Section 809 Panel Releases Volume 3 Report and Recommendations
Client Alert | 1 min read | 01.16.19
On January 15, the Section 809 Panel released the final installment of its three-volume report, this time including recommendations on, among other topics, bid protests, contractor accounting systems, and government-industry interactions. (The panel released Volume 1 in January 2018 and Volume 2 in June 2018).
The Volume 3 recommendations, if implemented, could have far-reaching effects. For example, the panel recommends eliminating certain bid protests, such as second bite at the apple Court of Federal Claims protests after earlier GAO protests; adopting a “professional practice guide” for DoD and those supporting DoD in its contract audits; and encouraging greater government “interaction with industry during market research.”
Keep an eye on our blog and podcasts in the coming weeks, as we will be providing further detailed analysis of the panel’s various recommendations.
Insights
Client Alert | 4 min read | 04.10.25
Hikma and Amici Curiae Ask Supreme Court to Revisit Induced Infringement by Generic “Skinny Labels”
In Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., C.A. No. 20-1630 (D. Del.), brand manufacturer Amarin brought an induced infringement claim against Hikma’s generic icosapent ethyl product, which lists Amarin’s Vascepa® as the reference listed drug. Vascepa was originally approved by the U.S. Food and Drug Administration (“FDA”) to treat severe hypertriglyceridemia, and later, Amarin obtained patents and approval for Vascepa as a treatment to reduce cardiovascular risk in certain patient populations. Hikma’s Abbreviated New Drug Application (“ANDA”) for generic icosapent ethyl included a Section viii statement that Hikma was not seeking approval for the patented cardiovascular indication along with a “skinny label” that included only the indication for severe hypertriglyceridemia.
Client Alert | 1 min read | 04.09.25
Client Alert | 12 min read | 04.09.25
Client Alert | 4 min read | 04.07.25
