Intellectual Property: Generic Pharmaceuticals and Biosimilars

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 represent 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 (USPTO).

Duane Morris attorneys' combination of extensive trial experience as lead counsel in litigation before state and federal courts, as well as unique trial experience within the U.S. Patent and Trademark Office, can help clients take advantage of, and respond to, inter partes review (IPR). Introduced by the America Invents Act (AIA) in 2012, IPR allows a petitioner to challenge the propriety of a patent claim after it has been granted by the USPTO. This increasingly popular strategy—a majority of filings at the USPTO are currently in parallel litigation—has been tapped as a less costly and more expeditious method than filing a litigation proceeding in federal district court. IPR remains a viable option for generic drug companies to challenge asserted patent claims.

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.

For Additional Information

For more information, please contact Vincent L. Capuano, Ph.D. or any of the lawyers referenced in the Attorney Listing.

Representative Matters