Senate Unanimously Passes Bill to Limit Patent Infringement Challenges by Drug Manufacturers

Senate Unanimously Passes Bill To Limit Patent Infringement Challenges By Drug Manufacturers

Senate Unanimously Passes Bill to Limit Patent Infringement Challenges by Drug Manufacturers

The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of reducing drug prices. The APPA would revise certain provisions of 35 U.S.C. § 271(e) to limit the number of patents a drug manufacturer can assert in a patent infringement lawsuit against biosimilars and generics companies. Specifically, the revisions to § 271(e) state that a drug manufacturer may assert no more than 20 patents in an infringement action and that no more than 10 of the 20 patents shall have been newly issued or licensed to the drug manufacturer, as defined by section 351(l)(1)7(A) of the Public Health Service (PHS) Act.

The limit on the number of patents that can be asserted may be increased (i) if the drug manufacturer makes a request without undue delay and (ii) if the interest of justice so requires or for good cause shown. Good cause will be established if the biosimilars or generics drug company fails to provide information that would enable a drug manufacturer to form a reasonable belief that a claim of infringement could reasonably be asserted. Good cause may be established if there is a material change to the biological product or process with respect to the biological product by the biosimilars or generics company, if there is a delay by the USPTO in issuing the patent of the drug manufacturer, or for another reason the court deems appropriate.

More recently, companion bill H.R. 9070, titled Affordable Prescriptions for Patients Act (APPA) of 2024, was introduced to the House on July 18, 2024 by U.S. Representatives Darrell Issa (R-Calif.) and Hank Johnson (D-Ga.).

Whether the bill passes the House of Representatives remains to be seen. Should the bill pass, the impact on biosimilar litigation is hard to predict. While there have been cases in which more than 20 patents are asserted, including litigations regarding Humira, in other litigations the patents at issue have not exceeded 20.

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Paige N. Chandler Ph.D.
Associate

Dr. Paige Chandler focuses her practice on patent drafting and prosecution and IP due diligence, with an emphasis on biomedical physiology.

Paige assists life sciences clients with drafting and prosecuting U.S. and foreign patent applications, conducting interviews with U.S. Patent and Trademark Office (USPTO) examiners, conducting landscape and freedom-to-operate analyses, and reviewing prior art in connection with Patent Trial and Appeal Board (PTAB) proceedings. She has

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Meghan McLean Poon Ph.D.
Partner

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.

Meghan has filed numerous Patent Term Extension applications to

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Matthew A. Chivvis
Partner

Matthew protects his clients’ intellectual property and defends his clients wrongly accused of infringement. His hearing and trial experience is extensive. Whether exploring complex technical issues regarding a biologic drug, or digging into the finer points of patent law, he excels at keeping his opponents on their toes. Intellectual Asset Management 1000 remarked that Matthew is “a skilled technical lawyer and brief writer who can

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