Cozen O’Connor's nationally recognized Hatch-Waxman and Biologics/Biosimilars practice provides strategic counsel to companies seeking to enter the U.S. small molecule and biologics/biosimilars markets.

Our dedicated team includes licensed patent attorneys with advanced degrees in organic chemistry, molecular cell biology, immunology, and biophysics; former research scientists in industry and academia; and intellectual property litigators with decades of first-chair trial experience.

The Hatch-Waxman Amendments to the Food, Drug & Cosmetic Act in 1984 created a new marketplace for generic pharmaceuticals by lowering barriers to FDA approval and establishing a period of exclusivity through the Abbreviated New Drug Application (ANDA) process. Cozen O’Connor has high-level experience representing both branded and generic drug companies from the earliest stages of drug development through regulatory review, and, in some cases, litigation. Our team has successfully partnered with clients on more than 60 drug products, including for Apotex Inc.; ApoPharma, Inc.; Amneal Pharmaceuticals, Inc; Sandoz Inc.; Mylan; Kyowa Kirin, Inc.; and Endo Pharmaceuticals Inc.

The firm also has a cutting-edge Biologics Price Competition and Innovation Act (BPCIA) practice. In September 2016, Cozen O’Connor attorneys won the first-ever patent trial under the BPCIA, which set the precedent that informs the “patent dance” and notice requirements under the BPCIA.  As the market for biologic/biosimilar products continues to grow, so will the need for legal counsel with a sophisticated understanding of the unique legal questions arising from the development, approval, sales, and marketing of biologic/biosimilar drugs.

Cozen O’Connor’s Hatch-Waxman and Biologics attorneys continue to distinguish themselves by providing comprehensive legal services. Our attorneys work closely with clients to monitor competitors, clear obstacles to the development and launch of new products, advise on the regulatory review process, and negotiate and draft settlement agreements between market competitors. When settlement is not possible or not advisable, Cozen O’Connor is fully prepared to go to trial — and win.

Services

• Competitive intelligence concerning patent strategy, patentability, and freedom-to-operate
• Assist with regulatory submissions, responses, and approvals
• Advise on regulatory requirements concerning patent listing, exclusivity, and forfeiture
• Guide strategic decisions around validity and/or infringement challenges to competitors’ IP
• Counsel on market entry and expansion
• Respond to government investigations
• Lead counsel for litigation and settlement negotiations under Hatch-Waxman and the BPCIA