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.
(A.B.,summa cum laude; Phi Beta Kappa)
District of Columbia
U.S. Supreme Court
Federal Circuit Court of Appeals
D.C. Circuit Court of Appeals
Third Circuit Court of Appeals
Fourth Circuit Court of Appeals
Seventh Circuit Court of Appeals
District of Columbia
American Bar Association (Litigation and Intellectual Property Sections)
Chicago Bar Association (Judicial Evaluation Committee)
Illinois Bar Association
- RMMS Obtains IPR Victory Related To Aflibercept November 11, 2022
- RMMS Receives Continued Recognition in IAM Patent 1000 – Two Firm Partners Individually Ranked July 6, 2022
- RMMS Ranked Nationally for Life Sciences IP – William Rakoczy Again Recognized as IP Star June 15, 2022
- RMMS Again Recognized by Chambers & Partners – RMMS, William Rakoczy Ranked Nationally for Life Sciences June 3, 2022
- Federal Circuit Affirms Judgment Involving DUEXIS® Tablets (800 mg ibuprofen and 26.6 mg famotidine November 16, 2021
- RMMS Receives Continued Recognition in IAM Patent 1000 – Five Firm Partners Individually Ranked July 2, 2021
- RMMS Ranked Nationally for Life Sciences IP – Paul Molino & William Rakoczy Again Recognized as IP Stars June 18, 2021
- RMMS Again Recognized by Chambers & Partners – William Rakoczy Ranked Nationally for Life Sciences May 24, 2021
- RMMS Secures Copaxone® Win under Administrative Procedures Act December 30, 2020
- RMMS Scores Win in Case Involving DUEXIS® tablets (800 mg ibuprofen and 26.6 mg famotidine) November 30, 2020
- LMG Life Sciences Hall of Fame Welcomes RMMS Founding Partner William Rakoczy September 28, 2020
- RMMS Nominated For 2020 LMG Life Sciences Awards August 3, 2020
- RMMS Scores Win in Case Involving CLENPIQ® June 23, 2020
- RMMS Again Recognized as Litigation Leader in IAM Patent 1000 – Firm Partners Receive Individual Recognition June 11, 2020
- RMMS Partners Paul Molino & William Rakoczy Recognized as IP Stars May 7, 2020
- RMMS Recognized as Leading Lawyers by Chambers USA April 23, 2020
- RMMS Secures Favorable Resolution in BPCIA Litigation Involving FULPHILA® (pegfilgrastim-jmdb) November 1, 2019
- RMMS Nominated For LMG Life Sciences Awards July 22, 2019
- RMMS Recognized as Litigation Leader in IAM Patent 1000 – William Rakoczy and Deanne Mazzochi Receive Individual R... June 10, 2019
- RMMS Recognized Nationally and Regionally for Life Sciences Litigation – William Rakoczy and Paul Molino Selected ... April 2, 2019
- RMMS Files Supreme Court Amicus Brief on Behalf of AAM Challenging The Federal Circuit’s Reading Of The IPR Time Bar U... February 13, 2019
- RMMS Secures Favorable Claim Construction Ruling in NEULASTA® (pegfilgrastim) BPCIA Litigation November 20, 2018
- Federal Circuit Affirms Invalidity Judgment Concerning COPAXONE® (Glatiramer Acetate) October 12, 2018
- RMMS Recognized as Industry Leaders by LMG Life Sciences for Seventh Consecutive Year September 27, 2018
- RMMS Listed as Highly Recommended Patent Firm by Managing IP; William A. Rakoczy and Paul J. Molino Recognized as IP Sta... June 22, 2018
- RMMS Recognized as a Leading Patent Firm in Litigation by IAM Patent 1000; William A. Rakoczy Individually Ranked “Gol... June 22, 2018
- Federal Circuit Affirms Invalidity Judgment Concerning AXIRON® (Testosterone) Transdermal Solution November 22, 2017
