Generic Drug (ANDA) Practice

Our Hatch-Waxman team has deep experience in leading the largest and smallest generic drug companies in Abbreviated New Drug Application (ANDA) cases. Our attorneys have represented clients in the largest blockbuster products and smallest products in the space. We are routinely called upon to represent clients in sole first-to-file cases. Our experience is deep because we have handled 100’s of ANDA cases.

Understanding Your Business 

Shashank Upadhye spent many years as the top legal officer at several global generic companies. Because of those many years at the Executive Committee level, he brings a keen understanding to the business aspects of generic drug development.

We literally wrote the book on pharmaceutical patent and FDA law. The 2020 Edition is more than 1400+ pages and is packed with legal understanding, scenarios and situations, and strategy. The book is available in paper, on Westlaw, and as a fully interactive e-book. Click HERE for more information. 

Our team understands the business. To this end, our representation is directly focused on achieving the client’s goals, not the law firm’s goal. We know that every client has its unique goals and each product deserves its own strategy. We are aligned with the client to achieve the goals transparently, efficiently, and cost-effectively. 

We provide a full range of counseling and litigation services to our clients, beginning as early as the product selection stage; continuing through to product development and regulatory submission encompassing all stages of patent and regulatory litigation, including settlements; and extending though to product approval and commercialization. We also assist our clients in exploring, negotiating and closing pharmaceutical ingredient (API) and finished dosage form supply agreements, licensing agreements and co-promotion and marketing agreements. 

Clients rely on our strong relationships with leading experts in pharmaceutics, pharmacology, formulation chemistry, methods of use, synthetic and medicinal chemistry, polymorphism, and all forms of analytical testing. We win cases because we align: (i) the expert’s testimony; (ii) the litigation strategy; and (iii) our ability to tell a simple story with complex facts. 

Hatch-Waxman Litigation & IPR Experience

Our attorneys are trial lawyers in the key federal courts in Delaware, New Jersey, California, the ED of Texas, the SD of New York, and the ND of Illinois. When clients need skilled courtroom lawyers, our firm is there on the front line. We have also been involved and argued numerous appeals at the Federal Circuit and U.S. Supreme Court. Furthermore, we have been involved in numerous US ITC litigation.

We do the same for PTAB proceedings (IPR/PGR) at the Patent Office. We have been involved in many PTAB proceedings both on the patentee and generic sides. We understand the role and strategy of the IPR/PGR in conjunction with or in lieu of the court litigation. We are acutely sensitive to if and when to file for a PTAB proceeding, how the estoppel may later apply, and ensuring a consistency between the PTAB proceeding and parallel court proceeding.  

But we also understand that patent litigation is not the desired end-result in every case. We do not litigate every possible defense. We disagree with scorched earth litigation tactics that needlessly complicate a case, irritate opposing sides and judges, and waste the client’s money. We want to deliver a meaningful result to the client based on alignment with the client’s goals. 

Pre-litigation Support

Every day we help clients with pre-litigation patent evaluations, provide advice on non-infringement and validity, conduct prior art searches, and prepare freedom to operate (FTO) opinions.

The Paragraph IV certification letters, detailed statements for notice letters, Section viii Statements

We help clients with the certification pages in the ANDA. We scrutinize the certifications to ensure it is aligned with the strategy. We draft the notice letters to satisfy the requirements of the Act. We also assist in proposed label review and help clients with Section viii Statements. We also help ANDA clients navigate the drug approval process and to ensure that the approval runs in parallel with any litigation.  

Exclusivity Issues

Our lawyers help clients understand and navigate the complex intersection of IP, patent, and antitrust laws, specifically on NDA’s, paper NDA/505(b)(2) applications, ANDA’s, suitability petitions for different forms, trademark issues in drug dosage forms (the issues related to size, shape, and color), the 180-Day Exclusivity, Forfeitures, Orphan Drug Exclusivity (ODE), REMS protections, and other FDA related non-IP exclusivity.


To learn more about our Patent Litigation expertise, please see our in-depth practice description HERE

For Branded Companies seeking NDA or 505(b)(2) approvals, please see our in-depth practice description HERE.