Life Sciences Litigation: Tracking the Paths of Regulatory and Patent Law During Drug Development

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.

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.

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.