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Inventing Chaos with the Moderna/NIH Dispute

“Court scrutiny to decide the inventorship of the Moderna patent application for the COVID-19 vaccine could reasonably result in changes to how an inventor is characterized based on current inventorship law.”

https://depositphotos.com/441471790/stock-photo-coronavirus-vaccine-bottle-corona-virus.htmlModerna and the National Institutes of Health (NIH) are poised for a legal battle over inventorship of a vaccine for COVID-19. While a court may resolve the dispute over inventorship for the patent application, court review of current inventorship rules could be a slippery slope to chaos.

Moderna and NIH collaborated on developing a functional vaccine for COVID-19, which is not in dispute. As a result of the collaboration, a vaccine labeled “mRNA-1273” was created and a U.S. patent application was filed by Moderna, with no NIH scientists listed as inventors. Moderna has commented that, after an internal review, no NIH scientists designed the actual vaccine claimed in the U.S. patent application. NIH has commented that it believes three scientists should be included in the U.S. patent application as co-inventors with the Moderna scientists.

No Smoking Gun

Current inventorship rules are codified in 35 U.S. Code § 116 and applied in accordance with guidelines put forth in in the U.S. Patent and Trademark Office’s (USPTO’s) Manual for Patent Examining Procedure (MPEP). A contributor to the content of a patent application is an inventor if the contribution is present in at least one claim. Hence, inventorship for a patent can be different from authorship for article publication purposes in the event a contributor does not provide any subject matter of any claim of a patent application.

With collaboration admittedly occurring among multiple scientists from both Moderna and NIH, all for a common purpose of finding a stable and effective COVID-19 vaccine, it seems unlikely that inventive contribution can be clearly assigned to particular individuals involved in the process of developing the vaccine claimed in the filed patent application. Indeed, if evidence existed that proved that only Moderna scientists created and developed the subject matter of each claim of the U.S. patent application, one would think that evidence would have likely already been presented, or at least alleged to exist. Yet, all we have, at least publicly, are assertions by both Moderna and NIH that they are both confident in their respective stance on different inventorship for the U.S. patent application.

With the assumed lack of a “smoking gun” to prove the particular contributions of each scientist involved in the development of the claimed subject matter of the Moderna patent application, a court battle would likely involve diverse implementations of the existing inventorship rules. Accordingly, it appears a potential legal battle over inventorship would involve a combination of challenges to the contribution of various scientists as well as challenges to how an inventor is determined with existing inventorship rules, which reveals the elephant in the room.

The Elephant

Currently, the test for inventorship for a U.S. patent application is if a person contributed to the conception of the subject matter of at least one claim. The present policy for inventorship, as laid out in the MPEP, explicitly clarifies that reduction to practice is not required for inventorship, nor is a person that suggests a result without means of accomplishing the result. For chemical compounds, the MPEP requires an inventor have a conception of the specific compounds being claimed. As such, a scientist for Moderna or NIH who contributed to the conception of the vaccine subject matter claimed in the filed patent application would be an inventor, which is likely the rationale NIH would employ in a legal dispute. In response, Moderna would likely challenge the broad and/or vague nature of the current inventorship rules and advocate for a more narrow interpretation that supports Moderna scientists being the only inventors in the present patent. For instance, Moderna could push for a reduction in practice of an idea to be required for inventorship or more than mere contribution to conception to be an owner and inventor of a patent application.

With a court review likely involving evaluation of the current implementation of the inventorship law of the United States Code, unexpected—and perhaps dramatic—changes could be made to the determination of a patent application inventor. In the event a court alters how inventorship is determined based on existing law, even if the alteration is narrow and applies only to pharmaceutical, compound, or chemical patent inventorship, currently issued and active patents could be invalidated. Imagine having an issued patent that has survived scrutiny by the Patent Office, but is questionably invalid due to having incorrect inventorship. The consequences of unsettled inventorship for existing patents could be far reaching with enforcement of patent rights, as well as market share secured by the threat of litigation, in jeopardy until inventorship is verified.

Court review of inventorship that results in a deviation of what contribution to a patent application equates to being a named inventor could drastically increase the number of lawsuits challenging patents and patent applications. When inter partes review (IPR) was initiated at the USPTO to provide an outlet to challenge the patentability of a patent application, a backlog of challenged patent applications soon followed. The questionable validity of issued patents, as well as patent applications, due to improper inventorship would likely spark a similar blaze of legal challenges that could overwhelm the capabilities of courts and the Patent Office. A drastic increase in legal challenges would leave patents in limbo until an official determination for inventorship and patent validity can be attained. Such patent validity limbo could wreak havoc on patent owner’s ability to capitalize on the time and money invested in developing technology, drafting a patent application, and prosecuting an application through the Patent Office. Questionable patent validity may further endanger the enforcement of international patents as inventorship is challenged with regard to the respective international inventorship rules and implementations.

Another potential consequence of a court changing how patent inventorship is determined involves the deterioration of the ability to monetize existing patents. Assorted licenses and sales of issued patents could be arguably revoked in response to improper inventorship or at least paused until inventorship can be officially validated. The consequences of jeopardizing the validity and monetization of patents resulting from questionable inventorship could threaten the supply chain of goods as manufacturers debate what items can be freely made without a license. Furthermore, licenses to questionably invalid patents could cause widespread competition as manufacturers begin creating previously unlicensed items due to a lowered risk of patent infringement lawsuits.

