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

Research Security Enforcement Updates

In this episode of the Enforcement and Investigations Podcast Series, Christine Savage and Mark McPherson discuss recent research security enforcement actions involving the University of Florida and Cleveland Clinic, as well as the biotechnology company Sigma-Aldrich. The discussion offers insights and takeaways from these matters that research security and compliance professionals can use to enhance their institutions’ research security programs, and highlights the impact of cooperating with the DOJ’s National Security Division Voluntary Self-Disclosure Program.

Demystifying Private Investments

In this episode of the Choate Family Office Services Podcast Series, Lanny Thorndike, President of Choate Investment Advisors, and Alison Svizzero, a Portfolio Manager and Head of Private Equity, explore the potential benefits of private equity investments for families looking to diversify their portfolios. The discussion covers how the addition of private equity investments to a portfolio can boost performance, broaden the opportunity offerings, and provide diversification benefits.

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. The opinion arises out of Hatch-Waxman litigation concerning Norwich’s Abbreviated New Drug Application (ANDA) to the FDA for approval to market a generic version of Salix’s drug, rifaximin, marketed under the brand name Xifaxan®. Sophie and Madison discuss two main components of the opinion: (1) the use of a clinical trial protocol as prior art to render obvious a claim directed to a method of treatment with particular dosages, and whether that supports a reasonable expectation of success, and (2) the implications of a post-trial ANDA amendment with a section 8 carveout (a.k.a. skinny label) on an injunction order from the litigated case.

Moab v. Macquarie Decision Narrows the Scope of 10b-5 Liability for Securities Litigation Cases

In this episode of our Litigation podcast series, Mike Gass, Chair of Choate’s securities litigation practice, and Kristen Perriello, a Principal in the Government Enforcement Group discuss the Supreme Court’s significant securities law decision in Macquarie Infrastructure Corp. v. Moab Partners. The decision focuses on whether Rule 10b-5(b) prohibits pure omissions or only half-truths. Mike and Kristen will provide an overview of the case and focus on the legal and practical takeaways arising from the decision.

Utilizing ESG as Criteria in Investment Analysis

In this episode of the Family Office Services Podcast Series [https://www.choate.com/insights/utilizing-esg-as-criteria-in-investment-analysis.html], Choate Investment Advisors’ [https://www.choateia.com/] Erin Kerr [https://www.choateia.com/team.html#erin-e-kerr-cfa] and Alison Svizzero [https://www.choateia.com/team.html#alison-svizzero] discuss how environmental, social, and governance (ESG) criteria are used by investors in evaluating companies, in addition to traditional fundamental analysis, to determine long-term performance. ESG has increased as an area of interest for investors over the past decade. Erin, who is a ChoateIA Chief Compliance Officer and the Chief Investment Officer, and Alison, a Portfolio Manager and the Head of Private Equity Investing, provide a comprehensive overview and debunk myths related to utilizing ESG as investment criteria.