Day 1 - Wednesday, September 21, 2022

8:00
Opening Remarks
8:15

LIVE AUDIENCE POLLING

60 Minutes on Patents, Politics and Policy: An Analysis of Proposed Hatch- Waxman Reform Measures
9:15

SCOTUS WATCH: PENDING PATENT PETITIONS AND THE FUTURE OF SKINNY LABELS, §101 and §112

Skinny Labeling: The Future of Carveouts and the Analyzing the Influence of GSK v. Teva on Competition
10:15
Networking Coffee Break
10:45
The Relationship Between Written Description and Enablement Post-Biogen v. Mylan: Best Practices for Strengthening or Invalidating Patent Claims
11:45
Is Your Case Dead in the Water? Redefining What Is Patent-Eligible Subject Matter Post-American Axle v. Neapco
12:45
Networking Luncheon
1:00
Test
2:00
VENUE WAR ROOM: Knowing, How, When, and Where to Plan Your Attack Based on Current Trends in MDL with Joint Defense Groups
3:00

Diversity, Equity & Inclusion

Implicit Bias in Life Sciences IP: How to Promote and Implement Bias-Reducing Strategies
4:00
Afternoon Refreshment Break
4:15

MAGISTRATE TOWN HALL

Understanding the Roles of the Magistrate Judges and Local Counsel in Paragraph IV Proceedings
5:15

VIEW FROM THE FEDERAL BENCH

District Court Judges on the Present State of Paragraph IV Litigation: Filing Trends, Counterclaims Settlements and Timings
6:15
Cocktail Reception

Day 1 - Wednesday, September 21, 2022

8:00
Opening Remarks

Ryan M. Daniel
Chief Patent Counsel
Region North America

Fresenius Kabi USA, LLC

Linda Friedlieb
Division Counsel
AbbVie

8:15

LIVE AUDIENCE POLLING

60 Minutes on Patents, Politics and Policy: An Analysis of Proposed Hatch- Waxman Reform Measures

This session will consider current and proposed legislation, as well as other potentially impactful measures which may influence on Paragraph IV litigation. Topics of discussion will include:

  • Pending bipartisan legislation to watch including:
    • S.2891 (Restoring the American Invents Acts)
    • S.3772 (Defend American Courts Act)
    • S.2076 (PASTEUR Act) / S.2209 (VALID Act)
  • Recent federal and state executive actions and legislative initiatives and which may impact biopharmaceutical products patents
    • Recent selected Hatch-Waxman and BPCIA amendments
    • Patent listing statutes
  • “Buy American” policies and executive orders

9:15

SCOTUS WATCH: PENDING PATENT PETITIONS AND THE FUTURE OF SKINNY LABELS, §101 and §112

Skinny Labeling: The Future of Carveouts and the Analyzing the Influence of GSK v. Teva on Competition

  • Analyzing whether a skinny label alone is enough to preclude induced infringement allegations.
  • Reviewing the implications of recent decisions for induced infringement.
    • Anticipating the impact of recent decisions on claim drafting and the availability of generic drugs
  • Devising strategic considerations of label language for inducement infringement.
    • What considerations should patent owners keep in mind when labeling drugs?
  • Reviewing the approval of generic drug labeling.
    • On what basis will FDA determine the scope of an appropriate carve-out?
    • Must FDA review the patent to ensure the only information carved out is covered by the patent?
    • Is the interpretation of the patent claims subject only to a jury’s interpretation?
  • Assessing the flurry of follow-on cases in the courts

10:15
Networking Coffee Break
10:45
The Relationship Between Written Description and Enablement Post-Biogen v. Mylan: Best Practices for Strengthening or Invalidating Patent Claims

As demonstrated by the Federal Circuit’s recent denial of Biogen’s petition for en banc review in Biogen International GmbH et al. v. Mylan Pharmaceuticals Inc., written description and enablement requirements have perplexed patent practitioners for years. The dissent demonstrates opposing views at the Federal Circuit and among the bar as to §112 and signals that the Supreme Court may grant cert.

  • Reviewing Biogen International GMBH v. Mylan Pharmaceuticals Inc. Appeal No. 20-1933, where the Federal Circuit affirmed invalidity of a method of treatment patent for lack of written description
  • Appreciating the importance of inventor testimony and the impact of post-filing clinical data
    • When can witness admissions strengthen a written description invalidity defense?
  • Identifying when to divide your opponent’s testimony between IPR proceedings and district court litigation
  • Considering the dissent and determining whether the district court erred in applying judicial estoppel
  • Analyzing litigation insights that inform patent drafting application strategies

11:45
Is Your Case Dead in the Water? Redefining What Is Patent-Eligible Subject Matter Post-American Axle v. Neapco

This session will review the latest developments and e most impactful cases from the last 12 months in 101 jurisprudence and review the Court’s attempt to resolve the “bitter divide” of patent subject matter eligibility.

