**** GENERIC’S SKINNY LABEL AND MARKETING STATEMENTS WERE NOT “AFFIRMATIVE STEPS TO ENCOURAGE INFRINGEMENT” NECESSARY TO SUPPORT A PLAUSIBLE CLAIM OF INDUCED INFRINGEMENT
Hikma Pharmas. USA Inc. v. Amarin Pharma, Inc., 24-889 — Yesterday in an opinion by Justice JACKSON, the U.S. Supreme Court reversed a Federal Circuit decision that held Hikma’s statements on its website, in press releases, and on its generic drug skinny label supported a plausible claim of induced infringement of Amarin’s patented brand of icosapent ethyl, marketed as Vascepa®. The FDA approved Vascepa in 2019 for a second indication, reducing cardiovascular risk in hypertriglyceridemia patients already taking statins, for which Amarin held two patents. Hikma obtained approval of a skinny label for generic icosapent ethyl that only included an indication for treatment of severe hypertriglyceridemia, which was invalidated in ANDA litigation. Amarin argued that doctors could plausibly read Hikma’s alleged statements as instructions to infringe its still-patented use.
The Court held that Amarin had not shown Hikma took “affirmative steps to encourage infringement.” In the Court’s view, Hikma had merely complied with the statutory requirement that its label be identical to Amarin’s except for the carved-out use; Hikma press releases describing its product as “generic Vascepa” were “standard industry practice,” and patient leaflets, website descriptions of an “AB” rating, and Vascepa sales figures were either not instructions to prescribe for a patented use or required a “myriad” of additional steps and background knowledge before a physician could use them to infringe.
In March, IPO filed an amicus brief in the case arguing that: (1) the Federal Circuit applied the correct pleading standard; (2) there was no statutory basis for special pleading standards for skinny label carveouts; (3) the Supreme Court had consistently cautioned against applying special, rigid standards in patent cases; and (4) the plausibility pleading standard preserved the statutory balance between generic competition and innovation.
(1 to 4 stars rate impact of opinion on patent & trademark law)
HOUSE IP SUBCOMMITTEE EXAMINES MEDICINES AND IP AS SUPREME COURT ISSUES SKINNY LABEL RULING
Yesterday the House Judiciary Subcommittee on Courts, Intellectual Property, Artificial Intelligence, and the Internet held a hearing on “Medicines and IP: Balancing Innovation and Access.” The purpose of the hearing was to consider whether the U.S. pharmaceutical patent system appropriately balances innovation incentives with timely access to lower-cost generic and biosimilar medicines. Chairman DARRELL ISSA (R-CA) flagged concerns about rising costs. Ranking Member HANK JOHNSON (D-GA) stressed patents’ essential role in supporting costly drug development while acknowledging unsustainably high prices. Full Committee Ranking Member JAMIE RASKIN (D-MD) framed the central question as whether reforms could expand generic access without undermining future R&D incentives.
Witnesses KRISTA CARVER (Covington & Burling) and JAMIE SIMPSON (Council for Innovation Promotion) defended existing frameworks and warned that patent reforms could erode U.S. competitiveness, particularly relative to China. RACHEL GOODE (Fresenius Kabi) and Professor MICHAEL CARRIER (Rutgers Law School) argued that terminal disclaimer abuse and patent thickets have undermined the Hatch-Waxman balance and supported the ETHIC Act and skinny-label legislation.
Q&A examined two legislative proposals. The ETHIC Act (H.R. 3269), which would limit patents assertable in Hatch-Waxman and BPCIA litigation to curb stacking of terminally disclaimed continuation patents, drew disagreement over whether such patents serve legitimate administrative functions and protect genuine innovation, as Carver and Simpson argued, or constitute duplicative litigation strategy warranting reform, as Goode and Carrier contended. The Skinny Labels Big Savings Act (H.R. 6485), which would provide a statutory safe harbor from induced infringement liability for carved-out labels, was discussed alongside the Supreme Court ruling that was issued during the proceeding. Goode and Carrier viewed the decision as favorable but incomplete, while Carver and Simpson argued the bill would do more harm than good regardless of the ruling. In advance of the hearing, IPO President JOHN CHEEK (Tenneco) sent a letter on behalf of IPO to Subcommittee Chair Issa and Ranking Member Johnson expressing opposition to both bills.Witness statements and a video of the hearing are available on the Judiciary Committee website.
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MORE ON LATIN WORDS AND PHRASES IN IP
Pronunciations ─ Last week I discussed Amicus. Another common Latin phrase is Stare Decisis. It can be pronounced stahr-ee di-si-sis or stair-ee di-si-sis. According to Black’s Law Dictionary, Pro Hac Vice is pronounced proh hahk vee-chay or proh hahk vi-see. The first may be most common.
When To Use Latin ─ It should be used sparingly. Don’t use it if there’s a simple plain English alternative. E.g., don’t write vel non for “or not.” The late JUSTICE ANTONIN SCALIA, a legendary after-dinner speaker, liked Latin, but he complained that, “There’s one field of law where they don’t write in either English or Latin. That field is patent law.”
IP Word of the Week ─ “Ideate” means to form an idea. The noun is “Ideation.” It’s an old word that may be making a comeback.
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