- RMMS Partner William Rakoczy Recognized by Chambers & Partners July 28, 2017
- Federal Circuit Affirms Collateral Estoppel Decision Concerning Latisse® (bimatoprost topical solution) March 17, 2017
- RMMS Secures Invalidity Win on Copaxone® 40 (glatiramer acetate 40 mg/mL) January 30, 2017
- RMMS Secures Invalidity And Non-Infringement Victories on Patents Related To Axiron® (Testosterone) Transdermal Solutio... August 22, 2016
- Federal Circuit Affirms Judgment of Invalidity Concerning OxyContin® (oxycodone extended-release tablets) February 1, 2016
- RMMS Secures Favorable Claim Construction Ruling In Suit Involving Generic Aripiprazole (Abilify®) November 16, 2015
- RMMS Recognized as Industry Leaders by LMG Life Sciences for Fourth Consecutive Year October 20, 2015
- RMMS Secures Summary Judgment Against Otsuka Related To Generic Aripiprazole (Abilify®) May 27, 2015
- Federal Circuit Affirms Judgment of Invalidity Concerning Pulmicort Respules® (budesonide inhalation suspension) May 7, 2015
- RMMS Secures Second Victory Against Otsuka Related To Generic Aripiprazole (Abilify®) April 30, 2015
- Chief Judge Simandle Allows Launch of Generic Aripiprazole (Abilify®) April 16, 2015
- Federal Circuit Affirms Invalidity Judgment Concerning Zymaxid®/Zymar® (Gatifloxacin) Ophthalmic Solutions March 20, 2015
- RMMS Files Supreme Court Amicus Brief on Behalf of GPhA Supporting Specific-Intent-to-Infringe Requirement for Induced I... February 26, 2015
- RMMS Secures Judgment of Patent Invalidity Following Remand Trial Involving Generic Pulmicort Respules® (Budesonide Inh... February 13, 2015
- Federal Circuit Affirms Judgment Of Non-Infringement Involving Generic Trizivir® (Abacavir Sulfate, Lamivudine, and Zid... February 12, 2015
- RMMS Recognized as Industry Leaders by LMG Life Sciences November 7, 2014
- RMMS Secures Reversal Before Federal Circuit, Invalidating Asserted Patents Concerning Latisse® (bimatoprost) Ophthalmi... July 10, 2014
- U.S. Court Of Appeals For The Federal Circuit Affirms RMMS’s Victory Involving Generic Ibandronate Products April 11, 2014
- RMMS Secures Judgment Of Patent Invalidity After A Trial Involving Gatifloxacin Ocular Formulation and Method August 9, 2013
- Federal Circuit Affirms Judgment Of Non-Infringement Involving Generic Mometasone Furoate Nasal Spray June 10, 2013
- RMMS Secures Judgment Of Patent Invalidity And Non-Infringement After A Trial Involving Budesonide Inhalation Suspension April 1, 2013
- RMMS Defeats Motion for Preliminary Injunction Involving Generic Tiagabine Hydrochloride Products December 20, 2012
- RMMS Secures Judgment Of Non-Infringement After A Trial Involving Generic Mometasone Furoate Nasal Spray June 15, 2012
- RMMS Defeats Motion for Preliminary Injunction Involving Generic Ibandronate Products March 14, 2012
- RMMS Secures Summary Judgment of Non-Infringement Involving Generic Guaifenesin Extended-Release Tablets, 600 mg January 11, 2012
- RMMS Defeats Motion for Preliminary Injunction Involving Generic Carbamazepine Extended-Release Capsules July 6, 2011
- RMMS Secures Federal Circuit Ruling Affirming Trial Decision of Patent Invalidity Involving Generic Galantamine September 25, 2009
- RMMS Secures Federal Circuit En Banc Ruling Affirming Summary Judgment Of Noninfringement Involving Generic Cefdinir May 19, 2009