Day 1 - Monday, April 24, 2017

7:00
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks
8:15
The Politics and Policy of Pharmaceutical Patents in the New Administration: Town Hall
9:00
USPTO Keynote: Patent Rights and Generic Entry – An International Perspective
9:45
Morning Coffee Break
10:00
The Dollars, Cents and Due Diligence of Pharmaceutical Patent Life Cycle Management and Litigation Planning
11:00
Focus on the Final MMA Rule
Q&A with the FDA on the Final MMA Rule: Understanding the Impact for Hatch-Waxman Practice
12:00
Revisiting Use Codes and Carve-Out Cases in Light of the Final MMA Rule
12:45
Networking Luncheon
1:45
The Ongoing Jurisdiction Debate: From Mylan to TC Heartland
2:30
On Sale Bar – Round II: Understanding The Impact of Helsinn on Pharmaceutical Patents in a Post-AIA Setting
3:00
Networking Refreshment Break
3:15
Understanding the Continuing Impact of 101 on Orange Book Listed-Method Claims
4:00
Obviousness Update for PIV Litigation: Latest Developments in the Federal Courts and PTAB
4:45
A View from the Bench: The Federal Judges Speak on Paragraph IV Litigation
6:00
Conference Adjourns to Day Two
6:01
Cocktail Party

Day 2 - Tuesday, April 25, 2017

7:00
Continental Breakfast
8:00
Co-Chairs’ Opening Remarks and Recap of Day One
8:15
Illusory Safe Harbors: Exploring Uncertainties in the Boundaries of 271 (e) (1) and the Scope of Divided and Induced Infringement
9:00
The PTAB Live: Thoughts on Practice, Procedure, IPRs and More in the World of Pharmaceutical Patent Validity Challenges
10:00
Morning Coffee Break
10:15
Alternate Forums for Pharmaceutical Patent Challenges

PTAB Pharmaceutical Patent Invalidity Round-Up: Update on Wins, Losses and Appeals
11:00
Examining the ITC as an Alternate Forum in an ANDA Challenge
11:30
A Magistrate Judge’s Insights on ANDA Practice
12:30
Networking Luncheon
1:30
FTC Keynote: Update on Reverse Payment Settlements and Other Antitrust Developments Concerning Brand Name and Generic Interests
2:15
Reverse Payment Settlements: The Industry Response
3:00
Networking Coffee Break
3:15
The REMS Conundrum: Exploring Challenges for Both Brands and Generics
4:00
Case Studies in New Ethical Developments Impacting Paragraph IV Practice
5:00
Conference Ends

ELITEPASS: Both Workshops

Apr 26, 2017 8:30am -

Workshop A – IPR Strategies and Parallel Proceedings Master Class: Devising Strategies for IPR Best Practices and Navigating Dual Forums in Hatch-Waxman Litigation

Apr 26, 2017 8:30am - 12:00pm

Speakers

Vishal C. Gupta
Partner
Steptoe & Johnson LLP (New York, NY)

Laura A. Vogel
Partner
Barclay Damon LLP (Boston, MA)

Ha Kung Wong
Partner
Fitzpatrick, Cella, Harper & Scinto (New York, NY)

Alyson L. Wooten PharmD
Attorney
Kilpatrick Townsend & Stockton LLP (Atlanta, GA)

Workshop B – Biosimilars 2.0 for the Paragraph IV Litigator

Apr 26, 2017 1:00pm - 4:30pm

Speakers

Corey M. Casey
Shareholder
Polsinelli PC (Kansas City, MO)

Erin Ator Thomson
Counsel
Vinson & Elkins LLP (Austin, TX )

Day 1 - Monday, April 24, 2017

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

Guy Donatiello
Senior Vice President
Intellectual Property

Endo Pharmaceuticals (Malvern, PA)

Timothy X. Witkowski, M.S., J.D.
Head, US Chemistry Patents
Novartis Institutes for BioMedical Research (Cambridge, MA)

8:15
The Politics and Policy of Pharmaceutical Patents in the New Administration: Town Hall

Mark E. Waddell
Partner
Loeb & Loeb (New York, NY)

Lisa M. Ferri
Partner
Mayer Brown LLP (New York, NY)

George G. Gordon
Partner
Dechert LLP (Philadelphia, PA)

