Pre-Conference Workshops

Workshop A | Biosimilar Litigation Boot Camp for the Hatch- Waxman Litigator

Oct 1, 2018 9:00am – 12:00pm

Speakers

Kevin E. Noonan Ph.D.
Partner
McDonnell Boehnen Hulbert & Berghoff LLP (Chicago, IL)

Workshop B | Parallel Proceedings Master Class: Strategies for Balancing and Streamlining Simultaneous Proceedings Before the Federal Courts, PTO & ITC in Pharmaceutical Patent Litigation

Oct 1, 2018 1:00pm – 4:00pm

Speakers

Jeffrey R. Gargano
Partner
Morgan Lewis LLP

Lisa J. Pirozzolo
Partner
WilmerHale

Day 1 - Tuesday, October 2, 2018

7:00
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks
8:15
Examining the Nexus Between Pricing and Patents in the Hatch-Waxman Landscape
9:00
The Future of Venue and Jurisdiction: Examining the Latest Interpretations and Applications of TC Heartland
9:45
Morning Coffee Break
10:00
Brand and Generic Perspectives on the Latest FDA Initiatives in the Hatch-Waxman Space
10:45
A Question of Sovereignty: A Retrospect on Invoking Tribal and State Sovereign Immunity as a Means of Patent Protection
11:30

Focus on Method of Use/ Treatment Patents

Assessing the Latest Use of §101 Challenges to Method of Use Patents in a Paragraph IV Setting
12:30
Networking Luncheon
1:30

Focus on Method of Use/ Treatment Patents

Evolving Tests for Induced Infringement Relative to Method of Use Patents: Implications for Labels, Carve-Outs and Proof of Actual Inducement
2:30
Legal and Business Perspectives on the On-Sale Bar: Examining the Continued Aftermath of Helsinn
3:15
Afternoon Refreshment Break
3:30
The Distinctive Role of The Magistrate Judge and Local Counsel in Paragraph IV Proceedings
4:45
A Chat With the Chiefs: Perspectives from Chief Judges Castillo and Linares on the Latest Paragraph IV Litigation Challenges
5:45
Conference Adjourns

Day 2 - Wednesday, October 3, 2018

7:30
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks and Re-Cap of Day One
8:15
Developing Effective Strategies for ANDA Litigation Management: Budgeting, Cost-Containment Strategies and Other Practical Considerations Based on Recent Trends
9:30

Focus on the PTAB

Assessing the Implications of the Supreme Court’s Recent Decision in SAS and Its Impact on PTAB Practice
10:15
Morning Coffee Break
10:30

Focus on the PTAB

PTAB Pharmaceutical Patent Invalidity Round-Up: Update on Wins, Losses, Appeals and the Latest Estoppel Considerations and Concerns
11:15

Focus on the PTAB

The PTAB Live: A Hatch-Waxman Practitioner’s Guide to Practice, Procedure, IPRs and More in the World of Pharmaceutical Patent Validity Challenges
12:15
Networking Luncheon
1:30
Obviousness Update: Addressing Matters of Obviousness-Type Double Patenting, Inherency, Anticipation and Secondary Considerations in the World of Paragraph IV Litigation
2:15
Antitrust Developments Concerning Brand Name, Generic and Hybrid Interests
3:00
Refreshment Break
3:15
Assessing the True Measure of Damages in an At-Risk Launch
4:00
Identifying and Avoiding Common Ethical Dilemmas in Paragraph IV Practice
5:00
Conference Ends

Day 1 - Tuesday, October 2, 2018

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

Rekha Hanu
Executive Director, Chief IP Counsel
Akorn Pharmaceuticals

James P. Leeds
Assistant General Patent Counsel
Eli Lilly & Company (Indianapolis, IN)

8:15
Examining the Nexus Between Pricing and Patents in the Hatch-Waxman Landscape

Jeffrey Francer
Senior Vice President & General Counsel
Association for Accessible Medicines

Sapna W. Palla
Partner
Wiggin & Dana LLP (New York, NY)

Jonathan Stroud
Chief Intellectual Property Counsel
Unified Patents

Moderator:

