Howard W. Levine focuses his practice on intellectual property litigation, advising on some of the most complex and valuable biotechnology and pharmaceutical litigation matters of the past 25 years. Mr. Levine has been at the forefront of legal development in these practice areas, including precedent concerning the written description requirement under 35 U.S.C. § 112. A recognized intellectual property lawyer, he is consistently ranked as an “Intellectual Property Star” by LMG Life Sciences.
Mr. Levine regularly conducts all aspects of pre-trial, trial, and post-trial proceedings, including appeals to the U.S. Court of Appeals for the Federal Circuit and the U.S. Supreme Court. He concentrates on patent litigation before the federal district courts and the U.S. Court of Appeals for the Federal Circuit. Mr. Levine also has extensive experience in cases arising from the filing of Abbreviated New Drug Applications (ANDA).
Mr. Levine represents clients from both the pharmaceutical and biotechnology industries on an array of technologies, ranging from the inhibition of NF-B to genetically engineered corn. Notably, he was involved in litigation regarding the first biotechnology product to be marketed, human insulin, between Eli Lilly, Genentech and the Regents of the University of California.
Some prominent products Mr. Levine has provided litigation counsel on include, Humulin®, Humatrope®, Zantac®, Paxil®, Evista®, Xigris®, Cymbalta®, Gemzar®, Differin®, Savella®, Bunavail® and Belbuca®. Most recently, he defended Allergan/Forest’s patent covering its Saphris® sublingual product, delivering the opening statements at two separate trials (one on infringement and one on validity) and taking key witnesses concerning the nonobviousness and infringement of Forest’s patent. He also argued the appeal before the Federal Circuit.
- Allergan and Forest Laboratories in multiple Hatch-Waxman litigations against defendants seeking to prematurely launch generic versions of Saphris® for the treatment of schizophrenia and bi-polar disorder, and Savella® for the treatment of fibromyalgia. Successfully represented Allergan/Forest in three trials and a Federal Circuit appeal.
- BioDelivery Sciences International, Inc. (“BDSI”) in multiple Hatch-Waxman litigations against defendants seeking to launch generic versions of Belbuca® for the treatment of chronic pain, and Bunavail for the treatment of opioid dependence.
- DuPont de Nemours, Inc. (“DuPont”) in multiple district court litigations and Federal Circuit appeals against MacDermid Graphics Solutions, and separately Agfa Graphics, concerning flexographic printing technology, including the chemical makeup and processes of developing flexographic printing plates and equipment regarding same. Mr. Levine also represented DuPont in a Federal Circuit appeal against Novozymes involving commercial enzyme technology that concerned the written description requirement of 35 U.S.C. § 112.
- Eli Lilly and Company (“Lilly”) in multiple litigations and appeals before the Federal Circuit. Mr. Levine successfully represented Lilly in the Ariad district court litigation, appeal, and en banc rehearing before the Federal Circuit concerning the written description requirement of 35 U.S.C. § 112. Mr. Levine also represented Lilly against defendants seeking to prematurely launch generic versions Cymbalta®, Lilly’s blockbuster drug for the treatment of depression. Mr. Levine won the Eli Lilly and Company Quality Advocate Award (2011) in connection with this litigation. Mr. Levine also represented Lilly against Teva at the Federal Circuit concerning the extension of the statutory stay in connection with Hatch-Waxman litigation. Mr. Levine was also involved on Lilly’s behalf in landmark litigation concerning Humulin® and Humatrope® against Genentech and the Regents of the University of California, both at the district level and on appeal to the Federal Circuit.
- GlaxoSmithKline plc in multiple district court litigations, appeals before the Federal Circuit, and proceedings before the U.S. Supreme Court involving Paxil® for the treatment of depression and, in separate litigation, Bactroban® for the treatment of skin infections.
- Syngenta in multiple litigations and an appeal before the Federal Circuit against Monsanto concerning genetically engineered crops, including successfully obtaining summary judgment on Syngenta’s behalf.
Includes matters handled at Dechert or prior to joining the firm.
- Georgetown University Law Center, J.D., 1993, cum laude
- Duke University, B.A., 1990, cum laude
- District of Columbia
- New York
- Supreme Court of the United States
- United States Court of Appeals for the Federal Circuit
- United States Patent and Trademark Office
- American Intellectual Property Law Association
- New York Intellectual Property Law Association
- District of Columbia Bar (Intellectual Property Section)