Corporate and Transactional
Pharmaceuticals provide great benefits to patients around the world. Patent laws create incentives for pharmaceutical companies to develop new drugs by providing them with exclusive rights to make, use and sell their drugs for the life of the relevant patent. Yet some patents may not deserve such protection, if they have been improperly obtained or are otherwise invalid, and invalid patents may unreasonably prevent competitors from bringing to market cheaper versions of these drugs. US public policy, through the Hatch-Waxman Act, seeks to achieve a balance between these competing interests by encouraging producers of generic drugs to challenge invalid patents listed in the "Orange Book," the FDA-maintained catalog of patents that each relevant pharmaceutical company has declared cover its approved drugs.
The expense of such patent challenges is extremely high for all parties involved, and the pharmaceutical company and the challenging generic company will often want to avoid further costs by settling the litigation before a final resolution. We have advised a number of pharmaceutical companies in structuring settlement agreements that maintain the validity of the patent while also permitting the generic company to bring a product to market before the expiration of the patent, thereby achieving a win for both parties and the public. Our TTL lawyers work closely with our litigation, intellectual property and antitrust colleagues to achieve the parties' business goals—and society's interests—in a legal manner.