Pharmaceutical Litigation and Counseling
Hatch-Waxman litigation presents unique regulatory and commercial complexities. Benesch’s IP Litigation attorneys have extensive experience representing both branded and generic pharmaceutical companies in Hatch-Waxman litigation and related opinion matters.
Our trial-savvy team has litigated and tried pharmaceutical patent cases in key jurisdictions like the District of Delaware and District of New Jersey and has litigated additional cases in the Southern District of New York, District of Nevada and Northern District of West Virginia. We have also represented clients in preliminary injunction hearings that arise in the context of at-risk launches of generic products, appeals to the Court of Appeals for the Federal Circuit and post-grant challenges before the Patent Trials & Appeals Board (PTAB).
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 the benefit of a jury or judge. Moreover, many of our attorneys have represented both brand and generic pharmaceutical companies at various points in their careers. As a result, our teams are able to provide our clients with a nuanced perspective based on a deep understanding of the strategic and technological options available to opponents. Our experience has given us particular insight in a variety of therapeutic areas (e.g., oncology, women’s health contraceptives and hormone replacement therapies, psoriatic and rheumatoid arthritis, neurological disorders) and dosage forms and drug delivery mechanisms (e.g., transdermal patches, oral transmucosal films, and injectables).
Our team members have worked on a number of drug products that included orange book or related patents directed to the compound (including polymorphs), formulations, solutions, method of treatment, method of manufacture, and delivery devices.
While our team members have been involved in Hatch-Waxman matters for over 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 that we are currently working on for a number of our clients, including branded pharmaceutical companies. We have counseled and rendered opinions on patents covering these products as well as a number of other products that were eventually not litigated.
Our team works hand in glove with FDA regulatory counsel to ensure that litigation positions and strategies are consistent with regulatory filings and reporting obligations. We have aided clients in the preparation of Citizens’ Petitions and reviewed proposed product labeling for overlap with key patent limitations and compliance with statutory requirements. Our group also works with clients on evaluating patents for Orange Book listing and de-listing.
Prior to litigation, we are often asked to provide opinions to support Paragraph IV certification notice letters or the filing of litigation. Our team also regularly works with our branded clients to evaluate their patent portfolios and strengthen them for assertion in litigation.