IP and COVID-19

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Pharmaceutical Executive, Pharmaceutical Executive-03-01-2021, Volume 41, Issue 3

Disputes over mRNA-related patents are poised to persist.

Today’s headlines are filled with stories about the new mRNA vaccines to address the COVID-19 pandemic. But what types of patent disputes could potentially be on the horizon for mRNA vaccine-related technology post-COVID?

In nature, when a cell wants to make a protein that is encoded by a specific gene, it transcribes its DNA into mRNA, and then that mRNA is translated into the specific protein that the gene encodes. The innovators of mRNA vaccines have figured out a way to use man-made mRNA molecules that encode viral proteins in formulations that elicit a protective immunological response to viruses. The mRNA molecules in COVID vaccines are the precursor code for making the COVID surface spike protein of the coronavirus. The mRNA molecules are generally contained in a delivery system that protects the molecules and allows the mRNA to enter cells. Once inside the cells, the mRNA is released and instructs the cells to make copies of the COVID spike protein. The protein is identified by the immune system as foreign and an antibody response is initiated. These antibodies protect against COVID.

Hundreds of mRNA-related vaccine patents have been filed globally in recent years. A September 2020 study found that patent filing activity related to mRNA vaccine development has accelerated dramatically in the last five years. The study identified 113 patent families directed to mRNA vaccines, 70% of which were filed by those in the life sciences industry.1 Almost half of the mRNA vaccine patent applications belong to four companies: Moderna, BioNTech (which partnered with Pfizer for the Pfizer COVID vaccine), CureVac, and GlaxoSmithKline. Many of these patents and patent applications claim compositions, such as mRNA delivery platforms; others claim modifications to the mRNA to increase stability of the molecule or to decrease immunogenicity. The study suggests that mRNA vaccine patent filings will continue to grow due to increased investment in this potent new technology.

BioNTech has more than a dozen patents and applications related to its mRNA COVID vaccine, including modified mRNA structures, mRNA formulations, and mRNA manufacturing processes. Moderna also has many patents and applications covering the COVID technology, ranging from compositions and formulations to manufacturing processes. Moderna has pledged not to assert its patents during the pandemic, but post-pandemic, it may choose to defend its rights. At this point, Pfizer and BioNTech have not publicly stated a position.

With so much patent activity concerning mRNA-related technology, it is inevitable that patent disputes will arise. Moderna is already in an ongoing dispute with Arbutus Biopharma regarding Arbutus’ patented delivery system technology. In 2016, Moderna lost its contractual rights to the Arbutus delivery system patents and has since filed inter partes proceedings in the US Patent and Trademark Office against Arbutus and invalidated two of the patents at issue.2 The results of these proceedings may encourage others to challenge delivery system and other mRNA-related patents in the future.

Moderna has not been alone in dealing with contentious proceedings. In October 2020, Allele Biotechnology and Pharmaceuticals filed a lawsuit against Pfizer and BioNTech in the Southern District of California, alleging that its mRNA COVID vaccine was developed using Allele’s patented fluorescent protein without a license. If Allele is successful, it may encourage other companies with patented inventions used as tools to develop mRNA-related technologies to challenge companies with successful products. That could potentially cause an avalanche of patent disputes in the biotechnology area that could last for decades.

Considering the complex web of technologies that are needed to develop mRNA-related advancements, some licensing collaborations and agreements may become strained due to conflicts, such as government interests in mRNA vaccine programs. During the pandemic, governments may expropriate IP, force compulsory licenses, or put strict price controls in place. After the pandemic is controlled, there may be contentious proceedings for many years as companies resolve royalty and other licensing disputes.

Pfizer, Moderna, and other vaccine developers may also have to deal with constraints against filing lawsuits, depending on external pressures for continued third-party involvement in production of mRNA vaccines. This may ultimately temper the appetite for filing patent lawsuits and encourage competitors to collaborate to avoid government regulation.

Only time will tell whether the current pandemic is followed by a never-ending cascade of new litigation, or new forms of collaboration that curb the volume of patent disputes.

References

  1. Martin, M., and Lowery, D., mRNA Vaccines: Intellectual Property Landscape. Nature Reviews Drug Discovery 19:578 (2020).
  2. IPR2018-00680; IPR2018-00739; IPR2019-00554

Patrice P. Jean, JD, PhD, Partner, Lynn Russo, JD, PhD, Associate; both with Hughes Hubbard & Reed