Moving forward with, or without, changes to how inventorship is determined, patenting entities can engage in various techniques to mitigate the risk of challenges to inventorship. First, entities can address inventorship and contributor characterizations in writing prior to research and development of technology, particularly in endeavors involving multiple entities. For instance, joint development agreements can explicitly stipulate how contributors to developments are defined, tracked, and correlated with subject matter of a patent application. Second, entities can enact policies that avoid inventorship disputes by filing patent applications for separate inventors. As an example, each contributor to a technology can file a patent application on strictly the subject matter they, respectively, have created, which can alleviate any confusion about which contributor provided what subject matter. However, it is noted that some technology cannot be easily divided into separate patent applications, such as a vaccine or single chemical compound.

Let’s Avoid Chaos

In sum, it is in the best interest of the patenting public at large for the existing inventorship rules and implementations to remain unaltered. Court scrutiny to decide the inventorship of the Moderna patent application for the COVID-19 vaccine could reasonably result in changes to how an inventor is characterized based on current inventorship law. Such a change would likely result in a period of chaos for existing patents as validity and licenses are questioned. The fact that correct inventorship is a critical aspect of patent validity begs for the status quo of inventorship determination to remain in lieu of increased written clarification of what each contributor to a technology invented.

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Join the Discussion

11 comments so far. Add my comment.

  • [Avatar for Craig Stankiewicz]
    Craig Stankiewicz
    December 6, 2021 08:01 am

    Government was developed for the people, of the people, and by the people. Only under this Administration the government has become against the people because moderna is a publicly owned company.

  • [Avatar for Xtian]
    Xtian
    December 6, 2021 10:29 am

    Has anyone yet connected how this inventorship dispute with NIH and the Arbutus patent infringement case is connected?

  • [Avatar for TFCFM]
    TFCFM
    December 6, 2021 11:46 am

    Article: Moderna and the National Institutes of Health (NIH) are poised for a legal battle over inventorship of a vaccine for COVID-19.

    The article is a timely reminder of the importance of focusing on technology when drafting claims and resolving claims involving patent claims.

    I think it might be a bit hyperbolic, however, to suggest that NIH and Moderna are imminently headed for a “legal battle.” Both organizations are well-served by professional teams of patent attorneys. There is essentially no doubt that NIH’s in-house or outside patent counsel will perform a careful review of the claims at issue and compare them with the work (which tends to be quite well documented in this data- and computer-rich day and age) that was performed by NIH folks, as well as the communications among the parties’ folks.

    In a complex, fast-moving technological area such as vaccine development, questions of researcher-contributions, claim scope/meaning, and commercial product characteristics (to the extent relevant) are bound to be extremely fact-specific. Nonetheless, with US law regarding inventorship for patent applications being relatively well settled and with reasonable, competent folks on both sides of competing assertions, it seems to me extremely likely that NIH and its partners will amicably resolve who-did-what and the corresponding issue of who-owns-what without resort to judicial proceedings.

    It may turn out that a difference of opinion continues as to which claimed elements of the subject matter rendered the allowed claims allowable (a dispute which can be tested in surely-pending applications which claim priority in common). Even in that unlikely event, though, a court-mediated resolution of an inventorship dispute seems to me unlikely here.

  • [Avatar for Greg DeLassus]
    Greg DeLassus
    December 6, 2021 12:27 pm

    [H]ow [are] this inventorship dispute with NIH and the Arbutus patent infringement case… connected?

    Two points:

    (1) There is, as yet, no infringement case. If there were, ModeRNA would have had Art. III standing to support its appeal from the PTAB. The CAFC concluded that ModeRNA lacks standing precisely because the court concluded that ModeRNA’s fear of such a suit was—as yet—too speculative.

    (2) There is no connection between ModeRNA’s present dispute with the NIH and its hypothetical dispute with Arbutus. If ModeRNA wins its dispute with NIH, that does not move Arbutus one micron closer to winning a judgment of infringement against ModeRNA, and vice versa.

  • [Avatar for xtian]
    xtian
    December 7, 2021 08:40 am

    Greg-thanks

    What I was thinking is if Arbutus wins against Moderna, then if the US gov’t under the TRIPS waiver, waived all IP of Moderna, the gov’t would also have to waive Arbutus IP too. (I know your position on this waiver from other threads. Just humor me here.)

    Additionally, if NIH gains inventorship on key Moderna patents and thus has an ownership interest in the IP to make the vaccine, it could presumably then license its ownership share to any third party. However, the NIH/gov’t would still need a separate license from Arbutus to have all the IP necessary to produce the vaccine…

  • [Avatar for Greg DeLassus]
    Greg DeLassus
    December 7, 2021 11:23 am

    I was thinking… if Arbutus wins against Moderna, then if the US gov’t under the TRIPS waiver, waived all IP of Moderna, the gov’t would also have to waive Arbutus IP too.

    Ah, got it. I stand by my position that there is no meaningful connection between the Arbutus v. ModeRNA story and the NIH v. ModeRNA story. I concede, however, that it is possible for connections to arise in a world in which we postulate the emergence of distantly unlikely contingencies that have not actually come to pass.

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