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By: Michael Furrow, DLA Piper, and Whitney Meier, Venable LLP
The Biologics Price Competition and Innovation Act (BPCIA) provides an abbreviated pathway for companies to bring biologic drugs to market that are biosimilar to previously approved branded reference products by relying on clinical studies that were performed by the reference product sponsor (RPS).
THIS ARTICLE INTRODUCES BIOSIMILARS AND THE LITIGATION process set up by the BPCIA to facilitate resolution of patent disputes between RPSs and biosimilar manufacturers, and touches on related trends, such as the potential use of inter partes review proceedings by biosimilar manufacturers as an alternative to or in addition to litigation.
Four out of the five top-selling prescription drugs in 2017 were biologics. Conventional drugs, like Tylenol® (acetaminophen), Nexium® (esomeprazole magnesium), and Advair® (fluticasone propionate), generally have fully characterized chemical structures, and are assembled through a sequence of chemical reaction and purification steps. Biologics, in contrast, tend to be complex mixtures of much larger proteins, polysaccharides, or nucleic acids that may not be fully structurally characterized and are produced by biotechnology methods that can result in variation between lots. Examples include:
In 1984, Congress modified the Food, Drug, and Cosmetic Act and the Patent Act to permit generic manufacturers of conventional drugs to apply for marketing approval through an abbreviated process by relying on clinical studies performed by the sponsor of the reference brand name drug. It was not until March 2010 that the BPCIA created an abbreviated pathway for companies to bring biologic drugs to market that are biosimilar to previously approved branded reference products by relying on clinical studies that were performed by the RPS.
To read the full practice note in Lexis Practice Advisor, follow this link.
Michael Furrow is a partner at DLA Piper. His experience with and understanding of the challenges innate to discovery in the pharmaceutical and biotechnology fields fuels his passion to enforce and defend life sciences patents. He has represented innovators across these industries in high-stakes patent disputes both in federal court and before the U.S. Patent and Trademark Office, concerning drugs or biologics. Michael’s experience covers all aspects of life sciences innovation, including new chemical entities, salt forms, solid state forms, dosage forms, combination products, methods of use, biologics, and laboratory tools. In addition to his work in contested matters, he also has experience providing opinions on infringement and validity issues and conducting due diligence in connection with patent-related business transactions. Whitney Meier is an associate at Venable LLP. Her practice focuses on complex patent litigation and contested proceedings before the U.S. Patent and Trademark Office with an emphasis in pharmaceuticals and biotechnology. Her litigation and counseling experience cover a range of technologies, including chemotherapies, bisphosphonates, antipsychotics, small molecule formulation, genetically modified mice, and antibody manufacturing. Whitney’s practice also includes many aspects of trademark law, including clearing and prosecuting U.S. and foreign trademarks.
For a discussion of the approval process for prescription drugs, see
> HATCH-WAXMAN ACT FUNDAMENTALS
RESEARCH PATH: Intellectual Property & Technology > Patents > Patent Litigation > Practice Notes
For an overview of the safe harbor provision in the Hatch Watchman Act, see
> HATCH-WAXMAN SAFE HARBOR CHECKLIST
RESEARCH PATH: Intellectual Property & Technology > Patents > Patent Litigation > Checklists
For practical guidance on seeking inter partes review, see
> INTER PARTES REVIEW — DRAFTING AN IPR PETITION
For information on the requirements and strategic considerations for responding to a petition for inter partes review, see
> PATENT OWNER’S PRELIMINARY RESPONSE TO A PETITION FOR INTER PARTES REVIEW
RESEARCH PATH: Intellectual Property & Technology > Patents > PTAB Proceedings > Practice Notes
1. See U.S. Food & Drug Administration, FDA 101: Regulating Biological Products (https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048341.htm).