Private pharmaceutical companies hold most of the patent rights covering COVID-19 vaccines, treatments, and diagnostics, even though the U.S. government invested roughly $31.9 billion in the underlying research between 1985 and early 2022. Several legal tools exist to override those rights for public health reasons, but the only mechanism that has meaningfully expanded global access so far is voluntary licensing.
Who Owns COVID-19 Vaccine and Drug Patents
The National Institutes of Health, the Biomedical Advanced Research and Development Authority, and the Department of Defense collectively poured tens of billions of dollars into the science and manufacturing behind COVID-19 countermeasures. NIH funded foundational mRNA research for decades before the pandemic. BARDA and the Defense Department financed clinical development and large-scale manufacturing contracts. But the companies that ran the trials and built the factories kept the patents.
That outcome flows from the Bayh-Dole Act. When a patented invention grows out of federally funded research, the contractor keeps title to the patent, and the funding agency receives a nonexclusive, irrevocable, paid-up license to practice the invention, or have it practiced on the government’s behalf, anywhere in the world.1GovInfo. U.S.C. Title 35 – Patents, Part II, Chapter 18 The government can use the technology royalty-free for its own purposes. It cannot, through that license alone, authorize unlimited commercial production by outside manufacturers. The patent holder still controls who else makes and sells the product.
How a patent holder chooses to license its rights effectively decides which countries get supply and at what price. An exclusive license gives one company the sole right to produce in a market. A non-exclusive license lets several manufacturers operate in parallel. During the pandemic, those private licensing decisions shaped global access more than any public policy did.
What COVID-19 Patents Actually Cover
The pandemic generated patents across the full range of medical countermeasures. Utility patents protect the messenger RNA platform itself, the lipid nanoparticle formulations that deliver mRNA into cells, and specific vaccine compositions. Others cover antiviral compounds such as nirmatrelvir and molnupiravir, monoclonal antibody therapies, and the diagnostic methods behind PCR and rapid antigen tests.
A U.S. patent runs 20 years from the filing date, giving the holder exclusive rights to make, use, or sell the invention during that period.2United States Patent and Trademark Office. Manual of Patent Examining Procedure 2701 – Patent Term Pharmaceutical patents often lose years of effective life to clinical trials and FDA review, and federal law allows a partial restoration of up to five years to offset regulatory delays.3Office of the Law Revision Counsel. 35 U.S. Code 156 – Extension of Patent Term Because COVID-19 products moved through emergency review at unusual speed, most of the 20-year term survived intact.
The TRIPS Waiver: What It Did and Didn’t Do
The most visible fight over COVID-19 patent rights ran through the World Trade Organization. In October 2020, India and South Africa proposed a temporary waiver of intellectual property protections under the Agreement on Trade-Related Aspects of Intellectual Property Rights, aiming to let generic manufacturers produce affordable vaccines, treatments, and diagnostics without negotiating individual licenses.4World Trade Organization. Members Discuss Intellectual Property Response to the COVID-19 Pandemic The original proposal reached across patents, industrial designs, copyrights, and undisclosed information (trade secrets and manufacturing know-how).
Low- and middle-income countries generally supported the proposal. High-income countries, where most major pharmaceutical companies are based, largely opposed it, warning that weaker patent protection would chill future investment in pandemic preparedness.
After nearly two years, WTO members adopted a compromise at the June 2022 Ministerial Conference that was far narrower than the original ask. It applied only to patents on COVID-19 vaccines, not therapeutics or diagnostics, and it worked by relaxing specific procedural requirements under TRIPS Article 31 for countries issuing compulsory licenses for vaccine production.5World Trade Organization. TRIPS and Public Health The decision left trade secrets and manufacturing know-how untouched. Those are the barriers that make it hardest for generic producers to replicate complex mRNA vaccines even when they have legal permission to try.
The June 2022 text directed members to decide within six months whether to extend the waiver to diagnostics and therapeutics.6World Trade Organization. Members Continue Discussion on TRIPS Decision Extension to Therapeutics and Diagnostics That December 2022 deadline came and went without agreement. At the 13th Ministerial Conference in early 2024, members formally acknowledged that no consensus could be reached.7World Trade Organization. Thirteenth WTO Ministerial Conference – Intellectual Property The vaccine-only decision remains the sole outcome of the TRIPS waiver effort.
