John J.Normile

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New York + 1.212.326.3777

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John Normile is a leading Hatch-Waxman patent litigator who has 30 years experience representing innovative pharmaceutical companies. He also has represented various plaintiffs and defendants in intellectual property cases involving diverse technologies. Among the clients for whom he has worked are Bic, Fenwal, King Pharmaceuticals, Merck, Purdue Pharma L.P., and Schweitzer-Mauduit.

John has acted as trial counsel before several of the federal district and appellate courts including the Federal Circuit and the U.S. Supreme Court. He has represented pharmaceutical companies in the enforcement of patents concerning blockbuster drugs including OxyContin®, Butrans®, Hysingla®, Skelaxin®, Buspar®, and MitomycinC®. John also has experience representing clients as lead counsel in USPTO (United States Patent and Trademark Office) post-grant proceedings. These representations have involved at least 50 district court actions and various appearances in the USPTO and the Federal Circuit. John is an adjunct professor at Fordham Law School, where he has taught a course in patent litigation for the past 20 years.

His clients have consistently praised his approach to Hatch-Waxman cases: "John is brilliant at creating and executing great litigation strategies. He makes complicated matters simple and takes a comprehensive approach that goes beyond patent law to accomplish the goals of his clients. He's one of the best litigators for complex pharmaceutical matters." (IAM Patent 1000: The World's Leading Patent Professionals (2018)).

John is a member of the President's Council and the Parent Leadership Council at Fordham University, the Fordham Law School Alumni Association, the Feerick Institute of Social Justice, and the New York Archdiocese Inner-City Scholarship Fund.

