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How and when to use ex parte re-examination to narrow or reshape asserted claims, weaken infringement theories, and create leverage without the visibility or estoppel risks of IPR.

As life sciences patent disputes increasingly span multiple jurisdictions and rely on a wider range of venues beyond the traditional US forums, litigation in the ITC, UPC and Brazil are becoming increasingly viable options. This session compares the benefits of these jurisdictions and sequencing forums to maximise leverage, manage risk, and protect market access across the ITC, UPC and Brazil.

  • Deciding between the ITC, UPC, and Brazil based on speed, remedies, and procedural posture.
  • When ITC Section 337 actions provide strategic advantage alongside or instead of Hatch-Waxman or BPCIA litigation.
  • How the UPC and Brazilian courts offer injunction pressure unavailable in US proceedings.
  • How venue choice affects discovery scope, timing, and settlement leverage in pharma and biologics patent disputes.
  • Coordinating US, European, and Brazilian actions to manage estoppel, delay, and strategic enforcement.

Author:

Eduardo Hallak

Partner
Licks Attorney

Eduardo Hallak is one of the founding partners at Licks Attorneys and one of our leaders at the Sao Paulo office. For more than a decade, he has been working as a litigator before state and federal courts in Brazil in several complex disputes and leading cases involving Patent law, competition, and regulatory compliance, most of them pursuing the interests of clients in the area of life sciences. He also has extensive practice in trademark litigation as well as technology transfer contracts, working together with multinational clients to establish strong brand protection and licensing programs in the country. Mr. Hallak also currently teaches IP litigation in the Post-Graduation course at the prestigious Pontifical Catholic University of Rio de Janeiro (PUCRJ), has taught Civil Procedure at the at the Brazilian Association of IP Agents (ABAPI), and is often invited to lecture on procedural and strategic aspects of IP litigation, in addition to being a member of the Special Commission on Mediation of the Rio de Janeiro Chapter of the Brazilian Bar Association (OABRJ) and the Enforcement Committee of INTA.

Eduardo Hallak

Partner
Licks Attorney

Eduardo Hallak is one of the founding partners at Licks Attorneys and one of our leaders at the Sao Paulo office. For more than a decade, he has been working as a litigator before state and federal courts in Brazil in several complex disputes and leading cases involving Patent law, competition, and regulatory compliance, most of them pursuing the interests of clients in the area of life sciences. He also has extensive practice in trademark litigation as well as technology transfer contracts, working together with multinational clients to establish strong brand protection and licensing programs in the country. Mr. Hallak also currently teaches IP litigation in the Post-Graduation course at the prestigious Pontifical Catholic University of Rio de Janeiro (PUCRJ), has taught Civil Procedure at the at the Brazilian Association of IP Agents (ABAPI), and is often invited to lecture on procedural and strategic aspects of IP litigation, in addition to being a member of the Special Commission on Mediation of the Rio de Janeiro Chapter of the Brazilian Bar Association (OABRJ) and the Enforcement Committee of INTA.

Author:

Molly Grammel

Partner
Goodwin Procter LLP

Molly Grammel

Partner
Goodwin Procter LLP
 

Rama Elluru

Senior Advisor for AI Governance and Intellectual Property
Special Competitive Studies Project

Rama Elluru

Senior Advisor for AI Governance and Intellectual Property
Special Competitive Studies Project

Rama Elluru

Senior Advisor for AI Governance and Intellectual Property
Special Competitive Studies Project

From MedTech devices and AI-enabled hardware to cloud platforms and AI drug discovery, AI technologies are increasingly central to inventorship and innovation across sectors. As AI becomes embedded in regulated medical technologies such as Software as a Medical Device (SaMD) and AI-enabled diagnostics, new evidentiary and regulatory considerations are emerging in patent disputes. This session reviews recent AI-related patent cases and examines how courts are shaping litigation and portfolio strategy going forward.

  • How are parameters around patent eligibility evolving in AI cases.
  • How litigation strategy and outcomes vary across a range of tech sectors including AI-enabled hardware, software, multifunction innovation products and MedTech.
  • Address new evidentiary and regulatory considerations for handling AI in regulated technologies such as SaMD.
  • How are infringement theories are being used in AI patent litigation.
  • A review of recent cases like Nueral AI, LLC v. NVIDIA Corp., and Solos Technology’s complaint against Meta and EssilorLuxottica.

Author:

Erin Bell

Senior Corporate Counsel
Premier Inc

Erin Bell

Senior Corporate Counsel
Premier Inc

Author:

Martin McGee

Honorable Judge
State of North Carolina, Judicial District

Martin McGee

Honorable Judge
State of North Carolina, Judicial District

Author:

Nirav Desai

Partner
Blank Rome

Nirav Desai

Partner
Blank Rome

Author:

Rama Elluru

Senior Advisor for AI Governance and Intellectual Property
Special Competitive Studies Project

Rama Elluru

Senior Advisor for AI Governance and Intellectual Property
Special Competitive Studies Project
 

Nirav Desai

Partner
Blank Rome

Nirav Desai

Partner
Blank Rome

Nirav Desai

Partner
Blank Rome

The rise of the 505(b)(2) pathway is changing how branded pharmaceutical and biotech companies approach lifecycle management and litigation. Unlike ANDA generics, 505(b)(2) applicants can enter earlier with differentiated products while relying on branded data, creating a hybrid competitive threat that often falls outside traditional Orange Book assumptions. Join this workshop to hear a discussion around defence strategies from a panel of experts from the generic and innovator industries.

  • How in-house teams can identify and defend against 505(b)(2) challenges.
  • Distinguish ANDA generics from 505(b)(2) applicants and the implications for defence strategy.
  • Identify early warning signs through development activity, regulatory engagement, and competitor monitoring.
  • Analyse how formulation, dosing, and delivery changes are used to avoid listed patents.

Author:

Chris Slavinsky

Chief Legal Officer
Innovo Research

Chris Slavinsky

Chief Legal Officer
Innovo Research