The latest salvo in the debate over patents protecting COVID-19-related drugs, devices and vaccines came this week from U.S. industry organizations, including Advamed, the Biotechnology Innovation Organization and the Pharmaceutical Research and Manufacturers of America.

In a March 29 letter to top Biden trade and commerce officials, the trade associations encouraged the administration to continue to oppose a proposal before the World Trade Organization (WTO) to waive global intellectual property (IP) protection for COVID-19 products. “This waiver is as vague as it is broad, removing patent, industrial designs, copyright and trade secret protection for any products and services so long as they can be tied to COVID-19,” according to the letter.

The waiver, proposed by more than 50 countries led by India and South Africa, has been opposed by the U.S., as well as the EU and countries such as Japan, Switzerland and the U.K. But there’s a growing effort to build global support for the proposal.

A week ago, more than 250 research and education organizations and individuals from around the world called on the WTO to temporarily waive IP protection for vaccines and treatments related to the pandemic, claiming that copyright barriers were preventing access to knowledge that could lead to new treatments.

Earlier this month when 115 countries were still waiting for their first vaccine doses, a handful of Democratic U.S. lawmakers held a press conference to urge President Joe Biden to support the waiver “so that greater supplies of vaccines, treatments and diagnostics tests can be produced globally.”

Reps. Rosa DeLauro (D-Conn.), Jan Schakowsky (D-Ill.), Earl Blumenauer (D-Ore.), Lloyd Doggett (D-Texas), Adriano Espaillat (D-N.Y.) and Andy Levin (D-Mich.) said more than 60 of their colleagues would be joining them in the coming weeks to write to Biden to again ask him to back the waiver.

Rather than addressing the real barriers, those supporting such efforts are using the pandemic as an opportunity “to pursue their longstanding goals to weaken IP rights,” the trade organizations said in this week’s letter.

As a result, the debate over the waiver is distracting from the complex manufacturing and logistical issues that are the real barriers to getting vaccines distributed globally, they said. Addressing supply chain bottlenecks and strengthening health systems in developing countries so they can deliver vaccines as quickly as possible would go further in fighting the pandemic than IP waivers, they added.

The industry letter also credited “clear and predictable IP rights” with making possible the “unprecedented collaboration among companies through licensing agreements to accelerate knowledge and technology sharing, and leverage manufacturing capacity to broaden supply and distribution” to respond in record time to COVID-19.

That collaboration – among businesses, nonprofits, universities and governments – has been seen since the beginning of the pandemic, but “recent weeks have seen a flurry of announcements of new licensing agreements between companies,” according to the letter.

Patents as policy tools

While the proposed WTO waiver was the focus of the industry letter, it’s not the only IP challenge facing companies in the U.S. Last week, Public Citizen, PrEP4All, two other advocacy groups and 16 academics sent a letter to NIH officials and Health and Human Services Secretary Xavier Becerra, urging them to use a pending government-owned patent as a policy tool to ensure global access to the COVID-19 vaccine co-developed by Moderna Therapeutics Inc. and the NIH’s National Institute of Allergy and Infectious Diseases.

When it comes to licensing the soon-to-issue Patent No. 10,960,070, which protects the use of proline-substituted coronavirus spike proteins stabilized in their prefusion conformation as a vaccine immunogen, to Moderna, it’s “imperative that the NIH . . . include provisions to help increase global access to this lifesaving technology, rather than just a monetary royalty,” according to the March 25 letter.

The Public Citizen-PrEP4All letter said the licensing agreement should:

  • empower the U.S. government to authorize manufacturing of the vaccine, including by government-owned production facilities;
  • require technology sharing with the World Health Organization to help ramp up global production of the vaccine;
  • include requirements for accessible pricing universally.

The letter goes on to claim that Moderna has only contracted with a single contract manufacturing organization, Lonza Group AG, to produce the drug substance for the vaccine, which means production could fall short of global demand. The company also has ignored requests from manufacturers in developing countries to share its technology, according to the letter.

The groups also attack Moderna’s pricing for the vaccine, between $10 to $40 per dose, when each dose costs less than $3 to manufacture. That price, “coupled with Moderna’s lack of planned market entry for many low- and middle-income countries,” will limit access to the vaccine, they said.

What the Public Citizen-PrEP4All letter fails to acknowledge is that the government’s pending patent is just one of several patents that apply to the mRNA-1273 vaccine. According to Cortellis, the vaccine also is protected by patents owned by Moderna, as well as ones shared by Biontech SE, Cellscript Inc. and the University of Pennsylvania.

The letter also ignores manufacturing complexities and the time involved in scaling up production. When Moderna announced last month that it was making investments to increase the vaccine capacity at its owned and partnered manufacturing facilities, it estimated that bringing the additional capacity online could take up to a year – six to nine months to add the capacity, plus the time needed for regulatory validation and ramp-up.