IP & FDA - Key Persons

Brent Batzer is an experienced patent lawyer, litigating patents for both brand and generic pharmaceutical companies for the last 15-plus years. Clients rely on Brent for quick answers when available, detailed analysis when called for, and a pragmatic approach befitting an attorney with an engineering background.

Shashank is widely regarded as one of the leading Hatch-Waxman "Paragraph IV" attorneys in the country. His clients range from small pharmaceutical development companies to Fortune 500 companies. Brand pharmaceutical companies trust him to protect their brand products from other branded and generic competitors. Generic companies turn to him to overturn brand patents in Paragraph IV litigations, aimed at bringing generic versions of medicines swiftly and effectively to the marketplace. Shashank's experience over the last 25 years has involved patent litigation on compounds/compositions of matter; polymorphs and crystal forms; formulations; methods of use; manufacturing and packaging of drugs and devices. Because drug development must result in timely approval of the drug, Shashank helps clients strategize for rapid development and approval of the drug. For example, initially the client began development with the typical Paragraph IV mentality. That strategy would have involved spending money on patent litigation and delays in drug application approval. Shashank examined the situation, proposed an alternative Section viii strategy, worked with the FDA to permit the Section viii strategy, and the helped obtain rapid drug approval, without patent litigation expenses. More importantly, other generic companies had pursued the Paragraph IV litigation process and did not have approval. Our client was able to "jump" over other generic company applicants and enter the market first. In another example, our client developed a strong non-infringement strategy but we anticipated that the patentee would seek to complicate and elongate impending litigation. We developed a strategy to front-load the legal work and discovery so that the trial judge would schedule an early trial. We prevailed on getting a trial date within months instead of years considering our non-infringement position and potential future antitrust concerns. The patentee withdrew its suit upon facing the early trial.

Shashank 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, Shashank is the author of dozens of articles, been interviewed or presented at 200+ conferences 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 14th Edition (2022). The book took an initial 3 years to write and he spends weeks each year to update it. He has previously worked in global large and small boutique law firms. This coupled with his in-house experience results in him providing practical, business savvy, and cost effective results. He has spearheaded complex projects, managed budgets worth more than $50 million, and built legal and alignment teams. He also helped his clients build governance and compliance programs, with a focus on executive strategy, succession planning, and structure. These efforts help provide the toolkit for boardroom practice and experience. Because of his long background in the industry and law firms, he is adept at managing projects efficiently and with an intense quality focus. He has completed certifications and course work in LEAN Six Sigma and as a Project Management Professional.

Yixin combines a creative and assertive litigation style with a superb technical training (molecular biology, bio-engineering) in his legal practice. Yixin 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. Yixin 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. Yixin serves as an arbitrator with the American Arbitration Association.