Shashank Upadhye
Partner
Amin Talati & Upadhye (Chicago, IL)

Moderator:

Honorable Teresa Rea
Partner
Crowell & Moring LLP (Washington, DC) (Former Acting Under Secretary of Commerce for Intellectual Property and Former Acting Director of the United States Patent and Trademark Office)

Pharmaceutical patents, especially small molecule, Orange-Book listed patents are unique entities. Under the Hatch-Waxman-Act and its subsequent amendments, these patents fall under the jurisdiction of three government agencies, the USPTO, the FDA and the FTC. At time of press, it is expected that the leadership as well as the objectives of each of these agencies will change during the Trump presidency. This begs the question of how these changes may affect these patents and Hatch-Waxman strategies. There are also questions as to how the status of pending legislation in the New Congress, the appointment of Judges in various courts including the Supreme Court may all impact these patents as well. This panel, in town hall fashion, will take questions as it explores such matters as:

 

  • How new PTO leadership may impact pharmaceutical patents
  • Exploring the future of Patent Reform II and possible statutory IPR carve-out for Hatch- Waxman patents
  • Understanding what changes at FDA and its parent agency HHS may mean for Orange Book patents
    •  calls for drug pricing reform and consequences for drug patents
  • Predicting how changes at FTC may impact the future of “pay for delay” enforcement and investigations

9:00
USPTO Keynote: Patent Rights and Generic Entry – An International Perspective

Karin Ferriter
Deputy Chief Policy Officer, Office of Policy and International Affairs
USPTO (Alexandria, VA)

  • Review of leading international standards regarding the relationship between patent rights and generic entry
  • Overview of the TRIPS Agreement
  • US Free Trade Agreements: from Australia to Central America to the Andean Region to Korea
  • Discussion of Hatch-Waxman provisions of the TPP—lessons learned
  • Future agreements

9:45
Morning Coffee Break
10:00
The Dollars, Cents and Due Diligence of Pharmaceutical Patent Life Cycle Management and Litigation Planning

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

Jeffrey N. Myers, Ph.D.
Vice President & Assistant General Counsel
Pfizer Inc (New York, NY)

Kevin J. Post
Partner
Ropes & Gray LLP (New York)

Vince Thomas
Senior Managing Director
FTI Consulting (Chicago, IL)

Moderator:

Kathleen B. Carr
Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (Boston, MA)

  • Appreciating new IP and economic due diligence strategies for brand name and generic manufacturers in view of current legal considerations and market trends
  • Understanding how the current stage of the patent cliff, the alternative litigation route at the PTAB and new federal court jurisprudence have reshaped Hatch-Waxman strategies
  • Examining how brand names and generics are utilizing this new legal and economic paradigm in determining which patents are ripe for challenge in the PTAB and District Courts
  • Comparing patent strength assessments in clinical testing phases I and II to predicted ROI in phases III and IV to determine drug value and probability of suit
  • Understanding why less lucrative branded drugs are becoming more attractive targets
  • Assessing probable win or loss at District Court and PTAB on patent type and recent decisions
  • Exploring cost saving options for ANDA District Court litigation and PTAB filing
  • Examining alternative billing, contingencies
  • Evaluating use of outside funding
  • Knowing when to aim, fire, fight, fold or license
  • Understanding when settlement is your best option sometimes even before suit is commenced

11:00
Focus on the Final MMA Rule
Q&A with the FDA on the Final MMA Rule: Understanding the Impact for Hatch-Waxman Practice

Maryll W. Toufanian, J.D.
Deputy Director, Office of Generic Drug Policy
Office of Generic Drugs, CDER

U.S. Food and Drug Administration (Silver Spring, MD)

Kurt R. Karst
Director
Hyman, Phelps & McNamara, P.C. (Washington, DC)

Margaret J. Sampson
Partner
Baker Botts L.L.P. (Austin, TX)

On December 5, 2016, new regulations to implement portions of the 2003 Medicare Modernization Act went into effect. According to FDA, the new regulations are intended to “reduce unnecessary litigation, reduce delays in approval of 505(b)(2) applications and ANDAs that are otherwise ready to be approved, and provide business certainty to both brand name and generic manufacturers.” The highly technical and far-reaching regulations significantly affect how NDA and ANDA applicants will interact with one another and with FDA both during and after approval of a marketing application.

