USA – NEW YORK Trends and Developments Contributed by: Naira Simmons, Pierson Ferdinand LLP
the same therapeutic effect). As a result, generic drug manufacturers need not conduct their own clinical trials on safety and efficacy, and often sell the drug at lower prices. ANDA filers must also propose labelling for the generic drug, which generally must be the same as the referenced brand-name drug’s labelling. Of note is the fact that an ANDA can be submitted with a Section viii statement, which provides a carve-out for specific patented indications or uses from the product label. Among the most consequential IP developments in 2026 in the United States is the Supreme Court’s unanimous decision in Hikma Pharmaceuticals USA Inc . v Amarin Pharma , Inc . (No 24-889), which square- ly addressed the boundaries of the “skinny label” pathway under the Hatch-Waxman Act. At issue was whether a generic drug manufacturer that files an ANDA with a Section viii carve-out – omitting a pat- ented method-of-use indication from its label – can nonetheless be held liable for induced infringement under 35 U.S.C. § 271 (b). The case arose from Ama- rin’s patented method of using icosapent ethyl (mar- keted as Vascepa) to reduce cardiovascular risk, and Hikma’s ANDA filing with a skinny label that carved out that patented indication. The Court reversed the Federal Circuit and held that Amarin did not plausibly allege that Hikma’s skinny label and marketing actively induced infringement of Vascepa’s cardiovascular-use patents – a decisive win for the generic industry that affirms skinny labelling as a shield against method- of-use liability. The New York Intellectual Property Law Association (NYIPLA) had filed an amicus brief in support of neither party, reflecting the balanced perspective of a bar association whose members represent both brand-name innovators and generic manufacturers.. The NYIPLA urged the Court to pre- serve the ordinary, generally applicable standards for both inducement and civil pleading, warning against the adoption of any bespoke, technology-specific rule. As the brief emphasised, the existing inducement standard “derives from the common law of aiding and abetting” and “has the benefit of providing uniformity and predictability across domains, unaffected by the technology at issue, while also being flexible enough to respond to differences across contexts and cases”. The NYIPLA cautioned that swinging too far in either direction (too rigid or too lax) would instead unsettle the “balance” Congress struck in the Hatch-Waxman
Act between incentivising research and enabling generic competition. New York Intellectual Property Law Association (NYIPLA) suggests that a properly carved skinny label, standing alone, should not constitute evidence of intent to use Critically, the NYIPLA rejected both parties’ character- isations of the standard. Hikma argued that a plaintiff must plead that the defendant specifically instructed the patented use in its label, while Amarin contended that Hikma sought a heightened pleading standard. The NYIPLA’s position was that neither extreme is war- ranted: a properly carved skinny label, standing alone, should not constitute evidence of intent to induce, but conduct outside the label – including marketing statements, digital outreach, and promotional strate- gies directed at the patented indication – may support an inducement claim under the totality of the circum- stances. The Federal Circuit, in the NYIPLA’s view, correctly applied this flexible, fact-intensive approach. This decision carries significant implications for patent portfolio prosecution strategy. For innovators holding method-of-use patents, the Court’s ruling that a prop- erly carved skinny label does not give rise to induce- ment liability means that such claims now provide materially less protection against generic competi- tion than they did before. The value of method-of- use claims has diminished relative to composition-of- matter claims, which are not subject to the Section viii carve-out and provide more robust protection against generic entry regardless of labelling. In light of this rul- ing, it will become more important than ever for brand- name companies to expand their method-of-use pat- ent portfolios in conjunction with approved uses to create new moats to protect their intellectual property. For patent prosecutors, this dynamic underscores the importance of building layered portfolios that include both composition-of-matter claims and method-of- use claims, rather than relying on any single claim type. Companies should also consider prosecuting claims directed to specific dosing regimens, formula- tions with particular dosage forms, and combination therapies, which may offer additional avenues of pro- tection that are more difficult for generic manufac- turers to carve around. Brand-name innovators must now think creatively about how to construct patent
411 CHAMBERS.COM
Powered by FlippingBook