Experience

  • Purdue Pharma defends petition for post-grant review of patent against Collegium Pharmaceutical Inc.Jones Day represented patent owner Purdue Pharma L.P. in a post-grant review (PGR) proceeding brought by petitioner Collegium Pharmaceutical Inc. relating to a patent directed to a pharmaceutical formulation containing gelling agent.
  • Purdue Pharma asserts patent infringement claims under Hatch-Waxman Act related to OxyContin® against Accord HealthcareJones Day represents plaintiffs Purdue Pharma L.P. and Purdue Pharmaceuticals L.P. ("Purdue") in a patent litigation under the Hatch-Waxman Act in the District of Delaware.
  • British American Tobacco Group and its subsidiaries settle global patent dispute with Philip Morris over heated tobacco and vapor productsJones Day advised British American Tobacco Group and its subsidiaries (BAT) in connection with its global settlement with Philip Morris International Inc (PMI) to resolve all ongoing patent infringement litigation between the parties related to heated tobacco and vapor products.
  • Purdue Pharma asserts patent infringement claims under Hatch-Waxman Act related to extended-release oxycodone analgesic productsJones Day represents plaintiffs Purdue Pharma L.P., Purdue Pharmaceuticals L.P. and Rhodes Technologies in a Hatch-Waxman pharmaceutical patent litigation in the District of New Jersey.
  • R.J. Reynolds successfully enforces patents in ITC trial against Philip Morris in dispute over cigarette alternativeJones Day's client Reynolds achieved a precedent-setting victory before the International Trade Commission (ITC) against its main competitors Philip Morris Products S.A. ("Philip Morris") and Altria Client Services LLC ("Altria") in a patent infringement dispute involving tobacco heating and vaping products.
  • Merck wins bench trial over patent term extension issue in Hatch-Waxman multi-party dispute involving BRIDION®Jones Day is representing Merck Sharp & Dohme, B.V. in Hatch-Waxman patent infringement actions originally against 16 generic drug maker defendant groups, relating to the defendant groups' submissions of Abbreviated New Drug Applications (ANDA) to the FDA seeking approval of generic versions of BRIDION®, a first-in-class agent for the reversal of certain types of neuromuscular blockade induced in adults undergoing surgery.
  • Purdue Pharma asserts patent infringement claims under Hatch-Waxman Act related to OxyContin® against Accord HealthcareJones Day represents Purdue Pharma L.P. in asserting patent infringement claims under the Hatch-Waxman Act against generic-drug company Accord Healthcare, Inc. involving several patents directed to OxyContin®.
  • Ocular secures win at the Federal Circuit on its IPR challengeJones Day successfully represented Ocular Therapeutix, Inc., a biopharmaceutical company that develops treatments for the eye, in upholding its inter partes review win against a patent of competitor Mati Therapeutics, Inc.
  • Purdue enforces formulation and compound patents against Collegium Pharmaceutical's Xtampza® ER extended-release oxycodone capsulesJones Day is representing Purdue Pharma L.P. in a Hatch-Waxman patent infringement action against Collegium Pharmaceutical, Inc., relating to Collegium's submission of a Section 505(b)(2) application for its Xtampza® ER extended-release oxycodone capsules.
  • Celgene acquired by Bristol-Myers Squibb for approximately $74 billionJones Day advised Celgene Corporation (NASDAQ: CELG) in connection with the intellectual property and technology transactions aspects of its cash-and-stock merger with Bristol-Myers Squibb (NYSE: BMY) which has an equity value of approximately $74 billion.
  • Xiaomi obtains complete dismissal in patent infringement action based on jurisdictional groundsJones Day successfully represented Xiaomi Inc. in a patent infringement case where the plaintiff asserted that Xiaomi infringed four patents relating to devices for controlling smartphone functions.
  • Purdue Pharma asserts patent infringement claims under Hatch-Waxman Act related to OxyContin® against IntellipharmaceuticsJones Day is representing Purdue Pharma L.P. in a Hatch-Waxman patent infringement action against defendants, relating to the defendants' submission of a Section 505(b)(2) New Drug Application to the FDA seeking approval of an extended-release oxycodone formulation.
  • Purdue Pharma successfully resolves Hatch-Waxman patent infringement claims against Ascent related to OxyContin®Jones Day successfully represented Purdue Pharma L.P. in related Hatch-Waxman patent infringement actions against defendant Ascent Pharmaceuticals, Inc., pertaining to the submission of an Abbreviated New Drug Application to the FDA seeking approval of a generic version of OxyContin®.
  • Purdue Pharma successfully moves for additional discovery regarding real-party-in-interest, leading to termination of IPRs before institutionJones Day defended patent owner, Purdue Pharma L.P., in connection with two inter partes review (IPR) petitions brought by the petitioner, Kashiv Pharma, LLC, against U.S. Patent Nos. 9,492,392 and 9,492,393.
  • Purdue Pharma successfully resolves Hatch-Waxman patent infringement claims against Epic Pharma related to OxyContin®Jones Day successfully represented Purdue Pharma L.P. in related Hatch-Waxman patent infringement actions against defendants Epic Pharma, LLC and PuraCap Pharmaceutical LLC, pertaining to the submission of an Abbreviated New Drug Application to the FDA seeking approval of a generic version of OxyContin®.
  • Purdue Pharma successfully resolves Hatch-Waxman patent infringement claims against Amneal and Kashiv related to OxyContin®Jones Day successfully represented Purdue Pharma L.P. in related Hatch-Waxman patent infringement actions against defendants Amneal Pharmaceuticals, LLC and Kashiv Pharma, LLC, pertaining to the submission of an Abbreviated New Drug Application to the FDA seeking approval of generic versions of OxyContin®, a widely prescribed treatment for pain relief.
  • Purdue Pharma asserts patent infringement claims under Hatch-Waxman Act related to OxyContin® against AbhaiJones Day successfully represented Purdue Pharma L.P. in a Hatch-Waxman patent infringement action against the defendant, Abhai LLC's, submission of an Abbreviated New Drug Application to the FDA seeking approval of generic versions of OxyContin®, a widely prescribed drug for pain relief.
  • Purdue Parma obtains discovery for Canadian patent proceedingsJones Day successfully represented Purdue Pharma L.P. in a Section 1782 discovery action to obtain discovery for use in Canadian proceedings brought to enforce Purdue's patents covering OxyContin®, a widely prescribed treatment for pain relief.
  • Purdue Pharma asserts patent infringement claims under Hatch-Waxman Act related to OxyContin® against MylanJones Day successfully represented Purdue Pharma L.P. in a Hatch-Waxman patent infringement action against defendants, relating to the defendants' submission of an Abbreviated New Drug Application to the FDA seeking approval of generic versions of OxyContin®, a widely prescribed treatment for pain relief.
  • Purdue Pharma successfully resolves Hatch-Waxman claims against companies seeking to make generic version of transdermal patch Butrans®Jones Day client Purdue Pharma L.P. successfully resolved a patent infringement action it brought under the Hatch-Waxman Act against two companies that sought FDA approval to market a generic version of Purdue's Butrans® product prior to the expiration of certain patents owned by Purdue.
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