Validity of Mallinckrodt's INOMAX® Patent Claims Upheld

CHESTERFIELD, United Kingdom, Sept. 23, 2016 /PRNewswire/ -- 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 DS_IR^® 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.

About INOMAX^®

In the U.S., INOMAX is approved for use by the FDA, to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Important Safety Information

• INOMAX is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
• Abrupt discontinuation of INOMAX may lead to increasing pulmonary artery pressure and worsening oxygenation even in neonates with no apparent response to nitric oxide for inhalation.
• Methemoglobinemia and NO₂ levels are dose dependent. Nitric oxide donor compounds may have an additive effect with INOMAX on the risk of developing methemoglobinemia. Nitrogen dioxide may cause airway inflammation and damage to lung tissues.
• In patients with pre-existing left ventricular dysfunction, INOMAX may increase pulmonary capillary wedge pressure leading to pulmonary edema.
• Monitor for PaO₂, methemoglobin, and inspired NO₂ during INOMAX administration.
• Use only with an INOmax DS_IR^®, operated by trained personnel.

Please see full Prescribing Information here for additional important safety information.

ABOUT MALLINCKRODT

Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products; and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Nuclear Imaging segment includes nuclear imaging agents. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

CONTACTS

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Meredith Fischer
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314-654-6649
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Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
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SOURCE Mallinckrodt plc

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