Chad A. Landmon
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TEL CT - 860.275.8170
TEL2 DC - 202.721.5415
FAX CT - 860.275.8101
FAX2 DC - 202.912.4701
clandmon@axinn.com
Hartford
Washington, DC
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Chad Landmon chairs Axinn's Intellectual Property and Food and Drug Administration Practice Groups and focuses his practice on patent litigation and counseling and food and drug law, with an emphasis on pharmaceuticals, biologics, medical devices, and human tissue products. He maintains a particular focus on patent trial work, having served as a first chair trial lawyer on multiple cases and having litigated over 50 cases during the past 10 years alone, many of which have included products with billions of dollars in annual sales. He was recently selected as a National Law Journal Healthcare/Life Sciences Trailblazer, ranked by IAM Patent 1000: The World’s Leading Patent Professionals and named a 2019 Life Sciences Star by LMG Life Sciences for his exemplary work in combining patent litigation skills with the ability to maneuver through the complicated FDA regulatory regime.

Chad's FDA matters involve petitioning FDA and litigating issues relating to marketing exclusivities, patent listing, certification and notification requirements, bioequivalence, labeling, and other issues relevant to the FDA drug approval process. His active FDA litigation practice has enabled clients to maintain their marketing exclusivity rights and obtain market entry. In fact, Chad led the efforts to obtain a court order that has been described as the first time a court has ordered FDA to approve a product.

By coupling his patent litigation experience with his FDA expertise, Chad enables life sciences clients to develop and execute on patent and FDA strategies to bring products to market in the most efficient and profitable manner. In fact, during the course of his career, Chad has worked on eight of the top ten generic drugs ranked by cost savings and nearly half of the top 100 generic drugs by sales volume.

With a practice that also includes matters involving the intersection of the antitrust and patent laws, such as issues arising from the settlement of patent and Hatch-Waxman exclusivity disputes, Chad frequently speaks and writes about issues relating to the Hatch-Waxman Act, the Biologics Price Competition and Innovation Act, and litigation in the life sciences industry. He has served as a member of Law360's Life Sciences Editorial Advisory Board since 2018. In addition, Chad is an active member in various professional committees, including the Food and Drug Law Institute’s Medical Products Committee and the Association for Accessible Medicines’ Biosimilars Council.

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Professional Activities

  • American Bar Association, Section of Intellectual Property Law
  • American Intellectual Property Law Association
  • Connecticut Bar Association
  • Connecticut Intellectual Property Law Association
  • Food and Drug Law Institute, Medical Products Committee (2018-2020)
  • Hartford County Bar Association
  • Law360 Life Sciences Editorial Advisory Board (2018-2020)

Experience

  • Served as lead appellate and trial counsel in obtaining a decision from the United States Court of Appeals for the Federal Circuit, affirming a decision entered after trial by the United States District Court for the District of Delaware (with Federal Circuit Judge William Bryson sitting by designation), that patents covering Zohydro® (hydrocodone extended-release capsules) and asserted against Axinn client Alvogen Malta Operations Ltd. were invalid. The decision removed the patents as a barrier to Alvogen bringing its lower-cost generic product to market more than a decade before the patents were set to expire.

  • Coupling patent litigation and FDA strategy, represented Zydus Pharmaceuticals in defending patent cases involving multiple patents directed to the blockbuster drug Abilify® (aripiprazole). Successfully fought off a temporary restraining order and obtained a favorable claim construction and non-infringement judgment at both the District Court and the Federal Circuit. At the same time, successfully defeated a lawsuit initiated by the brand company against the Food and Drug Administration, which sought to exclude Zydus and others from going to market for years, based upon a claim to orphan drug exclusivity.
  • Obtained favorable decision from the U.S. Court of Appeals for the Fourth Circuit to enable Watson Laboratories (now Teva) to speed its generic version of Celebrex® to market. An earlier lower court decision had effectively barred Watson and others from bringing their drugs to market. The Fourth Circuit Court of Appeals reversed and remanded the district court’s decision and the FDA’s determination, finding that Watson and another companies were eligible to share in a period of 180-day marketing exclusivity on the launch of their generic versions of Celebrex®, because a reissued patent was not part of the same “bundle of rights” as an original patent.
  • Defended client in patent case involving a billion-dollar product, obtaining a settlement after claim construction that was described as “company-changing” by the client.
  • Advanced a novel argument on behalf of client Endo Pharmaceuticals Inc., convincing FDA to grant final approval of Endo’s generic Valcyte® product and successfully intervening in a lawsuit brought by a third party to challenge FDA’s decision. The decisions by FDA and the US District Court for the District of Columbia opened up the lucrative Valcyte® and Nexium® markets to generic competition, providing significant savings to consumers and payers.
  • In what has been described as the first time a court has ever ordered FDA to approve a product, Axinn secured summary judgment on behalf of Watson Laboratories, Inc. in litigation against the U.S. Food and Drug Administration in the U.S. District Court for the District of Columbia. The case involved a dispute over the 180-day "first-to-file" marketing exclusivity for generic versions of the multi-billion dollar product Actos (pioglitazone hydrochloride).  The court's ruling includes an order that paved the way for the company to bring its generic diabetes drug to market.
  • Provided patent and FDA counseling on numerous biosimilar products in order to assist clients with biosimilar product development efforts and to navigate the "patent dance" and FDA approval issues under the Biologics Price Competition and Innovation Act.
  • After trying the patent case, obtained a favorable settlement that will enable Actavis to bring its generic version of Shire's ADHD product Intuniv to market. Through the course of the litigation and after conducting aggressive fact discovery, Shire dedicated its core method of use patent to the public, removing it from further dispute in the litigation. 
  • Obtained a favorable decision for our client, Alvogen, Inc. after intervening in an action against FDA by a competitor over generic versions of the antibiotic Vancocin. The competitor requested a preliminary injunction that would have forced Alvogen's generic version of Vancocin off the market.  Within less than a week, Axinn successfully moved to intervene, submitted opposition papers, and defeated the request for preliminary injunction, allowing Alvogen's version of Vancocin to remain on the market. 
  • Provided extensive counseling to a human tissue company developing platform technology using adult stem cells.  Such counseling has enabled the client to design around others' patents, secure its own patent protection and negotiate a license in a critical technology area at a fraction of the demanded royalty.  
  • Obtained a dismissal of a Lanham claim brought by Wyeth against Sun Pharmaceutical relating to the blockbuster drug Protonix.  The case involved allegations that Sun was engaged in false advertising in marketing its generic product.  The case was dismissed based upon an argument that the claims were preempted by FDA law. 
  • Successfully negotiated an extensive patent license and product distribution agreement relating to a blockbuster product. Chad was brought in to negotiate the agreement on the eve of trial given the complexities of the patent, FDA and business issues.

Honors

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Education

  • JD, with honors – University of Connecticut School of Law (1999)
  • BA, summa cum laude – University of Connecticut (1996)

Admissions

  • Connecticut
  • District of Columbia
  • US Court of Appeals for the District of Columbia Circuit
  • US Court of Appeals for the Federal Circuit
  • US Court of Appeals for the Fourth Circuit
  • US Court of Appeals for the Sixth Circuit
  • US District Court District of Columbia
  • US District Court District of Connecticut
  • US District Court Eastern District of Michigan
  • US District Court Southern District of New York