The “safe harbor” provision in US patent law (35 U.S.C. § 271(e)(1)) protects certain activities, including those related to biosimilar development, from patent infringement lawsuits. This defense applies to acts that are “solely for uses reasonably related to the development and submission of information” to the FDA under regulations for drugs or biologics. A company’s subjective intent or alleged alternative purposes are irrelevant when determining whether the safe harbor applies. What matters is whether the act was for a use “reasonably related” to the development or submission of information to the FDA.

Join us in this discussion as we discuss recent Safe Harbor case law and critical elements of the Safe Harbor defense, such as:

• Determining what is and is not shielded by the safe harbor following Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd.
• Analyzing the broad interpretation of the term ‘solely’ for regulatory purposes and the implications for patent enforcement
• Exploring Biosimilars and Biologics perspectives on the scope of conduct covered by the safe harbor
• Examining where safe harbor defenses are sustained – and where they are being defeated
• Allele Biotechnology & Pharm v. Regeneron Pharm
• Protecting third party manufacturing activities for the purpose of filing for approvals