Day 1 - Monday, October 5, 2020

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

The Covid-19 Effect on the Business and Practice of Hatch-Waxman Litigation

Part I
Finding Solutions to COVID-Related Pharmaceutical Patent Litigation Delays: Addressing Brand and Generic Concerns in the District Courts and at the PTAB
9:00
Part II
What Hatch-Waxman Litigators Need to Know About Compulsory Licensing, API Shortages, and Supply Chain Disruption: An Analysis of Patent Rights, Licenses, Market Entry, and Production in the Time of the Coronavirus
10:00
Morning Coffee Break
10:15
Biogen v. Banner: Examining How New and Narrow Interpretations of the Scope of Patent Term Extension Will Affect Patent Rights and Generic Entry
11:15

Vignettes in Venue and Jurisdiction

Navigating the Contours and Consequences of the Changed Venue Landscape: Insights into Leading Districts and New MDL Strategies for Paragraph IV Litigation
12:00
Celgene v. Sun and an Analysis of 271 (e) (2) Subject Matter Jurisdiction: How the Inclusion of Non-Orange Book Listed Patents in ANDA Litigation Will Alter Hatch-Waxman Strategies
12:45
Networking Luncheon
1:45
Understanding What New Findings of Infringement Under the Doctrine of Equivalents and Prosecution History Estoppel Mean for Your Paragraph IV Case
2:45
Afternoon Refreshment Break
3:00
FDA Developments Impacting Hatch-Waxman
3:45
And Now a Word from the District of Delaware: A Conversation with Chief Judge Stark and Chief Magistrate Judge Thynge (Pre-Recorded Session)
4:30
Section 101: Examining the Latest Patent Eligibility Developments in the Courts and at the PTO and How They are Influencing R&D, Claims Drafting, and Litigation Strategies
5:15
Addressing New Section 112 Concerns Specific to Small Molecules
6:00
Conference Adjourns to Day Two

Day 2 - Tuesday, October 6, 2020

7:00
Continental Breakfast
8:00
Co-Chairs’ Opening Remarks
8:15
AAM, BIO and PhRMA on Patents, Prices, and Politics: The Continuing Saga of Hatch- Waxman Reform
9:15
FTC Keynote
10:00
Morning Coffee Break
10:15
What Every Hatch-Waxman Litigator Needs to Know about the New California Pay For Delay Law and Other Recent Antitrust Developments
11:15
PTAB Stats and Substance: Questions and Controversies Surrounding Filings, Judicial Appointments, Standing, and Expanded Powers
12:15
Networking Luncheon
1:30
A Conversation With the PTAB: The APJs Speak on Practice, Procedure and Precedent
2:30
Afternoon Refreshment Break
2:45
New Studies in in Obviousness: Thoughts on Inherency, Structure, Prior Art, and Secondary Considerations
4:00
Hatch-Waxman Ethics Lab: Solving Ethical Dilemmas in Paragraph IV Disputes
5:00
Conference ends

Day 1 - Monday, October 5, 2020

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

The Covid-19 Effect on the Business and Practice of Hatch-Waxman Litigation

Part I
Finding Solutions to COVID-Related Pharmaceutical Patent Litigation Delays: Addressing Brand and Generic Concerns in the District Courts and at the PTAB

  • Examining how COVID-19 is causing havoc on ANDA litigation timetables established under Hatch-Waxman
  • Exploring brand name and generic concerns about the probability and consequences of potentially tolling the 30-month stay in light of COVID court delays
  • Assessing weather measures taken by the District of New Jersey and Delaware have been successful in mitigating COVID-19-related interruptions to ANDA litigation
  • Studying cases in which the parties agreed to a stipulation of a stay extension and related consequences
    • Mitsubishi v. Sandoz (D.N.J. 2020)
  • Looking at measures taken by the PTO relative to the extension of PTAB filings and proceedings under the CARES Act
    •  how this has impacted IPR proceedings as they relate to parallel proceedings and related stays
  • Analyzing whether the use of virtual media, such as tele-conferencing or web-related activity has been useful in mitigating litigation disruption
  • Understanding the economic and business impact of COVID -related ANDA and other patent litigation delays on:
    • Patent rights
    • Generic entry/180-day exclusivity

