How IP Rights Can Be Waived to Fight the COVID-19 Pandemic

Moderna, a biotechnology company based in Cambridge, Massachusetts, recently issued a statement that it wouldn’t enforce its COVID-19-related patents against other companies making vaccines to fight the virus.

The company “is a pioneer in the development of messenger RNA (mRNA) vaccines and therapeutics.”

As the National Institute of Health (NIH) explains,

Messenger RNA (mRNA) is a single-stranded RNA molecule that is complementary to one of the DNA strands of a gene. The mRNA is an RNA version of the gene that leaves the cell nucleus and moves to the cytoplasm where proteins are made. During protein synthesis, an organelle called a ribosome moves along the mRNA, reads its base sequence, and uses the genetic code to translate each three-base triplet, or codon, into its corresponding amino acid.

More simply, mRNA is a molecule that carries genetic code from DNA in a cell’s nucleus to ribosomes, which make proteins.

Moderna is working on its own COVID-19 vaccine, called mRNA-1273. The NIH reported in late September that a Phase 1 trial of the vaccine “has shown that the vaccine is well-tolerated and generates a strong immune response in older adults.”

Other vaccines being developed also use technologies patented by Moderna.

In addition to not enforcing its patents during the pandemic, Moderna has offered to license its COVID-19-related patents in the post-pandemic period.

The biotech and pharmaceutical industries have engaged in a number of initiatives to fight the pandemic. For example, as Bloomberg reported, as part of the “Open COVID Pledge,” companies and universities would give free licenses to their patents, copyrights and certain other property rights to anyone developing technologies for the diagnosis, prevention, or treatment of Covid-19, the disease caused by the new coronavirus. These licenses would last until a year after the World Health Organization has declared the coronavirus pandemic to be over.

The Open COVID Pledge website offers three forms of Open COVID Licenses (OCL). These are roughly similar to the open source licenses used in the software industry. Versions cover both patent and copyright, or patent rights only. The United States Patent and Trademark Office (USPTO) also recently launched the COVID-19 Response Resource Center to provide stakeholders and other interested parties with improved access to USPTO initiatives, programs, and other helpful intellectual property (IP)-related information regarding the COVID-19 outbreak.

A similar Open COVID-19 Declaration was launched in Japan. Signatories include Sony, Canon, Nikon, Honda, Nissan, Mitsubishi, and other major companies, who state:

Without seeking compensation, we, declarers commit not to assert certain intellectual property rights against any activities whose purpose is stopping the spread of COVID-19, including diagnosis, prevention, containment and treatment.

As Reuters reported, Gilead Sciences has engaged in negotiations with other companies around tthe world to produce its experimental drug remdesivir.

Although remdesivir is patented in the US, as Reuters notes, “international trade rules allow nations defined by the United Nations as least-developed countries (LDCs) to ignore the patent and make drugs such as remdesivir more affordable in their markets.”

36 countries qualify for this waiver on drug patents under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Remdesivir, also known as Veklury, is the first treatment approved by the FDA for COVID-19 patents requiring hospitalization.