Today, the Drug Price Competition and Patent Restoration Act - better known as the Hatch-Waxman Act - celebrates its 40th anniversary, marking four decades of success in fueling biopharmaceutical innovation while growing the U.S. generic market into the powerhouse it is today.

In the four decades since Hatch-Waxman’s passage, generic uptake in the U.S. has grown from a mere 19% of prescriptions being filled with generics to a whopping 90% today.

Today, 90% of the medicines patients get in the United States are generics and biosimilars, which are more affordable for patients and save the U.S. health care system hundreds of billions of dollars every year. But it wasn’t always this way.

USPTO’s findings confirm that assertions touted by patent critic groups that the patent system is broken and rampant with abuse are baseless.

The unique American intellectual property (IP) system – including patent protections – promotes biopharmaceutical innovation and affordability, giving U.S. patients more medicine choices than anywhere else in the world. And medicine costs have remained a small and stable 14% share of health care spending that is on par with other countries.

There has been increasing interest from some policymakers in Congress and the administration on terminal disclaimers and their use to resolve obviousness-type double patenting objections. Some proposed policies would even render entire patents unenforceable if a single claim in another patent is found invalid.

Intellectual property (IP) is the foundation of biopharmaceutical innovation that brings lifesaving treatments and vaccines to people around the world.

The Senate Judiciary Committee recently hosted a hearing to examine competition in the prescription drug marketplace, with an emphasis on intellectual property (IP) protections.

Biopharmaceutical research, development and manufacturing relies on the global IP and innovation ecosystem to enable risk-taking and collaboration on a massive scale.

One important piece of America's intellectual property (IP) framework is the Food and Drug Administration’s (FDA) Orange Book and the Hatch-Waxman patent process. The Orange Book provides information on approved drugs and related patents and exclusivities.

PhRMA recently submitted comments detailing critical concerns with the march-in guidance, highlighting its damaging impact on patients and the world-leading American innovation ecosystem.

Policymakers must re-evaluate whether they want to take us back to a time when nearly 28,000 patented inventions were gathering dust on government shelves.

The U.S. Federal Trade Commission (FTC) sent letters to 10 biopharmaceutical companies, challenging the listing of a number of patents in the U.S. Food and Drug Administration’s (FDA) Orange Book.

The Biden Administration is sending a very clear message to American innovators: “We no longer have your back.”

Misuse of march-in rights would chill innovation and undermine collaboration between the public and private sectors, which could return us to the pre-Bayh-Dole era where promising new technologies sat on the shelf benefitting no one.

By empowering academic institutions and industry to take ownership of their research, fostering collaboration, and streamlining the process of bringing discoveries to market, the Bayh-Dole Act has played a central role in shaping the biopharmaceutical landscape we know today.

Patents are clearly not stopping biosimilar and generic medicines from getting developed and reaching the market.

What They are Saying: “Reasonable pricing” clauses in government licensing agreements are unnecessary and would harm public-private collaboration

The National Institutes of Health (NIH) recently made the right decision to uphold the Bayh-Dole Act and not seize patent rights on an innovative medicine by exploiting part of the law known as the “march-in” provision.

PhRMA spoke with several women leaders in IP and innovation at biopharmaceutical companies to let them share in their own words why protecting IP rights is so important.

As the process of considering initiatives continues, we encourage the USPTO and FDA to keep in mind several key points.

PhRMA recently submitted comments in response to the USPTO's request for comments regarding initiatives to ensure the robustness and reliability of patent rights.

The Biden administration should support U.S. innovators abroad and policies that give patients timely access to the innovative medicines that help them live longer, healthier, more productive lives.

PhRMA submitted comments to the U.S. Senate Committee on Health, Education, Labor and Pensions regarding the Pandemic and All-Hazards Preparedness Act reauthorization draft expressing strong opposition to policy proposals that would inhibit the biopharmaceutical industry partnering with the government to address pressing public health needs

America’s biopharmaceutical research companies are central to the research and development (R&D) of innovative medicines in the United States.

At the request of the U.S. Trade Representative, the U.S. International Trade Commission (USITC) is conducting an investigation and will issue an accompanying report concerning the TRIPS Agreement and a variety of issues related to COVID-19 diagnostics and therapeutics.

Durable intellectual property (IP) and market access policies abroad increase patient access to medicines, improve public health, support American jobs and foster innovation.

The bipartisan Bayh-Dole Act created a framework for researchers receiving federal funds to patent and license their inventions to companies for further development and commercialization.

It’s disappointing to see yet more studies published by activist-funded industry critics that fail to recognize the nature of competition in the biopharmaceutical market and use cherry-picked data to draw misleading conclusions.

Intellectual property (IP) protections, including patents, incentivize manufacturers to continue working to improve their FDA-approved medicines.

PhRMA supports the goal of improving health care affordability for Americans, but we disagree that changes are needed to U.S. patent law and policy to increase generic and biosimilar competition.

The government’s flawed price setting plan under the Build Back Better Act will significantly upend the biopharmaceutical research and development (R&D) process.

Learn more about how our IP system benefits our economy, new treatment development and most importantly patients.

Utilizing march-in rights as proposed by the Biden Administration would chill innovation and undermine collaboration between the public and private sectors.

