Moderna Makes Milestone Pledge To “Not Enforce Our Patents” On COVID-19 Vaccine Technologies During Pandemic & Issue Open Licenses Afterward Intellectual Property 08/10/2020 • Raisa Santos & Elaine Ruth Fletcher Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Moderna’s mRNA research and innovation centre Moderna, Inc., developer of one of the four front-running COVID-19 vaccine candidates, announced on Thursday that the the company would “not enforce” its COVID-19-related patents against other companies making vaccines to combat the pandemic – and would also be willing to license intellectual property for their COVID-19 vaccines for the post pandemic period. “We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible.” said the company’s statement, which raises the bar on corporate policies around patents as the world fights a pandemic. “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.” Speaking at a webcast of the company’s 8 October update where the announcement was made public, Stephen Hoge, president of Moderna told investors, “It is our responsibility to be upfront and transparent, but we’re not going to be using those patents and try to enforce them.” Added Tal Zaks, Moderna Chief Medical Officer at the presentation: “It is the right thing to do, to protect the population.” Leading Medicine Access Advocate Applauds Moderna Announcement – Others Demand More The announcement was greeted with applause by one leading medicines access advocate, Jamie Love of Knowledge Ecology International, who said that the new Moderna policy offers a model that other pharma companies should follow: Statement by Moderna on Intellectual Property during COVID-19 Pandemic “Moderna is the only company manufacturing a drug or vaccine that has made a pledge to openly share its COVID-19 patents,” Love, generally an outspoken critic of pharma positions, told Health Policy Watch. “And the statement includes both the period during the pandemic, and an offer to license in the post-pandemic,” Love added that the commitment, “should be matched by every manufacturer of a therapeutic, vaccine or diagnostic test…” Love contrasted the Moderna pledge with the fact that Oxford University had granted the pharma company AstraZeneca exclusive rights to the IP associated with the adenovirus vector vaccine technology that they are co-developing, with backing from the Bill and Melinda Gates Foundation. “This makes the deal that Oxford and Gates struck with AstraZeneca look absurd,” Love said, adding that no matter how rights are used during the pandemic, the framework of the latter also leaves AstraZeneca to “tighten the screws” when the pandemic is over while, “Moderna will provide licenses that extend post-pandemic.” A KEI statement, however, added that Moderna should still go further and “engage with the WHO COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool” – which are serving as vehicles for more systematic pooling of vaccines and their patents. “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”. Other advocates expressed skepticism about the reasons behind the moves, saying that the announcement was motivated by pending legal challenges to Moderna IP claims, as well as rising consumer and political pressures: Moderna “should not be lionized for taking baby steps on access when we are in a race for our lives,” stated an op-ed by Asia Russell, Brook Baker and Jessica Bassett, published by HealthGap Global Access Project: “It is no accident that Moderna’s announcement comes less than a week after South Africa and India filed a petition to the World Trade Organization calling for waiver or suspension on the granting or enforcement of any intellectual property protections on COVID-19-related medical technologies for the duration of the pandemic. “But Moderna knows that this non-enforcement-of-patents concession is meaningless without a commitment to share not only the patents, but also all the information, know-how, data, and biologic resources needed for other qualified vaccine manufacturers to produce the vaccine economically and at scale to meet global need. Moderna should fully commit to sharing all necessary rights and knowledge through the WHO COVID-19 Technology Access Pool (C-TAP), with no artificial time limitation based on the severity of the pandemic.” Moderna To Submit Vaccine Candidate to FDA 25 November for Approval The Moderna announcement comes just days after Moderna’s chief executive officer Stéphane Bancel said that the company aims to submit the candidate vaccine to the FDA for emergency use authorization by 25 November 2020. The company then intends to submit the vaccine as a candidate for the general population by late January. If approved, the vaccine would be available for widespread distribution by spring 2021. Stéphane Bancel, CEO of Moderna Based in Cambridge, Massachusetts, Moderna is a biotechnology company pioneering the development of messenger RNA (mRNA) vaccine and therapeutics. The mRNA-1273 technology contains the “coding” for a stabilized form of the Spike (S) protein that is characteristic of the SARS-CoV2 virus that, which was co-developed by Moderna and investigators from NIAIDS’s Vaccine Research Center. Moderna’s vaccine candidate uses novel mRNA technology to prime and boost the immune response in regards to antibody neutralization across all age groups. Effectively, the vaccine “teaches” human cells to induce an immune response that could build the body’s own defense against COVID-19. The company’s Phase 3 study of RNA-1273, the vaccine candidate against COVID-19 began in July, and is close to its target enrollment of around 30,000 US participants. AstraZeneca and Pfizer are also in late-stage Phase 3 testing; however, AstraZeneca’s timeline has been stalled after reports of severe side effects from several trial participants administered its vaccine candidate, which is based on a different technology. Participants from both Moderna and Pfizer’s Phase 3 studies have reported symptoms of high fever, body aches, headache, and exhaustion after receiving the respective candidate vaccines. The two companies have recognized that there is potential for the recipients of their vaccines to induce “mild” side effects similar to mild COVID-19 symptoms. Tal Zaks, chief medical officer at Moderna Other Pharma Companies Received Billions in Public Subsidies – But Holding Patents Close Only recently, KEI sharply criticized Moderna for failing to disclose public funding from BARDA [US Biomedical Advanced Research and Development Authority]as well DARPA, (Defense Advance Research Projects Agency), in its patent applications, and the two agencies are currently examining the alleged omissions. But even if the company made the announcement under burgeoning consumer and government pressure, its new policy still contrasts sharply with other firms that have benefited from similar public subsidies for urgent COVID-19 research, but are retaining their patent rights close to their chest. Among those, BioNTechSE, partner of Pfizer Inc., have been adamant about their about complete ownership of their vaccine patents – even when they, too, benefitted from large US government subsidies. “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,” said Love in the KEI statement.. “Moderna is also making it clear that government agencies like the NIH [National Institutes of Health] and BARDA have been too willing to grant or enable exclusive rights when subsidizing COVID-19 research.” Image Credits: Moderna, Moderna, Moderna, Moderna TX. 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