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Safe Harbor & Bolar Exemption: A Review of Case Law, Regulatory Reform, and Pre-Approval Strategy

With US courts continuing to refine the scope of § 271(e)(1) and the European Pharma Package proposing to extend and reshape Bolar exemptions across member states, this session examines the latest litigation and regulatory developments shaping how life sciences companies structure pre-approval activity on both sides of the Atlantic.

Examine where the line is currently being drawn under § 271(e)(1), and what recent decisions including Jazz v. Avadel (Fed. Cir. May 2025) and Ascendis v. BioMarin (ITC, ongoing), tell us about the boundaries of protected pre-approval activity.
How to structure pre-approval activity to make the most of safe harbor protection, and where its limitations continue to drive disputes.
Discuss the European Pharma Package's proposed extension and reshaping of Bolar exemption means for originator and generic strategy, and how US companies are adapting their pre-approval strategies in response.

Author:

Aaron Clay

Director - Intellectual Property Litigation

Merck

Author:

Chuck Sholtz

Head of IP

Verdiva Bio

Author:

Sophie Wang

Co-Head - IP Litigation

Choate

Sophie Wang is a Partner in Litigation and is Co-Head of the IP Litigation practice. She is a first-chair trial lawyer who represents biotech, pharmaceutical, and technology companies in complex and high stakes intellectual property and commercial disputes across the country. Sophie is a go-to resource for clients in the life sciences industry, including for “bet-the-company” patent litigation (including Hatch-Waxman and biosimilar litigation), post-grant review (PGR) and inter partes review (IPR) proceedings before the United States Patent Trial and Appeal Board (PTAB), trade secrets litigation, and contract, licensing, and other commercial disputes. She also routinely advises clients on the management of their US and global patent and litigation strategies, including regularly consulting with counsel before the EPO and in the UK, Germany, and other foreign jurisdictions.

Author:

Dr. Sarah Salaschek

Attorney at Law and Patent Litigator

Bonabry

Dr. Sarah Salaschek is attorney at law and patent litigator, working in the Hamburg office of Bonabry. She mainly advises clients in the pharmaceutical industry and represents them before German courts as well as before the Unified Patent Court. Her practice covers all questions of intellectual property law with a particular focus on pharma patents, SPCs and related regulatory issues.

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Panel Debate: Reforming Patent Damages in Tech Litigation

Damages remain a key driver of uncertainty in tech patent disputes. This debate explores practical ways damages analysis is evolving and where targeted reforms could improve predictability and settlement outcomes.

Reasonable royalty and apportionment lessons from cases such as Ericsson v. D-Link and VirnetX.
Use of comparable licences and portfolio evidence in complex tech products.
Judicial gatekeeping and procedural tools shaping damages outcomes.
Practical reforms that could improve damages predictability in tech cases.