Shashank Upadhye
Partner
Amin Talati & Upadhye, LLC

  • Understanding how drug prices and drug patents are connected and how this nexus impacts Paragraph IV litigation
    • Examining the relationship to secondary patent challenges
  • Comprehending how Senator Hatch’s proposed amendment (the Hatch-Waxman Integrity Act of 2018) to the CREATES Act will affect pricing and patents and the future of Hatch-Waxman litigation
  • Deciphering pending legislation (sponsored by Senator Susan Collins – Maine) and its implications for patent evergreening and pricing
  • Identifying and assessing what the Trump Administration is proposing in the Hatch Waxman space relative to pricing and patent life
    • Assessing the implications of the new administration’s view of 180-day exclusivity
    • Analyzing how Trump’s budget proposal could actually lead to less generic competition and price increases?
    • Understanding how these measures dovetail with current FDA initiatives regarding patents and pricing
  • Examining various policy approaches that could prevent price gouging, protect patents, and potentially stabilize the market

9:00
The Future of Venue and Jurisdiction: Examining the Latest Interpretations and Applications of TC Heartland

Karen E. Brown, Ph.D.
Vice President & Chief Intellectual Property Counsel
Ironwood Pharmaceuticals

Gary E. Hood
Practice Chair Intellectual Property Proceedings
Polsinelli

Jason G. Winchester
Partner
Jones Day

Moderator

Faye Paul
Partner
Bartlit Beck Herman Palenchar & Scott LLP

  • Understanding the repercussions and practical implications of the TC Heartland decision on pharmaceutical patent infringement filings
  • Examining how different jurisdictions are interpreting the TC Heartland decision
  • Exploring venue and jurisdiction strategies that are being used in the wake of TC Heartland?
  • Assessing how patent holders are increasing their reliance on the second prong of the venue statute
  • Examining post-TC Heartland legal challenges relative to:
    • Regular and established place of business
    • Active infringement
    • Corporate affiliates
    • Pre-suit contacts
    • States with multiple districts
  • Assessing the filing and docket challenges of new hot bed jurisdictions in the aftermath of TC Heartland
  • Addressing the current challenges of Multi-District Litigation
    • What happens if the MDL judge is located in a jurisdiction where no party “resides?”

9:45
Morning Coffee Break
10:00
Brand and Generic Perspectives on the Latest FDA Initiatives in the Hatch-Waxman Space

David M. Fox
Partner
Hogan Lovells

Kurt R. Karst
Partner
Hyman, Phelps & McNamara, P.C.

  • Revisiting the FDA Reauthorization Act– an updated analysis of the regulatory framework and how it is playing out
  • Tracking the initiatives of the FDA Hatch- Waxman Working Group aimed at increasing generic competition
  • Assessing the key goals of the DCAP (Drug Competition Action Plan) and what strides are actively being taken to achieve those goals
  • Re-examining the continued impact of the FDA Final MMA Rule

10:45
A Question of Sovereignty: A Retrospect on Invoking Tribal and State Sovereign Immunity as a Means of Patent Protection

Taras A. Gracey
Shareholder
Polsinelli PC

James Kellerman
Vice President, Intellectual Property
Astellas Pharma US, Inc.

On July 20, 2018, the Federal Circuit upheld the PTAB’s denial of the St. Regis tribe’s invocation of the tribal sovereign immunity defense to an IPR proceeding in Allergan, Inc. v. Teva Pharmaceuticals. With this matter now decided, the Federal Circuit has still to rule on a novel question of state sovereign immunity in an IPR action. This panel will explore these matters as well as the latest developments in the Sovereign Immunity arena.

  • Analyzing the significance of the Federal Circuit’s decision holding that the defense of tribal sovereign immunity does not apply to IPR proceedings
    • Assessing the probability of Supreme Court review in this matter
  • Update on the Preserving Access to Cost Effective Drugs (PACED) Act seeking to prevent the abuse of sovereign immunity defenses
  • Examining matters in which state sovereign immunity has been invoked by public universities as a bar to IPRs and as a means of patent protection
    • Regents of the University of Minnesota v. LSI Corp., case number 18-1559, pending (Fed. Cir. 2018)
    • Covidien LP v. University of Florida Research Foundation Inc. (Fed. Cir. 2017)

11:30

Focus on Method of Use/ Treatment Patents

Assessing the Latest Use of §101 Challenges to Method of Use Patents in a Paragraph IV Setting

John Bennett
Partner
Goodwin Procter LLP

Daniel P. DiNapoli
Partner
Arnold & Porter Kaye Scholer LLP

Thomas J. Filarski
Partner
Steptoe & Johnson LLP

Moderator:

