LEAHY INSTITUTE OF ADVANCED PATENT STUDIES

Breakfast and Registration

Opening remarks

Issue 1:

Life Sciences and Beyond: Impact of the IRA on patents and licensing after another year of implementation; developments on patent thickets, evergreening, continuation practice and double patenting after the Allergan decision; government’s use of private companies’ confidential information to train government AI systems at FDA, NIH, and USPTO; developments on drug-device patents including Orange Book-listability; developments of Most Favored Nation drug pricing and TrumpRx.gov.

Issue 2:

Artificial Intelligence: Examples of the good, the bad and the ugly. AI use in evidence and Daubert tests of same. AI impact on enablement and written description. Impact on estoppel. Use of AI in litigation and prosecution. PTO search pilot, use by PTO of AI to prepare office actions and counter-use of AI by applicants.

Issue 3:

Patent Tax Proposal and Bayh-Dole Restrictions: The impact of multiple new rules, draft guidance and policy proposals that override the Bayh Dole Act (including march-in rights based on price); Secretary Lutnick’s proposal that the government should seize 50% of academic royalties resulting from licensing federally funded inventions; new NIH licensing guidelines (how will this impact universities); Commerce’s march-in letter to Harvard.

Issue 4:

Patent damages: Impact of Ecofactor; are damages awards for patent cases shrinking and how do they compare with damages for trade secrets cases (what causes the disparity)? Why is the Federal Circuit reversing so many large damages awards?

Lunch and Fireside Chat

Issue 5:

PTAB in the Squires/Stewart Era. No IPRs for “old” patents based on settled expectations? Bifurcation of discretionary denials: is it good policy, is it helping with workload and staffing issues? Are discretionary denials without any reasoned basis for decision appropriate? Do the Director’s early moves on Section 101 signal an opportunity to change the law,? Director Review to undo a Final Written Decision and de-institute trial. Should PTAB have rotating commissioners, like the USITC, to increase its independence? New notice of proposed rulemaking.

Issue 6:

Developments in litigation finance and insurance: Shift toward transparency (when and why disclosure is warranted). Use of AI and data analytics to assess case viability. Viability of judgment preservation insurance. New insurance offerings.

Issue 7:

How to effectively mediate patent cases: Pros/cons of mediation; is it worth pursuing and if so when and how? Various mediation offerings from ADR providers, and which offer advantages over others.

Issue 8:

Socio-economic benefits economies can achieve through IP protection: Is there a correlation between effective IP protection and a strong economy; what impact do strong IP rights have on foreign and domestic investment; how does it impact global competitiveness and the race with China?

Breakfast

Issue 9:

Patent pools and SEPs: What value do pools bring in solving global licensing issues and how? What are best practices for the operation of pools? Who has the better policy in the tussle between the UPC and UK courts with respect to granting of “interim license”? What should we take from the UKIPO’s consultation on regulator rate setting and injunctions, given the recent abandonment of similar regulations by the EU?

Issue 10:

The success of the EU patent courts: Emergence of the UPC and EU patent courts as the dominant venues for patent infringement adjudication (why is it and will the trend continue?). Impact of Regeneron and Bayer preliminary injunction spanning 23 countries. Tension between the UK interim license law and UPC jurisdiction. Update on harmonization efforts.

Issue 11:

Mistakes in patent prosecution that affect litigation outcomes: What are the top three pitfalls to avoid and how to avoid them?

Patent Agenda for the 120th Congress

Closing remarks