Offerors Beware: Exceptions to Data Rights Requirements May Prove Fatal
Client Alert | less than 1 min read | 02.03.16
In Deloitte Consulting, LLP (released Jan. 14, 2016), GAO held that, because the awardee’s proposal had taken exception to a solicitation provision that granted the government broader rights in materials (including software source code) than the rights conveyed by the FAR's standard data rights clause, it was unacceptable. This case serves as a reminder that the time for objecting to solicitation provisions, including those relating to technical data and computer software rights, is prior to proposal submission.
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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