  • Analyzing the unique 101 questions posed by American Axel and assessing its chance of have cert. granted
    • Understanding the significance of the Court’s invitation to the Solicitor General to file a brief in this case
  • Considering the Biden administration’s views on patent law and eligibility
  • Reviewing recent District Court cases tackling 101 at the motion to dismiss and summary judgment stages
  • Taking stock of the recent 101 cases applying the Supreme Court’s Alice/Mayo tests before the Federal Circuit
    • Boehringer Ingelheim Pharmaceuticals, Inc. v. Mylan Pharmaceuticals, Inc. (Fed. Cir. 2020)
    • Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020)
  • Deciding whether a new application of an abstract idea is abstract
  • Analyzing when courts will conclude that any claim at issue is deemed invalid as claiming ineligible subject matter
    • Whether there was direction to a natural phenomenon
    • Assessing the competing interests keeping 101 reform at bay

12:45
Networking Luncheon
1:00
Test
2:00
VENUE WAR ROOM: Knowing, How, When, and Where to Plan Your Attack Based on Current Trends in MDL with Joint Defense Groups

With the latest rulings on venue, deciding where to file your case is mission critical.

In this session, our panelists will consider the proper venue for Hatch-Waxman cases and address the unanswered question of what constitutes “actions related to the ANDA submission”. Topics of discussion will include:

  • Reviewing Celgene Corp. v. Mylan Pharmaceuticals, Inc. 17 F.4th 1111 (Fed. Cir. 2021)
    • As in Valeant, the question of whether the location where ANDA submissions are sent (i.e., Maryland) might be a proper venue/where an “act of infringement” occurs, was not addressed by CAFC.
  • Determining whether “relevant acts involved in the preparation and submission of an ANDA” limited to submission of the ANDA after Celgene?
  • Analyzing if Valeant and Celgene have impacted where Hatch-Waxman suits are being filed
  • Outlining the pros and cons of joint defense groups
  • Recognizing when to contest venue

3:00

Diversity, Equity & Inclusion

Implicit Bias in Life Sciences IP: How to Promote and Implement Bias-Reducing Strategies

Implicit bias refers to the unconscious attitudes or stereotypes that affect our understanding, actions, and decisions. In this interactive session, our panelists will introduce the topic of implicit bias in pharmaceutical patent litigation, share bias-reducing strategies, and will invite attendees to share their thoughts and perceptions on implicit bias. Topics of discussion will include:

  • Analyzing both involuntary and voluntary behaviors that hinder diversity, recruiting, and retention efforts in life sciences IP careers
  • Understanding the economic and other costs of implicit bias, especially in areas of law, science, IP, and innovation
  • Recommending strategies for reducing or eliminating bias
    • Identifying tests designed to aid in determining where biases exist

4:00
Afternoon Refreshment Break
4:15

MAGISTRATE TOWN HALL

Understanding the Roles of the Magistrate Judges and Local Counsel in Paragraph IV Proceedings

This panel will explore the intricacies of local rules and offer solutions to your most rigid Paragraph IV pickles.

  • Understanding when to reduce claims and defenses to a manageable level
  • How to masterfully manage protective order disputes
  • Analyzing practical strategies and tactics for effective settlement negotiation

5:15

VIEW FROM THE FEDERAL BENCH

District Court Judges on the Present State of Paragraph IV Litigation: Filing Trends, Counterclaims Settlements and Timings

Distinguished jurists with some of the liveliest Paragraph IV litigation dockets in the country will examine decision-making practices employed by the judicial system and provide sage advice for both patent holders and patent challengers.

6:15
Cocktail Reception

Workshop A — The Three C’s: An Intimate Discussion on the Expectations of In-House Counsel from Their Law Firm Partners

Sep 20, 2022 9:00am – 12:00pm

What is it about?

This unique, interactive discussion group will provide the medium for exclusive, intimate networking and benchmarking opportunities that will shed light on the expectations of in-house counsel from their law firm partners. Esteemed members of ACI’s Hatch-Waxman Series Advisory Board will lead this workshop contemplating “The Three C’s: Cost, Communication and Competency”:

Cost: Monitoring Legal Spend and Balancing the Budget
  • Establishing best practices for cost reduction to enhance predictability for cash flow purposes
  • Identifying processes to assist with budgeting, fee arrangements and billing
  • Examining the value of licensing deals and structures

Competency: Overcoming Talent Limitations with Time-Proven Tips
  • Considerations in selecting outside counsel
  • Evaluating the appropriateness of work product
  • Reconciling firm versus individual reputation and ability

Communication: Communicating Value and Collaboration Between Corporate Legal and Outside Counsel
  • Establishing early-on in the relationship the desired level of commitment, availability and responsiveness
  • Succinctly focusing on shared, pragmatic business goals
  • Determining preferences for formality of correspondence and practical versus academic guidance

Workshop B — A Comprehensive Handbook for Pharmaceutical Patent Litigation Funding Arrangements

Sep 20, 2022 1:00pm – 4:00pm

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