Area Of Focus

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Biosimilars

Innovators of biologic products and biosimilar applicants require comprehensive strategies and integrated legal teams to address the unique challenges posed by biological products.  We established our biosimilars/follow-on-biologics practice to leverage our scientific, technical and legal experience to serve our clients in this area.

Our practice is distinguished by:

Biotechnology Experience: Our team has substantial scientific and legal experience in key areas like molecular biology, cellular biology, immunology and pharmacology.  A number of our attorneys and agents have M.S and Ph.D. degrees in these fields, as well as in-house scientific and/or legal experience. 

Post Grant Experience: Our team has extensive experience in U.S. post-grant proceedings such as inter partes review, post grant review, ex parte and inter partes reexamination, and supplemental examination.

Patent Litigation Experience: Our team has experience litigating in venues across the United States, including the District of Delaware, District of New Jersey, Southern District of Indiana, Eastern District of Texas, Northern District of Illinois, as well as the International Trade Commission and the Federal Circuit.

Trade Secret Experience: Our team has experience counseling clients and litigating trade secret disputes in a variety of industries.

Whether it is establishing a strategy to protect an innovator biologic with patents and trade secrets, identifying and clearing a freedom-to-operate obstacle, or defending or challenging one or more patents that protect a biological product in a post grant proceeding or litigation, our team has the backgrounds and experience to help our clients address these issues.

What Are Biologics?

Biological products (or “biologics”) are medicinal products produced in whole or in part in a living system, such as a microorganism, plant cell, or animal cell.  The active ingredients in biologics typically are large, complex molecules, such as proteins and antibodies.  Biologics represent a large and growing sector of the pharmaceutical industry, accounting for 4 of the top 5 best-selling drugs worldwide in 2016.

What Are Biosimilars?

Congress created an abbreviated approval process for follow-on biologics in 2009, when it passed the Biologics Price Competition and Innovation Act (“BPCIA”).  Under the BPCIA, a follow-on biologic that is shown to be “biosimilar” to a previously-approved product (“reference product”) can be licensed without submission of the full complement of safety and effectiveness data typically required for licensure of a biological product.  42 U.S.C. § 262(k)(3).  To qualify as “biosimilar” to a reference product, a biological product must be “highly similar to the reference product,” and there must be “no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”  42 U.S.C. § 262(i)(2). 

Where a biosimilar product is shown to meet certain additional requirements, the biosimilar is deemed to be “interchangeable” with the reference product.  An interchangeable product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.  42 U.S.C. § 262(i)(3).  To qualify a biosimilar product as interchangeable, it must be shown that the biosimilar product “can be expected to produce the same clinical result as the reference product in any given patient,” and that, for a biological product that is administered more than once to an individual, “the risk … of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.”  42 U.S.C. § 262(k)(4).

What is Biosimilar Patent Litigation?

The BPCIA establishes a framework for resolving patent disputes between the applicant for licensure of a proposed biosimilar product and the sponsor of the corresponding reference product.  42 U.S.C. § 262(l).  Under this framework, the applicant provides the reference product sponsor with a copy of the application, and the parties exchange information and contentions regarding the patents that allegedly would be infringed by the proposed biosimilar product.  These exchanges are referred to as the “patent dance” and result in a list patents that will be subject to litigation between the applicant and reference product sponsor.  Much of the early litigation under the BPCIA has focused on the obligations of the applicant and reference product sponsor in the patent dance.

Useful Links

FDA Biosimilars Page

FDA Biosimilars Guidances

FDA Biologics Page

FDA Biologics Guidances

FDA Purple Book

42 U.S.C. 262 (the BPCIA)

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