Polsinelli’s multidisciplinary pharmaceuticals team includes trial attorneys, FDA and antitrust counsel, patent attorneys and agents. We are skilled courtroom advocates, and we bring to bear our team members’ backgrounds in chemistry, organic chemistry, biochemistry, biology, pharmacy, medicine, molecular biology, microbiology, neuroscience, pharmacology, genetics, immunology and molecular biophysics, among others. We have knowledge and experience in cases related to compositions and APIs, formulations (e.g., oral dosage forms, controlled release, ODTs, transdermal, topical, ophthalmic, transmucosal, parenteral, etc.), methods of use, polymorphs, enantiomers, drug delivery devices (including combination products), and methods of manufacture, including cell lines and expression systems. Our attorneys have first-chair experience litigating cases on behalf of pharmaceutical companies in key venues, including the federal courts in Delaware, New Jersey, the Eastern District of Texas, the Southern District of New York, the Northern District of Illinois and the District of Massachusetts.

Hatch-Waxman

Polsinelli’s attorneys have significant experience representing both brand and generic drug companies in Hatch-Waxman drug patent cases. We assist clients every step of the way—from pre-litigation planning and strategy, assistance with the regulatory review process, and advocating for our clients through trial, appeal and/or settlement.

Our attorneys have litigated everything from blockbuster products to smaller market and specialty pharmaceuticals. We understand that each case, and each client, requires its own approach, and we partner with our clients to develop a strategy to achieve their specific business goals in a cost-efficient manner.

Biologics Price Competition and Innovation Act (BPCIA)

Polsinelli also has a robust Biologics Price Competition and Innovation Act (BPCIA) practice. The framework of the BPCIA process is unique and requires attorneys with experience in the specialized considerations that drive strategic decisions, including the “Patent Dance” and notice provisions of the BPCIA. Our attorneys have counseled some of the world’s largest, best-known, and most influential pharmaceutical companies regarding the regulatory and legal issues associated with this process and have repeatedly presented at conferences and seminars on these topics. We provide patent landscape opinions, due diligence reviews, and pre-litigation strategy in advance of the filing of BLA and aBLA applications and stand prepared to guide clients through successful resolution of litigation. Our deep bench of attorneys with specialized technical degrees and industry experience are instrumental to both understanding the intricate science involved and to being able to explain it in a compelling manner to judges and juries.

Food and Drug Administration (FDA)

Polsinelli is one of the few firms in the country that have attorneys that assist clients in navigating not only the thicket of patent issues involved in getting products to market but also the complex FDA regulatory issues involved in clearing approval hurdles and bringing product to market in the most profitable manner. Our attorneys regularly use their regulatory and scientific experience to provide counseling, advocacy and litigation services on behalf of clients before the FDA. Our attorneys have in-depth knowledge and first-hand experience with the complex and shifting regulatory landscape, enabling them to provide a holistic approach to supporting our pharmaceutical and biologic clients.

Related Capabilities
BiosimilarsIntellectual PropertyIntellectual Property Counseling & OpinionsLicensing & TransactionsPatent LitigationPatent Preparation & ProsecutionRestrictive Covenants & Trade Secrets LitigationTrademark, Copyright & Branding
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Supreme Court Hands Generics a Unanimous Win on Skinny Labels in Hikma v. Amarin
A unanimous Supreme Court reversed the Federal Circuit and held that Amarin did not plausibly allege that Hikma’s skinny label and marketing actively induced infringement of Vascepa’s cardiovascular-use patents — a decisive win for the generic industry that affirms skinny labeling as a shield against method-of-use liability. Key Takeaways A decisive win for the generic industry. On June 4, 2026, a unanimous Court — in an opinion by Justice Jackson — reversed the Federal Circuit and held that Amarin failed to state a claim for active inducement under 35 U.S.C. §271(b). The decision affirms skinny labeling and will generally shield generic companies that properly carve out a patented indication from induced-infringement liability. The Court ruled unanimously and just five weeks after argument — a
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Federal Circuit Addresses Prosecution History Estoppel, Disclosure-Dedication Rule in Affirming ANDA Product Noninfringement Decision
Key Takeaways The Federal Circuit held that an ANDA product formulation did not infringe, literally or under the doctrine of equivalents, patent claims that require lyophilized pharmaceutical compositions of epoprostenol “having a pH of 13 or higher.” Relying on both intrinsic and extrinsic evidence, the court affirmed the District Court’s construction of the pH claim phrase, which required the pH value to be measured at a standard temperature rather than at lower temperatures where the pH value may be different. The decision underscores how scientific measurement conditions can affect infringement outcomes in pharmaceutical patent cases. The decision also reinforces the continued importance of prosecution history estoppel and the disclosure-dedication rule in cases involving infringement allegations under the doctrine of equivalents. Patent litigants should
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