Agenda

Day 1 - Wednesday, April 19, 2023

7:00
Breakfast and Registration
8:00
Co-Chairs’ Opening Remarks
8:15
Patents, Politics and Policies: Fortifying Your Business and Legal Strategies in Anticipation of The Inflation Reduction Act and Patent-Focused Efforts to Reduce Drug Prices
9:15
§112: Reconciling the Scope of Enablement, the Relationship with Written Description and Preparing for the Implications of the SCOTUS Decision on Brands and Generics
10:30

FEDERAL CIRCUIT FIRESIDE CHAT

An Interview with Current and Retired Federal Circuit Judges
11:00
Morning Networking Break
11:15
Skinny Labeling and the Infringement of Repurposed Patents and: Winning Strategies, New Approaches to Carve Outs and Induced Infringement of Method Claims
12:15
Networking Luncheon
1:45
§101: The Current Eligibility Requirements of Patents for Inventions and Patent- Eligible Subject Matter Reform
2:45
Networking Break
3:00

The Practice of PIV Disputes

Track 1 — Cross-Border Business Considerations in a Hatch-Waxman Scenario: Masterfully Managing Global Litigation

Track 2 — Patent Reissue and Reexamination: Strategies for Correcting Errors and Determining When to Pursue
3:45

The Business of PIV Disputes

Track 1 — The Cost and Worth of a Patent: The Economics of a Paragraph IV Challenge

Track 2 — 505(q) Citizens Petitions: Best Practices for Utilizing FDA’s Citizen Petition Process to Achieve Market Access and Petitions for Reconsideration
4:30
Networking Break
4:45
View from the Bench: Spotlight on PIV Litigation in DE and NJ
6:00
Cocktail Reception

Day 2 - Thursday, April 20, 2023

7:15
Breakfast and Registration
8:00
Co-Chairs’ Opening Remarks
8:15

BRAND AND GENERIC INSIGHTS ON FDA INITIATIVES IMPACTING PHARMACEUTICAL PATENTS

Part I: Analyzing GDUFA III, User Fee Reauthorization Riders and Current Litigation with FDA
9:00
Part II: Understanding the USPTO-FDA Collaboration and the Efforts to Promote Competition
9:30
Morning Networking Break
10:00

The Business of PIV Disputes

Track 1 — Doing More with Less: Monitoring Legal Spend and Balancing the Budget

Track 2 — Revisiting Damages in an At-Risk Launch Scenario: Questions of Remedies and Valuation
10:45

The Business of PIV Disputes

Track 1 — Communicating Value and Collaboration Between Corporate Legal and Outside Counsel

Track 2 — Joint Defense Groups: A Risk Benefit Analysis for the Hatch-Waxman Practitioner
11:30

ANTITRUST MATTERS IN THE SETTLEMENT OF PIV DISPUTES

FTC KEYNOTE
12:00
Networking Luncheon
1:45
Reverse-Payment Settlements: Non-Monetary Provisions, State Legislation, Expert Testimony, and Recent Litigation
2:45
Networking Break
3:00

THE PATENT TRIAL AND APPEAL BOARD THINK TANK

The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes
4:00
IPR Strategy Session: Masterfully Maneuvering through the District Court and Inter Parte Review
5:00

CYBERSECURITY, PRIVACY and ETHICAL DATA PROTECTION

ETHICS CASE STUDIES: Cybersecurity, Information Security, and the Ethical Protection of Data
6:00
Conference Concludes

Post-Conference Workshops

Workshop A (IN-PERSON ONLY) — Diversity, Equity, and Inclusion: Implementing Change and Expanding Innovation

Apr 21, 2023 9:00am – 12:00 PM

Workshop B (IN-PERSON ONLY) — A Comprehensive Handbook for Pharmaceutical Patent Litigation Funding Arrangements

Apr 21, 2023 1:00pm – 04:00 PM

Day 1 - Wednesday, April 19, 2023

7:00
Breakfast and Registration
8:00
Co-Chairs’ Opening Remarks
8:15
Patents, Politics and Policies: Fortifying Your Business and Legal Strategies in Anticipation of The Inflation Reduction Act and Patent-Focused Efforts to Reduce Drug Prices
9:15
§112: Reconciling the Scope of Enablement, the Relationship with Written Description and Preparing for the Implications of the SCOTUS Decision on Brands and Generics
10:30

FEDERAL CIRCUIT FIRESIDE CHAT

An Interview with Current and Retired Federal Circuit Judges
11:00
Morning Networking Break
11:15
Skinny Labeling and the Infringement of Repurposed Patents and: Winning Strategies, New Approaches to Carve Outs and Induced Infringement of Method Claims
12:15
Networking Luncheon
1:45
§101: The Current Eligibility Requirements of Patents for Inventions and Patent- Eligible Subject Matter Reform
2:45
Networking Break
3:00