Richard Berman
Partner
Arent Fox LLP

  • Examining the latest post-Alice decisions on patentability and their implications for branded pharmaceuticals
  • Assessing the implications of the Federal Circuit’s decision in Vanda v. West-Ward
    • How does this ruling circumvent the Mayo/Alice rule?
  • Examining other recent rulings on §101 motions and their potential implications within the Hatch-Waxman space:
    • Berkheimer v. HP, Inc.
    • Aatrix Software v. Green Shades Software
    • Exergen Corp. v. Brooklands Inc.
  • Practical advice for overcoming USPTO rejections and asserting and defending against §101 arguments in the courts

12:30
Networking Luncheon
1:30

Focus on Method of Use/ Treatment Patents

Evolving Tests for Induced Infringement Relative to Method of Use Patents: Implications for Labels, Carve-Outs and Proof of Actual Inducement

David Abramowitz
Partner
Locke Lord LLP

Adam Chiss
Division Counsel, Intellectual Property Litigation
Abbvie

Daniel J. Minion
Partner
Fitzpatrick, Cella, Harper & Scinto

Robert F. Shaffer
Partner
Finnegan, Henderson, Farabow, Garrett & Dunner LLP

Moderator:

Stephen R. Auten
Partner
Taft Stettinius & Hollister LLP

  • Reviewing the state of the law on induced infringement and its repercussions for Hatch-Waxman
  • Examining the continued implications of Sanofi v. Watson
  • Assessing the District of Delaware’s recent ruling in Glaxo Smith Kline v. Teva
    • How does this ruling change the way in which infringement is proven in an active inducement case?
    • Revisiting the law of inducement and what this means for Section viii carve-outs
    • The importance of Judge Stark’s reasoning regarding why this case was different from the Federal Circuit’s precedent in Sanofi
  • Analyzing how the Federal Circuit’s ruling in Vanda v. West-Ward impacts established principles of induced infringement in the Hatch-Waxman context
  • Understanding how extensive labeling information on a generic drug may encourage an act of inducement
    • Intent to induce vs. actual inducement
  • Looking beyond indications, usage, dosage and administration to establish inducement
  • Comprehending the importance of how the doctor’s reading of the label as a whole may lead to an act of induced infringement

2:30
Legal and Business Perspectives on the On-Sale Bar: Examining the Continued Aftermath of Helsinn

Ali Ahmed
Chief Intellectual Property Counsel
Fresenius Kabi USA

Charles M. Lizza
Partner
Saul Ewing Arnstein & Lehr, LLP

Joseph O’Malley
Partner
Paul Hastings

After two opinions by the Federal Circuit on the on-sale bar in Helsinn Healthcare v Teva Pharmaceuticals, the Supreme Court granted Helsinn Healthcare’s writ of certiorari on the question of whether “an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.”   This panel will examine the present status of the on-sale bar and the significance of this latest chapter of the Helsinn saga. Points of discussion will include:  

  • Assessing the on-sale bar provision of the Patent Act as amended by the AIA
    • Exploring the fine line between pre and post-AIA on-sale bar analysis
  • Evaluating the impact of the Helsinn and Medicines Co. decisions
  • Identifying triggering events for the on sale bar under this jurisprudence
  • Following the Supreme Court’s activity since granting certiorari in this case
  • Exploring new questions of due diligence for brands relative to manufacturing contracts, purchase and distribution agreements, clinical trials, etc.
    •  Identifying best practices for keeping track of existing agreements within the applicable time period
  • Assessing new defenses for generics relative to on-sale bar findings
  • Determining opportunities and evaluating monetary consequences and circumstances in which the generic may invoke the on-sale bar provision

3:15
Afternoon Refreshment Break
3:30
The Distinctive Role of The Magistrate Judge and Local Counsel in Paragraph IV Proceedings

Honorable Douglas E. Arpert
Magistrate Judge
United States District Court, District of New Jersey

Honorable Christopher J. Burke
Magistrate Judge
United States District Court, District of Delaware

Honorable Roy Payne
Magistrate Judge
United States District Court, Eastern District of Texas

Honorable Sidney I. Schenkier
Magistrate Judge
United States District Court, Northern District of Illinois

Eric I. Abraham
Partner
Hill Wallack LLP

Adam W. Poff
Partner
Young Conaway Stargatt & Taylor, LLP

Moderator:

Marc R. Wezowski
Partner
Husch Blackwell LLP

Magistrate Judges have a unique role in ANDA cases. They hear key motions and resolve the disputes which the parties encounter throughout the course of litigation. Many jurisdictions where Paragraph IV disputes are heard have their own local patent rules, with some jurisdictions exhibiting subsets of local patent rules for Hatch-Waxman matters, which dictate everything from scheduling, to discovery to dispositive motions. Recently, several jurisdictions have modified their local rules, calling for the patent bar to significantly adjust their practices. With these unfamiliar local rules in mind, the importance of retaining local counsel becomes paramount. This panel will explore the intricacies of the local rules and how Magistrate Judges effectively working with local counsel can help the parties reach an amicable “yes”.

