Protecting Intellectual Property as a Catalyst for Societal Progress

A guest perspective by: Henry Hadad, Senior Vice President, Innovation Law, Bristol Myers Squibb

Over the past century, the biopharmaceutical industry has delivered extraordinary advances that have fundamentally transformed human health. Immuno-oncology has extended survival for patients with metastatic melanoma from eight months in the 1990s to six years today. Antiretrovirals allow HIV patients to live normal lives. Antibiotics have slashed mortality from infectious diseases. And behind every survival statistic is a human story like Josh, a renal cell cancer patient who achieved remission after receiving immunotherapy and is enjoying watching his grandchildren grow.

These advances did not happen by chance. They were made possible by an ecosystem that supports sustained, high-risk innovation, with a strong and predictable patent system at its core. For those who depend on continued breakthroughs, it is worth pausing to both celebrate this progress and reaffirm the critical role intellectual property plays as the backbone of biopharmaceutical innovation. That foundation cannot be taken for granted.

A worrying trend of IP erosion

In recent years, we have seen growing efforts to weaken the patent system, particularly in countries like the United States and the European Union that have historically championed strong IP protection. This trend should concern anyone who views medical innovation as essential to both public health and economic prosperity.

In the U.S., patent eligibility standards for diagnostics and biologics have become increasingly uncertain following recent judicial decisions. At the same time, patent durability has been undermined by serial, duplicative challenges through inter partes review at the Patent Trial and Appeal Board. In debates over pricing and access to medicines, IP is framed as a barrier rather than an enabler – overlooking the fact that patents drive competition by supporting innovation first, and generic entry later. This perspective has fueled proposals such as limiting the number of patents that can protect a single product or, in the EU, reforms under the General Pharmaceutical Legislation that weaken patent enforcement by significantly broadening the Bolar research exemption. These approaches may appear attractive in the short term, but they carry long‑term negative consequences for innovation.

Innovation requires certainty, not whiplash

The journey from scientific discovery to approved medicine is long, uncertain, and costly. It often takes more than a decade and costs on average $2.6 billion, with only one in 10 therapies that enter clinical trials ultimately reaching patients. A predictable and enforceable patent system is essential to transform this extraordinary risk into a rational, economically sustainable investment. Patents provide a limited window to generate returns on investment and fund the development of the next generation of breakthroughs. Without the assurance of returns on investment, capital would likely flee to safer sectors with faster and more reliable returns.

When policy shifts and judicial uncertainty make patent outcomes unpredictable, innovators are forced to rethink their strategies at a fundamental level. Research becomes more cautious, platforms less exploratory, and long‑horizon projects harder to justify. The consequence is not lower medicine prices, but fewer new therapies. For patients waiting on treatments for unmet medical needs, that loss translates directly into human cost.

Robust IP drives innovation and competitiveness

Despite the remarkable healthcare advances achieved to date, much remains to be done. Scientific potential has never been greater – but realizing it requires sustained investment.  At the same time, policymakers increasingly see a competitive biopharmaceutical sector as a strategic asset for economic resilience and growth. A robust IP system is indispensable for achieving both objectives. 

As global competition for leadership in biopharmaceutical innovation intensifies, policymakers in the U.S. and Europe should resist attempts to weaken IP protections in the name of short‑term cost containment. Instead, they should pursue reforms that enhance predictability and reinforce investment incentives – such as clarifying U.S. patent eligibility standards through the Patent Eligibility Restoration Act, limiting duplicative post‑grant challenges through the PREVAIL Act, and strengthening the EU’s supplementary protection certificate (SPC) system through initiatives like the Biotech Act and the unitary SPC, while also ensuring robust enforcement of IP rights.

We face a fundamental choice: a future of sustained medical progress and technological leadership, or one of stagnation and declining competitiveness. Honoring our commitment to the patients still waiting for the next breakthrough means taking meaningful action now to defend the IP rights that make progress possible.