Among other things, the new regulations deal with the submission of patent information by NDA holders and patent certifications from ANDA applicants, patent use codes, 30-month patent litigation stays, application amendments and supplements, and, to some extent, 180-day exclusivity. This session, formatted in a Q&A fashion, will provide analysis other new regulations as well as strategies for incorporation into daily practice.

12:00
Revisiting Use Codes and Carve-Out Cases in Light of the Final MMA Rule

Vincent L. Capuano, Ph.D.
Partner
Duane Morris LLP (Boston, MA)

Anil Patel, Ph.D.
Counsel
Kilpatrick Townsend & Stockton LLP (Atlanta, GA)

Paul Simboli
Vice President, Intellectual Property & Asst. General Counsel
Depomed, Inc (Newark, CA)

Michael Sitzman
Partner
Gibson, Dunn & Crutcher LLP (San Francisco, CA)

Moderator:

William L. Mentlik
Partner
Lerner, David, Littenberg, Krumholz & Mentlik, LLP (Westfield, NJ)

Use code manipulation, carve-outs and skinny labeling have been a proverbial tempest in the Orange Book teapot. The Supreme Court blessed the carve-out concept in 2012 with Caraco, but the utilization of carve-outs has still led to many a dogfight. The final MMA Rule seeks to put an end to this. However, questions remain as to how use code dilemmas will be handled in the aftermath of the Rule.

  • Review of recent Paragraph IV carve-out and skinny labeling challenges
  • Examining FDA determinations relative to use code listings
  • Understanding the uniqueness and significance of the Depomed NUCYNTA ER (tapentadol) citizen’s petition
  • FDA’s authority to unilaterally change use code
  • Exploring how final Rule may remedy the current use code landscape

12:45
Networking Luncheon
1:45
The Ongoing Jurisdiction Debate: From Mylan to TC Heartland

Paul A. Ainsworth
Director
Sterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC)

Bradford J. (Jim) Badke
Partner
Sidley Austin LLP (New York, NY)

Nicolas G. Barzoukas
Partner
Reed Smith LLP (Huston, TX)

Lisa A. Jakob
Legal Director, IP Litigation
Merck & Company (Rahway, NJ)

John J. Molenda, Ph.D.
Partner
Steptoe & Johnson LLP (New York, NY)

Moderator:

Steven M. Coyle
Partner and Pharmaceutical Litigation Group Leader
Cantor Colburn LLP (Hartford, CT)

  • Analyzing the Federal Circuit’s finding of jurisdiction in in Acorda -Therapeutics Inc. v. Mylan Pharms. Inc. and AstraZeneca AB v. Mylan Pharms. Inc.,
  • Reviewing the District of Delaware’s decisions in these matters
  • Comprehending how Judges’ Sleet and Stark each found jurisdiction and how this compared to the Federal Circuit’s findings
  • Examining the significance of the Federal Circuit’s dissent
  • Understanding the significance of the Supreme Court’s denial of cert. in Mylan in view of the Court’s grant of cert. in TC Heartland LLC v. Kraft Food Brands Group LLC
  • Exploring possibility of amendment to Hatch- Waxman to remedy jurisdictional uncertainty

2:30
On Sale Bar – Round II: Understanding The Impact of Helsinn on Pharmaceutical Patents in a Post-AIA Setting

Joseph M. O’Malley, Jr.
Partner
Paul Hastings LLP (New York, NY)

Steven A. Nash
Senior Patent Counsel
Xellia Pharmaceuticals, Inc. (Raleigh, NC)

Richard T. Ruzich
Partner
Taft Stettinius & Hollister LLP (Chicago, IL)

  • At the time of our last meeting, we explored the question of patent invalidity through an on sale bar in a pre-AIA setting in the Medicines Company’s Angiomax case. Now, we revisit the same question, but this time on a patent issued post-AIA.
  • Analyzing the on- sale bar provision of the Patent Act as amended by the AIA
    • comparison to pre-AIA statute
  • Examining the facts of Helsinn Healthcare S.A. et al. v. Teva Pharmaceuticals USA, Inc. et al. (Nos. 2016-1284, -1787) and understanding how the language of the amended statute led to the District Court’s (DNJ) finding that a so-called non-public, secret sale did not trigger the on-sale bar provision to invalidate the patent
  • Anticipating the Federal Circuit’s decision in Helsinn
    • assessing repercussions which would ensue should the Federal Circuit reverse the lower court’s finding
    • what can we glean from the Federal Circuit’s ruling in The Medicines Co. v. Hospira, Inc., 827 F.3d 1363 (Fed. Cir. July 11, 2016)?
  • Exploring the consequences of either scenario in future Hatch-Waxman settings

