Life Sciences Litigation: Hatch-Waxman, 2023 Year in Review

Join Cooley’s Andrew Epstein and Brooke Fritz as they discuss Washington’s My Health My Data (MHMD) Act. The MHMD Act is arguably one of the most stringent privacy laws in the US, and it further complicates the already byzantine US patchwork approach to privacy. While the MHMD Act purports to focus on healthcare-related data and close the “gap” that exists for entities not governed by the Health Information Portability and Accountability Act (HIPAA), it applies on a much wider basis to more data, as well as to organizations whose core business may have nothing to do with healthcare.

This presentation will cover the scope and applicability of the MHMD Act, specific requirements and enforcement issues, and other frequently asked questions.

Join Cooley lawyers Geoff Biegler, Betsy Flanagan and Bonnie Fletcher Price for a recap of Hatch-Waxman litigation in 2023 and a look forward to 2024. In this session, Geoff, Betsy and Bonnie will discuss 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. The discussion also included an overview of 2023’s biosimilar approvals, biosimilar-related post-grant proceedings and a discussion of what to watch for in 2024.

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. Sonia Nath, chair of Cooley’s global life sciences and healthcare regulatory practice group, and Chad Shear, experienced life sciences patent trial lawyer, explored those inflection points in this session.

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. Please join members of Cooley’s life sciences litigation team as they explore the origins and application of the act, as well as where the law is headed as it turns 40. This program is designed for in-house lawyers and pharmaceutical industry executives who are new to the act, along with those who have been working with it for some time.

Since its enactment in late 2019, the CREATES Act has provided certain eligible drug developers with a private right of action to sue branded reference drug companies, who fail to provide samples of their products to support abbreviated drug applications. Join Cooley as we provide an overview of the CREATES Act, discuss its implications, and highlight issues to consider in responding to a CREATES Act request.

Since its enactment in late 2019, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act has provided certain eligible drug developers with a private right of action to sue branded reference drug companies that fail to provide samples of their products to support abbreviated drug applications. In this session, Cooley provided an overview of the CREATES Act, discussed its implications and highlighted issues to consider in responding to a CREATES Act request.

Companies with platform technologies that have broad applicability can often benefit from early discovery collaborations with pharma companies in certain therapeutic areas or on particular targets. These discovery collaborations can validate and improve the platform, provide research and development funding, and diversify the company’s economic interest beyond its internal programs. We dove into some of the most common structures and pitfalls for discovery collaborations.

Patents give companies exclusive rights in their inventions – and when a competitor is encroaching on your market share, you can use your patents to stop them, although the outcome will depend on the strength of the patent claims. This session discusses claiming strategies from a litigation perspective. We provide the do’s and don’ts of claim drafting, so you can ensure your patent claims are strong, defensible and able to withstand scrutiny in litigation.