Compulsory Licensing Under TRIPS
Even without a special waiver, TRIPS itself already lets governments override patent rights in certain situations. Under a compulsory license, a government authorizes a third party to produce a patented product without the patent holder’s consent.8World Trade Organization. TRIPS and Public Health: Compulsory Licensing of Pharmaceuticals and TRIPS This tool predates COVID-19, but the pandemic made it a live question for many countries that had never seriously considered it.
TRIPS Article 31 sets the conditions. The would-be producer normally must first try to negotiate a voluntary license on reasonable commercial terms, though that requirement can be skipped during a national emergency, extreme urgency, or for public non-commercial use. Any license must be non-exclusive, limited in scope and duration, and subject to judicial review, and the patent holder must still receive adequate remuneration reflecting the license’s economic value.
One long-standing limitation weakened this tool for pandemic response: Article 31(f) originally required that products made under a compulsory license be used predominantly for the domestic market of the issuing country. An amendment, Article 31bis, later allowed exporting countries to produce pharmaceuticals under compulsory license for countries lacking their own manufacturing capacity.9World Trade Organization. Intellectual Property – Fact Sheet – Pharmaceuticals The June 2022 COVID-19 decision built on that same principle, streamlining export requirements further for vaccines.
U.S. Government Use Under Section 1498
The United States has a domestic mechanism that operates differently from a TRIPS compulsory license. Under 28 U.S.C. § 1498, the federal government, or a contractor acting with government authorization, can use a patented invention without the patent holder’s permission.10Office of the Law Revision Counsel. 28 U.S. Code 1498 – Patent and Copyright Cases The patent holder cannot obtain an injunction. Its only remedy is to sue the United States in the Court of Federal Claims for “reasonable and entire compensation.”
In practice, the statute lets the government act first and settle the price later. Public health advocates urged the government to invoke § 1498 during the pandemic to authorize generic production of patented vaccines and treatments. The government did not do so.
March-In Rights Under Bayh-Dole
When a patent traces back to federal research funding, the government holds one more card: march-in rights under 35 U.S.C. § 203. March-in rights let the funding agency require the patent holder to license the invention to other manufacturers. The statute lists four triggers, including a failure to achieve “practical application” and situations where action is necessary to meet health or safety needs the patent holder is not reasonably satisfying.
No federal agency has ever exercised march-in rights since Bayh-Dole was enacted in 1980. In December 2023, the National Institute of Standards and Technology published draft guidance that would have made the price of a federally funded product a factor in the march-in analysis under the “practical application” and “health or safety” criteria. The guidance was never finalized. As of early 2026, NIST reported no timeline for completing it, citing a lack of interagency consensus.11U.S. Government Accountability Office. Intellectual Property: Information on Draft Guidance to Assert Government Rights Based on Price March-in remains a theoretical power that has never been tested, even as COVID-19 vaccine pricing drew intense public scrutiny.
Voluntary Licensing: Where Access Actually Happened
While governments debated compulsory tools, voluntary licensing did the practical work of expanding access to COVID-19 treatments. The Medicines Patent Pool, a United Nations-backed organization, negotiated licenses with patent holders that let dozens of generic manufacturers produce affordable versions of key antivirals for low- and middle-income countries. MPP signed agreements covering nirmatrelvir (the active ingredient in Paxlovid) with 35 generic manufacturers for supply to 95 countries, molnupiravir with 27 manufacturers for 105 countries, and ensitrelvir with manufacturers for 117 countries.12Medicines Patent Pool. COVID-19
The World Health Organization launched a separate platform, the COVID-19 Technology Access Pool (C-TAP), where developers could voluntarily share intellectual property, data, and manufacturing know-how with qualified producers worldwide.13World Health Organization. How WHO C-TAP Works C-TAP drew participation from public research institutions like NIH but failed to attract meaningful engagement from major pharmaceutical companies. That gap illustrates the recurring theme of the pandemic IP debate: legal permission to reproduce a patented product matters less than access to the trade secrets and technical expertise needed to actually manufacture it.
Individual companies made their own gestures. Moderna publicly pledged not to enforce its COVID-19 vaccine patents against manufacturers producing vaccines to combat the pandemic, and offered to license its technology for the post-pandemic period on request. These voluntary commitments were unilateral and revocable, a fundamentally different kind of assurance than a binding waiver or compulsory license.