What We Do

ANDA/Hatch Waxman

For over half a century Sughrue has helped pharmaceutical clients develop, protect and leverage their Intellectual Property rights. Our attorneys understand the critical role that IP rights play in this sophisticated industry. Sughrue attorneys are well-versed in the United States regulation of the pharmaceutical industry under the Hatch-Waxman Act and routinely provide clients with their expertise regarding this complex body of laws at the interface of patent law and FDA regulatory law.

Our Pharma and Hatch-Waxman group members routinely provide pre-litigation counseling that includes overall strategies for addressing Orange Book listed patents for 505(j) and 505(b)(2) applicants, related FDA certification and litigation planning, prior art analyses and opinions / Paragraph IV certifications, infringement and design around reviews, strategies for preparing 505(b)(2) applications and anticipated challenges, and litigating Paragraph IV disputes through trial and appeal as necessary. More recently, our practice has expanded to employ Patent Office inter partes procedures, such as IPR’s, in formulating and executing Orange Book listed patent strategies. Sughrue has developed significant experience in handling all types Patent Office contested proceedings, based on its extensive interference and reexamination practice throughout the firm’s history

Sughrue’s attorneys also counsel clients in all phases of patent procurement on behalf of pharmaceutical and biotechnology companies including patent prosecution, PTE and PTA applications; FTO investigation and clearance, due diligence analysis, licensing and technology transfer and Patent Office appeals, in order to provide them with the strongest possible protection available. Our ANDA litigation team strategizes with our clients to vigorously enforce and defend these rights. Working closely with our biotechnology and pharmaceutical lawyers, our ANDA litigation team has successfully represented our clients in a number of cases that required innovative and challenging strategies to obtain successful results.

In addition to multiple annual speaking engagements on ANDA and Hatch-Waxman practice from the traditional small molecule perspective, Sughrue has also been at the forefront of the burgeoning biosimilars / complex molecule practice, with a number of projects in-hand and routine speaking engagements at prestigious international conferences.

Sughrue’s combination of first rate technical ability, legal knowledge and courtroom skills provides an unparalleled skill set for our clients at the pre-litigation, trial, and appeal stages of an ANDA litigation. Our record of pretrial, courtroom and settlement successes for pharmaceutical clients reflects Sughrue’s strength in this complex field.