Sarepta Therapeutics (SRPT) Says USPTO Issued Favorable Decisions on Exon 51 and Exon 53 Composition in Case vs BioMarin (BMRN)

September 20, 2016 5:17 PM EDT

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Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) has issued two favorable decisions for Sarepta in the composition of matter patent interferences for exon 51 (Interference No. 106,008) and exon 53 (Interference No. 106,007). These decisions, subject to appeal, finally refused all of BioMarin’s claims in the exon 51 and exon 53 composition of matter interferences that, if granted, could have formed a basis for a claim of infringement against eteplirsen and SRP-4053. The PTAB decision for exon 53 allows BioMarin to obtain a narrow composition of matter claim, however, SRP-4053 does not infringe this claim. The PTAB ended the exon 51 interference in our favor based on a statute of limitations bar.

Accordingly, the PTAB did not decide the patentability of the Sarepta exon 51 patents involved in the interference (U.S. Patent Nos. 7,807,816 and 7,960,541). Although the PTAB did decide to cancel the Sarepta exon 53 patent involved in the interference (U.S. Patent No. 8,455,636), that exon 53 decision does not negatively impact Sarepta’s key composition of matter patent protection for EXONDYS 51 and SRP-4053 (U.S. Patent Nos. 9,018,368 and 9,024,007, respectively). Neither of these key patents are involved in any pending interferences and are presumed valid and enforceable. These patents expire in June 2025, not including any potential patent term extension or regulatory exclusivity that would extend this date.

BioMarin has appealed the exon 53 composition of matter interference (Interference No. 106,007) to the Court of Appeals for the Federal Circuit. The exon 51 composition of matter interference (Interference No. 106,008) decided today by the PTAB remains subject to appeal.

“We are pleased that today’s exon 51 PTAB decision provides further clarity concerning BioMarin’s interfering patent claims as we begin commercialization of EXONDYS 51” said Edward M. Kaye, M.D., Sarepta’s interim chief executive officer and chief medical officer. “Moreover, we are optimistic that our key patents for eteplirsen and SRP-4053 will provide sufficient protection for the duration of further development and commercialization.”

In addition, previously decided Interference No. 106,013 concerning exon 51 methods for treating Duchenne muscular dystrophy with exon 51 skipping oligonucleotides is currently on appeal at the Court of Appeals for the Federal Circuit. BioMarin’s method claims currently on appeal involve the exon 51 skipping oligonucleotides found unpatentable in today’s exon 51 PTAB decision.

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