NYS Science & Technology Law Center

JANUARY 2026 NEWSLETTER

News From the Innovation Law Center

Innovation Law Center

Innovation Law Center

The ILC is the designated NYS Science & Technology Law Center. It is funded by the Empire State Development Corp. to provide information and research on legal issues relevant to the technology commercialization process. Research is available to early-stage companies, research centers, economic development agencies, technology transfer offices, and researchers throughout New York State.  Research on the intellectual property, competitive, and market landscapes relevant to a new technology are completed by law and business students under the supervision of faculty. 

If you are interested in having the ILC complete research, please submit a request here.

IP / Regulatory Law Watch

Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.

The Hatch-Waxman Act (of 1984), formally known as the Drug Price Competition and Patent Term Restoration Act, establishes the framework for generic drug approvals through ANDAs. The “carve out” Section of this Act, Section viii, specifically allows generic manufacturers to carve out patented method-of-use indications (medical uses) from their labeling to facilitate generic competition for unpatented uses while brand-name companies maintain exclusivity over patented indications. This is now known generically as a “Skinny Label”.

A “skinny label” is a regulatory mechanism under the Hatch-Waxman Act that allows generic drug manufacturers to obtain FDA approval for a drug while omitting patent-protected uses from their labeling. When a brand-name drug has multiple FDA-approved indications but only some are still patent-protected, generic manufacturers can file an Abbreviated New Drug Application (ANDA) with a statement that carves out the patented methods of use. This allows the generic (drug or company) to enter the market for unpatented uses while the brand name (drug or company) retains exclusivity over the patented indications (medical uses). The FDA requires the generic’s label to exclude any information corresponding to the carved-out, still-patented uses.

The Complaint

Amarin Pharma sued Hikma Pharmaceuticals for induced patent infringement under 35 U.S.C. § 271(b) in federal court in 2020. Amarin’s drug Vascepa, is FDA-approved for two medical uses: (1) high triglyceride levels, and (2) cardiovascular risk reduction. Hikma obtained FDA approval to market a generic version of Vascepa but used a skinny label that carved out the cardiovascular risk reduction medical use, including only the high triglyceride levels (which was no longer patent-protected after Amarin’s patents were invalidated in earlier litigation).

Despite Hikma’s proper use of the skinny label carve-out, Amarin alleged that Hikma’s marketing materials and public statements induced doctors to prescribe the generic for the patented cardiovascular use. Specifically, Amarin pointed to: (1) Hikma’s press releases and website statements referring to its product as “generic Vascepa” or the “generic version” of Vascepa without clarifying that it was only approved for specific uses; and (2) Hikma’s statements that its product was AB-rated (therapeutically equivalent) to branded Vascepa, which Amarin claimed encouraged off-label prescribing for the patented cardiovascular illness.

Lower Court Decisions

District Court (2022): The Court dismissed Amarin’s case, finding that neither Hikma’s skinny label nor its public statements rose to the level of inducing patent infringement. The court held that Amarin failed to state a claim because the allegations did not show that Hikma actively encouraged physicians to prescribe its generic for the patented cardiovascular use.

Federal Circuit (June 2024): Amarin appealed, and the U.S. Court of Appeals for the Federal Circuit reversed the district court’s dismissal. The appellate panel found that, when taken together, Hikma’s skinny label combined with its marketing statements and press releases “at least plausibly stated a claim for induced infringement.” The court emphasized that Hikma publicly referred to its drug as “generic Vascepa” without clarifying that it was approved only for the high triglyceride levels, and cited sales figures attributable largely to the cardiovascular use. The Federal Circuit concluded these actions could plausibly encourage doctors to prescribe the generic, even though the label itself did not explicitly promote the patented indication.

Supreme Court Status & Implications

The Supreme Court granted certiorari on January 16, 2026, following an appeal from Hikma. The Solicitor General recommended the Court hear the case, arguing that the Federal Circuit’s decision “subverts Congress’ balance between competing interests” and threatens to undermine the Hatch-Waxman Act’s skinny label pathway. The Solicitor General’s brief stated that the law “cannot function as Congress intended if a generic manufacturer’s anodyne descriptions of its product create a serious risk of massive patent liability.”

This case represents the Court’s first opportunity to directly address the intersection of the patent inducement doctrine and the Hatch-Waxman Act’s carve-out provision. The decision could have far-reaching implications for generic drug availability and pharmaceutical competition, with many stakeholders arguing that the Federal Circuit’s permissive pleading standard effectively “nullifies” skinny label protections and could delay generic entry and increase drug prices.

Around NY State

A graphic in the shape of New York state

Micron Technology Commences Construction on Historic $100 Billion Semiconductor Manufacturing Complex in Central New York

On January 16, 2026, Micron Technology officially broke ground on its transformative semiconductor fabrication complex in Clay, New York, marking a pivotal moment in American manufacturing and technological advancement. This unprecedented $100 billion investment over the next two decades represents the largest private investment in New York State history and positions the United States to reclaim leadership in advanced memory chip production.

The groundbreaking ceremony assembled a distinguished delegation of federal, state, and local officials, underscoring the project’s national significance. Micron CEO and Chairman Sanjay Mehrotra, New York Governor, were joined by senior Trump Administration officials, including Commerce Secretary Howard Lutnick and Labor Secretary Lori Chavez-DeRemer.  New York Governor Kathy Hochul attended alongside U.S. Senators Chuck Schumer and Kirsten Gillibrand, Representative Paul Tonko, Representatives Mannion and Tenney, Syracuse Mayor Sharon F. Owens, and Onondaga County Executive Ryan McMahon. The event also drew business leaders, labor organization representatives, community members, and academic partners from regional universities. Following the site ceremony, attendees celebrated at Syracuse University’s National Veterans Resource Center.

