Patent Rights Battles Escalate as Debate over Drug Costs and Access Drags On

Consumer advocates continue to press for initiatives to lower drug prices by revising or reducing patent protections, as seen in the recent campaign to implement “march-in rights” for drugs developed with federal government support. At the same time, governments around the world are advancing a proposed agreement on a waiver to intellectual property (IP) protections for COVID-19 vaccines. Disagreement on these and related issues has put IP claims at the center of debates over biopharma R&D policy and funding, particularly as Congressional leaders fail to set limits on US prices for new therapies for COVID-19, cancer, and other serious conditions.

These issues recently gained attention as reformers renewed calls for the National Institutes of Health (NIH) to seize patent rights to drugs it helps develop, a popular strategy for activists seeking broader access to valuable medicines that has long been rejected by government officials as well as manufacturers and academic researchers. Now the battle has gained headlines as a group of nonprofit organizations petitioned Health and Human Services (HHS) Secretary Xavier Becerra to seize patent rights to six important therapies for cancer, COVID-19, HIV, hepatitis C, insulin, and asthma that the critics claim are too costly for patients to realize benefits. A main target is patents on Pfizer’s prostate cancer drug, Xtandi, which reformers and some members of Congress have identified as particularly expensive.

The Biotechnology Innovation Organization (BIO) responded by emphasizing how “strong, predictable” patent protections have been critical for the fast development of new COVID-19 vaccines and therapeutics and that dismantling the current IP system will weaken the response to the next pandemic. Similar arguments were voiced by a coalition of nearly 100 academics, R&D organizations, and IP experts, who called on Becerra to reject any seizure of patent rights. They emphasized that the exercise of “march-in” rights undermines deals between commercial companies and universities that develop important new cures with support from federal research funds

Advancing global waiver

In addition to challenging biopharma patent protections at home, international public health and consumer organizations have pressed the World Trade Organization (WTO) to revise IP policy governing COVID-19 vaccines and therapies to facilitate broader production and access around the world. Now after two years of discussion, key members of the Council for Trade Related Aspects of Intellectual Property Rights (TRIPS) announced an agreement in mid-March on a possible IP waiver for these vaccines. This initial proposal was backed by the United States, European Union, India, and South Africa and now seeks broader support from WTO as well as industry.

The compromise, however, generated objections on all sides. Public health groups said the proposal does not go far enough in applying only to vaccines, and not to diagnostics and much-needed antivirals and other therapeutics. They seek “bolder steps” to extend reforms beyond patents to include trade secrets and to address broader WTO efforts to gain compulsory licenses.

In turn, biotech and pharma companies predicted that such an agreement would dry up investment in biomedical R&D, particularly in smaller companies that have been the source of much R&D related to combatting the pandemic. BIO criticized the proposal as a first step towards dismantling patent rights. Similarly, the International Council for Biotechnology Associations (ICBA) said that the IP waiver agreement would have a “chilling impact” on investment in smaller companies, where IP is particularly important for encouraging research leading to new breakthroughs.

The strong objections from all sides, observed some patent experts, may signal that the agreement probably struck a reasonable balance between the opposing parties. The WTO hailed the plan as an important “breakthrough,” while acknowledging that it would take many more months of work to gain agreement from all 164 WTO members. That timeframe supports the more telling criticism that such a patent waiver comes too late in the COVID-19 pandemic to have much impact, as manufacturers already have produced hundreds of millions of vaccine doses and taken steps to broaden global distribution. However, this type of agreement could set a precedent for future global health emergencies, and it could be extended to therapies and diagnostics in six months.

About the author

Jill Wechsler is Washington editor for Pharmaceutical Technology.