By Alice Prokofyeva and Jaden Jackson
For biopharmaceutical companies, a predictable patent system is essential to attracting investment, long-term research commitments, and bringing new treatments to patients. Yet decisions across all three branches of government are raising questions about how reliably that system will protect continued innovation after a medicine’s first approval. This approval is not only the culmination of years of investment and scientific innovation, it is often also the beginning of new chapters in medical progress. Continued research may reveal improved dosages, safer delivery methods, and entirely new uses—including treatments for rare diseases. This “living innovation” was a central focus of the Hatch-Waxman Act, a legislative bargain that established the legal framework incentivizing new biopharmaceutical innovation through time-limited market exclusivity while encouraging rapid generic competition once patents expire.
The Supreme Court’s recent decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (“Hikma”), brings that pressure into sharp focus. In addressing when a generic manufacturer’s “skinny label” (which omits patented uses while preserving approval for unpatented uses) and related communications induce infringement, the Court confronted the tension in modern biopharmaceutical patent law: how to foster timely generic competition without undermining the incentives that drive medical progress. The Court’s decision increasing the evidentiary burden required for proving infringement by a generic company undermines the balance that has made Hatch-Waxman such a success.
By granting innovators a predictable period of exclusivity (in exchange for wide-open competition with sharply lower prices after patents expire), Hatch-Waxman supports both the development of new medicines and continued investment in new uses for existing ones. However, recent judicial, executive, and legislative developments increasingly risk treating patents as legal barriers to be sidestepped rather than incentives for continued innovation.
The stakes extend beyond any single patent or medicine. Although the United States remains the global leader in intellectual property (IP) protection, its advantage has narrowed as competing countries strengthen their own IP systems and attract a growing share of biopharmaceutical research. Preserving strong and predictable patent protection is essential not only to sustaining the financial model for life-saving research, but also to maintaining U.S. leadership in biopharmaceutical innovation.
Setting the Stage: America’s Biopharmaceutical Innovation Leadership Is At-Risk
While a patent generally lasts twenty years from filing, the scientific reality is considerably more complex. Developing a single new medicine can take over a decade, and cost approximately $2.6 billion, while only about 12% of investigational medicines entering clinical trials ultimately receive FDA approval. Because lengthy research and development (“R&D”) and FDA review can consume up to ten years of the patent term, biopharmaceutical innovators may lose a substantial portion of their effective patent protection before their medicine reaches a single patient.
This compressed period of effective patent protection has implications beyond any individual product. Further pressure on already limited exclusivity threatens the competitive position of the United States, which should not take its global IP leadership for granted. Although the U.S. remains ranked first overall in the Global Innovation Policy Center’s (“GIPC”) IP index, its advantage has steadily narrowed. In 2016, the U.S. led the United Kingdom by approximately 3.6 percentage points, but that margin fell to about 1.3 points between 2020 and 2024 and reached a historic low of 1.17 points in 2026.
At the same time, other countries are strengthening their IP systems. Between 2012 and 2021, China’s GIPC score increased more than 18.34% and India’s by 13.44%, largely driven by reforms in enforcement and patentability guidelines. This progress coincides with a broader shift of increasing clinical research to China, where trials are described as being “half the cost and two to five times faster” than in the U.S.
While the U.S. continues to top the overall GIPC IP index, its score in patent protection lags at fifth place—a result of legal uncertainty regarding patent-eligible subject matter and the unpredictability of Patent Trial and Appeal Board (“PTAB”) proceedings following several major Supreme Court decisions. These factors have contributed to the U.S. trailing global leaders like Singapore and Japan in patent protection. Critically, both the 2025 and 2026 GIPC IP indexes warned that advanced economies risk eroding their own leadership by introducing policies that effectively weaken biopharmaceutical IP protections. For example, the Index suggests that price controls—such as Inflation Reduction Act “negotiations” and so-called Most-Favored Nation pricing—may have the effect of undermining future R&D investment.
As IP protections become less reliable, so too would the financial model that supports future life-saving research. Preserving the patent bargain is therefore fundamentally necessary to maintaining U.S. leadership in biopharmaceutical innovation.
