Moderna has been engaged in a patent dispute with the National Institutes of Health (NIH) over whether three NIH scientists should be named as inventors for discovering the genetic sequence that’s central to the vaccine.
As the New York Times reported,
The vaccine grew out of a four-year collaboration between Moderna and the N.I.H., the government’s biomedical research agency — a partnership that was widely hailed when the shot was found to be highly effective. A year ago this month, the government called it the “N.I.H.-Moderna Covid-19 vaccine.”
But when a US patent application was filed by Moderna, no NIH scientists were listed as inventors.
According to the US Patent and Trademark Office (USPTO),
The definition of inventorship can be simply stated: “The threshold question in determining inventorship is who conceived the invention. Unless a person contributes to the conception of the invention, he is not an inventor. … Insofar as defining an inventor is concerned, reduction to practice, per se, is irrelevant [except for simultaneous conception and reduction to practice, Fiers v. Revel, 984 F.2d 1164, 1168, 25 USPQ2d 1601, 1604-05 (Fed. Cir. 1993)]. One must contribute to the conception to be an inventor.” In re Hardee, 223 USPQ 1122, 1123 (Comm’r Pat. 1984). ). A person who shares in the conception of a claimed invention is a joint inventor of that invention. In re VerHoef, 888 F.3d 1362, 1366-67, 126 F.2d 1561, 1564-65 (Fed. Cir. 2018). See also Board of Education ex rel. Board of Trustees of Florida State Univ. v. American Bioscience Inc., 333 F.3d 1330, 1340, 67 USPQ2d 1252, 1259 (Fed. Cir. 2003) (“Invention requires conception.” With regard to the inventorship of chemical compounds, an inventor must have a conception of the specific compounds being claimed. “[G]eneral knowledge regarding the anticipated biological properties of groups of complex chemical compounds is insufficient to confer inventorship status with respect to specifically claimed compounds.”); Ex parte Smernoff, 215 USPQ 545, 547 (Bd. App. 1982) (“one who suggests an idea of a result to be accomplished, rather than the means of accomplishing it, is not a coinventor”).
Under 35 U.S. Code § 116,
When an invention is made by two or more persons jointly, they shall apply for patent jointly and each makes the required oath, except as otherwise provided in this title. Inventors may apply for a patent jointly even though (1) they did not physically work together or at the same time, (2) each did not make the same type or amount of contribution, or (3) each did not make a contribution to the subject matter of every claim of the patent.
If there’s a dispute between the inventors,
If a joint inventor refuses to join in an application for a patent or cannot be found or reached after diligent effort, the application may be made by the other inventor on behalf of himself and the omitted inventor. The Director, on proof of the pertinent facts and after such notice to the omitted inventor as he prescribes, may grant a patent to the inventor making the application, subject to the same rights which the omitted inventor would have had if he had been joined. The omitted inventor may subsequently join in the application.
Also, if an inventor is named in error or isn’t named, the director of the USPTO can amend the application.
As the Times explains,
If the three agency scientists are named on the patent along with the Moderna employees, the federal government could have more of a say in which companies manufacture the vaccine, which in turn could influence which countries get access. It would also secure a nearly unfettered right to license the technology, which could bring millions into the federal treasury.
As The Guardian recently reported, Moderna founder Robert Langer said
Moderna has offered the NIH co-ownership of the patent. Moderna has always thought highly of working with the NIH, and I think also vice versa. We are still working together. The relationship has been a win for us both and for the world.
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