Hatch-Waxman

Fish has particular strength and expertise litigating on behalf of innovator pharmaceutical companies in Paragraph IV patent challenges under the Hatch-Waxman Act.

Fish does not follow a cookie-cutter approach to ANDA litigation. We place Hatch-Waxman issues properly into the broader context of pharmaceutical competition and the regulatory and commercial infrastructure of drug innovation, and use a multidisciplinary legal strategy for maximizing exclusivity for clients.

In the Hatch-Waxman context, from the earliest stages, we bring together litigators, patent prosecutors, and regulatory experts to strategize the best course of action to achieve our clients' business objectives. We draw upon our PhDs and Federal Circuit clerks for insight into the underlying science and broader legal issues, and the exceptional strength of our patent litigation teams to devise and implement comprehensive litigation strategies that also include FDA filings. Hatch-Waxman is a door into the courthouse, but once in court, parties must still litigate the underlying science. It is there that our patent litigation experience and technical mastery become evident.

We maintain a simple but deeply rooted objective: protecting our clients' intellectual property to allow them to maximize their market share and obtain a fair return on their hard work and investment in innovation.

News/Events

• Fish Wins Patent Infringement Suit for Allergan, Inc. and Duke University Over LATISSE®
• Interchangeable Biosimilars - Time to Reform the Orange Book
• Fish & Richardson Principals Named “Life Sciences IP Stars” for 2012 by LMG Life Sciences
• Biosimilars vs. Generics - Major Differences in the Regulatory Model
• Orange Book Listing Opportunities for Drug-Device Combinations