The Judicial Front: Validating Skinny Labels
The Supreme Court’s unanimous June 2026 decision in Hikma illustrates how judicial rulings can weaken the practical value of biopharmaceutical patents. In that case, Amarin Pharma, Inc. (“Amarin”) developed Vascepa, which the FDA originally approved to treat severely elevated triglyceride levels (the “SH indication”), and later approved to reduce cardiovascular risk (the “CV indication”). In 2020, a Nevada District Court invalidated Amarin’s core patents covering the SH indication, allowing generic manufacturers to market Vascepa for that use. Subsequently, Hikma (a generic manufacturer) sought approval to sell a generic version with a skinny label that omitted the still-patented CV indication and listed only the unpatented SH indication. Amarin sued Hikma, alleging that Hikma’s label, website, and press releases induced providers to prescribe the generic drug for the patented use.
The Supreme Court held that induced infringement requires conduct that actively encourages infringement, not merely statements that doctors could interpret as supporting an infringing use. Because Hikma used standard industry language and complied with FDA label requirements, the Court characterized its actions as mere “omissions or inactions,” rather than affirmative promotion.
The decision imposes a high evidentiary burden on innovators seeking to challenge generic manufacturers that launch products with skinny labels. The generic may enter the market for an unpatented use knowing that its product will be substituted for patented indications. That substitution undermines valid patents and erodes the incentives to develop new indications for existing drugs. An innovator could spend years proving that a drug treats a new condition, only to see a generic without an approval for that indication reap the benefit from research it did not fund—bypassing method-of-use patents, weakening the innovator’s ability to recover its investment, and disturbing the Hatch-Waxman bargain.
Generic entry can cause immediate brand erosion, with innovators sometimes losing up to eighty percent or more of their market share within just six months. Regardless of a generic label’s carved-out uses, these substitutions occur because doctors and pharmacists know that the generic is chemically identical to the original. The practical effect is that, once a generic enters the market with a skinny label, meaningful exclusivity is effectively over—even if the generic strictly complies with its FDA-approved label.
The Executive Branch: The USPTO
The uncertainty involving biopharmaceutical patents is not limited to the courts, skinny labels and generic substitution. A recent dispute before the U.S. Patent and Trademark Office (“USPTO”), Ex parte Baurin (“Baurin”), now affects how biopharmaceutical companies protect their inventions through related patent portfolios. The case concerns obviousness-type double patenting (“OTDP”), a judicially created doctrine intended to prevent companies from improperly extending the life of their patent rights through minor variations of an earlier invention. In Baurin, however, the doctrine was used to challenge claims in an earlier-filed application based on later-filed patents. Critics argue that this approach turns the rule “on its head” by using a tool meant to prevent improper patent extensions as a weapon to vitiate earlier, lawfully earned patents.
Initially, the PTAB sided with the patent holder. However, the USPTO Director took the rare step of convening an Appeals Review Panel to reconsider the matter. In August 2026, the panel reversed the PTAB and rejected the patent, holding that a rejection may rest on the OTDP’s underlying rationale even where no patent term extension is at issue. The consequences extend well beyond Baurin, particularly for biopharmaceutical companies that patent successive improvements: a company’s own later improvement patent can now retroactively block an earlier foundation patent. Although the panel viewed binding precedent as requiring rejection of the patent application, it invited the Federal Circuit to clarify whether OTDP rejections may rest solely on the risk of harassment from multiple patent owners—an issue already before the court in In re: Ablynx N.V. Anticipating that clarification, the panel proposed an OTDP framework that “endeavor[s] to apply the doctrine in a way that avoids harm to existing and future innovation.”
The Legislative Threat: Patent Integrity and ETHIC Acts
The same tensions inherent to the patent bargain and Hatch-Waxman are reflected in two pending congressional proposals: the Medication Affordability and Patent Integrity Act (“S2658”) and the Eliminating Thickets to Increase Competition Act (“ETHIC Act”), both of which put at risk the cumulative nature of innovation.
