October 25, 2021

Volume XI, Number 298

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October 22, 2021

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Withheld Prior Art and Inconsistent Arguments Used to Obtain FDA Approval Renders Patent Unenforceable

In Belcher Pharms., LLC v. Hospira, Inc., No. 2020-1799 (Fed. Cir. Sept. 1, 2021), the Federal Circuit affirmed the district court’s holding that U.S. Patent No. 9,283,197 is unenforceable due to inequitable conduct.

The asserted claims of the ’197 patent are generally directed to pharmaceutical epinephrine formulations having a pH between 2.8 and 3.3 and certain impurity levels.  The district court found that Belcher’s CSO, who was involved in the preparation of Belcher’s NDA and the prosecution of the ’197 patent, intentionally withheld a prior art reference and two prior art products that disclosed the claimed pH range and impurity levels.

The Federal Circuit affirmed, rejecting Belcher’s argument that its CSO genuinely believed the withheld prior art was immaterial.  Specifically, the Court noted that Belcher’s CSO drafted the NDA and cited withheld prior art to expedite approval of its NDA.  The Court further noted that during prosecution, the CSO argued that the claimed pH range was “critical” and yielded “unexpected results,” which contradicted Belcher’s arguments to the FDA.  Therefore, the Court found that there was no clear error in finding that the single most reasonable inference was that Belcher’s CSO possessed specific intent to deceive the PTO.

© 2021 Finnegan, Henderson, Farabow, Garrett & Dunner, LLPNational Law Review, Volume XI, Number 251
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About this Author

Ken Guerra Pharmaceutical & Healthcare Intellectual Property Attorney Finnegan, Henderson, Farabow, Garrett & Dunner Law Firm
Associate

Ken Guerra focuses on complex patent litigation and client counseling in the areas of biotechnology and pharmaceuticals before U.S. district courts and the U.S. Court of Appeals for the Federal Circuit, primarily on Abbreviated New Drug Application (ANDA) challenges to innovator pharmaceutical manufacturers.

Ken’s litigation experience covers numerous aspects of trial and appeal preparation, including conducting discovery and handling day-to-day litigation activities. He is actively involved in all phases of litigation, including pre-litigation...

202 408 4124
Elizabeth Ferrill Patent Attorney Finnegan Law Firm
Partner

Elizabeth Ferrill is an “undisputed expert on design patents” who is “always updated and enlightening others with her deep knowledge,” “very involved in the design bar,” and “gives her clients an outstanding service” as noted in Intellectual Asset Management Patent 1000. She focuses her practice on all aspects of design patents, including prosecution, counseling, post-grant, and litigation.

Elizabeth counsels clients who hold design patents as well as those accused of infringement. She has experience with design patents related to consumer and industrial products, medical...

202 408 4445
Caitlin O’Connell Intellectual Property Litigation Attorney Finnegan Law Firm
Associate

Caitlin O’Connell focuses her practice on patent litigation and client counseling in the areas of biotechnology and pharmaceuticals, with particular emphasis on Abbreviated New Drug Application (ANDA) cases.

Caitlin is involved in all phases of litigation, including pre-litigation analysis, claim construction, fact discovery, expert discovery, and trial. Caitlin’s litigation experience includes drafting pleadings, preparing fact and corporate witnesses for depositions, coordinating discovery, working with experts to develop infringement and validity positions, preparing expert...

202 408 4004
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