9:00
Part II
What Hatch-Waxman Litigators Need to Know About Compulsory Licensing, API Shortages, and Supply Chain Disruption: An Analysis of Patent Rights, Licenses, Market Entry, and Production in the Time of the Coronavirus

Compulsory Licensing
  • Evaluating compulsory licensing concerns in the US and globally in view of the pandemic
  • Understanding how the Bayh- Dole Act works regarding drugs developed to treat COVID-19 specifically
    • Predicting the enforcement of march-in rights
  • Exploring the government’s power to “license” or compel production of existing drugs and treatments that might be helpful to fight the virus
  • Examining strategies employed by the corporate sector to circumvent compulsory licensing threats
    • Gilead’s strategy, re: remdesivir
    • Sanofi, Novartis, Teva, and Mylan’s strategies, re: hydroxychloroquine
  • Examining new Canadian legislation which may preclude patent rights; i.e., Covid-19 Emergency Response Act
  • Looking at the current atmosphere in India and China with respect to patent takings

API Shortages, Supply Chain Disruption, and Their Impact on the Brand and Generic Dynamic
  • Understanding the economic repercussions and related IP litigation consequences of API and supply chain disruption precipitated by the pandemic
  • Assessing the IP litigation consequences in moving API manufacturing and supply chains from China and India due to COVID-19 to new countries
    • Examining the specific risk of the SPCs manufacturing waivers in the EU to patent life
  • Analyzing how generic and brand name API sourcing differs and how this may affect market entry and exclusivities

10:00
Morning Coffee Break
10:15
Biogen v. Banner: Examining How New and Narrow Interpretations of the Scope of Patent Term Extension Will Affect Patent Rights and Generic Entry

  • Understanding how the Federal Circuit’s decision in Biogen Int’l GmbH v. Banner Life Scis. LLC (Fe. Cir. 2020) may influence the future application of patent term extension
  • Exploring the Federal Circuit’s as well as the District of Delaware’s reasoning as the scope and limitation of PTE rights as being specific to “the active ingredient of… a new drug… including any salt or ester of the active ingredient.”
  • Examining the Biogen decision as part of developing PTE jurisprudence
  • Assessing how this case may impact the Hatch-Waxman realm

11:15

Vignettes in Venue and Jurisdiction

Navigating the Contours and Consequences of the Changed Venue Landscape: Insights into Leading Districts and New MDL Strategies for Paragraph IV Litigation

  • Examining the new District Court map relative to venue in ANDA cases in the three years since TC Heartland
  • Analyzing MDLs and ANDA consolidation relative to venue concerns
  • Assessing situations and analyzing outcomes where certain litigation elements such as discovery are consolidated in one jurisdiction and a case may be tried in another
  • Knowing when it makes more sense to consent to venue instead of opposing it

12:00
Celgene v. Sun and an Analysis of 271 (e) (2) Subject Matter Jurisdiction: How the Inclusion of Non-Orange Book Listed Patents in ANDA Litigation Will Alter Hatch-Waxman Strategies

  • Examining the significance of the District of New Jersey’s findings on subject matter in Celgene v. Sun (D.N.J. 2020)
    • Exploring jurisdiction for non-Orange Book listed patents and the absence of a Paragraph IV certification
    • Analyzing Celgene via Vanda and AstraZeneca for guidance in litigating no-Orange Book patents in a Hatch-Waxman setting
  • Assessing the proper disposition of non-Orange Book listed patents in a Hatch-Waxman case in light of this jurisprudence

12:45
Networking Luncheon
1:45
Understanding What New Findings of Infringement Under the Doctrine of Equivalents and Prosecution History Estoppel Mean for Your Paragraph IV Case

