SBA Proposes Sweeping Expansion of the Mentor-Protégé Program
Client Alert | 1 min read | 02.13.15
On February 5, 2015, the SBA issued a proposed rule implementing portions of FY 2013 NDAA regarding the establishment of a universal mentor-protégé program available to all small businesses (instead of just certain SBA-approved 8(a) contractors under the current program) that would allow, among other benefits, approved mentor-protégés to compete as a joint venture for set-aside awards for which the protégé would otherwise be eligible. The SBA is seeking comments (due by April 6, 2015) on a number of aspects of this proposed rule, including whether the SBA should require all joint ventures in this program to be formed as separate legal entities and whether there should be a maximum of two mentors per protégé.
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
