Hahn Loeser has one of the most experienced Hatch-Waxman/ANDA generic drug groups in the country. We recognize that our 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) 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 client’s products to market. 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 Boniva®. Other cases of note include Treanda ®, Antara®, Abilify® (oral solution), Plavix®, Benicar®, Benicar® HCT, Uroxatral®, Eloxatin®, Treanda®, Zometa®, Reclast® and Ultracet®. 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 strategies. We also have experience in related FDA and regulatory litigation and counseling directed to obtaining marketing approval for generic drugs. This experience and understanding of the Hatch-Waxman Act regulatory scheme is critical in crafting a successful patent litigation and product development strategy. We also have experience with advising clients on supply agreements and partnering strategies.