Written By Caitlin Grow
One of the key ways the world has combated the coronavirus has been through the use of vaccines. Specifically, the Moderna COVID-19 vaccine, now branded as “Spikevax,” has played an essential role in this fight by allowing an individual’s body to create an immune response to the virus. Moderna, Inc.’s (“Moderna”) vaccine is one of three mRNA vaccines made available to combat the coronavirus, the others being the BioNTech-Pfizer vaccine and Johnson & Johnson’s vaccine, heralding a new era for vaccines from a technological viewpoint. On January 31, 2022, Spikevax was granted official approval by the U.S. Food and Drug Administration (“FDA”), demonstrating that the vaccine meets the FDA’s scrupulous health and safety requirements and that emergency use authorization is no longer in place.
While official FDA approval is a triumph for the powerhouse biotechnology company, the company still faces another battle: the battle for patent rights to the product. This conflict began in July of 2021 when Moderna filed a patent on their COVID-19 vaccine, without including the names of three scientists from the National Institutes of Health (“NIH”) on its list of inventors for the product. This sparked outrage from the NIH, with NIH director Francis Collins stating that Moderna “has made a serious mistake here in not providing the kind of co-inventorship credit to the people who played a major role in the development of the vaccine that they’re now making a fair amount of money off of.” This outrage stems from the NIH providing Moderna with government scientists and facilitates, as well as over one billion dollars in funding towards the development of the vaccine.
Last fall Moderna halted its patent application, commenting that the company “would like to avoid any distraction to the important public-private efforts ongoing to addressing the SARS-CoV-2 variants, including Omicron” but added that it would “continue the discussion over the patent issue at a later date.” In late November 2021, Moderna dropped the originally filed patent and filed a new one. This allows the patent to be issued at a later date, thereby allowing more time for discussions between the NIH and Moderna. Moderna does not agree that these government scientists should receive credit for the mRNA sequence stating that it was “selected exclusively by Moderna scientists using Moderna’s technology and without input of [these] scientists, who were not even aware of the mRNA sequence until after the patent application had already been filed.” Moderna’s reference to “public-private efforts” in its released statement may be leveraged by Moderna in future negotiations as to how the vaccine was developed. Moderna could allege that this was a typical public-private partnership whereby the public governmental agency (here the NIH) helps fund the research but the private company (here Moderna) typically sells the product for profit.
What Does a Patent Right Mean?
A company that receives a patent is granted the right to exclude others from making, using, selling, or importing their invention. A new patent is typically granted for 20 years from the date the patent application is filed on. Having a patent on a product allows the producer to make business decisions regarding who to sell the product to, for how long, and for what price. If another company produces replicas of a patented product, the patent holder has the right to seek legal recourse for patent infringement.
Patents can be held by an individual, or jointly by two or more persons or entities as joint owners. Each co-inventor of a product owns 100% of the patent, regardless of the amount he/she contributed to the development of the product. Any joint owner of a patent may make, use, offer for sale, sell, and import the invention for his or her own profit, without regard to the other owners, and may sell the interest, or grant licenses to others, without regard to the other joint owner, unless the joint owners have a separate contract governing their relationship.
How can the outcome of this patent affect the public?
If the vaccine patent is jointly owned by the U.S. government and Moderna, then the government can share in the profits Moderna makes off the vaccine’s distribution. According to the NY Times, Moderna has lined up about $35 billion in sales for supplying the vaccine through the end of 2022. If the patent had joint ownership, some of these profits could be returned to the government in repayment of the public funds initially invested.
Furthermore, co-ownership allows the government to have a say in where the vaccine is distributed and for what price. It also allows the government some control over licensing or sublicensing production of the vaccine and can affect how the technology is transferred. Throughout the public health emergency, the government has worked diligently to make the vaccine available at no cost to the public, but this will not be the case forever. The government having a say in the pricing of the vaccine would be beneficial to the public, those whose taxpayer dollars went towards some of the research and development of the product. Co-ownership also can help accomplish the Biden administration’s mission to assist third-world countries in the disbursement of the COVID-19 vaccine to their people.
The recent FDA approval of Moderna’s vaccine may lure Moderna and the government back into this controversy over who has patent rights to the product. Some have seen this as a step towards the government pushing back on pharmaceutical companies creating empires through intellectual property rights while others take the standpoint that giving private biotech companies patents on their products is necessary to incentivize the research and development that goes into the product. This debate will be ongoing, causing the potential side effects on the public of this patent ownership to remain uncertain.
Ajeet Kumar, Moderns vs US Govt: COVID-19 Vaccine Manufacturer Halts Dispute Over Patent Issues, Republic (last updated Dec. 19, 2021).
Constance E. Bagley & Christina D. Tvarnoe, Pharmaceutical Public-Private Partnerships: Moving from the Bench to the Bedside, 4 Harvard Bus. L. Rev. 373, 376 (2014).
COVID-19, Moderna, CDC (updated Feb. 1, 2022).
FDA News Release, Coronavirus (COVID-19) Update: FDA Takes Key Action by Approving Second COVID-19 Vaccine, FDA (Jan. 31, 2022).
General Information Concerning Patents, USPTO (last visited Feb. 22, 2022).
Julia Steenhuysen, Moderna COVID-19 vaccine patent dispute headed to court, U.S. NIH head says, Reuters (Nov. 11, 2021).
Moderna Statement on Intellectual Property, Moderna (Nov. 11, 2021).
Owen Dyer, Covid-19: Moderna seeks to exclude US government scientists from vaccine patents, despite public investment, BMJ (Nov. 12, 2021).
Sheryl Gay Stolberg & Rebecca Robbins, Moderna and U.S. at Odds Over Vaccine Patent Rights, N.Y. Times (updated Nov. 11, 2021).
Zachary Snowdon Smith, Moderna Drops COVID-19 Vaccine Patent Application, Cooling Legal Fight With Government, Forbes (Dec. 17, 2021).