4:45
A Chat With the Chiefs: Perspectives from Chief Judges Castillo and Linares on the Latest Paragraph IV Litigation Challenges

Honorable Ruben Castillo
Chief Judge
United States District Court, Northern District of Illinois

Honorable Jose L. Linares
Chief Judge
United States District Court, District of New Jersey

Moderators:

Kathleen B. Carr
Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Paul J. Molino
Managing Partner
Rakoczy Molino Mazzochi Siwik LLP

Join us for a Fireside Chat with Chief District Court Judges from two of the liveliest Paragraph IV litigation dockets in the country. These federal judges will examine decisionmaking practices employed by the judicial system, provide invaluable advice for both patent holders and patent challengers, and furnish you with solutions to your most pressing Paragraph IV predicaments.

5:45
Conference Adjourns

Day 2 - Wednesday, October 3, 2018

7:30
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks and Re-Cap of Day One
8:15
Developing Effective Strategies for ANDA Litigation Management: Budgeting, Cost-Containment Strategies and Other Practical Considerations Based on Recent Trends

Owen Byrd
Chief Evangelist and General Counsel
Lex Machina

Monique Heyninck
Vice President, Intellectual Property
Avanir Pharmaceuticals, Inc.

Brian Hirsch
Vice President, Global IP and Legal Head
Glenmark Pharmaceuticals

Lars Taavola
Senior Director/Senior Patent Counsel, Global Intellectual Property Head of Patent Litigation
Amneal Pharmaceuticals

Jessica Jamieson
V.P., Global Head Hematology IP
Shire Pharmaceuticals

Moderator:

Miki Goodin
Partner
Locke Lord LLP

  • Understanding how PIV litigation costs have been affected by multiple filers
  • Assessing the pros and cons of joint defense groups /multiple defendants
  • Budgeting, forecasting and aligning litigation costs to business goals
  • Crafting creative ways to reduce the monetary burden
  • Alternative fee agreements
    • Which ones are parties finding useful?
    • Which ones have not worked/ not worked?
  • Conducting an effective patent lawsuit risk assessment:
    • Assessing litigation cost considerations relative to new product/pipeline development
  • Balancing cost savings with ensuring negotiation of a favorable agreement

9:30

Focus on the PTAB

Assessing the Implications of the Supreme Court’s Recent Decision in SAS and Its Impact on PTAB Practice

Jonathan Bachard
Partner
Knobbe Martens Olson & Bear LLP

Jessamyn S. Berniker
Partner
Williams & Connolly LLP

Andrew Kessel
Counsel, IP Litigation
Gilead Sciences

In April, the Supreme Court issued a landmark decision in SAS, ruling that when the Patent Office institutes an Inter Partes Review, it must decide the patentability of all of the claims the petitioner has challenged. In short – partial institutions of petitions are not authorized. Whether you are a patent holder or a patent challenger, this pivotal Supreme Court ruling will have a tremendous impact on your approach to PTAB practice. This panel will:  

  • Assess the recent Supreme Court ruling in SAS and what its implications will be for PTAB practice going forward
  • Analyze the Supreme Court’s reasoning in this case and explore what matters are still left for further interpretation
  • Explore how the PTAB has changed its operations since SAS and whether those changes have affected case outcomes and/or party behavior
  • Evaluate the implications of the STRONGER Patents Act of 2018 (H.R. 5340) regarding burden of proof in IPRs

10:15
Morning Coffee Break
10:30

Focus on the PTAB

PTAB Pharmaceutical Patent Invalidity Round-Up: Update on Wins, Losses, Appeals and the Latest Estoppel Considerations and Concerns

John L. Abramic
Partner
Steptoe & Johnson LLP

Gerald J. Flattmann Jr.
Partner
King & Spalding LLP

  • Survey of notable pharmaceutical patent wins and losses at the PTAB
  • »» IPR vs. PGR vs. CBM
  • Examining statistics for types of challenges brought and types of patents challenged
  • Developing parallel proceedings protocols
  • Update on activity of reverse patent trolls
  • Status of pending patent reform legislation 10
  • Assessing how PTAB estoppel is impacting patent prosecution
    • Examining the potential effects on failed petitioners and unsuccessful patent owners
    • Analyzing the challenges of patent owner estoppel stemming from adverse AIA trial results

