Kenneth Schuler, a member of Latham & Watkins’ Intellectual Property Practice, is a seasoned patent litigator, with a particular emphasis in pharmaceutical patent litigation involving claims arising under the Hatch-Waxman Act.

Mr. Schuler joined Latham in 1994 after serving as a judicial clerk to Judge James B. Loken, United States Court of Appeals for the Eighth Circuit. Since joining Latham, Mr. Schuler has acquired extensive litigation experience in federal and state courts, as well as in commercial arbitrations. He has extensive trial experience, having been admitted to the Trial Bar of the Northern District of Illinois in 2002.

Mr. Schuler has handled a significant number of pharmaceutical and life sciences patent-related cases for clients such as Mallinckrodt Pharmaceuticals, Cadence Pharmaceuticals, Eagle Pharmaceuticals, Endo Pharmaceuticals, Boehringer-Ingelheim GmbH, Par Pharmaceuticals, and Alvogen. He also has substantial experience litigating other intellectual property matters, including patent, trade secrets, and trade dress suits, representing Overhead Door, ADA Carbon Solutions, Neuromedical Systems, Inc., and Libbey Glass, Inc., with respect to myriad technologies, including activated carbon, manufacturing, barrier system operators, oxygen barrier plastic containers, ATM networks, mass spectrometers, and diagnostics. Intellectual Asset Management magazine named Mr. Schuler to the IAM Patent 1000 from 2014-2019.

Mr. Schuler’s recent experience includes representation of:

  • Overhead Door Corp. v. Chamberlain Group, Inc. – Lead counsel for Overhead Door in ITC action involving various patents concerning barrier operator technology; tried to ALJ in April, 2021.  The ITC determined that 3 asserted patents were infringed and valid, leading to an exclusion order for virtually all of the Defendants’ imported products.
  • Cadence Pharmaceuticals, Inc. v. Exela Holdings, Inc. – Lead counsel for Cadence in this successful ANDA patent infringement suit in which he obtained an injunction against Exela’s efforts to market a generic equivalent to Cadence’s Ofirmev® IV product. The case was tried before Judge Stark of the District of Delaware and judgment was entered in favor of Cadence on all issues and both asserted patents and subsequently affirmed by the Federal Circuit.
  • Par Pharmaceutical v. Hospira, Inc. – Co-lead counsel for Par in Hatch-Waxman litigation in the District of Delaware involving Hospira’s effort to obtain approval to market a generic equivalent to Par’s Adrenalin® product.  Following a week-long trial, the trial court issued judgement in favor of Par on all asserted claims, finding them infringed and valid.  Affirmed on appeal.
  • Eagle Pharmaceuticals v. Slayback Pharma Ltd. – Co-lead counsel for Eagle in Hatch-Waxman litigation in the District of Delaware involving efforts by Apotex, Fresenius Kabi, Slayback, and Mylan to market a generic equivalents to Eagle’s Bendeka® oncology product. Following a 2-week trial, Judge Connolly found all asserted patents infringed and valid.  Affirmed on appeal.
  • Alvogen Inc. v. Nevada State Dep’t of Corrections – Lead counsel for Plaintiff Alvogen Inc. in lawsuit concerning improper acquisition of drug product for potential use in lethal injunction. Mr. Schuler led the Alvogen team in obtaining both a landmark TRO and preliminary injunction (following a four-day evidentiary hearing) prohibiting the Nevada DOC from using Alvogen’s Midazolam product in capital punishment.
  • Boehringer Ingelheim International GmbH v. Mylan Pharmaceuticals – Lead trial counsel to Boehringer in this ANDA patent infringement suit involving efforts by generic pharmaceutical manufacturers to market generic versions of Boehringer’s successful drug Mirapex®, which is used to treat Parkinson’s disease and Restless Leg Syndrome. On appeal, the United States Court of Appeals for the Federal Circuit upheld the validity of Boehringer patent at issue over Mylan’s claim of double patenting.
  • Endo Pharmaceuticals v. Lupin Atlantis Holdings – Co-lead counsel for Endo in Hatch-Waxman litigation involving Lupin’s effort to market a generic version of Endo’s branded Nascobal® Nasal Spray. Endo and Lupin entered into a consent judgment with Lupin acknowledging infringement and validity and agreeing to refrain from entering the market until licensed.
  • Cadence Pharmaceuticals, Inc. v. Fresenius Kabi USA – Lead counsel for Cadence in this ANDA patent infringement suit involving Fresenius’ 505(b)(2) application seeking to market a generic equivalent to Cadence’s Ofirmev® IV product. The matter settled on favorable terms following the District Court’s denial of Fresenius’ motion for summary judgment with Fresenius agreeing not to market its proposed generic product until December 2020, approximately six months prior to expiration of the last-to-expire patent listed in the Orange Book for Ofirmev®.
  • Eagle Pharmaceuticals v. Hospira, Inc. – Co-lead counsel for Eagle in Hatch-Waxman litigation involving Hospira’s effort to market a generic equivalent to Eagle’s Bendeka® oncology product. Matter settled favorably after Eagle prevailed on claim construction.
  • Cadence Pharmaceuticals, Inc. v. InnoPharma – Lead counsel for Cadence in this ANDA patent infringement suit involving InnoPharma’s efforts to market a generic equivalent to Cadence’s Ofirmev® IV product. The matter settled with InnoPharma agreeing not to market its proposed generic product until December 2020, approximately six months prior to expiration of the last-to-expire patent listed in the Orange Book for Ofirmev®.
  • Chamberlain Group v. Overhead Door Corporation – Lead counsel for Overhead Door in this patent infringement lawsuit involving obstruction sensing technology for automatic garage door operators filed in the United States District Court for the Northern District of Illinois. The case settled on favorable terms after the completion of briefing on Chamberlain’s motion for preliminary injunction.
  • ATM Communications International, Inc. v. U.S. Bancorp – Lead counsel for U.S. Bancorp in this patent infringement lawsuit involving ATM networks. The matter settled on terms favorable to U.S. Bancorp following mediation.
  • Boehringer Ingelheim Pharmaceuticals Inc. v. Apotex Inc. (D. Del.) – Lead counsel for Boehringer in this ANDA patent infringement suit involving efforts by Apotex to market a generic version of Zantac® 150 mg OTC tablets. The matter ended favorably when Apotex withdrew its ANDA.

