In This Issue:

Federal Courts Debate Safe Harbor Exemption for Patent Infringement Under 35 U.S.C. § 271(e) Following Merck v. Integra; If I Prioritize Examination of My Application, Should the Patent Office?; InterDigital Communications v. ITC: (Some) Non-Practicing Entities are Welcome; and Conducting Efficient Patent Litigation Discovery, Part 2.

Excerpt from Federal Courts Debate Safe Harbor Exemption for Patent Infringement Under 35 U.S.C. § 271(e) Following Merck v. Integra -

Patent protection is a critical driver of value for the biotech industry. One of the unique aspects of biotech patents, however, is that many otherwise infringing activities are exempt from claims of patent infringement when those activities are “reasonably related to the development and submission of information” to the Food and Drug Administration (FDA). The scope of this exemption has been hotly contested since the passage of the Hatch-Waxman Act in 1985 (the Act). The Supreme Court has weighed in on this exemption twice, the last time being in Merck KGaA v. Integra LifeSciences I, Ltd. In that case, the Supreme Court expressly side-stepped the question of whether research tools are exempt from infringement. Since Merck, there have been a number of Federal Circuit and district court decisions that interpret the Act. The Supreme Court just recently refused to review another important Federal Circuit decision regarding the question of whether activities engaged in after FDA approval fall within the scope of the Act. Each case is noteworthy for being factually intensive and having difficult to predict outcomes. The following review of the post-Merck decisions is intended to guide patent holders and would be infringers in analyzing whether the use of research tools and other activities are exempt from infringement under the Act.