William 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, chemical, biotechnology, healthcare, consumer products, telecommunications, finance/private equity, manufacturing, and reinsurance. 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, Mr. Rakoczy'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.
Intellectual Property Litigation and Counseling—Hatch-Waxman, Patent, Trade Secret and Trademark
Mr. Rakoczy has extensive experience at both the trial and appellate level litigating highly specialized Hatch-Waxman statutory patent infringement and other actions involving prescription pharmaceutical drugs, including such blockbuster drugs as Neurontin® (gabapentin), Paxil® (paroxetine hydrochloride), Pravachol® (pravastatin sodium), Accupril® (quinapril hydrochloride), Zoloft® (sertraline hydrochloride), Tricor® (fenofibrate), Imitrex® (sumatriptan succinate), Alphagan® (brimonidine), Depakote® (divalproex sodium), Prozac® (fluoxetine hydrochloride), Zantac® (ranitidine hydrochloride), Glucophage® (metformin hydrochloride), and Coumadin® (warfarin sodium).
Some of his successes include, among others, obtaining a final judgment of invalidity before the United States Court of Appeals for the Federal Circuit (Federal Circuit) on GlaxoSmithKline's main patent for Paxil®, one of the world's best selling antidepressants. He was also a member of the team that won a decision of noninfringement on that patent in the district court before Judge Richard A. Posner. Mr. Rakoczy also obtained judgments of invalidity for his client on the asserted claims of three other Paxil® patents in related litigation. In other Hatch-Waxman patent litigation, he obtained two district court judgments of noninfringement for his pharmaceutical clients on two of Pfizer's patents for the multi-billion dollar prescription drug Neurontin®. On appeal before the Federal Circuit, Mr. Rakoczy obtained a ground-breaking decision for the generic drug industry on off-label method-of-use patents. The opinion has been recognized as one of the biggest patent decisions of 2002.
In addition to considerable Hatch-Waxman experience, Mr. Rakoczy 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.
Mr. Rakoczy 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
Mr. Rakoczy has significant experience representing pharmaceutical companies in regulatory matters before the Food and Drug Administration (FDA), with particular expertise in Hatch-Waxman and related issues involving abbreviated new drug applications (ANDAs), section 505(b)(2) applications, and new drug applications, 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 the Department of Health and Human Services (HHS) at the federal trial and appellate level.
Some of his 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. The FDA's decision, if left unchallenged, would have stripped the client of more than $50 million in generic Paxil® sales. The day before the competitor's launch, Mr. Rakoczy obtained a final judgment for his client setting aside the FDA's decision; awarding his client sole 180-day marketing exclusivity for generic Paxil®; and enjoining the FDA from approving any other generic Paxil® products until the expiration of that exclusivity. The decision preserved his client's exclusivity and more than $50 million in additional generic Paxil® sales. In other Hatch-Waxman regulatory litigation against the FDA and HHS, Mr. Rakoczy obtained emergency injunctive relief for his client from the U.S. Court of Appeals for the District of Columbia Circuit staying FDA approval of a competitor's ANDA for generic Neurontin®.
Mr. Rakoczy also counsels clients in the pharmaceutical, chemical and biotechnology industries on related regulatory and compliance, approval, labeling and good manufacturing issues for ANDAs, 505(b)(2) applications, and drug master files (DMFs).
He is a regular invited speaker and lecturer on Hatch-Waxman patent and regulatory issues at various industry conferences. Mr. Rakoczy 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
Mr. Rakoczy'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 a $6.4 million judgment on behalf of two private equity clients in an action for breach of an investment and securities agreement. Mr. Rakoczy also 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.
Mr. Rakoczy also counsels his clients on antitrust and unfair competition issues, including proceedings involving the FTC.
Prior to founding Rakoczy Molino Mazzochi Siwik LLP, Mr. Rakoczy 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, Mr. Rakoczy 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.