Todd Werner’s practice focuses on helping clients navigate patent disputes with their competitors. Leveraging his degree in biochemistry, Todd has represented pharmaceutical companies in ANDA litigation for nearly two decades. For example, Todd led the efforts of Hetero Labs in defeating the patent covering Biogen’s blockbuster Tecfidera® product indicated for multiple sclerosis. Todd also helped Teva Pharmaceuticals defeat several patents directed to abuse-deterrent formulation patents covering multibillion-dollar opioid products, and maintain those judgments on appeal. Other representative ANDA matters include Millennium v. Teva (Velcade® lyophilized anti-cancer agent), Alcon v. Teva (ophthalmic olopatadine formulations), Merck Sharpe & Dohme B.V. v. Dr. Reddy’s Laboratories, Inc. (Nuvaring® contraceptive), and Pharmacyclics LLC v. Sun Pharma (ibrutinib polymorph patents).
Todd has also litigated a variety of other patent disputes in the life sciences, electrical, mechanical, and chemical arts. For example, Todd served as lead counsel for a nutraceutical client asserting its patent in a multi-district dispute, which included the defense of that patent in IPR proceedings before the USPTO. Todd successfully defended the validity a number of instituted claims and went on to secure a favorable settlement for his client. In M-I Drilling Fluids UK Ltd. v. Dynamic Air Inc., Todd secured invalidity judgments on 114 of 117 claims in IPR proceedings that challenged five Schlumberger patents directed to the pneumatic conveyance of drill cuttings generated by offshore drilling operations. In a related federal court proceeding, Todd helped win an award of over $1.3 million in attorney fees under 35 U.S.C. § 285.
In addition to contested proceedings, Todd counsels clients in the negotiation of intellectual property licenses, joint development agreements, SaaS agreements, as well as monetization of patent portfolios.
Todd has been named a Super Lawyer in patent litigation each year since 2013, and he was previously selected as a Rising Star each year from 2008–2012. He was also recognized for legal excellence in the 2021 and 2022 Editions of The Best Lawyers in America. Todd has represented military veterans through the Veteran’s Consortium Pro Bono Program and has also taught Intellectual Property Moot Court at the University of Minnesota Law School. He also runs a non-profit, Hopeful Halos, that raises funds to support research for a cure for Angelman Syndrome.
J.D. University of Minnesota Law School, cum laude
B.S. Biochemistry, Michigan Technological University, summa cum laude
Minnesota Supreme Court
U.S. District Court for the District of Minnesota
U.S. Court of Appeals for the Federal Circuit
- Best Lawyers (2021, 2022)
- Minnesota Super Lawyer (2013-2022)
- Minnesota Super Lawyers “Rising Star” (2008-2012)
- Patexia’s “Top 50 Most Successful and Best Performing ANDA Attorneys” (2020, 2021)
Biogen v. Hetero Labs Ltd. (dimethyl fumarate)
Todd’s team successfully represented Hetero in the challenge of a patent directed to the use of dimethyl fumarate to treat multiple sclerosis, which involved the blockbuster drug Tecfidera®. Todd secured a finding that the patent was invalid because of fatal defects in the patent’s written description due to the lack of disclosure for the claimed dosing regimen. The win paved the way for Hetero to begin marketing its own dimethyl fumarate product.
M-I Drilling Fluids UK Ltd. v. Dynamic Air Inc. and Dynamic Air Ltda.
M-I Drilling Fluids, a Schlumberger subsidiary, sued Minnesota-based Dynamic Air Inc. for infringement of five patents directed to the pneumatic conveyance of drill cuttings generated by the drilling of offshore oil wells. Todd and his team submitted IPR petitions that challenged 117 claims across five patents. The PTAB invalidated 114 of the 117 claims, which ultimately forced M-I Drilling to dismiss its claims. Todd then helped its client recover about $1.4 million in attorney fees and maintained the judgment on appeal. The saga was summarized in the Star Tribune (Linked here).
Purdue v. Teva Pharmaceuticals USA (oxycodone)
Todd prevailed in a series of significant matters for Teva Pharmaceuticals against Purdue involving patents related to abuse-deterrent formulations covering products with billions in annual sales. Todd first helped secure invalidity judgments in a bench trial in the Southern District of New York on four of Purdue’s asserted patents. He also won a judgment of non-infringement and invalidity on a fifth Purdue patent. Todd and his team maintained all of these rulings on appeal. He also represented Teva in a second bench trial involving two additional tamper-resistance patents. Shortly before the parties began a third trial, and before the Court issued a verdict on the second trial, Teva secured a favorable settlement.
Valensa and University of Illinois v. Cyanotech and Nutrex-Hawaii
Todd represented Valensa, an innovator in the extraction, stabilization, and delivery of botanical extracts, in the enforcement of a patent it licensed from the University of Illinois. The patent was directed to the use of astaxanthin to defend against a number of potential ophthalmic maladies. The dispute began with competing cases in the Middle District of Florida and the District of Hawaii, with Todd securing dismissal of the Hawaii action. Eventually the defendant filed petitions for inter partes review petitions with the United States Patent and Trademark Office. Todd’s team successfully avoided institution on a number of challenged claims (this was a pre-SAS proceeding) and prevailed on a number of the claims on which trial was instituted. The case settled before trial.
Nycomed v. Teva Pharmaceuticals USA Inc. (pantoprazole)
After Teva filed a Paragraph IV ANDA challenging the validity of a patent covering Protonix® (pantoprazole), a product that had annual U.S. sales in excess of $2 billion, the patentee filed a motion for a preliminary injunction seeking to enjoin Teva from selling its proposed product. The asserted patent was directed to the active pharmaceutical ingredient, generally the most important and strongest type of patent covering pharmaceutical products. Todd helped defeat the motion, marking the first time a court ever denied a motion for a preliminary injunction in a case involving a pharmaceutical compound patent. The team also defeated an appellate challenge at the Federal Circuit, which opened the door for Teva to begin selling its product.
“Key IP Legal Trends 2017-2018 in Brief – Biotechnology, Medical Devices, and Digital Health,” Chapter 12, The IP Book 2018, 16th Ed. (2018).