Denise Main Ph.D.
Denise Main's practice focuses on U.S. district court and appellate litigation, with particular experience related to the Hatch-Waxman Act governing the approval of pharmaceutical drugs. She manages day-to-day litigation activities in actions involving multiple parties. Dr. Main's broad experience includes conducting offensive and defensive discovery, drafting and arguing dispositive motions, taking and defending witnesses in court, drafting trial and appellate briefs, conducting U.S. and foreign prosecution, and preparing patent applications and ex parte reexaminations.
Dr. Main has handled matters involving a wide array of technologies with a focus on the pharmaceutical, chemical, biotechnology, and mechanical arts. She has assisted clients in the fields of pharmaceutical products, cosmetics, hair dyes, pesticides, packaging materials, polymeric materials, and drug delivery systems.
In addition to her litigation practice, Dr. Main advises clients on a variety of patent matters, including polymorph issues, Orange-Book listing patents, U.S. and foreign IP portfolio management, freedom to operate, settlement, licensing, and antitrust issues.
- Otsuka Pharmaceutical Co. v. Teva Pharms. USA, Inc. (D.N.J.). Represents Otsuka in Hatch-Waxman patent infringement litigations against several Abbreviated New Drug Application (ANDA) filers seeking FDA approval to market generic versions of Otsuka's Abilify® Oral Solution.
- Ferring B.V. v. Watson Laboratories, Inc. (D. Nev.). Represents Ferring in Hatch-Waxman patent infringement litigations against Watson and Apotex concerning ANDAs seeking FDA approval to market generic versions of Ferring's Lysteda®.
- Otsuka Pharmaceutical Co. v. Sandoz, Inc. (D.N.J., Fed. Cir., S. Ct.). Represented Otsuka in Hatch-Waxman litigation, securing patent rights for Otsuka involving the blockbuster antipsychotic Abilify® (aripiprazole), which became the number one selling drug in the United States in 2012.
- Classen Immunotherapies, Inc. v. King Pharmaceuticals, Inc. (D. Md., Fed. Cir.). Represents defendant Elan in patent infringement action brought by Classen. The district court granted summary judgment of non-infringement in favor of Elan and stayed further action pending the outcome of U.S. Patent and Trademark Office (USPTO) reexamination proceedings instituted by Elan.
- Pfizer Inc. v. Bayer AG (D. Del.). Represented GlaxoSmithKline in patent infringement action brought by Pfizer against Levitra®, ultimately resolved through confidential settlement.
- Elan Pharmaceuticals, Inc. v. Ivax Pharmaceuticals, Inc. (D.N.J.). Represented Elan in Hatch-Waxman patent infringement action against Ivax seeking FDA approval to market generic copies of Permax®. Involvement ended when Elan transferred product and litigation responsibility to another party.
- Research scientist at the Pacific Northwest National Laboratory, in various areas including catalysis, supercritical fluids, and organic/organo-metallic synthesis, 2000-2001.
- Graduate studies focused on alternative synthetic routes to HIV protease inhibitors.
- Undergraduate studies focused on synthesis of heterocyclic compounds as potential anti-cancer agents.
- American Bar Association
- American Chemical Society
- American Intellectual Property Association
- Coauthor. "Subject Matter Jurisdiction in Patent Cases Not Dependent on ANDA Certification Requirement," Westlaw Journal Intellectual Property, March 5, 2014.
- Coauthor. "IP in Business Transactions: United States," PLC's IP in Business Transactions Multi-Jurisdictional Guide, Jan. 1, 2014.
- Coauthor. "Patents, Trade Marks, Copyright, and Design in United States," PLC's IP in Business Transactions Multi-Jurisdictional Guide, Jan. 1, 2014.
- Coauthor. "FTC Champions Inconsistent Positions on the Reverse Payment Settlement Debate," Intellectual Property Today, Nov. 2012.
- Coauthor. "A Closer Look at the Post-Ariad Written Description Requirement," Intellectual Property Today, Nov. 2012.
- Coauthor. "Federal Circuit Rules on Joint Invention of Chemical Compounds" Intellectual Property Magazine, April 2012.
- Coauthor. "IP in Business Transactions: United States," PLC's IP in Business Transactions Multi-Jurisdictional Guide, March 1, 2012.
- Coauthor. "Main IPRs: United States," PLC's IP in Business Transactions Multi-Jurisdictional Guide, March 1, 2012.
- Coauthor. "Unpredictability: Understanding the U.S. Enablement Requirement," CIPA Journal, March 2012.