KEI on Moderna’s Oct 8, 2020 Statement on Intellectual Property Matters during the COVID-19 Pandemic

(More on KEI’s work on coronavirus here: https://www.keionline.org/coronavirus, and on Moderna, here: https://www.keionline.org/moderna)

Oct 8, 2020

Moderna’s statement on intellectual property matters during the COVID-19 pandemic is very good, and should be matched by every manufacturer of a therapeutic, vaccine or diagnostic test. We also encourage Moderna to engage with the WHO COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool. Every manufacturer of a vaccine, drug or diagnostic should follow suit and publish the patents relevant to the technology, waive or license rights in those patents, and  provide constructive transfer of manufacturing know-how and access to cell lines and data when necessary.

It is notable that Moderna has addressed both the pandemic and the post pandemic period, stating “to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post pandemic period.”

One nuance about the Moderna announcement is that the company’s list of the mRNA-1273 COVID-19 vaccine patents is only “representative” of the issued US patents relevant to the vaccine, which suggests that the list is not complete and does not extend to patent applications. It includes only one of the granted patents that KEI cited in our letter to DARPA regarding failures to disclose federal funding, and both DARPA and BARDA are investigating several applications and granted patents for failures to disclose federal funding.

Contrasts should be drawn between Moderna and other companies, including in particularly those that have benefited from massive subsidies from governments and foundations, that are not even making patent landscapes transparent, let alone making the inventions widely available. Moderna is also making it clear that government agencies like the NIH and BARDA have been too willing to grant or enable exclusive rights when subsidizing COVID-19 research. In the past, KEI has called upon federal agencies to involve the authorities in the Bayh-Dole Act to condition federal funding on access to both foreground and background intellectual property rights and know-how as relates to the pandemic response. Moderna is showing that is feasible, and government officials in the United States, Europe and elsewhere need to reflect on this.

James Love, KEI Director


https://investors.modernatx.com/news-releases/news-release-details/statement-moderna-intellectual-property-matters-during-covid-19

Statement by Moderna on Intellectual Property Matters during the COVID-19 Pandemic
October 8, 2020 at 6:39 AM EDT
Moderna is a pioneer in the development of messenger RNA (mRNA) vaccines and therapeutics. From its inception in 2010, Moderna saw the potential of this new class of medicines to make a significant difference in patients’ lives. With the support of our investors we have invested billions of dollars into research and development to make mRNA medicines a reality. One of the exciting discoveries advanced by Moderna was the combination of mRNA and lipid nanoparticles (LNPs) to make vaccines, and the demonstration of this potential in human clinical trials for eleven different infectious disease vaccines since 2015. Those discoveries and the expertise we developed have uniquely positioned Moderna to respond to the COVID-19 pandemic quickly. Information on our work toward a COVID-19 vaccine can be found here.

As a company committed to innovation, Moderna recognizes that intellectual property rights play an important role in encouraging investment in research. Our portfolio of intellectual property is an important asset that will protect and enhance our ability to continue to invest in innovative medicines. A summary of our intellectual property can be found here. A selection of representative issued US patents relevant to our mRNA-1273 vaccine against COVID-19 is available here.

Beyond Moderna’s vaccine, there are other COVID-19 vaccines in development that may use Moderna-patented technologies. We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible. Accordingly, while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic. Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post pandemic period.

Moderna is proud that its mRNA technology is poised to be used to help end the current pandemic.

Forward-Looking Statements

This statement contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding Moderna’s stance with respect to enforcement and licensing of its intellectual property rights during and following the COVID-19 pandemic. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this statement are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this statement in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.


https://www.modernatx.com/patents

A selection of representative issued US patents relevant to our mRNA-1273 vaccine against COVID-19 is available here.

Program Patents
The following are protected by patents in the United States and in foreign jurisdictions for ModernaTx, Inc.

mRNA-1273
COVID-19 VACCINE
US 10,703,789
US 10,702,600
US 10,577,403
US 10,442,756
US 10,266,485
US 10,064,959
US 9,868,692