Speak Now Or Forever Hold Your Protest: Intervenor’s Silence Waives Future Protest Grounds
Client Alert | 1 min read | 05.05.21
When is the deadline to file a bid protest, and what actions or inactions can cause potential future protest arguments to be waived? These seemingly simple questions can have surprising answers. In a recent bid protest decision, GAO held that a contract awardee can waive potential protest grounds by failing to raise them when intervening in a competitor’s bid protest of its award. See VS2, LLC, B-418942.4, B-418942.5, Feb. 25, 2021, 2021 CPD ¶ --, 2021 WL 873343. C&M’s Eric Ransom and Rob Sneckenberg explain the VS2 decision and provide useful takeaways for contract awardees in this “Feature Comment” published in The Government Contractor.
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