When I stepped off the plane in New Delhi in March 2020, the world was reeling. COVID-19 was spreading rapidly, exposing how urgently global health relies on innovation -- and how deeply that innovation depends on strong intellectual property (IP) protections.
I was honored to serve as the U.S. IP Counselor for South Asia for the past five years. I forged relationships with IP experts and relentlessly worked hand-in-hand to strengthen IP protections throughout the region. I also saw what happens when some of those protections fall short.
The Indian government's efforts to promote innovation are ambitious and longstanding. Yet decades-old policies -- narrow patentability standards, lack of regulatory data protection, opaque procedures, and unreliable enforcement -- continue to impede India's innovation landscape.
Perhaps this is best exemplified when it comes to protecting life-saving innovations, where these influences deter the development of new treatments. Without a solid IP foundation, there can be no steady pipeline of next-generation medicines and no durable path to health security. From clean energy to semiconductors, every advanced sector depends on a predictable IP system to provide incentives for inventors. I experienced this firsthand in South Asia, where I actively participated in discussions between the United States and its trading partners to pursue opportunities to expand innovation and address longstanding policies and procedures impacting IP systems globally.
After returning from overseas, I was surprised to see legislation in the United States, like the Affordable Prescriptions for Patients Act and the Drug Competition Enhancement Act, that appear to take cues from countries that have allowed misguided policies to impede their ability to foster robust IP-driven innovation. These and other bills, like the recent Eliminating Thickets to Increase Competition (ETHIC) Act, as well as the Medication Affordability and Patent Integrity Act, Interagency Patent Coordination and Improvement Act, and the Preserve Access to Affordable Generics and Biosimilars Act, claim to benefit patients. In reality, these bills would undermine the system that fuels medical progress in the first place. There are no generic copies of drugs that are never developed.
India is improving its IP infrastructure, streamlining procedures, and enhancing IP office operations. Yet meaningful innovations are too often denied protection, particularly if deemed "incremental" -- despite offering patient benefits such as innovative formulations that can be taken orally instead of intravenously or reduce side effects. This disincentivizes researchers from advancing their discoveries. And when patents are granted, enforcement remains difficult -- hindering innovation and making investments riskier.
Still, U.S. leadership isn't guaranteed -- as these latest bills indicate.
The Affordable Prescriptions for Patients Act misrepresents having different inventive aspects of a product being covered by different patents as "patent thickets," claiming companies file multiple patents to delay generics. But protecting novel aspects of a product is standard practice across industries. In tech, products like smartphones are covered by many patents -- for innovative aspects of screen design, processing, communications, and battery usage. Medicines are no different. Patents can cover ingredients, dosing regimens, and delivery methods -- each a distinct innovation deserving protection.
Yet critics and entities that would benefit from a weak IP system continue to chase this non-issue with more legislation. Consider the recently introduced ETHIC Act, which would limit drug manufacturers to asserting only one patent from a defined group of patents in an infringement case -- eroding that company's ability to defend the full scope of its sophisticated products. While the bill targets biopharmaceuticals, its precedent could ripple across industries, inviting broader efforts to weaken patent enforcement and devalue American ingenuity.
Despite these critics' claims, patents don't delay generic entry. A recent U.S. Patent and Trademark Office (USPTO) study found no link between the number of patents and when generics launch, corroborating other analyses. The USPTO also recently confirmed that large groups of closely related patents are uncommon within the pharmaceutical space, further dispelling the myth that generic competition is systematically blocked by patents.
Indeed, regardless of how many patents may cover the original product, generics typically enter the market three to sixteen years after FDA approval of the original -- well before the standard 20-year patent term of any of the applicable patents. Undermining patent protections would not speed up generics, it would only discourage innovators from pursuing meaningful advances.
The Drug Competition Enhancement Act rests on a similar misconception -- targeting "product hopping," another fabricated concept that accuses companies of blocking generics by patenting improved versions of a medicine and discontinuing or discouraging use of the original. But every industry phases out outdated models. In medicine, those novel improvements mean safer, easier-to-use treatments. And patenting improvements doesn't extend an original patent -- generics can still enter when that patent expires. The "product hopping" narrative misrepresents how the system works, aiming to mislead the public and lawmakers into thinking such innovations shouldn't be protected.
Let's not forget: 90% of prescriptions in the United States are filled by generics. Our patent system is already balanced to ensure timely competition. The U.S. bills under consideration would disrupt what's made us a global leader in medical innovation and access -- echoing India's past policy decisions, just as India is working on strengthening its own system.
The fallout won't stop with medicines, leading to economy-wide ramifications given that patents underpin investment across every advanced sector -- agriculture, aerospace, manufacturing, and more. IP-intensive industries account for 44% of U.S. jobs and contribute over $7.8 trillion to the U.S. economy.
America's innovation edge rests squarely on a patent system that rewards ingenuity, risk-taking, and long-term investment. If Congress erodes that foundation, we'll face fewer medical breakthroughs, slower progress in emerging technologies, and weakened economic and national security -- leaving us unprepared for the next global crisis.
John Cabeca is the former U.S. Intellectual Property Counselor for South Asia and the current Chief Operations Officer at the Council for Innovation Promotion.
