David Ludwig’s practice focuses on patent litigation, with an emphasis on pharmaceutical cases brought under the Hatch-Waxman Act. He has experience in the pharmaceutical, mechanical and optical arts, with significant skill in litigating patent cases involving medical devices and scientific instruments. David’s practice also includes food and drug law, with a particular emphasis on Section 505 of the Federal Food, Drug and Cosmetic Act. In addition, he has represented clients in several USPTO inter partes review proceedings and interference proceedings.
A selection of David's representative matters include:
- Currently defending multiple pharmaceutical companies in patent infringement suits.
- Represented a spinal implant manufacturer in a suit against a non-practicing entity, including by filing multiple inter partes review petitions.
- Represented a scientific instruments manufacturer in a patent infringement suit against a competitor. The patents in the litigation related to elemental mass spectrometry.
- Represented a scientific instruments manufacturer in multiple interference proceedings relating to high pressure liquid chromatography.
- Successfully challenged the FDA's interpretation of Section 505 of the Federal Food, Drug and Cosmetic Act on appeal to the United States Court of Appeals for the Fourth Circuit.
- Advised clients on patent issues relating to optical systems such as high-power lasers.
- Axinn Leads Alvogen to Victory in Hatch-Waxman Case for Generic Zohydro®
- Axinn Protects Client Endo Pharmaceuticals Inc.’s Approval for Generic Valcyte®
- Axinn Obtains Fourth Circuit Victory in Generic Celebrex® Case
- Axinn Successful In Protecting FDA Approval for Client Endo Pharmaceuticals Inc.
- Axinn Wins Preliminary Injunction for WEX Health (formerly known as Evolution1)
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- Joint Infringement Post-Akamai, The Intellectual Property Strategist, February 2017
- JD – University of Virginia School of Law (2013)
- MBA – Union Graduate College (2010) Beta Gamma Sigma Business Honor Society
- BS, Physics and Philosophy, magna cum laude – Union College (2009) Harold A. Larrabee Prize for Excellence in Philosophy
- US District Court District of Connecticut
- US Court of Appeals for the Federal Circuit
- US Patent and Trademark Office