  • Examining the significance of recent series of ANDA cases before the Federal Circuit which involved findings of infringement through the Doctrine of Equivalents
    • Eli Lilly & Co. v. Hospira, Inc. (Fed. Cir. 2019)
    • Galderma Laboratories, L.P. v. Amneal Pharmaceuticals LLC (Fed. Cir. 2020)
  • Analyzing the role of the DOE’s sister doctrine, prosecution history estoppel relative to this line of cases
    • Tangential relationship test
  • Exploring how this new line of DOE and PHE cases will influence findings of infringement in future ANDA cases
  • Anticipating whether the Supreme Court will grant cert. in Lilly and what could this mean for the Hatch-Waxman landscape

2:45
Afternoon Refreshment Break
3:00
FDA Developments Impacting Hatch-Waxman

  • Understanding the significance of the conversion of certain Orange Book NDAs to BLAs under the BPCIA and how this may influence Hatch-Waxman litigation strategies
    • Teva’s Copaxone citizen’s petition
  • Exploring branded and generic interests in GDUFA and PDUFA renewals
  • Examining new attacks on 180-day exclusivity per the propose Blocking Act
  • Assessing status of FDA activity concerning Hatch-Waxman reform

3:45
And Now a Word from the District of Delaware: A Conversation with Chief Judge Stark and Chief Magistrate Judge Thynge (Pre-Recorded Session)
4:30
Section 101: Examining the Latest Patent Eligibility Developments in the Courts and at the PTO and How They are Influencing R&D, Claims Drafting, and Litigation Strategies

  • Exploring the latest 101 jurisprudence relative to Hatch-Waxman
  • Understanding how the Supreme Court’s denial of cert. in Vanda has impacted Hatch-Waxman and Paragraph IV
  • Examining Federal Circuit’s ruling in Vanda relative to secondary patents
    • Mallinckrodt v. Praxair (Fed. Cir. 2019)
  • Analyzing the PTO’s Revised Patent Subject Matter Eligibility Guidance and how it applies to Hatch-Waxman patents
  • Assessing faults in claim construction relative to a 101 denial
    • How does a claim need to be written in order to satisfy 101?
    • Evaluating proof and proffers which can uphold or defeat 101 assertions
  • Predicting R&D trends in pharmaceuticals relative to the 101 conundrum

5:15
Addressing New Section 112 Concerns Specific to Small Molecules

  • Examining the Federal Circuit’s recent approach and interpretation of written description under 112 as it applies to small molecules
    • Nalpropion Pharmaceuticals, Inc. v. Actavis Labs. FL, Inc.,
    • Nuvo Pharmaceuticals, Inc. v. Dr. Reddy’s Laboratories Inc.,
  • Comparing and contrasting the approaches outlined in Nalpropion and Nuvo as a guide for future interpretations of 112
  • Assessing current patents for written description vulnerabilities under these Federal Circuit opinions
  • Examining patent challenges and defenses in ANDA proceedings under this new 112 jurisprudence

6:00
Conference Adjourns to Day Two

Day 2 - Tuesday, October 6, 2020

7:00
Continental Breakfast
8:00
Co-Chairs’ Opening Remarks
8:15
AAM, BIO and PhRMA on Patents, Prices, and Politics: The Continuing Saga of Hatch- Waxman Reform

  • Re-examining the nexus between drug prices and Hatch-Waxman
  • Review of recent proposed reforms to drug pricing which may amend the Hatch-Waxman Act
    • Affordable Prescriptions for Patients Act
    • Affordable Prescriptions for Patients Through Promoting Competition Act
  • Analyzing the impact of the CREATES Act on patents and drug prices
  • Assessing the “price” of reform on patent value

9:15
FTC Keynote
10:00
Morning Coffee Break
10:15
What Every Hatch-Waxman Litigator Needs to Know about the New California Pay For Delay Law and Other Recent Antitrust Developments

