Practice Areas & Industries: Duane Morris LLP


Generic Pharmaceuticals Return to Practice Areas & Industries

Group Profile Lawyers in this Group Offices Locations for this Group

Practice/Industry Group Overview

Duane Morris lawyers have significant experience with the complexities involved in bringing generic pharmaceuticals to market. Our lawyers' and registered patent agents' experience involves biotechnology processes and products, chemical processes, synthesis and products, medical devices, formulations, experiments and polymorphic products to name a few.

Attorneys at Duane Morris specialize in the representation of worldwide generic pharmaceutical companies in their quest to enter the U.S. market with new products. We have significant experience in representing clients in litigation related to abbreviated new drug applications (ANDAs) filed under the Hatch-Waxman law, as well as generation of non-infringement, invalidity and freedom-to-operate opinions with respect to patents listed in the Orange Book.

Duane Morris also coordinates with international networks of law firms to secure and maintain patent protection throughout the world. The firm's Intellectual Property attorneys thoroughly grasp the science and technology behind each client's ideas. All of the firm's patent lawyers and agents have science or engineering backgrounds, many with advanced degrees, and most have significant industry experience in their respective disciplines, including:

  • Advanced materials
  • Biochemistry
  • Biotechnology
  • Medical and mechanical devices
  • Pharmaceuticals
  • Abbreviated New Drug Application (ANDA) and related litigation
  • Medicinal chemistry
  • Small molecule chemistry
  • Combinatorial chemistry
  • Formulations
  • Organic chemistry/synthetic pathways

When our IP attorneys enter a courtroom, they are adept at explaining complex technical issues in a straightforward manner and presenting our client's story to the judge and jurors in the most compelling way possible. We handle patent litigation for large and small corporations as well as individual inventors and start-up enterprises. We also are experienced in conducting interference proceedings before the U.S. Patent and Trademark Office.

We help our clients in understanding how to maximize the value of patents and we appreciate the importance of carefully managing and implementing patent portfolios for the benefit of their businesses. We offer our clients technology solutions for real-time patent docket management through the Duane Morris IP Portal, giving clients anytime/anywhere access to information on their IP holdings, including status updates on filings and alerts to upcoming deadlines. Also, our IP Practice Group has substantial experience in the domestic and international licensing and transfer of all forms of intellectual property, including patents, trademarks, copyrights and trade secrets.

Group Presentations
  Duane Morris Partner Michael Swit to Speak at the CFPA's Generic Drug Approvals Course, New Brunswick, NJ, May 6, 2014
Duane Morris Special Counsel Michael Swit to Present an "Update on FDA Development for Biosimilars", Sheraton Philadelphia Downtown Hotel, Philadelphia, February 12, 2014
Duane Morris Attorney Michael Swit to Speak at "Understanding Crucial Issues in the 510(k) Process" Webinar, January 29, 2014