Mr. Schuler’s recent experience includes representation of:

  • Overhead Door Corp. v. Chamberlain Group, Inc. – Lead counsel for Overhead Door in ITC action involving various patents concerning barrier operator technology; tried to ALJ in April, 2021.  The ITC determined that 3 asserted patents were infringed and valid, leading to an exclusion order for virtually all of the Defendants’ imported products.
  • Cadence Pharmaceuticals, Inc. v. Exela Holdings, Inc. – Lead counsel for Cadence in this successful ANDA patent infringement suit in which he obtained an injunction against Exela’s efforts to market a generic equivalent to Cadence’s Ofirmev® IV product. The case was tried before Judge Stark of the District of Delaware and judgment was entered in favor of Cadence on all issues and both asserted patents and subsequently affirmed by the Federal Circuit.
  • Par Pharmaceutical v. Hospira, Inc. – Co-lead counsel for Par in Hatch-Waxman litigation in the District of Delaware involving Hospira’s effort to obtain approval to market a generic equivalent to Par’s Adrenalin® product.  Following a week-long trial, the trial court issued judgement in favor of Par on all asserted claims, finding them infringed and valid.  Affirmed on appeal.
  • Eagle Pharmaceuticals v. Slayback Pharma Ltd. – Co-lead counsel for Eagle in Hatch-Waxman litigation in the District of Delaware involving efforts by Apotex, Fresenius Kabi, Slayback, and Mylan to market a generic equivalents to Eagle’s Bendeka® oncology product. Following a 2-week trial, Judge Connolly found all asserted patents infringed and valid.  Affirmed on appeal.
  • Alvogen Inc. v. Nevada State Dep’t of Corrections – Lead counsel for Plaintiff Alvogen Inc. in lawsuit concerning improper acquisition of drug product for potential use in lethal injunction. Mr. Schuler led the Alvogen team in obtaining both a landmark TRO and preliminary injunction (following a four-day evidentiary hearing) prohibiting the Nevada DOC from using Alvogen’s Midazolam product in capital punishment.
  • Boehringer Ingelheim International GmbH v. Mylan Pharmaceuticals – Lead trial counsel to Boehringer in this ANDA patent infringement suit involving efforts by generic pharmaceutical manufacturers to market generic versions of Boehringer’s successful drug Mirapex®, which is used to treat Parkinson’s disease and Restless Leg Syndrome. On appeal, the United States Court of Appeals for the Federal Circuit upheld the validity of Boehringer patent at issue over Mylan’s claim of double patenting.
  • Endo Pharmaceuticals v. Lupin Atlantis Holdings – Co-lead counsel for Endo in Hatch-Waxman litigation involving Lupin’s effort to market a generic version of Endo’s branded Nascobal® Nasal Spray. Endo and Lupin entered into a consent judgment with Lupin acknowledging infringement and validity and agreeing to refrain from entering the market until licensed.
  • Cadence Pharmaceuticals, Inc. v. Fresenius Kabi USA – Lead counsel for Cadence in this ANDA patent infringement suit involving Fresenius’ 505(b)(2) application seeking to market a generic equivalent to Cadence’s Ofirmev® IV product. The matter settled on favorable terms following the District Court’s denial of Fresenius’ motion for summary judgment with Fresenius agreeing not to market its proposed generic product until December 2020, approximately six months prior to expiration of the last-to-expire patent listed in the Orange Book for Ofirmev®.
  • Eagle Pharmaceuticals v. Hospira, Inc. – Co-lead counsel for Eagle in Hatch-Waxman litigation involving Hospira’s effort to market a generic equivalent to Eagle’s Bendeka® oncology product. Matter settled favorably after Eagle prevailed on claim construction.
  • Cadence Pharmaceuticals, Inc. v. InnoPharma – Lead counsel for Cadence in this ANDA patent infringement suit involving InnoPharma’s efforts to market a generic equivalent to Cadence’s Ofirmev® IV product. The matter settled with InnoPharma agreeing not to market its proposed generic product until December 2020, approximately six months prior to expiration of the last-to-expire patent listed in the Orange Book for Ofirmev®.
  • Chamberlain Group v. Overhead Door Corporation – Lead counsel for Overhead Door in this patent infringement lawsuit involving obstruction sensing technology for automatic garage door operators filed in the United States District Court for the Northern District of Illinois. The case settled on favorable terms after the completion of briefing on Chamberlain’s motion for preliminary injunction.
  • ATM Communications International, Inc. v. U.S. Bancorp – Lead counsel for U.S. Bancorp in this patent infringement lawsuit involving ATM networks. The matter settled on terms favorable to U.S. Bancorp following mediation.
  • Boehringer Ingelheim Pharmaceuticals Inc. v. Apotex Inc. (D. Del.) – Lead counsel for Boehringer in this ANDA patent infringement suit involving efforts by Apotex to market a generic version of Zantac® 150 mg OTC tablets. The matter ended favorably when Apotex withdrew its ANDA.

Bar Qualification

  • Illinois

Education

  • JD, University of Michigan Law School, 1993
  • BA, University of Northern Iowa, 1990