable Conduct With Intent Inferred From Litigation...

Foley & Lardner LLP on

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

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

Schwabe, Williamson & Wyatt PC on

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

McDonnell Boehnen Hulbert & Berghoff LLP

Apotex Inc. v. UCB, Inc. (Fed. Cir. 2014)

McDonnell Boehnen Hulbert & Berghoff LLP on

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

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