  • Understanding how the California Pay-for- Delay law may affect pharmaceutical patent settlements in all 50 states
    • Assessing whether this law will further FTC scrutiny of these agreements
    • Determining whether the law will meet Constitutional muster under the Rule of Reason test set forth under Actavis
  • Examining questions of antitrust violation through improper device listings in Orange Book in In re Lantus Direct Purchaser Antitrust Litig., 18-2086, 2020 WL 728628 (1st Cir. Feb. 13, 2020)
    • Questions of patent thickets preventing generic competition
  • Exploring the latest antitrust theories relative to the State Coalition of Attorneys General price fixing lawsuit
  • Surveying plaintiffs and AGs direct and indirect purchasers’ activity

11:15
PTAB Stats and Substance: Questions and Controversies Surrounding Filings, Judicial Appointments, Standing, and Expanded Powers

  • Surveying the types and numbers of life sciences patent cases brought before the PTAB in the last year
  • Comparing and contrasting the number of small vs. large molecule cases in IPRs and PGRs
  • Understanding the significance of the Federal Circuit’s denial of rehearing in Arthrex Inc. v. Smith & Nephew (Fed. Cir. 2020) and what it means for the future of IPRs as well as the PTAB under the Appointments clause.
    • Anticipating Supreme Court and/or Congressional review
    • Examining the nexus between injury and standing to appeal an IPR
      • Argentum v. Novartis (Fed. Cir. 2020)
      • Analyzing how the Supreme Court in Thryv, Inc. v. Click-to-Call Technologies, LP, et al. (Supreme Court 2020) essentially expanded the powers of the PTAB through its ruling that the time bar cannot be appealed

12:15
Networking Luncheon
1:30
A Conversation With the PTAB: The APJs Speak on Practice, Procedure and Precedent

Join us for an in-depth discussion of PTAB practice and pharmaceutical patents with some of the savviest APJs in this area.

2:30
Afternoon Refreshment Break
2:45
New Studies in in Obviousness: Thoughts on Inherency, Structure, Prior Art, and Secondary Considerations

Is it so Obvious to be Inherent? New Developments in the Inherency Defense and its Implications for ANDA Litigation
  • Assessing whether inherency exists in obviousness
    • Evaluating offensive and defensive strategies
    • Determining whether inherency demonstrates obviousness
  • Understanding the importance of Hospira v. Fresenius (Fed. Cir. 2020) relative to future findings of obviousness in inherency
  • Under this decision when can the inherency defense be raised
  • Determining the necessity of prior art disclosures

Structural Obviousness Implications for Secondary Patents
  • Understanding the significance of findings of structural obviousness and lead compound analysis obviousness as illustrated in:
    • Valeant Pharmaceuticals Int’l, Inc. v. Mylan Pharmaceuticals Inc., No. 2018-2097 (Fed. Cir. April 8, 2020)
    • Sanofi-Aventis U.S., LLC v. Fresenius Kabi USA, LLC (Fed. Cir. 2019)
  • Assessing the impact of these cases on formulation and method patents in the Hatch-Waxman arena

Obviousness-Type Double Patenting Review
  • Analyzing the latest Federal Circuit and District Court trends related to OTDP
  • Examining District Court decisions and subsequent Federal Circuit activity on OTDP as it applies to PTA
  • Evaluating circumstances in which a terminal disclaimer must be made

New Considerations in Secondary Considerations
  • Understanding the implications of Fox Factory, Inc. v. SRAM, LLC (Fed. Cir. 2019) for findings of non-obviousness due to secondary considerations
    • Re-examining requirements to meet the nexus presumption
    • Assessing applicability of Fox Factory to secondary considerations raised in ANDA obviousness challenges

4:00
Hatch-Waxman Ethics Lab: Solving Ethical Dilemmas in Paragraph IV Disputes

  • Analyzing rulings on conflicts of interest and how they apply to the Hatch-Waxman realm
  • Examining ethics pronouncement by Director Iancu relative to patent filings
  • Developing strategies for avoiding conflicts in joint defense arrangements

5:00
Conference ends