Hatch-Waxman Litigation

In this webinar, Cooley life sciences intellectual property litigation partner Chad Shear and life sciences patent partner Jon Cousin discussed common pitfalls in patent drafting and prosecution that are exploited during litigation, structuring patent portfolio to align with development milestones, clinical trials and product approval and drafting strong and focused patent applications while avoiding unnecessary disclosure that can render future invention obvious.

In this webinar, Cooley life sciences litigation partners Betsy Flanagan and Orion Armon discussed the top issues and trends in these industries to provide decision-makers with information they can use to strengthen their organizations.

Cooley life sciences litigation partners Chad Shear and Geoff Biegler discussed strategies for branded companies to best position themselves for success in Hatch-Waxman litigation. Leveraging 40+ years of combined experience in abbreviated new drug application (ANDA) cases. Chad and Geoff walked through when one should prepare for Hatch-Waxman litigation, what steps one should take and how to avoid common pitfalls.

In this webinar, Chad Shear, experienced Cooley life sciences patent trial lawyer, and Vince Sampson, who leads the firm’s public policy practice, discussed the process and impacts of the IRA’s drug pricing program – and what expanded march-in rights could mean for federally funded life science research.

Following the Federal Trade Commission’s September 2023 policy statement, the FTC initiated Orange Book patent listing disputes against 10 companies’ pharmaceutical products. During this presentation, intellectual property litigation partner Jon Davies and antitrust special counsel David Burns discussed the backdrop for these drug device patent listing disputes and the implications of the FTC’s recent related policy statements.

Cooley lawyers Geoff Biegler, Betsy Flanagan and Bonnie Fletcher Price gave a recap of Hatch-Waxman litigation in 2023 and a look forward to 2024. In this session, Geoff, Betsy and Bonnie discussed the need-to-know case outcomes, legal developments, and government initiatives from the past year impacting Hatch-Waxman litigants in both the courtroom and the boardroom. This program is designed for in-house lawyers and executives interested in the latest topics and trends in Hatch-Waxman litigation, whether they are new to the field or have decades of experience.

Over the past year, the landscape for biosimilars litigation has continued to evolve, as the field moves into a new wave of products and cases. Cooley lawyers Brianna Patterson, Geoff Biegler and Michelle Rhyu recapped the most important cases, decisions and industry developments from the past year, as well as new strategy considerations gleaned from those developments – both from the reference product sponsor and biosimilar applicant perspectives.

From the inception of a drug through approval, there are any number of inflection points that have significance from either a regulatory or patent perspective. Often, decisions that are made at those points have long-lasting implications.

We are approaching the 40-year anniversary of the Hatch-Waxman Act – the comprehensive legal framework governing pharmaceutical industry innovation, patent terms and price competition. In this session, members of Cooley’s life sciences litigation team explored the origins and application of the act, as well as where the law is headed as it turns 40.

In this session, Cooley lawyers discuss induced infringement in the context of Hatch-Waxman litigation, with an emphasis on recent cases examining "skinny labelling."

In this session, Cooley lawyers discuss the development and scope of Safe Harbor under 35 USC § 271(e)(1), and its impact on Hatch-Waxman, other pharmaceutical patent litigation, and freedom to operate and licensing considerations during product development and fundraising.

This program was targeted at innovative life science companies that have filed, or will soon file, NDA or 505(b)(2) applications and are anticipating their first Hatch-Waxman litigation.

This program was targeted at innovative life science companies that have filed, or will soon file, NDA or 505(b)(2) applications and are anticipating their first Hatch-Waxman litigation.