The 505(b)(2) Pathway: Patent Certifications, Exclusivity, and Choosing Between an NDA and an ANDA

Mr. Batzer is an experienced patent lawyer, litigating patents for both brand and generic pharmaceutical companies for the last 15-plus years. With extensive experience in Paragraph IV litigation on both the generic and brand sides, including 505(b)(2) products, and additional experience in patent prosecution of brand portfolios, both domestic and worldwide, he brings knowledge from all angles to his client’s cases. Mr. Batzer has also litigated patent cases in the medical device, dietary supplement, mechanical, and gaming fields, as well as experience in trademark and commercial litigation. His litigation experience also includes numerous Federal Circuit appeals. Mr. Batzer is also an experienced patent prosecutor outside of pharmaceuticals, with experience in the dietary supplement and medical and dental device industries, as well as design patents. Additionally, he commonly advises clients on a variety of contracts and intellectual property matters, including freedom to operate opinions, trademarks, supply and distribution agreements, trademark and patent licenses, confidentiality agreements, and the like.

Mr. Bruno is a seasoned patent litigator with 15+ years of experience representing branded, biosimilar, and generic pharmaceutical companies in high-stakes disputes. Known for his courtroom command and strategic creativity, he has guided clients to victory at every level, from bench trials and IPRs to the Federal Circuit and U.S. Supreme Court. Mr. Bruno has co-first-chaired a Hatch-Waxman trial, direct- and cross-examined inventors and expert witnesses, and championed impactful case strategies through discovery in many pharmaceutical cases, including matters involving antibiotics, oncology drugs, sleep aids, ocular drops, topical treatments, and biologics. He was among the first to litigate under the Biologics Price Competition and Innovation Act. His litigation experience and success spans the full range of forums, including district courts, the ITC, the PTAB, the Federal Circuit, and the Supreme Court. Known for sharp deposition skills and creative procedural tactics, Mr. Bruno often finds unconventional paths to favorable outcomes, including through early dispositive motions and tailored discovery strategies.

Mr. Tang combines a creative and assertive litigation style with a superb technical training (molecular biology, bio-engineering) in his legal practice. He has appeared regularly and argued recently in the Federal Circuit, led and participated in bench trials in Federal District Courts and inter partes review in the Patent Office, and litigated numerous patent cases covering a broad range of technical fields, such as pharmaceuticals, methods of treatment, and electronics. Mr. Tang is also experienced in handling cases involving shareholder and partnership disputes, white collar defense, trademark disputes, and allegations and counter-allegations of false advertisement, unfair business practice, antitrust violation, and theft of trade secret. He serves as an arbitrator with the American Arbitration Association. Mr. Tang is particularly adept at working with expert witnesses in a wide range of technology spaces, including medicine, pharmaceutics, formulation design, dosage form manufacturing, the chemical arts, crystal forms and amorphous forms, the drug discovery process, biotechnology, biologics production, mechanical devices, computer software, computer modeling, engineering (for example computer chip design and manufacturing), economics, sales and marketing, and patent office and FDA procedures.  

Mr. Upadhye has one of the most recognizable brands in the world of brand and generic drug development. As the former chief in-house counsel at three leading pharmaceutical companies (Apotex, Inc., Sandoz-Novartis, and Eon Labs, Inc.) and as a division counsel for a medical device company (The Cook Group), he is known for spearheading innovative business and legal strategies to protect existing drug or device patents – or challenge those of a competitor. A prolific writer and frequent speaker, Mr. Upadhye is the author of dozens of articles and has spoken on topics dozens of times at key industry conferences nationally and internationally. Further, he writes the 1400+ page leading book on navigating complex U.S. laws of FDA brand/generic drug development: Generic Pharmaceutical Patent & FDA Law, now in its 13th Edition (2020).