On January 4, 2022, Judge Andrews from the United States District Court for the District of Delaware denied Sarepta Therapeutics, Inc.’s (“Sarepta”) Rule 12(b)(6) motion to dismiss a complaint for infringement of U.S. Patent No. 10,526,617 filed by Regenxbio, Inc. (“Regenx”) and the University of Pennsylvania (“UPenn”).

The ‘617 patent claims a “cultured host cell containing a recombinant nucleic acid molecule encoding the capsid protein.”  Regenx and UPenn alleged that Sarepta manufactured and used cells covered by the ‘617 patent in order to make certain gene therapy products including Sarepta’s “SRP-9001.”

Sarepta moved to dismiss the complaint on the basis that the allegations in the complaint related to activities that fall within the protections of 35 U.S.C. 271(e)(1) (the Hatch-Waxman Act’s “Safe Harbor”).  In response, Regenx argued that (1) the Safe Harbor did not apply as a matter of law because the patented cells were not themselves subject to regulatory approval; and (2) there was a dispute of fact relating to Sarepta’s commercialization of SRP-9001 and dismissal was therefore improper. Interestingly, UPenn joined Regenx in the second argument but not the first.

In denying Sarepta’s motion, Judge Andrews agreed with Regenx and relied on Proveris Sci. Corp. v. Innovasystems, Inc., 536 F.3d 1256 (Fed. Cir. 2008), a case which found that the Safe Harbor did not apply to use of a patented optical spray analyzer that was used in connection with regulatory submissions for aerosol drug delivery systems but was itself not subject to regulatory approval. Citing several district court rulings following Proveris,  Judge Andrews held that “a patented product that is not subject to FDA premarket approval is not a ‘patented invention’ under §271(e)(1)” and is therefore not covered by the Safe Harbor.

Judge Andrews also rejected Sarepta’s argument that UPenn would gain an effective patent term extension by precluding Sarepta from working on SRP-9001 until the ‘617 patent expires (the so-called “second distortion” that the Hatch-Waxman Act was meant to remedy through its enactment). Judge Andrews stated that that argument “makes no sense” because “Sarepta is not using the patented cultured host cells to obtain FDA approval to introduce generic cultured host cells to compete in the marketplace when the ‘617 expires. Instead, Sarepta is using the patented cells to develop its own patented product. Sarepta can begin using the patented host cells immediately upon expiration of the patent because the cells are not subject to any FDA regulatory approval process. Thus, Plaintiffs will not receive effective patent term extension.”

A copy of the ruling can be found here.