3:00
Networking Refreshment Break
3:15
Understanding the Continuing Impact of 101 on Orange Book Listed-Method Claims

Dominic A. Conde
Partner
Fitzpatrick, Cella, Harper & Scinto (New York, NY)

Paul B. Sudentas
Attorney
Locke Lord LLP (New York, NY)

Peter Waibel
Head, US Patent Litigation
Novartis Pharmaceuticals Corporation (East Hanover, NJ)

Bruce M. Wexler
Partner
Paul Hastings LLP (New York, NY)

Jason A. Wietjes
Shareholder
Polsinelli PC (Dallas, TX)

Moderator:

Martin B. Pavane
Vice Chair, Intellectual Property Department
Co-Chair, Hatch-Waxman & Biologics Litigation

Cozen O’Connor (New York, NY)

  • Understanding the implications of the Federal Circuit’s decision in Rapid Litigation Management Ltd., et al. v. CellzDirect, Inc., et al., No. 2015-1570 (Fed. Cir. Jul. 5, 2016) on subject matter eligibility of method claims in the life sciences sector
  • Determining subject matter patentability of method patents based on this latest case and prior 101 jurisprudence post-Myriad
  • Exploring the Federal Circuit’s adherence or nonadherence in 101 matters under PTO’s Alice Rules
    • MacroPoint LLC v. FourKites Inc., case number 16-1286, Federal Circuit 2016.
  • Comparing the Federal Circuit’s findings in CellzDirect to two Delaware Court decisions in the last year involving 101 challenges to Orange Book listed method claims, i.e., Endo v. Actavis (2015) vs. Vanda Pharmaceuticals Inc. v. Roxane Laboratories, Inc., C.A. Nos. 13-1973, 14-757-GMS (D. Del. Aug. 25, 2016)
  • Understanding how Judges Andrews and Sleet arrived at different 101 decisions with respect to the patents in question
  • What can we glean from this jurisprudence with respect to drafting subject matter eligible method claims and bringing 101 motions?

4:00
Obviousness Update for PIV Litigation: Latest Developments in the Federal Courts and PTAB

Richard J. Berman
Partner
Arent Fox LLP (Washington, DC)

Mark T. Deming
Patent Attorney
Polsinelli PC (Chicago, IIL)

Michael R. Dzwonczyk
Partner
Sughrue Mion PLLC (Washington, DC)

Josephine Liu, Ph.D., J.D.
Head, US IP Litigation
Sandoz Inc. (Princeton, NJ)

Lisa B. Pensabene
Partner
O’Melveny & Myers LLP (New York, NY)

Moderator:

Brandon M. White
Partner
Perkins Coie LLP (Washington, DC)

Prior Art

  • Understanding how the Federal Circuit’s obviousness ruling in Apple Inc. v. Samsung Electronics Co. Ltd., No. 2015-1171, __ F.3d __, 2016 WL 5864573 (Fed. Cir. Oct. 7, 2016) may impact obviousness findings in life sciences patents
  • Review of recent obvious decisions involving Paragraph IV litigation at the District Court, PTAB and Federal Circuit
    • comparison of statistics for obvious invalidity findings at these courts
    • impact of Cuozzo
  • Exploring unique obviousness issues in Purdue Oxycodone cases, i.e., Grunenthal GmbH et al v Teva Pharmaceuticals USA Inc, U.S. Court of Appeals, Federal Circuit, No. 2014-1311. currently on petition for cert. at the Supreme Court
    • inherency by anticipation
    • method of solving problem
  • Re-visiting secondary considerations

 

Double Patenting- Type Obviousness

  • Bayer Pharma AG v. Watson Labs., Inc., Case No. 12-1726-LPS, 2016 U.S. Dist. LEXIS 96267 (D. Del. July 18, 2016)

