Lamar Smith: “Mr. Speaker, I'm opposed to the inclusion of the Preserve Access to Affordable Generics Act in H.R. 4899. Most cases in…”

“Mr. Speaker, I'm opposed to the inclusion of the Preserve Access to Affordable Generics Act in H.R. 4899. Most cases in the United States, whether civil or criminal, antitrust or patent, settle. The reasons for this are simple. Litigation is expensive and its outcomes are uncertain. The supposed problem involves a payment of cash in a settlement of a patent case brought by a generic drug manufacturer. Such payments are said to frustrate the intent of Federal law by allowing the brand name pharmaceutical company to pay to delay entry of the generic competitor into the market. The proposed solution to this problem incorporated in this bill goes much too far. It creates a presumption that all such settlements are unlawful. The bill sets forth the criteria that a court may use to determine whether to uphold the settlement. However, the validity of the underlying patent is not one of those specified criteria. Also, the bill dramatically reduces the ability of the companies to settle these cases.”