Posts Tagged: "§ 271"

Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. State law claims are preempted by the BPCIA on both field and conflict grounds, which means only remedy available against biosimilar applicants refusing to engage in the patent dance is filing for a declaration of infringement, validity, or enforceability of a patent that claims the biological product or its use. Notably, this must be done before receiving manufacturing information from the biosimilar company. Patent lawsuits are notoriously costly so, in the short term, the decision will have the greatest impact on innovator start-ups with limited financial resources. In the long term, relying on costly litigations to keep biosimilar drugs off the market will likely increase the consumer price for any biologic drug.

The facts of the underlying case were incredibly simplistic and not representative of a typical patent infringement case involving complex technologies. The parties agreed that the exported product consisted of one of five total “components of the patented invention,” so the Court did not address “how identify the ‘components’ of a patent or whether and how that inquiry relates to the elements of a patent claim.” Id. at FN2. Addressing the issue in a case with minimal real-world applicability does little to help the finder of fact determine whether a product contains one or multiple components of a patented invention. The decision in Promega does not relieve manufacturers from the risk that their single-part product could be used inadvertently to infringe a U.S. Patent overseas. When disputes arise under § 271(f), defendants will need to build strong evidence showing that their product only contains one component to avoid infringement, while plaintiffs will be crafting arguments that the total number of patented components is low and the exported product contains multiple components.

The U.S. government weighs in on Life Technologies’ side because “the application of U.S. patent law to participation by U.S. exporters in foreign markets also raise issues concerning the competiveness of American companies abroad and the respective roles of the United States and other nations’ patent laws.” The government argues that the Federal Circuit has not given a workable definition to determine when a component is sufficiently important or essential as to be “a substantial portion of the components.” The government also argues that, in legislating § 271(f), Congress’s purpose was to outlaw evasion of a U.S. patent by conduct that tantamount to manufacturing the patented invention in the U.S. for export. The government argues that there is no clear expressed Congressional intent for § 271(f) to reach supplying a single staple article: when the product is made abroad except for such a staple article, Congress left that predominantly foreign conduct to be regulated by foreign law. Finally, the government argues that the presumption against extraterritoriality requires the courts to assume both that “legislators take account of the legitimate interests of other nations” and “foreign conduct is generally the domain of foreign law.”