William A. Rakoczy is one of the founding partners of RMMS. He serves as lead counsel in a variety of high-stakes litigation and regulatory matters for a wide range of clients, with an emphasis in the life science and pharmaceutical industries. 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 tribunals throughout the country, Bill's practice is both highly focused and specialized, but also quite diverse, including significant patent and intellectual property, regulatory, competition, and complex commercial litigation matters and emergency injunction proceedings.
Bill is widely regarded as a leading advocate and trusted advisor. Described as a 'formidable first chair patent litigator for life science cases,' a 'top first chair trial lawyer,' and 'brilliant with a well-deserved reputation,' Bill was inducted into the 2020 LMG Life Sciences Hall of Fame . LMG Life Sciences has repeatedly recognized Bill as a 'Life Science Star,' lauding his courtroom experience, and repeatedly nominating him as Hatch-Waxman Litigator of the Year. IAM Patent 1000: The World's Leading Patent Professionals called Bill "one of the deans of the Hatch-Waxman bar," who "has great presence in court and is an excellent advocate who is admired by judges," 'excel[s] at everything from writing to oral advocacy and negotiation,' is 'an excellent and extremely strategic trial lawyer who develops creative arguments that others overlook,' and 'is a top regulatory expert too.' Managing Intellectual Property recognized Bill as an "IP Star."
Intellectual Property Litigation and Counseling
Bill has acted as lead counsel in over 300 patent infringement and related actions involving over 160 different drug products, biologics and biosimilars. He has extensive experience at both the trial and appellate level, including litigating highly specialized Hatch-Waxman, BPCIA and related regulatory and commercial actions.
Among Bill's numerous wins are district court and trial victories involving Copaxone® (glatiramer acetate) (recognized by LMG life Sciences as Impact Case of the Year in 2019), Neulasta® (pegfilgrastim), Axiron® (testosterone), Pulmicort® (budesonide), Nasonex® (mometasone), Abilify® (aripiprazole), Mucinex® (guaifenesin), Boniva® (ibandronate), Zymaxid® (gatifloxacin), Omnicef® (cefdinir), Altace® (ramipril), Razadyne® (galantamine), Strattera® (atomoxitine) and Paxil® (paroxetine).
Bill has also distinguished himself as an appellate advocate, including a ground-breaking Federal Circuit decision on off-label method-of-use patents in the Neurontin® (gabapentin) litigation.
In addition to considerable patent litigation experience, Bill has also acted as lead counsel in other intellectual property matters involving in trade secret, trademark and trade dress.
Bill also counsels his domestic and international clients on intellectual property licensing, due diligence, and transactional issues in the United States and throughout the world.
FDA and Hatch-Waxman/BPCIA Regulatory Litigation and Counseling
Bill has significant experience representing pharmaceutical/life science 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.
Bill has also acted as lead counsel in over 25 APA actions and emergency injunction proceedings involving the FDA and HHS at the federal trial and appellate level. His APA wins include district court or appeal victories involving Abilify® (aripiprazole), Zosyn® (piperacillin/tazobactam), Carbatrol® (carbamazepine), Allegra-D® and Paxil®.
He also counsels clients in the pharmaceutical and life science industries on related regulatory and compliance, approval, labeling and good manufacturing issues for ANDAs, BLAs, 505(b)(2) applications, and DMFs.
Bill has been a regular invited speaker and lecturer on patent and regulatory issues at various industry and client conferences. He has also represented the national trade association for the generic drug industry as an amicus in numerous Supreme Court and the Federal Circuit briefs.
Complex Commercial Litigation and Counseling
Bill's 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 of 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.
Prior to founding RMMS, Bill was a partner in the national law firm of Lord, Bissell & Brook LLP (n/k/a Locke Lord). 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.