K&L Gates’ Pharma & Biopharma Litigation group delivers its clients extensive experience, knowledge, and technical acumen to handle patent litigation around the world.
In the United States, Germany, Australia, and various arbitration fora, we counsel clients with a global perspective supported by a deep understanding of the science (organic chemistry, molecular biology, biochemistry, and pharmacology) as well as the venues (U.S. 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 more than 40 Hatch-Waxman cases over the past decade, numerous inter partes review (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:
K&L Gates’s Hatch-Waxman team represents generic and branded pharmaceutical clients in all stages of litigation. Our team counsels clients in all aspects of regulatory and litigation strategy for successfully launching and protecting pharmaceutical products. 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.
Our experience includes:
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 Pharmaceutical 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 IND, NDA, ANDA, NADA, ANADA, BLA, 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, cGMPs, and inspectional issues, and we help clients respond to enforcement issues and numerous other regulatory matters before the FDA, Drug Enforcement Agency (DEA), FTC, and state agencies. Our lawyers understand our clients’ businesses and often play a major role in strategic decisions concerning life-cycle management, Hatch-Waxman (paragraph IV) patent challenges or defenses, and related competitive marketing activities.
We also advise on the medical therapies that do not require FDA preapproval, such as products subject to over-the-counter monographs, the DESI 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.