Insights

Chicago – June 11, 2025: Managing Intellectual Property has recognized 12 Crowell & Moring attorneys and four practices in its 2025 IP Stars guide. The guide, which is in its seventh edition, “brings together the world’s foremost law firm and corporate trademark experts, allowing the wider community to benefit from their insight, experience and perspectives.”

The U.S. Court of International Trade (CIT) is having a big year. While the U.S. Supreme Court’s affirmance of the CIT tariff ruling may be at the top of the headlines, the CIT is also making its mark on Hatch-Waxman pharmaceutical litigation. In late April 2026, the U.S. District Court for the District of New Jersey (DNJ) reassigned numerous Hatch-Waxman patent infringement cases involving 10 different drugs to Judge Jennifer Choe-Groves of the CIT, sitting by designation in the District of New Jersey. The cases currently assigned to Judge Choe-Groves relate to several different drug products, including LYNPARZA® (olaparib), RADICAVA ORS® (edaravone), NEXLETOL®/NEXLIZET® (bempedoic acid), ZEJULA® (niraparib), QULIPTA® (atogepant), UBRELVY® (ubrogepant), CREXONT® (carbidopa and levodopa), EVRYSDI® (risdiplam), SUFLAVE® (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution), and CAPLYTA® (lumateperone).

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.

Before leaving for an extended recess period ahead of the November general election, Congress left unfinished several proposals with ramifications for generic and biosimilar drug competition. This client alert summarizes some of that legislation and possible next steps in the “lame duck” period before the end of the year.