Project Scope and Economic Impact

Micron’s phased development plan calls for up to four state-of-the-art fabrication facilities (fabs) to be constructed over 20-plus years, with an initial $20 billion investment targeted by the end of this decade.  The complex will feature the nation’s largest cleanroom space at approximately 2.4 million square feet, equivalent to nearly 40 football fields, and will deploy the semiconductor industry’s most advanced manufacturing processes, including extreme ultraviolet (EUV) lithography technology.

The economic ramifications extend far beyond direct employment. The project is projected to create 9,000 high-quality jobs directly at Micron, with an average salary of $100,000, alongside over 50,000 permanent positions throughout the region over the next 30 years.  Construction alone will generate tens of thousands of prevailing wage jobs over the 20-year build-out period.  Economic analysis projects an additional $9.5 billion in regional economic output annually starting in 2027, escalating to over $16 billion annually by 2041, with Central New York residents expected to gain $3.3 billion in additional annual disposable income by 2035, rising to $5.4 billion per year through 2055.

Federal and State Support

The project benefits from substantial public-sector investment designed to rebuild America’s semiconductor manufacturing capabilities. Micron has secured up to $6.4 billion in direct CHIPS and Science Act funding to support construction of two New York fabs and two Idaho facilities, as well as expansion and modernization of its Virginia fab.  The State of New York has committed up to $5.5 billion in Green CHIPS incentives over the project’s lifetime, while Onondaga County is providing critical infrastructure support, including power transmission and utility upgrades.

Beyond financial incentives, Micron and New York State announced a historic $500 million investment in community, education, and workforce development, with Micron contributing $250 million to the Green CHIPS Community Investment Fund and an additional $250 million expected from state, local, and national partners.

Strategic Significance and Sustainability Commitments

This investment directly addresses a critical national security vulnerability. Currently, the United States produces less than 2% of the world’s advanced memory chips, with production concentrated in East Asia. Micron’s strategy aims to gradually increase U.S.-based DRAM production to 40% of the company’s global output within the next decade, strengthening supply chain resilience for artificial intelligence, automotive, networking, defense, and consumer applications.

Micron has committed to comprehensive sustainability standards, including achieving 100% water reuse, recycling and restoration; utilizing 100% renewable electricity; incorporating green infrastructure and sustainable building attributes to attain LEED Gold certification; and employing state-of-the-art technology to mitigate and control greenhouse gas emissions.

Timeline and Current Status

The first phase is expected to commence operations in 2030, with subsequent facilities following at intervals of several years.  Initial construction activities focus on site preparation, infrastructure development, and utility expansion to support the facility’s substantial operational requirements. The 445-acre site requires extensive groundwork, including the import of approximately 9 million cubic yards of gravel for site leveling.

This groundbreaking represents more than a construction milestone; it signals America’s renewed commitment to technological sovereignty, advanced manufacturing, and the revitalization of communities historically built on industrial strength. By establishing Central New York as a premier global semiconductor hub, Micron’s investment promises to reshape the region’s economic trajectory for generations. Learn more about the project here:

Upcoming Events

AI for Startups: Increasing Productivity While Protecting Your Ideas

  • What: How to use AI tools productively, without putting ideas or data at risk. Register here.
  • When: January 21, 2026, 12:00 p.m – 1:00 p.m 
  • Where: Virtual

The Microelectronics Innovation Challenge

  • What: The FuzeHub-led Upstate Defense Innovation Challenge is driving microelectronics innovation to strengthen defense readiness and the supply chain across Upstate New York.
  • When: Deadline February 17, 2026
  • Check Eligibility Here: FuzeHub 

Medical Device Innovation Challenge

  • What: A 6-month virtual program mentoring selected early-to-mid stage start-up companies each year. The MDIC serves as a complementary and collaborative initiative to assist teams in preparation for incubation programs, expand their innovation ecosystem, and assess strategic planning by providing mentorship, resources, funding/pitch opportunities, and connections. 
  • When: Deadline March 1, 2026
  • How to Apply: CNY Biotech Accelerator’s (CNYBAC) 

Québec-New York Transportation Rendezvous & B2B

  • What: Opportunity for manufacturers and companies in the ground transportation and aerospace industries to meet and network with potential customers, suppliers, and resources. In addition to an exciting day filled with informational sessions, panels, and presentations, attendees will have access to a B2B platform they can use to request meetings to find new customers, suppliers, or assistance. Register here.
  • When: March 10, 2026
  • Where: Plattsburgh, NY

 

SAVE THE DATE: Manufacturing Expo: Vitality in the Valley 2026 

  • What:  NYS companies in the food, beverage, and agriculture ecosystem, along with traditional manufacturers, connect with resources that can help them grow. Exhibitors also wanted! For more information, click here.
  • When: June 2-3, 2026
  • Where: Herkimer College

 

Do you have an event or schedule you would like to advertise? Contact Karen Scullion at nysstlc@syr.edu to share it in our next monthly newsletter. 

Funding Opportunities

From early-stage non-dilutive funding to tax benefits and investment funds, NYS has a number of funding resources for inventors and entrepreneurs. Check out the links below for more information:

 

Questions or Suggestions: Contact Innovation Review Editor Patrick Cramer at nysstlc@syr.edu