Pharmaceutical Litigation and Counseling
Benesch’s IP Litigation attorneys deliver strategic, science-driven advocacy for both branded and generic pharmaceutical companies in Hatch-Waxman matters and related opinion work. Our team brings deep trial experience, technical fluency and a long track record of navigating the regulatory and commercial pressures unique to Hatch-Waxman matters. This combination allows us to guide clients through the full lifecycle of a dispute while anticipating the complexities inherent in pharmaceutical patent litigation.
Litigation Experience in Key Jurisdictions
Our trial-focused team has litigated and tried pharmaceutical patent cases in key jurisdictions, including the District of Delaware and District of New Jersey, and has handled additional cases in the Southern District of New York, District of Nevada and Northern District of West Virginia. We also represent clients in preliminary injunction hearings arising from at-risk generic launches, appeals to the U.S. Court of Appeals for the Federal Circuit and post-grant challenges before the Patent Trial and Appeal Board.
Technical Strength and Life Sciences Background
Our teams typically blend attorneys and patent agents with undergraduate and graduate degrees in relevant life sciences with experienced trial attorneys who know how to translate complex biological and chemical principles for judges and juries. Many of our attorneys have represented both brand and generic pharmaceutical companies at different points in their careers, enabling us to offer a nuanced perspective grounded in a deep understanding of the strategic and technological options available to opponents. Our experience spans a variety of therapeutic areas such as oncology, women’s health contraceptives and hormone replacement therapies, psoriatic and rheumatoid arthritis and neurological disorders, as well as dosage forms and drug delivery mechanisms including transdermal patches, oral transmucosal films and injectables.
Experience With Orange Book and Related Patents
Our team members have worked on numerous drug products that included Orange Book or related patents directed to the compound, including polymorphs; formulations; solutions; methods of treatment; methods of manufacture; and delivery devices.
Hatch-Waxman Experience
While our team members have been involved in Hatch-Waxman matters for more than 10 years, recent exemplary products include:
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Apixaban (Eliquis) |
Dapaglifozin Metformin (Xigduo) |
Naltrexone HCl (Contrave) |
Sitagliptin (Januvia) |
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Apremilast (Otelza) |
Dronabinol (Syndros) |
Pemetexred (Pemfexy) |
Tavaborole (Kerydin) |
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Bupropion HCl (Wellbutrin) |
Empagliflozen (Jardiance) |
Pierfenidone (Esbriet) |
Teriflunomide (Aubagio) |
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Crisaborole (Eucrisa) |
Erlotinib HCl (Tarceva) |
Rivaroxaban (Xarelto) |
Tavaborole (Kerydin) |
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Dapagliflozin (Farxiga) |
Melphalan (Evomela) |
Selexipeg (Uptravi) |
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This product listing excludes confidential products we are currently working on for several clients, including branded pharmaceutical companies. We have counseled and rendered opinions on patents covering these products as well as others that ultimately were not litigated.
Regulatory Alignment and FDA Collaboration
Our team works closely with FDA regulatory counsel to ensure litigation positions and strategies align with regulatory filings and reporting obligations. We have supported clients in preparing citizen petitions and reviewed proposed product labeling for overlap with key patent limitations and compliance with statutory requirements. We also assist clients in evaluating patents for Orange Book listing and de-listing.
Pre-Litigation Counseling and Patent Strategy
Before litigation, we are often asked to provide opinions supporting Paragraph IV certification notice letters or the initiation of litigation. We also regularly work with branded clients to evaluate their patent portfolios and strengthen them for future assertion.