This year, the Senate Health, Education, Labor & Pensions (“HELP”) Committee advanced S2658, which would require applicants seeking FDA approval of a drug to certify that their submissions are consistent with information provided to the USPTO in connection with related patent applications. Although framed as a transparency measure targeting so-called “secondary” patents, critics warn that the bill could “introduc[e] greater uncertainty and administrative costs into the patent system,” weakening the protections that make medical innovation commercially viable and ultimately discouraging investment in new treatments and breakthroughs.
Even more concerning is the ETHIC Act, framed as a means of lowering prescription-drug costs by curbing so-called “patent thickets”—portfolios of overlapping patents that protect different features, uses, or improvements associated with a single product. The bill seeks to impose a “one patent per patent group” restriction in infringement lawsuits, preventing biopharmaceutical innovators from defending their full IP portfolios by allowing them to assert only one patent from each group of related patents legally tied together to expire at the same time. This effectively prevents innovators from enforcing other valid patents within the same group—even when those patents contain distinct claims protecting different aspects or improvements of a product.
Opponents of these bills and other similar bills point to the faulty premise underlying supporters’ assertions: what critics label “patent thickets” often reflects the cumulative nature of innovation, particularly in the biopharmaceutical sector, where products embody distinct advances developed through ongoing R&D. As a 2026 IP policy trends analyst noted, “the legislation denies enforcement of [] patents inventors have a right to defend, based merely on a presumption that just because more than one patent may attach to a complex product, this somehow reduces competition.” Similarly, the Alliance for Aging Research has warned that such legislation “would allow generic manufacturers to infringe on what the brand manufacturers spent additional time and money researching—and it would do so under the false pretense of preventing an imagined patent extension.”
Moreover, the Congressional Budget Office estimates that these proposed patent restrictions would reduce average drug prices by less than one percent—placing the entire innovation ecosystem at risk while achieving only a negligible impact on cost. Research has further shown that, if market exclusivity periods had been reduced by five years over the last decade, patients would have had thirty-two fewer treatments, resulting in an estimated one million additional deaths in the United States alone. Thus, when it comes to restricting patent protections for biopharmaceutical innovators, the potential savings would be trivial, while the costs to innovation (and, ultimately, to patients) could be profound. The careful balancing inherent in the Hatch-Waxman bargain protects not only innovators, but also the patients who depend on the living, cumulative process of post-approval research for medical advances and new cures. The human cost of weakening that bargain cannot be ignored.
A Moral and Economic Imperative
Taken together, these judicial, executive and legislative developments reflect a broader challenge to the living innovation that defines modern biopharmaceutical progress. By treating post-approval research and the patents it produces as loopholes or abuses, these actions risk weakening the incentives that transform high-risk R&D into life-saving treatments. That risk is especially consequential today, as rival countries modernize their IP framework and seek to attract the clinical research and investment on which U.S. leadership in medical innovation has long depended.
Ultimately, protecting IP is both a moral and economic necessity. Patent rights do more than incentivize innovators and allow them to recover past investments; they enable emerging companies to demonstrate their value to investors, obtain financing, and sustain the continued research through which existing medicines become safer, more effective, and useful for new conditions. For policymakers, the priority should be preserving a predictable patent framework that supports both continued innovation and timely generic competition. For biopharmaceutical companies and investors, these developments underscore the importance of engaging early in the policy debates shaping that framework. Getting the balance right is essential to sustaining U.S. leadership in life sciences innovation and delivering the future treatments patients are waiting for today.
Alice Prokofyeva is a Fall Intern at Christie 55 Solutions. She is currently a third-year student at Seton Hall University School of Law, with a strong interest in intellectual property law. Alice earned her B.A. from CUNY Hunter College in 2022.
Jaden Jackson is an Associate at Christie 55 Solutions, where he supports clients across multiple sectors on public policy, regulatory, and government affairs matters. He is admitted to practice law in New Jersey. Jaden earned his J.D. from Seton Hall University School of Law in 2022 and his B.A. from Montclair State University in 2017.