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Pharma and BioPharma Litigation

Our pharma and biopharma litigation group provides intellectual property litigation and counseling experience to pharmaceutical and biopharmaceutical clients around the world.

From product development, launch, litigation, and life-cycle management, our lawyers break down the legal hurdles standing in the way of our life sciences clients. Our group works closely with other core groups at the firm to provide comprehensive services, including our lawyers in litigation, inter partes review (IPR), patent prosecution, regulatory, and transactional. With our global footprint, we can also offer a global perspective supported by offices and venues around the world (United States district courts, Patent Trial and Appeal Board, Federal Court of Australia, and the Unified Patent Court).

Our team is singularly focused on pharmaceutical patent work with a successful track record of representing pharmaceutical companies in numerous Hatch-Waxman cases over the past decade, IPR proceedings, hundreds of opinions, and thousands of patent applications. Underpinning our work is a deep understanding of the pharmaceutical industry and technology from first-hand knowledge and experience.

Hatch-Waxman Litigation

Our Hatch-Waxman team represents generic and branded pharmaceutical clients in all stages of litigation. Starting with product selection, the team advises clients on design-around opportunities, performs patent landscape analyses, and provides opinions related to the infringement and validity of patents. When it comes to litigation, our team represents clients in all aspects of litigation, trial, and settlement strategy for successfully launching and protecting pharmaceutical products.

Our experience includes:

  • Handling dozens of Hatch-Waxman litigations over the past decade
  • Achieving favorable settlements in launch-at-risk cases
  • Counseling clients on U.S. Food and Drug Administration (FDA) regulatory hurdles
Post-Grant Proceedings

A key feature of our practice is our knowledge of and success at the Patent Trial and Appeal Board (PTAB). Since the inception of the America Invents Act, the PTAB has increasingly asserted its utility as an effective and efficient forum for patent dispute resolution. On behalf of clients, we have achieved victories through final decision and strategically used IPR to facilitate resolution on a range of technologies, including pharmaceuticals, surgical instruments, software relating to pharmacy supervision, power generation, and nitric oxide treatment methods.

Our experience includes:

  • Recently ranked as a top firm at the PTAB by Managing IP
  • Handling over 50 IPR matters (including non-pharma cases)
  • High institution rate for Life Sciences IPRs (Tech Center 1600)
  • High institution rate for IPRs on Orange Book listed patents
  • Multiple victories through favorable final written decisions
Regulatory Experience

Our pharma and biopharma litigation lawyers draw on the support of our FDA team to assist clients with the regulatory aspects affecting new drugs. We provide strategic direction on research and development and market entry pathways for clients seeking to enter the drug and biologics market. We assist with the investigational new drug application, new drug application, abbreviated new drug application, new animal drug application, abbreviated new animal drug application, biologics license application, and biosimilar approval and orphan designation processes. The value we provide to our clients does not stop when the FDA issues an approval letter. We also work with our clients to maintain compliance with FDA post-approval requirements, including labeling, advertising, current good manufacturing practices, and inspectional issues, and we help clients respond to enforcement issues and numerous other regulatory matters before the FDA, Drug Enforcement Agency, Federal Trade Commission, and state agencies. Our lawyers understand our clients’ businesses and often play a major role in strategic decisions concerning life-cycle management, Hatch-Waxman patent challenges or defenses, and related competitive marketing activities.

We also advise on the medical therapies that do not require FDA pre-approval, such as products subject to over-the-counter monographs, the Drug Efficacy Study Implementation program, homeopathic rules, and grandfather statutes. We counsel clients on the risks, limitations, and legal boundaries for marketing claims for such products. Our lawyers also handle regulatory due diligence investigations and review contractual language for joint venture, investment banker, and venture capital transactions.

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