The Practice of PIV Disputes

Track 1 — Cross-Border Business Considerations in a Hatch-Waxman Scenario: Masterfully Managing Global Litigation

Track 2 — Patent Reissue and Reexamination: Strategies for Correcting Errors and Determining When to Pursue
3:45

The Business of PIV Disputes

Track 1 — The Cost and Worth of a Patent: The Economics of a Paragraph IV Challenge

Track 2 — 505(q) Citizens Petitions: Best Practices for Utilizing FDA’s Citizen Petition Process to Achieve Market Access and Petitions for Reconsideration
4:30
Networking Break
4:45
View from the Bench: Spotlight on PIV Litigation in DE and NJ
6:00
Cocktail Reception

Day 2 - Thursday, April 20, 2023

7:15
Breakfast and Registration
8:00
Co-Chairs’ Opening Remarks
8:15

BRAND AND GENERIC INSIGHTS ON FDA INITIATIVES IMPACTING PHARMACEUTICAL PATENTS

Part I: Analyzing GDUFA III, User Fee Reauthorization Riders and Current Litigation with FDA
9:00
Part II: Understanding the USPTO-FDA Collaboration and the Efforts to Promote Competition
9:30
Morning Networking Break
10:00

The Business of PIV Disputes

Track 1 — Doing More with Less: Monitoring Legal Spend and Balancing the Budget

Track 2 — Revisiting Damages in an At-Risk Launch Scenario: Questions of Remedies and Valuation
10:45

The Business of PIV Disputes

Track 1 — Communicating Value and Collaboration Between Corporate Legal and Outside Counsel

Track 2 — Joint Defense Groups: A Risk Benefit Analysis for the Hatch-Waxman Practitioner
11:30

ANTITRUST MATTERS IN THE SETTLEMENT OF PIV DISPUTES

FTC KEYNOTE
12:00
Networking Luncheon
1:45
Reverse-Payment Settlements: Non-Monetary Provisions, State Legislation, Expert Testimony, and Recent Litigation
2:45
Networking Break
3:00

THE PATENT TRIAL AND APPEAL BOARD THINK TANK

The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes
4:00
IPR Strategy Session: Masterfully Maneuvering through the District Court and Inter Parte Review
5:00

CYBERSECURITY, PRIVACY and ETHICAL DATA PROTECTION

ETHICS CASE STUDIES: Cybersecurity, Information Security, and the Ethical Protection of Data
6:00
Conference Concludes

Workshop A (IN-PERSON ONLY) — Diversity, Equity, and Inclusion: Implementing Change and Expanding Innovation

Apr 21, 2023 9:00am – 12:00 PM

What is it about?

The Director of the National Institute of Health (NIH) recently announced that the agency plans “new ways to support diversity, equity, and inclusion,” and will also correct policies within the agency “that may harm our workforce and our science.” The growing call to action seems clear: the pharmaceutical IP community must support equity-mindedness and conscious inclusion if they are to realize the full benefits of a diverse workforce. In this interactive session, points of discussion will include:

  • Growing the awareness of the pharmaceutical IP practitioners among underrepresented racial and ethnic groups
    • Championing their representation in the pharmaceutical IP work force
    • Advocating for diverse and young attorneys appearing in the court room
  • Reviewing data showing the benefits of a diverse workforce
  • Accelerating the advancement of a more diverse pharmaceutical IP community via mentoring and networking
  • Understanding what specific evidence of diversity pharmaceutical companies, and IP departments, are seeking from their law firm counterparts
  • Implementing organizational changes that promote diversity
    • How clients can seek out partnerships with firms that promote:
      • Utilizing NAMWOLF lists
      • Abiding by the Mansfield Declaration
      • Using a DuPont Legal Model
  • Identifying best practices for evaluating your outside firm’s efforts in promoting diversity
    • Reviewing firm statistics on women, minorities, sexual orientation, etc.
  • Sharing data-driven strategies to address current diversity challenges in STEM

Workshop B (IN-PERSON ONLY) — A Comprehensive Handbook for Pharmaceutical Patent Litigation Funding Arrangements

Apr 21, 2023 1:00pm – 04:00 PM

What is it about?

Litigation funding can help businesses pay for legal fees and expenses, including increasingly costly expert fees. Financing can provide risk averse litigants with the confidence to see cases through to their conclusion, even against the best-capitalized defendants. In this interactive workshop, topics of discussion will include:

  • Reviewing litigation funding and its advantages for litigants
  • Recognizing the essential criteria of a feasible funding opportunity based on meritorious claims
  • Analyzing the mechanics of the financer’s underwriting process
  • Exploring the key modules of a pharmaceutical patent litigation funding agreement