Paul J. Molino
Tel: (312) 222-6300
Paul Molino is the Managing Partner and one of the founding partners of Rakoczy Molino Mazzochi Siwik LLP. Paul routinely handles complex patent infringement litigation matters in federal courts throughout the United States, with particular emphasis and expertise in the pharmaceutical, biopharmaceutical, chemical, medical device and agriculture industries. He is registered to practice before the United States Patent and Trademark Office and holds a Bachelor of Science in Pharmacy.
Paul has extensive experience handling and litigating highly specialized Hatch-Waxman statutory patent infringement and other actions on behalf of generic pharmaceutical companies involving prescription pharmaceutical drugs. Mr. Molino's experience extends from pre-litigation counseling up and through trial, and includes numerous trials through verdict in the past few years, along with preliminary injunction proceedings. Over the past few years, Paul's work has expanded into the field of biopharmaceuticals, biologics and biosimilars.
His litigation experience includes such blockbuster drugs as NeurontinÂ® (gabapentin), PaxilÂ® (paroxetine hydrochloride), PravacholÂ® (pravastatin sodium), ZoloftÂ® (sertraline hydrochloride), TricorÂ® (fenofibrate), AntaraÂ® (fenofibrate), CeftinÂ® (cefuroxime axetil), DepakoteÂ® (divalproex sodium), ZantacÂ® (ranitidine hydrochloride), GlucophageÂ® (metformin hydrochloride), OmnicefÂ® (cefdinir), AltaceÂ® (ramipril), Wellbutrin XLÂ® (buproprion), Effexor XR (venlafaxine), XopenexÂ® (levalbuterol), KeppraÂ® (levetiractam), MegaceÂ® (megestrol acetate); FosomaxÂ® (alendronate), ClarinexÂ® (desloratadine), TrileptaÂ® (oxcarbazepine), FemaraÂ® (letrozole), LipitorÂ® (atorvastatin), Crestor (rosuvastatin), UroxatralÂ® (alfuzosin), CymbaltaÂ® (duloxetine), BonivaÂ® (ibandronate), NamendaÂ® (memantine), Pulimicort RespulesÂ® (budesonide), CarbetrolÂ® (carbamazepine), LunestaÂ® (eszopiclone), Â®OraceaÂ® (doxycycline), EvoxacÂ® (cevimeline), NasonexÂ® (mometasone), TrizivirÂ®, LumiganÂ®, LatisseÂ®, RanexaÂ® (ranolazine), ZymarÂ® and ZymaxidÂ® (gatifloxacin), AtriplaÂ® and AprisoÂ® (mesalamine), TruvadaÂ® (emtricitabine and tenofovir), EpzicomÂ® (abacavir and lamivudine), RestasisÂ® (cyclosporin), SpirivaÂ® (tiotropium) and many others.
Paul also assisted in obtaining a final judgment of invalidity before the United States Court of Appeals for the Federal Circuit on GlaxoSmithKline's main patent for PaxilÂ®. He was a member of the trial team that won a decision of noninfringement on that patent in the district court before Judge Richard A. Posner. This trial victory received national attention and was highlighted in the American Lawyer, National Law Journal, New York Times and other national publications. Paul's practice also includes counseling clients regarding patent strategies and developing and protecting intellectual property rights, including identifying and creating design-around opportunities and counseling on patent scope and validity issues, in addition to preparing for litigation relating to biosimilars and biologics.
Mr. Molino also counsels pharmaceutical and other companies in FDA regulatory matters, with particular expertise in Hatch-Waxman and related issues involving abbreviated new drug applications (ANDAs) and related regulatory submissions. He has developed a detailed understanding of the scientific, business and legal issues important to pharmaceutical companies, including biologics and biosimilar products.
Last updated September 2018