Gregory Dennis

Dennis D. Gregory Counsel

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Dennis is a life-science patent litigator and registered patent attorney, with a particular emphasis on Hatch-Waxman litigation. Dennis has represented numerous brand and generic pharmaceutical companies in Hatch-Waxman Act litigation, and counseled clients on related issues such as exclusivity, claiming strategy, freedom to operate, due diligence, assertability, the Bayh-Dole Act and pharmaceutical antitrust.

Dennis also has counseled client issues related to the Biologics Price Competition and Innovation Act (BPCIA).

Experience

Dennis represents leading pharmaceutical companies in patent infringement actions, including:

  • An action in the Northern District of West Virginia regarding client’s ANDA for a generic version of the irritable bowel syndrome drug Trulance® (plecanatide), and related IPRs. Action pending.
  • An action in the District of Delaware appealed to the Federal circuit regarding client’s ANDA for a generic version of the ready-to-dilute chemotherapy drug Bendeka® (bendamustine).
  • An action in the District of New Jersey regarding client’s ANDA for a generic version of the injectable iron therapy Infectafer® (ferric carboxymaltose). Case settled on favorable terms to client following trial.
  • An action in the Eastern District of Texas regarding competitor’s attempt to import a version of the imaging dye isosulfan blue leading to the entry of a temporary restraining order and eventual settlement.
  • An action in the District of Delaware regarding client’s ANDA for a generic version of the oral iron supplement Aurxyia® (ferric citrate). Case settled on favorable terms to client.
  • An action in the District of Delaware regarding client’s ANDA for a generic version of the oral multiple sclerosis drug Gilenya® (fingolimod). Case settled on favorable terms to client.
  • An action in the District of Delaware regarding client’s ANDA for a generic version of suppository ulcerative colitis drug Canasa® (mesalamine suppository). Case settled on favorable terms to client.
  • An action in the District of Delaware regarding client’s ANDA for a generic version of the lyophilized intravenous chemotherapy drug Treanda® (bendamustine). Case settled on favorable terms to client.
  • An action in the District of Delaware regarding client’s ANDA for a generic version of the oral chemotherapy drug Nexavar® (sorafenib). Case settled on favorable terms to client.
  • An action in the District of New Jersey regarding client’s ophthalmic antibiotic drug AzaSite® (azithromycin).
  • An action in the Southern District of New York regarding client’s calcium metabolism nasal spray drug Miacalcin® (calcitonin salmon), resulting in a favorable summary judgment decision that was affirmed on appeal.
  • An action in the District of New Jersey regarding client’s chewable oral contraceptive drug Generess Fe® (norethindrone, ethinyl estradiol and ferrous fumarate chewable tablets)
  • An action in the District of Delaware regarding client’s oral cholesterol drug Crestor® (rosuvastatin calcium), resulting in a favorable trial decision that was affirmed on appeal.
  • An action in the District of Delaware regarding client’s oral anti-psychotic NDA drug Seroquel XR® (quetiapine), resulting a favorable trial decision that was affirmed on appeal.
  • An action in the Eastern District of Missouri regarding client’s oral sustained release hypertension drug Toprol XL® (metoprolol succinate).
  • An action in the Eastern District of Pennsylvania regarding client’s oral cardiovascular drug Plendil® (felodipine), resulting a favorable grant of summary judgment partially upheld on appeal.