11:15

Focus on the PTAB

The PTAB Live: A Hatch-Waxman Practitioner’s Guide to Practice, Procedure, IPRs and More in the World of Pharmaceutical Patent Validity Challenges

Honorable Jacqueline D. Wright Bonilla
Vice Chief Administrative Patent Judge
Patent Trial and Appeal Board, USPTO

Honorable Michelle N. Ankenbrand
Lead Administrative Patent Judge
Patent Trial and Appeal Board, USPTO

Moderator:

Gregory A. Morris, Ph.D.
Partner and Leader, Life Sciences Litigation
Honigman Miller Schwartz and Cohn LLP

IPRs have become an important component of the Hatch-Waxman arsenal. As such, knowing the “ins and outs” of PTAB practice is a critical competency for today’s Hatch-Waxman petitioner. To help you with this task, Judges from the PTAB will discuss protocols and the art of appearance before this administrative body.

12:15
Networking Luncheon
1:30
Obviousness Update: Addressing Matters of Obviousness-Type Double Patenting, Inherency, Anticipation and Secondary Considerations in the World of Paragraph IV Litigation

Laura DeMoor
Senior Counsel
Baxter Healthcare

Irena Royzman
Partner
Patterson Belknap Webb & Tyler LLP

  • Examining the continued evolution of the obviousness-type double patenting doctrine
    • In re Janssen Biotech, Inc., (Fed. Cir. Jan. 23, 2018)
  • Deciphering recent Federal Circuit opinions addressing inherency and anticipation in an ANDA setting
    • Millennium Pharm. v. Sandoz, Inc., Appeal no. 2015-2066 (Fed. Cir., July 17, 2017)
  • Dissecting the concept of inherent obviousness and establishing the correct standard
    • Requirements for rejections based on inherency and burden of proof determinations
    • Understanding how ‘that which may be inherent is not necessarily known’ and that which is unknown cannot be obvious’
  • Examining inherency rejections
  • Survey of recent cases at the District Courts highlighting the importance of secondary considerations in an obviousness determination
  • Examining trends at the District Court and PTAB indicating a receptiveness to the use of secondary considerations
  • Applying these findings to ANDA litigation
    • Analyzing factors of commercial success, unmet need, licensing
    • Exploring the ongoing debate on copying and its relevance or irrelevance to Hatch-Waxman litigation

2:15
Antitrust Developments Concerning Brand Name, Generic and Hybrid Interests

Lauren Peay
Attorney
Federal Trade Commission (FTC)

In this interactive session, a Senior Attorney from the FTC will discuss the FTC’s position on pharmaceutical patent settlements and explore industry challenges in light of recent court decisions and FTC activity. She will examine the Commission’s stance with respect to designing settlement agreements that will not only withstand FTC scrutiny, but also benefit the parties and receive a judicial blessing. Topic to be covered include:  

  • Developing jurisprudence regarding patent settlements post-Activis
  • The latest FTC challenges of reverse payment settlement agreements, including those of settlement agreements filed prior to the Activis decision
  • Treatment of settlements based on the brand’s agreement not to launch an authorized generic
  • Structuring settlements in light of developing jurisprudence
  • Best strategies to communicate risks and rewards of settlement to clients

3:00
Refreshment Break
3:15
Assessing the True Measure of Damages in an At-Risk Launch

Valentina Freeman
Director
Epsilon Economics

Steven H. Sklar
Member
Leydig, Voit & Mayer, Ltd.

Jeanna Wacker
Partner
Kirkland & Ellis LLP

The decision of whether or not to launch a generic product “at risk” brings with it many potential dangers, as well as very lucrative benefits. A drug launched at risk presents a unique risk-benefit analysis, including assessment of profit, if successful, and calculation of lost profits royalties, and other damages, if not successful. Also, adding to this analysis, is a recent case pending before the Supreme Court posing the novel question of whether U.S. patentees will be able to recover lost profits damages arising under §271(f) for certain activities occurring outside the United States.   In this interactive case study, the speakers will take part in a hypothetical at risk launch scenario addressing damages and mitigation strategies from the generic and branded viewpoints.

