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.

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Photo of Dan Shores Dan Shores

Dan Shores is Partner at Rothwell Figg.  Dan Shores is a dedicated patent lawyer and strategist who believes in his clients and the power of their ideas. He focuses on serving biotech, medical device, energy, software, cybersecurity, and other technology-based companies and understands

Dan Shores is Partner at Rothwell Figg.  Dan Shores is a dedicated patent lawyer and strategist who believes in his clients and the power of their ideas. He focuses on serving biotech, medical device, energy, software, cybersecurity, and other technology-based companies and understands the myriad of challenges that such companies face when breaking through and establishing themselves in their respective markets. Dan works with clients to build robust patent portfolios, protect trade secrets, negotiate strategic collaborations, conduct due diligence and landscape investigations, and prepare for success in funding rounds and exits. An engineer by education, and having extensive experience in transactional, litigation, procurement, and strategic counseling matters for technology-based companies, Dan is a problem-solver who excels at deciphering key translational aspects of a broad array of technologies to maximize leverage in the context of clients’ desired implementation of such technologies whether as participants in dynamic markets or as first movers.

Dan has served companies utilizing the following technologies (without limitation): mRNA therapies; lipid nanoparticle delivery technologies; genetically engineered swine and organs for xenotransplantation; artificial intelligence for drug discovery; CAR-T therapies; oligonucleotide development; pharmaceutical treatment of rhinitis with levocetirizine; pharmaceutical treatment of hepatitis B with telbivudine; genetically-modified cotton seed; fiber-optic probes for tissue investigation; implantable glucose-sensing devices; high throughput genetic seed-chipping technology; cybersecurity threat assessment platforms; interactive media systems for healthcare institutions; artificial intelligence (various applications); identification systems for cable-based medical devices; identification of digital positions of interest on media items; heat-treated glass with multilayer low-emissivity coatings; automotive and agricultural equipment; pressure-sensitive adhesives; three dimensional printing of buildings and other structures; and integrated electronic securities marketplace systems.

Dan is a registered patent attorney licensed to practice before the United States Patent and Trademark Office, and is admitted to practice law in Massachusetts and in the District of Columbia. He is a member of the bars of the Supreme Court of the United States, United States Court of Appeals for the Federal Circuit, and United States District Court for the District of Massachusetts. Dan lives in Boston with his wife Lindsay and their two English Bulldogs Jarves and Rosie.