Insights

BIOSECURE Act - Looking Ahead

In this episode of Choate’s Life Sciences Insights podcast series, Adam Bookbinder and Sara Frank discuss the current status of the BIOSECURE Act in Congress, and the related implications and practical takeaways life science companies may want to consider at this time.

Salix v. Norwich Patent Infringement Opinion and the Implications of a Post-Trial ANDA Amendment and Section 8 Carveout

In this episode of our Life Sciences Insights podcast series, Sophie Wang and Madison Garrett discuss the Federal Circuit’s recent opinion in a patent infringement case between Salix Pharmaceuticals and Norwich Pharmaceuticals.

A Debrief of the Supreme Court’s Decision in Amgen v. Sanofi

In this episode of Choate’s Life Sciences Insights Podcast Series, Sophie Wang, Stephanie Schonewald and Peter Flynn discuss the US Supreme Court’s opinion in Amgen v. Sanofi, one of this term’s most highly-watched cases for our clients concerning the law of enablement as it applies to patents directed to antibody therapeutics.

PTAB Podcast: Recent USPTO Update on Fintiv Factors and Discretionary Denials

Steph Schonewald, Sophie Wang and Emily Miller discuss the recent memo issued by USPTO Director Vidal concerning the Fintiv factors and discretionary denials in AIA post-grant proceedings.

Conducting Clinical Trials Part 5: Confidentiality Issues

In the fifth and final installment of Choate’s Conducting Clinical Trials series, Julia Hesse and Danielle Pelot analyze confidentiality issues that can arise with clinical trial information and provide cautionary takeaways for when sponsors (life sciences companies) are planning and working with sites in structuring trials.

Conducting Clinical Trials Part 4: Financial Conflicts of Interest

In the fourth installment of Choate’s Conducting Clinical Trials series, Mark McPherson and Greta Fails cover what financial conflicts of interest are in a clinical trials context, how federal funding agencies regulate them, and enforcement trends.

Conducting Clinical Trials Part 3: Common Mistakes in Press Releases

In the third installment of Choate’s Conducting Clinical Trials series, Diana Lloyd and Melissa Tearney discuss common mistakes made in clinical trial related press releases and how companies can avoid unnecessary government investigations and disastrous consequences caused by problematic press releases.

Conducting Clinical Trials Part 2: Avoiding Mistaken Public Disclosures

In the second installment of Choate’s Conducting Clinical Trials series, Christine Savage and Eric Marandett cover issues that can arise when there is premature or mistaken public disclosure of sensitive clinical trial information and discuss strategies companies can use to minimize the likelihood of encountering issues from inadvertently releasing information.

Conducting Clinical Trials Part 1: When Should You File Your Patent Applications?

As the first installment of Choate’s Conducting Clinical Trials series, Bryana McGillycuddy and John Rearick discuss a range of implications associated with the timing of filing, including the validity of the patent and the risk of inadvertent disclosure.