4:00
Identifying and Avoiding Common Ethical Dilemmas in Paragraph IV Practice

This session will identify common ethical dilemmas in Hatch-Waxman litigation and help you incorporate protocols to avoid them. Points of discussion will include:  

  • Evaluating typical ethical predicaments that may arise in Paragraph IV litigation
  • Ethical considerations for Paragraph IV matters before the PTO and District Courts
  • Examining post-Therasense developments in the district courts, federal circuit and USPTO proceedings
  • Exploring considerations involving willfulness and exceptional cases

5:00
Conference Ends

Workshop A | Biosimilar Litigation Boot Camp for the Hatch- Waxman Litigator

Oct 1, 2018 9:00am – 12:00pm

Kevin E. Noonan Ph.D.
Partner
McDonnell Boehnen Hulbert & Berghoff LLP (Chicago, IL)

What is it about?

Registration begins at 8:30 AM – Continental Breakfast will be served   In the landmark Amgen v. Sandoz decision, the Supreme Court granted more flexibility to biosimilar companies and filers of abbreviated biologics license applications. This intimate and interactive working group will examine the core components of the Court’s decision and provide an essential analysis of biosimilar litigation as well as the approval process and other key points of regulation for the benefit of Hatch-Waxman practitioners. Points of discussion will include:   LEGAL AND REGULATORY BACKGROUND:
  • Comparing and contrasting the biosimilar pathway to 505(b)(2) and BLA pathways
    • Determining whether research and development resources are best spent pursuing a biosimilar pathway or going the traditional BLA route
    • Breakdown of relevant considerations with each route including timing, costs, and IP litigation considerations, and exclusivity
  • Overview of the 2010 Biologics Price Competition and Innovation Act (BPCIA)
    • Exclusivity provisions
    • Criteria for biosimilarity and interchangeability
    • Clinical trials and safety studies
    • Patent litigation and exchange provisions: Understanding the major differences between
  • Hatch-Waxman and biosimilars litigation as outlined in the statute
  LITIGATION UPDATE:
  • Review of Amgen v. Sandoz and its impact on other biosimilar cases currently being litigated
  • Exploring new strategies to engage in the patent dance in wake of the Supreme Court’s decision
  • Timing of patent filings: making the decision to file pre-suit, waiting out the lengthy legal process, or launching without the benefit of having discovery of the other party’s patents and legal positions
  • Evaluating the use of IPRs with biosimilars
  • Developing patent certainty
    • Factoring decisions in recent BPCIA cases into your overall patent validity analysis
    • BLA versus biosimilar application Choosing between District Court, PTAB,and the ITC
  Luncheon will be served at 12:00 for registrants attending both workshops

Workshop B | Parallel Proceedings Master Class: Strategies for Balancing and Streamlining Simultaneous Proceedings Before the Federal Courts, PTO & ITC in Pharmaceutical Patent Litigation

Oct 1, 2018 1:00pm – 4:00pm

Jeffrey R. Gargano
Partner
Morgan Lewis LLP

Lisa J. Pirozzolo
Partner
WilmerHale

What is it about?

Registration begins at 12:30 PM   Parallel litigation in the District Court and PTAB in a Hatch-Waxman setting is becoming more and more commonplace and adds to the “no-holds barred” atmosphere of this high stakes type of litigation. The art of navigating proceedings between to these two forums has been described as akin to walking a tightrope. In navigating these dual forums, even the most seasoned of District Court litigators is only now learning the art of appearing before the PTAB.   They are developing best practices and also becoming aware of certain things to avoid in these procedures. In this very interactive session, we will illustrate the “ins and outs” of IPR practice and appearing in related proceedings in both the District Court and PTAB.   Topics to be covered include:
  • Devising strategies relative to the filing of an IPR or similar proceeding during the pendency of District Court litigation
  • Formulating strategies based on type of pharmaceutical patent
  • Establishing jurisdiction at the PTAB
  • »» Special considerations for ex-U.S. parties
  • Ensuring all RPIs are properly named
  • Assessing split petition strategies
  • Understanding when requests for joinder can be made and when they should be made
  • Analyzing secondary considerations
  • Developing sound discovery strategies relative to dual proceedings
  • Evaluating chances of getting a stay granted in the District Court
  • Understanding claim construction dichotomy in both forums and devising tactics to address both simultaneously
  • Managing experts and use of experts in both forums
  • Best practices for simultaneous trials
  • Appealing decisions in both forums
  • Addressing settlement in both forums
  • Managing desire and expectations of parties to settle despite PTAB’s insistence on moving the petition forwar
  Luncheon will be served at 12:00 for registrants attending both workshops