Which patents cover the COVID-19 vaccine candidates for Moderna, AstraZeneca, J&J and Novovax?

Zachary Silbersher

A number of companies have announced candidates for a COVID-19 vaccine, including Moderna Therapeutics ($MRNA), AstraZeneca ($AZN), Johnson & Johnson ($JNJ) and Novovax ($NVAX).  We looked into the existing landscape of patents that cover many of the existing candidates.  

One difficulty uncovering the patent landscape for the existing COVID-19 vaccine candidates is that patent applications are typically not publicly-available when filed.  Most of the companies developing the current candidates did not likely commence their work targeting COVID-19 until earlier this year.  While there are exceptions, patent applications filed with the USPTO are not typically made public for 18 months.  Thus, the companies may have already filed numerous patent applications earlier this year that specifically cover their vaccines, but those applications may not yet be public.  

Nevertheless, several companies already appear to hold key patents covering some of the candidates.  As detailed below, in some cases (Moderna), the company has taken an older patent application that covered their vaccine technology for other coronaviruses and filed a follow-on application.  In other cases (Novovax), the company’s vaccine uses proprietary technology that was already patented years ago.  In another case (AstraZeneca), the company appears to have done both—recently filed a follow-on patent application from an older patent covering the technology used to develop its current COVID-19 candidate.  In yet another case (J&J), the company may end up relying upon patents covering the manufacturing of the vaccine, or in particular, large batches of the vaccine.

Any company with a successful vaccine is likely to use both older patents and newer patents to protect their drug.  Patents can cover the vaccine itself or methods of treating patients with the vaccine, but they may also cover methods of manufacturing the vaccine, manufacturing large-scale batches of the vaccine, or other proprietary features required to make or use the vaccine.  That is why older patents that issued long before the emergence of COVID-19 may nevertheless provide IP protection for a newly-developed vaccine.  That said, in all of these cases, it is still likely that the companies have pending patent applications specifically targeting their existing candidates, but these applications have not yet become publicly-available. 

Moderna 

In 2015, Moderna filed a number of preliminary (provisional) patent applications directed to mRNA vaccines for respiratory illnesses (e.g., U.S. Provisional Patent Application 62/245,031).  The applications covered different mRNA vaccines for numerous respiratory diseases, including the betacoronavirus (BetaCoVs), one of four coronaviruses, including MERS-CoV and SARS. 

On February 28, 2020, Moderna filed a follow-on application from this patent family.  In a matter of months, Moderna was granted a patent directed to mRNA comprising an “open reading frame encoding a betacoronaviru (BetaCoV) S protein or S protein subunit formulated in a lipid nanoparticle.”  The patent is U.S. Patent No. 10,702,600, which is titled Betacoronavirus mRNA vaccine.  The patent covers mRNA vaccines where the betacoronavirus structural protein is spike protein (S).  Thus, this patent appears to cover Moderna’s mRNA vaccine encoding for a prefusion stabilized form of the Spike (S) protein.

In addition, Moderna has two more pending patent applications that claim priority to this patent family, the first filed on May 21, 2020 (Serial No. 16/880,829) and the second filed on June 10, 2020 (Serial No. 16/897,734).  These patent applications are not yet public.  Based upon a restriction requirement issued by the Patent Office during prosecution of the ‘600 patent, one of these pending applications is likely directed to a method of administering the mRNA vaccine to a patient to induce “an immune response specific to BetCoV.”  (The Patent Office will issue a restriction requirement in response to a patent application when the applicant is attempting to patent two separate inventions.  The common response is to pick one invention, patent it, and then file a follow-on application and patent the other invention.) 

It will not be surprising if Moderna files more follow-on applications that continue to mine its patent disclosure from 2015 for more features of its vaccine.  It would also not be surprising if Moderna has filed new patent applications in recent months that cover its mRNA vaccines specifically for COVID-19, but these applications are not yet public.

