Biosimilars Litigation

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The Biologics Price Competition and Innovation Act (BPCIA), enacted in 2010 as part of the Affordable Care Act, ushered in a new era for large-molecule therapeutics. It provided an abbreviated pathway for regulatory approval of biosimilar and interchangeable biologics, as well as a statutory framework for resolving patent disputes involving those products. Rothwell Figg's Biosimilars Litigation practice offers clients both the subject matter expertise and the trial savvy needed to effectively operate, and prevail, in this new era.

Biosimilar litigation is similar in many ways to the Hatch-Waxman litigation our firm is known for, in that it operates within the exacting statutory structure of the BPCIA. Working within that framework requires a team with precise knowledge of procedure, a deep understanding of the science, and extensive litigation experience.

This is where Rothwell Figg excels. Many of our attorneys have either industry experience or advanced academic degrees in fields like molecular biology, biochemistry, chemistry, biology, and biomedical sciences. We are known for our ability to work with the scientific concepts at the heart of matters, as well as our ability to communicate clearly and persuasively about them. This capability comes into play during all stages of biologic litigation and is, for our clients, a major competitive advantage.

The path to market for biosimilars often turns on a careful, thorough, and accurate analysis of the patent landscape in which the biosimilar will operate. We excel at this highly specialized skill. For many of our clients, our team is involved from the earliest stages of biosimilar development, beginning with careful freedom-to-operate searches and guidance on both appropriate design-around and invalidity strategies.

Rothwell Figg’s strategic analysis of the patent landscape is critical in preparing our clients for the high-stakes pre-litigation procedures established by the BPCIA, often referred to as the “patent dance.” We provide customized strategies for performing the patent dance to align with our client’s best interests.

We also excel at District Court litigation -- the heart of this practice. From initial pleadings and motions to trial or negotiation of settlement, our attorneys have an unmatched level of experience and courtroom expertise with disputes involving complex scientific concepts. While we litigate vigorously, we perform with the client’s objectives as our instruction to best support their strategic and competitive interests.

This levelheaded and objective ability to evaluate both long-term goals and short-term needs is the engine of our capability to litigate these cases. Biosimilars litigation tends to be intricate and scientifically demanding. It often also has exceptionally high stakes, considering the years of work and the millions of dollars invested to develop a successful biosimilar. When trying these cases, our attorneys never forget that the end goal is a business one. We are keenly aware that litigation is an investment of time, money, and management attention.

Often, we are told our team-oriented approach is highly regarded by our clients. We do not overstaff matters, and we pride ourselves on operating as an integral part of a client’s team. We strive to eliminate silos and to become trusted advisors. We never forget that even large, highly complex cases proceed through a series of smaller steps. By bringing our experience, our scientific knowledge, and our legal skills to bear on those steps, and by ensuring that the client is actively involved in each of them, our biosimilar litigation team delivers legal representation that is cost-effective, efficient, and above all, delivers desired results.



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