Hahn Loeser has one of the most experienced Hatch-Waxman groups in the country. We recognize that our pharmaceutical clients benefit most by getting their products to market fast and remain focused on that goal in developing strategies that position our clients for a successful product launch, be it through summary judgment, trial, Inter Partes Review (IPR)/Post Grant Review (PGR) at the Patent Office, licensing, settlement or just good advice.

We pride ourselves on getting the science right and building our legal theories around technically sound arguments. In the courtroom, our litigators have a long history of success in getting our clients’ products to market. Most recently we assisted a client in defeating not one, but two preliminary injunction motions following two separate hearings before Judge Albright in the Western District of Texas in a case involving a levothyroxine liquid formulation. We have invalidated patents on a number of major drugs, including Norvasc®, Actonel®, Floxin® Otic (resulting in a $5 million judgment to our generic client) and Bonivav®. Other cases of note include Treanda®, Antara®, Abilify® (oral solution), Plavix®, Benicar®, Benicar® HCT, Uroxatral®, Eloxatin®, Treanda®, Zometa®, Reclast®, Ultracet®, Levothyroxine, Xiidra® and Oxtellar®

Our group is equally sophisticated at counseling clients outside of the courtroom. We regularly prepare opinion letters and assist clients in developing formulation and design around ANDA and 505(b)(2) strategies. 

We also have experience in related FDA and regulatory litigation and counseling directed to obtaining marketing approval for competitive generic and new drugs. This experience and understanding of the Hatch-Waxman Act regulatory scheme is significant in crafting a successful patent litigation and product development strategy. We also have experience advising clients on sourcing and supply agreements, partnering strategies, merger and acquisition due diligence, U.S. Made requirements, licensing and distribution agreements, as well as related FTC and antitrust issues arising out of pharmaceutical settlements.