AstraZeneca

AstraZeneca’s COVID-19 vaccine is ChAdOx1 nCoV-19, also known as AZD1222.  The vaccine was developed in connection with Oxford University.  Oxford filed a British patent application in May 2011 that was directed to novel adenoviral vectors derived from a chimpanzee adenovirus.  This application was GB Patent Application No. 1108879.6, and it described the ChAdY25/ChAdOx1 vector and appears to relate to Oxford’s use of “a replication-deficient chimpanzee viral vector based on a weakened version of a common cold (adenovirus) virus that causes infections in chimpanzees.”   

In July 2017, Oxford received a follow-on U.S. patent from British application: U.S. Patent No. 9,714,435.  Interestingly, on April 15, 2020, Oxford filed an application for another follow on patent from this family.  The application is not yet public, but given the timing of the filing (well after the emergence of COVID-19), and the fact that the disclosure includes ChAdOx1, Oxford is may be using this patent family to target a patent on its ChAdOx1 vaccine for COVID-19.

Johnson & Johnson

J&J has developed a candidate—AD26.COV2-S—along with Beth Israel Deaconess Medical Center, which is part of Harvard Medical School.  The candidate is developed from the AD26 adenoviral vector.  Janssen, which is J&J’s pharmaceutical division, has numerous patents covering different aspects of AD26.  For instance, Janssen has a patent (U.S. Patent No. 9,701,718) covering an AD26 vaccine for Ebola, and Janssen has a pending patent application covering large-scale production of recombinant adenovirus 26 (U.S. Patent Publication No. 2018/0080010.)  It would therefore not be surprising if J&J has pending patent applications, which have not yet been made public, that are specifically directed to its AD26 adenoviral vector for a COVID-19 vaccine.

This highlights an interesting facet of patenting a vaccine.  Patents can cover many different features of a particular drug such as the composition-of-matter of the vaccine formulation itself.  In this case, J&J appears to have a patent that covers manufacturing large batches of a particular vaccine.  That technology may be particularly relevant to a drug that may have to be mass-produced on a global scale. 

Novavax

Novavax has developed a coronavirus vaccine candidate, NVX-CoV2373.  The candidate is described as a “stable, prefusion protein made using its proprietary nanoparticle technology,” and it was developed using Novovax’s proprietary Matrix-M™ adjuvant technology.  Novovax has patented features of its Matrix-M™, such as U.S. Patent Nos. 7,838,019; 9,205,147; 9,901,634 and 8,821,881, as well as at least one pending U.S. patent application that has been filed, but it not yet public (Serial No. 16/701,948).  To the extent Novovax’s NVX-CoV2373 candidate cannot be made without use of its Matrix-M™ adjuvant technology, these patents may technically be sufficient IP protection for its vaccine.

Novovax filed a patent application in 2013 including a disclosure for a vaccine for the MERS coronavirus including an “immunogenic composition comprising a MERS-CoV nanoparticle.”  The patent application (U.S. Patent Application Publication No. 2016/0206729) has been allowed, but not yet issued.  While this patent appears limited to a vaccine for MERS, it nevertheless suggests that Novovax may have filed a similar patent application earlier this year, which are not yet public, that may be more specifically directed to using its Matrix-M™ adjuvant technology for its vaccine for COVID-19.

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Overall, any vaccine for COVID-19 will be meeting a market demand that is unfamiliar for any normal pharmaceutical drug.  While the pharmaceutical business is one that is generally not shy about suing competitors for patent infringement, any COVID-19 vaccine will undoubtedly raise different distribution, ethical and policy concerns.  Just because drug companies with existing vaccine candidates may be aggressively pursuing IP protection for their drugs does not necessarily mean that they intend to aggressively charge monopoly prices for that vaccine.  Rather, the costs of pursuing patents is generally negligible compared to the potentially significant downside of not doing so.  Without locking up IP protection, any vaccine candidate may lose control over its ability to recoup its investment, even if that means otherwise agreeing to sharing part of the market.