USA – NEW YORK Trends and Developments Contributed by: Naira Simmons, Pierson Ferdinand LLP
portfolios that cannot be neutralised by a simple label carve-out – whether through narrower formulation claims, device-drug combination patents, or claims tied to biomarker-guided treatment protocols that are difficult to separate from the product itself. The Hikma v Amarin decision will serve as a defin- ing precedent for how pharmaceutical IP portfolios are constructed and enforced in the years ahead, and brand-name companies that fail to adapt their pros- ecution strategies risk losing meaningful exclusivity to generic entrants armed with the skinny label shield. How federal changes affect New York Patent prosecution does not exist in a vacuum. Although the patents themselves are prosecuted at a federal level, drug reimbursement and regulation of exclusivity are managed at both federal and state levels. New York’s regulatory and reimbursement landscape makes it par- ticularly sensitive to federal policy shifts in drug approv- al and pricing. If the FDA accelerates drug approvals through expedited pathways, the downstream effects on New York’s healthcare system and its IP-related regula- tory framework will be significant. First, New York’s Medicaid programme – one of the largest in the nation – directly incorporates federal drug approval decisions into its formulary and coverage determinations. Under New York Social Services Law, the state’s Medicaid Drug Utilization Review Board and Pharmacy and Therapeutics Committee evaluate new drugs for inclusion on the state’s preferred drug list. Accelerated federal approvals will compress the timeline for these state-level reviews, potentially forc- ing New York to make coverage and reimbursement decisions on an unexpectedly compressed timeline. For patent holders, the speed of state formulary inclu- sion can either extend or shorten the practical window of market exclusivity. Second, New York’s generic substitution laws will interact directly with the skinny label framework. Under New York Education Law § 6816-a, pharma- cists may – and in many cases must – substitute a less expensive generic equivalent when dispensing prescriptions, provided the prescriber has not indi- cated otherwise. If a generic manufacturer enters the market with a skinny label under an accelerated
approval framework, New York pharmacists could substitute that generic for the branded product even though the generic’s label omits the patented indica- tion for which the drug was prescribed. This creates practical enforcement challenges for brand-name patent holders and underscores why the outcome of Hikma carries particular weight in New York. It also underscores the importance of understanding how the mechanisms for procuring and enforcing patents occur at the federal level. Potential for accelerated drug approval, directly impacting New York In 2025, major shifts in leadership at the FDA, the Advisory Committee on Immunization Practices (ACIP), and the Centers for Disease Control and Pre- vention (CDC) drove considerable uncertainty. For the first time in decades, changes in public health lead- ership may lead to earlier-than-expected approvals at the federal level, with significant implications for reimbursement practice at the state level. Notable developments include the increased use of artificial intelligence in regulatory review processes and the launch of the Commissioner’s National Priority Vouch- er Program, both of which could enable faster drug and device approvals. From a patent prosecution standpoint, companies should ensure their prosecution strategies are tightly aligned with the accelerated timelines these programmes may offer, so that market exclusivity is maximised when products receive approval. As a result, they may be bet- ter positioned to take advantage of expedited regulatory pathways. In the wake of the Supreme Court’s decision in Hikma , the value of standalone method-of-use patents has diminished as a defensive tool, since generics can now at least partially rely on skinny labels as a shield against inducement liability. This makes it all the more critical for brand-name companies to pursue sequen- tial method patents for distinct indications as part of broader, layered portfolios – combining method-of-use claims with composition, formulation, and dosing claims – to create durable moats that cannot be easily carved around. For New York pharmacists operating under the state’s generic substitution laws, the practical effect is clear: generic substitution will become easier, and inno- vators must build patent portfolios robust enough to maintain exclusivity even in a post- Hikma landscape.
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