New report demonstrates industry leadership in drug development in partnership with NIH

PhRMA submits comments to NIST in effort to safeguard Intellectual Property protections

Earlier today, 31 PhRMA board members signed a letter to President Joe Biden applauding the Administration’s accelerating COVID-19 vaccine rollout, but also warning against efforts to undermine American intellectual property and innovation-dependent manufacturing jobs.

The biopharmaceutical industry uses its scientific and technical expertise to research, develop, manufacture and distribute safe and effective treatments and vaccines to patients around the world. The intellectual property (IP) system enables this investment and supports competition. Regulatory data protection (RDP) is a critical element of effective IP systems and is a critical component of international IP rules.

Erosion of the Bayh-Dole Act would put the U.S. innovation ecosystem at risk. It’s important to understand the immense success of Bayh-Dole and the potential devastating impacts of rewriting the march-in provision to allow the government to seize patent rights.

Congress passed the Bayh-Dole Act in 1980 with strong bipartisan support, creating a framework where researchers receiving federal funds could patent their inventions and license them to private companies so they could continue to research and develop them into products that benefit the public. This landmark legislation ensures that innovative ideas are protected and brought to market. It has contributed nearly $2 trillion to the U.S. economy and supported 6.5 million jobs.

America’s biopharmaceutical research ecosystem is the global leader in the development of innovative medicines, allowing patients in the U.S. to access new medicines faster than the rest of the world. This is the result of a carefully balanced policy environment that includes robust intellectual property (IP) protections that foster investment in groundbreaking research and development (R&D), while also promoting access for patients and the sustainability of the U.S. health care system. Here are the real facts about how patents help drive innovation and access, contrary to what some claim.

What’s so important about intellectual property rights, or IP for short? Robust IP protections spur innovation, increase competition and lead to more effective treatments and cures for every patient — whether they’re battling cancer, heart disease or COVID-19.

As the world has grappled with the current pandemic, there has been increased focus on biopharmaceutical manufacturing and its global supply chain. Many wondered whether the biopharmaceutical industry could ensure continued and uninterrupted supply of innovative medicines relied on by so many Americans, as well as develop and supply new treatments and vaccines to address the pandemic. We are nearly a year into this public health crisis, and the biopharmaceutical manufacturing industry has stepped up to help beat COVID-19 in more ways than one. A new report from TEConomy Partners takes a closer look at what makes the U.S. biopharmaceutical manufacturing industry so globally competitive. While highlighting U.S. leadership, the report also makes clear the critical steps needed to secure that leadership: addressing the gaps in infrastructure investments, as well as investing in the growth of a STEM workforce.

The Drug Price Competition and Patent Term Restoration Act - better known as the Hatch-Waxman Act, is a comprehensive legal  framework enacted by Congress in 1984 to streamline the process for generic pharmaceutical approvals and preserve incentives for innovation, including the creation of a procedure for patient litigation involving generic pharmaceuticals. The Hatch-Waxman Act established the legal and economic foundation for today's generic pharmaceutical industry.

The Bayh-Dole Act (commonly referred to simply as “Bayh-Dole” and codified at 35 U.S.C. §§ 200-211) created the uniform framework that facilitates orderly and efficient technology transfer from universities and other institutions receiving government research funding to the private sector. Bayh-Dole allows universities and other institutions to own title to the patents arising directly from their research activities. This paper focuses specifically on the contributions of Bayh-Dole in fostering technology transfer in the life sciences and current threats to this robust framework.

Intellectual property (IP) protections, including patents, are the foundation for biopharmaceutical innovation and the development of new treatments, cures and vaccines for patients. The U.S. patent system provides critical incentives for innovation and fuels the creation of new medicines. Yet, there can be confusion around what it takes for a patent to be granted and maintained. These two infographics describe the process of obtaining a patent and legal challenges patentholders are subject to once the patent has been granted.

America's IP system - including patents - promotes competition and is the foundation for new treatments and cures.

PhRMA Amicus brief field to U.S. Supreme Court in support of Ethicon Endo-Surgery, Inc.

Comments of PhRMA on PTO's 2014 Interim Guidance on Patent Eligibility

Established by the Trade Act of 1974, the Special 301 review provides the Administration with a critical opportunity to confirm its strong commitment to defend these and other American inventions in overseas markets and is a critical tool to address damaging market access and intellectual property barriers abroad that harm America’s innovative and creative industries and the 63 million jobs that they support across the country.

PhRMA’s comments to the Office of the U.S. Trade Representative (USTR)’s 2023 Special 301 Report reinforce how the United States can defend American innovators in overseas markets and address damaging market access and intellectual property barriers abroad.

PhRMA’s comments to the Office of the U.S. Trade Representative (USTR)’s 2022 Special 301 Report reinforce how the United States can confirm its strong commitment to defend American inventions in overseas markets and address damaging market access and intellectual property barriers abroad.

In its Special 301 submission, the Pharmaceutical Research and Manufacturers of America (PhRMA) encourages the Office of the United States Trade Representative (USTR) to redouble longstanding U.S. government efforts to protect American innovations abroad.

PhRMA submitted comments to inform the proceedings of National Institutes of Health’s (NIH) Workshop on Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer. PhRMA believes that maximizing the timely transfer of federal investments in science and technology and attracting greater private sector investment to create innovative products, processes, and services as well as new businesses and industries, is critically important for America’s patients, the U.S. economy, and our national security.