Continuing Resolution Expires April 28, 2017
Client Alert | less than 1 min read | 04.07.17
The Continuing Resolution funding government operations will expire on April 28, 2017. Absent a budget agreement or a new CR, certain government operations will cease. While Congress is working on the budget, contractors wishing to plan for the end of the CR and a potential shutdown might consider: (1) maintaining open lines of communication with their customers; (2) cataloguing contracts by funding source, performance period, option exercise dates to assess impact on their businesses, while paying attention to changes clauses for opportunities for mitigation; (3) preparing for human resources impacts on staff; and, (4) reviewing subcontracts to understand rights and obligations on both sides.
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