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 number of pharmaceutical patent-related cases for clients such as Mallinckrodt Pharmaceuticals, Cadence Pharmaceuticals, Eagle Pharmaceuticals, Endo Pharmaceuticals, Roxane Laboratories, Actavis, Orchid Chemicals & Pharmaceuticals, Boehringer-Ingelheim GmbH, Alvogen, Par Pharmaceuticals, and Roxane Laboratories. 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. In addition, Mr. Schuler has extensive experience involving securities, class action, and complex commercial litigation, handling such matters for U.S. Bancorp, Jefferies & Company, Nissan, and National Presto Industries. Intellectual Asset Management magazine named Mr. Schuler to the IAM Patent 1000 from 2014-2019.
Mr. Schuler's recent experience includes representation of:
- Purdue Pharma, L.P. v. Actavis Elizabeth, Inc.: Co-lead counsel to Actavis in this ANDA patent infringement suit involving three “high purity” patents asserted by Purdue with respect to Actavis’ ANDA for generic oxycodone extended release tablets, which was tried before Judge Stein of the Southern District of New York in November-December 2012. The matter settled in April 2013 pursuant to a settlement agreement that Actavis publicly announced would generate more than US$100 million in combined gross profit. The District Court subsequently utilized the trial record generated by Mr. Schuler and the Latham trial team to invalidate each of the three asserted patents.
- GlaxoSmithKline LLC v. Roxane Laboratories, Inc.: Lead counsel to Roxane Laboratories in this ANDA patent infringement suit involving Roxane’s ANDA for generic dutasteride capsules (bioequivalent to GSK’s AVODART® capsules) which was tried before Judge Andrews of the District of Delaware in January 2013. Awaiting decision.
- Hoffman-La Roche v. Roxane Laboratories: Lead counsel for Roxane Laboratories in this patent infringement suit involving Roxane’s ANDA for generic capecitabine tablets (bioequivalent to Xeloda® tablets). The matter settled favorably after the district court granted Roxane’s motion to dismiss for lack
- Cadence Pharmaceuticals, Inc. v. Paddock Labs: Lead counsel for Cadence in this ANDA patent infringement suit involving Paddock’s efforts to market a generic equivalent to Cadence’s Ofirmev® IV product. The matter settled with Paddock 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®.
Mr. Schuler's additional Abbreviated New Drug Application (ANDA) representations include:
- Purdue Pharma L.P. v. Par Pharmaceuticals (Generic extended release oxycodone tablets)
- Novartis Pharmaceuticals Corp. v. Roxane Laboratories, Inc. (Generic famciclovir tablets; bioequivalent to Novartis’ FAMVIR® tablets)
- Cadence Pharmaceuticals, Inc. v. Exela Holdings, Inc. (Generic equivalent to Cadence’s Ofirmev® IV product)
- Teva Pharmaceuticals v. Orchid Chemicals & Pharmaceuticals (Generic rasagiline tablets; bioequivalent to Teva’s AZILECT® tablets)
- Wyeth v. Orgenus Pharma, Inc. (Generic extended-release venlafaxine tablets; bioequivalent to Wyeth’s EFFEXOR XR® tablets)
- Boehringer Ingelheim International GmbH v. Mylan Pharmaceuticals (Generic versions of Boehringer’s successful drug Mirapex®)
- Nabi Biopharmaceuticals v. Roxane Laboratories (Generic calcium acetate product)
- Boehringer Ingelheim Pharmaceuticals Inc. v. Apotex Inc. (D. Del.) (Generic version of Zantac® 150 mg OTC tablets)
- Boehringer Ingelheim International GmbH v. Barr Laboratories (Generic versions of Boehringer’s successful drug Mirapex®)
- Abbott Laboratories v. Roxane Laboratories, Inc. (Generic version of the antibiotic clarithromycin (BIAXIN®)
- CIMA Labs v. Orchid Chemicals & Pharmaceuticals (Orally disintegrating desloratadine tablets; bioequivalent to Clarinex®)
- Schering Corp. v. Zydus Pharmaceuticals, USA (Immediate release desloratadine (Clarinex®) tablets)
- Forest Laboratories v. Cobalt Laboratories Inc. (Memantine (Namenda®) tablets