William A. Rakoczy is one of the founding partners of RAKOCZY MOLINO MAZZOCHI SIWIK LLP. He serves as litigation and regulatory counsel in a variety of high-stakes proceedings for clients in a wide range of industries, including pharmaceutical, biopharmaceutical, chemical, biotechnology, healthcare, consumer products, telecommunications, and manufacturing. With a broad base of legal, technical and business knowledge, together with substantial experience as lead counsel at the trial and appellate level in federal and state tribunals throughout the country, Bill's practice is both highly focused and specialized but also quite diverse, including significant patent, regulatory, antitrust, and complex commercial litigation matters and emergency injunction proceedings.
Bill is widely regarded as a leading advocate and trusted client advisor among the pharmaceutical and biopharmaceutical industry and has been recognized by legal industry media for his skills. LMG Life Sciences recognized Bill as a “Life Science Star,” lauding his courtroom experience, which has led RMMS to become “a go-to partner for generic clients.”
Intellectual Property Litigation and Counseling
Bill has extensive experience at both the trial and appellate level litigating highly specialized Hatch-Waxman patent infringement and related regulatory, commercial and antitrust actions involving prescription pharmaceutical drugs, including such blockbuster drugs as Epzicom® (abacavir and lamivudine), Truvada® (emtricitabine and tenofovir), Atripla® and Apriso® (mesalamine), Zymar® and Zymaxid® (gatifloxacin), Pulimicort Respules® (budesonide), Boniva® (ibandronate), Ranexa® (ranolazine), Lumigan® and Latisse® (bimatoprost), Trizivir® (abacavir/lamivudine/zidovudine), Nasonex® (mometasone), Carbatrol® (carbamazepine), Lunesta® (eszopiclone), Crestor® (rosuvastatin), Cymbalta® (duloxetine), Namenda® (memantine), Femara® (letrozole), Lipitor® (atorvastatin), Coumadin® (warfarin), Pravachol® (pravastatin), Zofran® (ondansetron), Keppra® (levetiracetam), Altace® (ramipril), Reminyl® (galantamine), Fosamax® (alendronate), Tequin® (gatifloxacin), Depakote® (divalproex), Tricor® (fenofibrate), Imitrex® (sumatriptan), Alphagan® (brimonidine), Proscar® (finasteride), Macrobid® (nitrofurantoin), Prilosec® (omeprazole), Accupril® (quinapril), Zoloft® (sertraline), Prozac® (fluoxetine), Zantac® (ranitidine), Glucophage® (metformin), Neurontin® (gabapentin), Paxil® (paroxetine) and many others.
Bill has obtained numerous favorable judgments for his pharmaceutical clients, including recent trial victories involving Nasonex® (mometasone), Zymar® and Zymaxid® (gatifloxacin). He has also distinguished himself as a leading appellate advocate on behalf of his clients, beginning with a ground-breaking Federal Circuit decision for the generic drug industry on off-label method-of-use patents in the Neurontin® (gabapentin) litigation. Among Bill's most recognized successes are summary judgments of non-infringement for his generic client in multidistrict litigation involving the primary patent for Pfizer’s multi-billion dollar prescription drug Neurontin® and final judgment of invalidity before the United States Court of Appeals for the Federal Circuit on GlaxoSmithKline’s main patent for Paxil®, one of the world’s best selling antidepressants.
In addition to considerable Hatch-Waxman experience, Bill has also prosecuted and defended traditional actions for patent infringement, trade secret, trademark, and copyright matters for a variety of other industries such as manufacturing, consumer products and telecommunications.
Bill also counsels his international clients on intellectual property licensing, due diligence, and transactional issues in the United States and throughout the world.
Food and Drug and Hatch-Waxman Regulatory Litigation and Counseling
Bill has significant experience representing pharmaceutical companies in regulatory matters before the FDA, with particular expertise in Hatch-Waxman and related issues involving ANDAs, section 505(b)(2) applications, and NDAs, together with various non-patent innovator and generic drug market-exclusivity issues. He has handled numerous APA actions and emergency injunction proceedings against the FDA and HHS at the federal trial and appellate level.
Some of his regulatory litigation successes include obtaining a final judgment and permanent injunction against the FDA and HHS that preserved his client’s lucrative 180-day marketing exclusivity for generic Paxil®—which was threatened when FDA awarded so-called “shared exclusivity” to at least four other generic companies, one of which was poised to launch a competing product shortly. In another matter, he secured his client’s right to sole 180-day generic exclusivity for its generic version of Allegra-D®.
Bill also regularly counsels clients in the pharmaceutical, chemical and biotechnology industries on related regulatory and compliance, approval, labeling and good manufacturing issues for ANDAs, ABLAs, 505(b)(2) applications, and DMFs.
He is a regular invited speaker and lecturer on Hatch-Waxman patent and regulatory issues at various industry conferences. Bill has also represented the national trade association for the generic drug industry, the Generic Pharmaceutical Association, as an amicus before the United States Supreme Court and the Federal Circuit.
Antitrust and Complex Commercial Litigation and Counseling
Bill's considerable litigation experience extends to the complex commercial and business arenas as well. He has served as litigation counsel in a variety of corporate and shareholder disputes, including complex commercial, business torts, antitrust and qui tam/False Claims Act matters.
Some of his successes include, among others, obtaining favorable settlements for his generic clients in commercial disputes involving active pharmaceutical ingredient supply agreements. Bill also obtained a $6.4 million judgment on behalf of two private equity clients in an action for breach of an investment and securities agreement. In addition, he successfully defended one of the world’s largest investment companies and its reinsurance affiliates in an antitrust and business tort action, obtaining dismissal of all pending claims. He has also obtained several dismissals for his manufacturing, healthcare and reinsurance clients in corporate and shareholder disputes involving various alleged business torts.
Bill also counsels his clients on antitrust and unfair competition issues, including proceedings involving the FTC.
Prior to founding Rakoczy Molino Mazzochi Siwik LLP, Bill was a partner in the national law firm of Lord, Bissell & Brook LLP. He joined that firm as an associate in 1997 and was elected one of the youngest partners in firm history in 2001. Before that, Bill spent two years as a law clerk to the Honorable Wayne R. Andersen, United States District Court Judge for the Northern District of Illinois, Eastern Division.