Who invented the Kovid-19 vaccines? Drug manufacturer patent fight

The US government and Moderna Inc., whose collaboration gave rise to one of the most widely used shots, fought over who discovers a key ingredient and owns the rights to it. Meanwhile, Pfizer Inc. And BioNTech SE, makers of another major vaccine, are in a patent battle with a smaller company, and some analysts think they could face off against Moderna.

At the center of controversies: Who can claim to have invented key ingredients of COVID-19 vaccines?

Millions of dollars are at stake. If anyone is successful in establishing a role in the discovery of vaccines, Pfizer and Moderna will have to share with others a huge cut of tens of billions of dollars in sales of vaccines.

“It’s scientific credit and money. That’s what people want,” said Jacob Sherko, a professor specializing in biotechnology intellectual property at the Illinois College of Law. “This is a major biotech invention, with billions of dollars riding on the line.”

Emerging patent disputes cast a shadow over what has otherwise been a remarkable scientific, government and commercial achievement: the development of multiple effective COVID-19 vaccines at unprecedented speed during a pandemic.

Who deserves credit for medical discoveries has long been a battleground for companies, academia and the government. Patents are especially valuable in the pharmaceutical industry because they can give a company the exclusive right to sell a drug or vaccine for many years, free from generic competition.

If a pharmaceutical company licenses patents and pays royalties on sales, they could be valuable to scientists—and also to the universities and government laboratories they work for. Princeton University built a $278 million chemistry lab using royalties from the sale of Eli Lilly & Co.’s cancer drug Alimta, based on research from a university professor.

Yet disputes can be difficult to resolve because they involve complex research that is often based on a series of iterative discoveries.

Multi-company patent battles have erupted in the past over lucrative new drug markets such as hepatitis C treatments in the mid-2010s.

The market for COVID-19 vaccines has proved bigger than Wall Street initially expected. Pfizer and Moderna have booked a combined $35 billion in COVID-19 vaccine sales globally for the first nine months of 2021.

Analysts estimate that the two vaccines will post combined sales of more than $52 billion in 2022, helped by demand for booster shots.

Pfizer, BioNTech and Moderna already pay royalties on sales of their vaccines because they rely on research done elsewhere. Both BioNTech and Moderna previously licensed patents on messenger RNA research conducted by scientists at the University of Pennsylvania, and BioNTech has obtained a patent license from the federal government, to which Pfizer has a sublicense. Moderna paid $400 million in royalties for the first nine months of 2021 on sales of its COVID-19 vaccine, including to companies holding the rights to the pen patent.

One controversy stems from Moderna’s decision to deny a National Institutes of Health request to list government scientists as co-inventors for a US patent covering a key component of its COVID-19 vaccine. was applied for.

The patent would have claimed the invention of a genetic sequence included in the Moderna vaccine to trigger an immune response against the coronavirus. The controversy was first reported by the New York Times.

Moderna had been working with the NIH on vaccine research for a few years before the novel coronavirus emerged, and they collaborated with the development and testing of the COVID-19 vaccine shortly after the pandemic began.

Moderna said it credits government scientists on other patent applications related to its vaccine, such as a covering dose, but did not help government scientists invent the genetic sequence used in the vaccine.

Moderna said only its scientists have come up with the messenger RNA sequence, which instructs the body’s cells to make a version of the spike protein found on the surface of the coronavirus and triggers an immune response.

This month, Moderna dropped the patent application, saying it wanted to devote more time to discussions with the NIH aimed at an amicable solution.

NIH said it welcomed the opportunity to work with the company to resolve patent issues that recognize the contributions of NIH scientists.

A second dispute may emerge over an NIH patent for an engineered version of the coronavirus spike protein. The engineered spike protein helps generate a strong immune response to a vaccine. Versions of the genetic sequence of the spike protein are found in mRNA vaccines, including Moderna and Pfizer.

Vaccine manufacturers, including Pfizer and partner BioNTech, licensed the NIH patent, but Moderna did not.

Unless Moderna has a license, its vaccine infringes on NIH patents, according to Christopher Morton, associate clinical professor of law at Columbia Law School who researches biotech and other patents. He has estimated that Moderna may be on the hook for paying the government more than $1 billion for patent infringement.

Moderna did not respond to a request for comment regarding the patent.

Both Pfizer and Moderna are already engaged in patent battles with other companies regarding their vaccines.

In October 2020, a smaller San Diego-based company, Allele Biotechnology & Pharmaceuticals, sued Pfizer and BioNTech, saying the companies were using a protein in their vaccine trial that infringed on an Allele patent.

Pfizer and BioNTech dispute the claim, and the lawsuit is pending.

Before the pandemic, Moderna launched a US patent-office proceedings to invalidate a patent held by Arbutus Biopharma Corp. They claim to have invented some nanoparticles, such as those found in Moderna’s COVID-19 vaccine, that help deliver a vaccine’s RNA inside human cells.

Moderna said it uses its own proprietary nanoparticles, which are not included in the Arbutus patent claims.

According to some analysts, Moderna’s loss could eventually cause the company to pay royalties to Arbutus. On December 1, a US appeals court upheld some of Arbutus’ patent claims. Arbutus and a partner company that licenses the patent said they were happy with the court’s decision.

More patent lawsuits may arise. Last year, Moderna said it would not enforce patents related to its COVID-19 vaccine while the pandemic emergency continued, but would try to license its patents to other companies after the pandemic emergency was over.

According to some patent experts and Wall Street analysts, that possibility has left open the possibility that Moderna could file patent-infringement lawsuits against Pfizer and other companies, including BioNtech, if they don’t agree to the license terms.

A Pfizer spokesperson said the company does not expect intellectual property to be a barrier to vaccine availability. The Company expects that any desired third-party licenses will be available on reasonable terms.

This story has been published without modification in text from a wire agency feed