Patent Infringement, Safe Harbor, and Drug Development

This CLE webinar will guide patent counsel on the Hatch-Waxman safe harbor and the scope of its protection. The panel will discuss drug development and the implications of the safe harbor. The panel will offer best practices for leveraging the safe harbor.

Companies developing products regulated by the FDA can rely on the Hatch-Waxman Act "safe harbor" to protect them from patent infringement during development. Specifically, importing, making, using, and even selling "a patented invention . . . solely for uses reasonably related to the development and submission of information" to the FDA is statutorily excluded from patent infringement under 35 USC §271(e)(1). This can be important to many different companies and technologies, including generic small molecule, biosimilars, medical devices, and innovative products. However, the boundaries of the safe harbor are limited.

While the Supreme Court indicated in Merck I (2005) that the safe harbor provision provides a wide berth for patented drugs in the regulatory approval process, it is not all encompassing. There has been debate as to the definition of "patented invention" as used in the statute. Questions have also been raised concerning what falls within "reasonably related uses." Further, whether "research tool" patents lie within the safe harbor has been a point of contention. It is important for companies—both those developing a product for submission to the FDA and patent owners—to understand the safe harbor and what falls within and outside of it when developing products that require FDA approval.

Listen as our authoritative panel of patent attorneys examines drug development and the role of the safe harbor. The panel will address the implications of the safe harbor and patent infringement in this context and offer best practices for leveraging the safe harbor.