Cozen O’Connor: Hatch-Waxman & Biologics

Cozen O’Connor is an Am Law 100 firm with a nationally recognized Hatch-Waxman and Biologics/Biosimilars practice. We provide 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., Dr. Reddy’s Labs, 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

Publications

Hatch-Waxman and BPCIA Cases and Trends to Watch in 2021 [IPWatchdog]

January 25, 2021

Blake Coblentz and Aaron Lukas co-authored an article about two major cases in 2021 that could have long-lasting effects on where and how Hatch-Waxman and Biologics Price Competition and Innovation Act (BPCIA) cases are litigated.

The PTAB Puts Hatch-Waxman Defendants on Notice: File IPRs Early or Risk Fintiv Discretionary Denial [IPWatchdog]

October 29, 2020

Blake Coblentz, Aaron Lukas, and Keri Schaubert wrote about the Patent Trial and Appeal Board (PTAB) denying the institution of Mylan Labs Ltd.’s petition for IPR of U.S. Patent No. 9,439,906 (“the ’906 patent”) in IPR2020-00440.

Maybe Biosimilar Applicants Should Dance After All [Biosimilar Development]

June 30, 2020

Blake Coblentz and Aaron Lukas wrote an article about the Biologics Price Competition and Innovation Act and the issues applicants face whether to go through the patent dance.

First Circuit Permits Antitrust Claims for Improperly Listing a Device Patent on the FDA’s Orange Book to Move Forward [Alert]

February 25, 2020

In a holding that could significantly broaden the antitrust inquiry in the context of the Hatch-Waxman regulatory scheme, on February 13, 2020, the U.S. Court of Appeals for the First Circuit issued an opinion that may have wide-ranging implications for both branded companies that own, and generic companies that challenge, patents listed on FDA’s Orange Book that claim drug delivery devices.

Breathing New Life Into The “Tangential” Exception to Prosecution History Estoppel [Alert]

August 26, 2019

Martin B. Pavane and Darren S. Mogil discuss the importance of carefully analyzing the prosecutorial history of a patent to determine the reason for the narrowing amendment. If the reason was only tangential to the equivalent at issue, estoppel will not apply.

FDA Issues Final Guidance on “Labeling for Biosimilar Products” [Alert]

October 18, 2018

The guidance emphasizes biosimilarity while recognizing key differences between biosimilar and reference products.

Sham Litigation in a Hatch-Waxman Action [Intellectual Property Alert]

July 09, 2018

Marilyn Neiman and Martin B. Pavane discuss the largest award in a litigated FTC antitrust case and what it means for brand pharma and their Hatch-Waxman case filings.

Events & Seminars

Past Events