Mallinckrodt (MNK) Announces INOMAX Patent Upheld

September 23, 2016 8:17 AM EDT

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Mallinckrodt Pharmaceuticals (NYSE: MNK), a leading global specialty pharmaceutical company, today announced that the U.S. Patent and Trademark Office (USPTO) has upheld the validity of commercially significant claims related to five patents covering gas delivery systems as well as methods of using such systems related to INOMAX® (nitric oxide) gas, for inhalation.

The USPTO decisions came in the context of Inter Partes Review (IPR) proceedings, instituted by the Patent Trial and Appeal Board (PTAB) following petitions filed by Praxair Distribution, Inc. The decisions concerned five patents that expire in 2031, part of 17 total INOMAX patents listed in the U.S. Food and Drug Administration (FDA) Orange Book.

"INOMAX is protected by comprehensive intellectual property covering both the drug and INOmax delivery systems – patents which extend late into the next decade and beyond. Additionally, we believe the customer service and delivery model established for INOMAX provides a high level of account insight that most customers appreciate," said Michael-Bryant Hicks, Mallinckrodt Senior Vice President and General Counsel. "Mallinckrodt will continue to vigorously defend the validity of and enforce the company's intellectual property rights concerning INOMAX."

Independently, on Sept. 22, 2016 the Patent Trial and Appeal Board dismissed a second set of petitions for IPR proceedings concerning four of five patents that expire in 2029 and cover use of a drug like INOMAX. The PTAB had denied Praxair's first request to institute IPR proceedings on these four patents in July 2015, and has now declined a second request seeking to institute such proceedings.

The PTAB instituted an IPR proceeding for the fifth patent expiring in 2029, U.S. patent no. 8,846,112 (the '112 patent). On July 7, 2016, the PTAB upheld the patentability of a claim in the '112 patent that relates to distribution of a drug like INOMAX in conjunction with its approved labeling. The '112 patent was further upheld in an Aug. 25, 2016 PTAB decision dismissing a second petition for IPR proceedings on that patent, noting it had reached a "final decision" regarding the validity of the claims of that patent. Praxair has filed an appeal of this PTAB decision to the U.S. Court of Appeals for the Federal Circuit, and Mallinckrodt subsequently filed a cross-appeal.

In February and March 2016, the USPTO granted two new U.S. patents associated with delivery of nitric oxide utilizing devices like Mallinckrodt's INOmax DSIR® delivery system (expiring in 2031) and a third new U.S. patent relating to the use of nitric oxide gas sensors (expiring in 2034). These three INOMAX new patents were listed in the FDA Orange Book for INOMAX and added to the company's pending patent litigation against Praxair in the U.S. District Court for the District of Delaware.



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