4:45
A View from the Bench: The Federal Judges Speak on Paragraph IV Litigation

Honorable Ruben Castillo, Chief Judge

United States District Court, Northern District of Illinois (Chicago, IL)

Honorable Jose L. Linares, U.S.D.J.
United States District Court
District of New Jersey (Newark, NJ)

Honorable Roy Payne, U.S.M.J.
United States District Court
Eastern District of Texas (Marshall, TX)

Moderator:

Barry P. Golob
Vice Chair, Intellectual Property Department
Cozen O’Connor (Washington, DC)

Irena Royzman, Ph.D.
Co-Chair, Biotechnology Practice
Patterson Belknap Webb & Tyler LLP (New York, NY)

Renowned jurists with some of the most active Paragraph IV litigation dockets in the country will share their thoughts and insights on complex challenges facing both patent holders and patent challengers. Come prepared with your most pressing questions.

6:00
Conference Adjourns to Day Two
6:01
Cocktail Party

Day 2 - Tuesday, April 25, 2017

7:00
Continental Breakfast
8:00
Co-Chairs’ Opening Remarks and Recap of Day One
8:15
Illusory Safe Harbors: Exploring Uncertainties in the Boundaries of 271 (e) (1) and the Scope of Divided and Induced Infringement

Andrew M. Alul
Partner
Taft Stettinius & Hollister LLP. (Chicago, IL)

Jared C. Bunker
Partner
Knobbe, Martens, Olson & Bear, LLP (Irvine, CA)

Gregory F. Corbett
Shareholder
Wolf, Greenfield & Sacks, P.C. (Boston, MA)

Uma N. Everett
Director
Sterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC)

Averie K. Hason
Assistant General Patent Counsel, IP Litigation NY/NJ
Eli Lilly and Company (Bridgewater, NJ)

Moderator:

Joseph Evall
Partner
Gibson, Dunn & Crutcher LLP

  • Understanding which post-approval activities fall within the scope of the safe harbor per Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc
  • Revisiting the pre-approval v. post approval debate under 271(e)(1)
  • Examining the state of the law on divided infringement and its implications for Hatch-Waxman
    • Akamai standard
    • Eli Lilly and Company v. Teva Parenteral Medicines, No. 10-1376, S.D. Ind, Fed. Cir. Appeal No. 15-2076
  • Examining the nexus between these two categories of infringement
  • Exploring scenarios in which infringement can be alleged through safe harbor violation and inducement
    • e.g., method of manufacture patent with foreign manufacturers, finishers and US distributors

9:00
The PTAB Live: Thoughts on Practice, Procedure, IPRs and More in the World of Pharmaceutical Patent Validity Challenges

Honorable Brian P. Murphy
Lead Administrative Patent Judge
Patent Trial and Appeal Board, USPTO (Alexandria, VA)

Honorable Kimberly McGraw
Administrative Patent Judge
Patent Trial and Appeal Board

United States Patent and Trademark Office (Alexandria, VA)

Honorable Rama G. Elluru
Administrative Patent Judge
Patent Trial and Appeal Board, USPTO (Alexandria, VA)

Moderator:

Ralph J. Gabric
Shareholder
Brinks Gilson & Lione (Chicago, IL)

Filko Prugo
Partner
O’Melveny & Myers LLP (New York, NY)

IPRs have become an important component in 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.

10:00
Morning Coffee Break
10:15
Alternate Forums for Pharmaceutical Patent Challenges

PTAB Pharmaceutical Patent Invalidity Round-Up: Update on Wins, Losses and Appeals

Joshua P. Davis
Partner
Reed Smith LLP (Huston, TX)

Laura A. Lydigsen
Shareholder
Brinks Gilson & Lione (Chicago, IL)

Gregory A. Morris, Ph.D.
Partner, Leader, Life Sciences Litigation Practice Group
Honigman Miller Schwartz and Cohn LLP (Chicago, IL)

Pearl T. L. Siew
Senior Vice President and Head, Intellectual Property
Eagle Pharmaceuticals, Inc. (Woodcliff Lake, NJ)

Moderator:

Stephen C. Stout, Ph.D.
Partner
Vinson & Elkins LLP (Austin, TX )

  • Survey of notable wins and losses at the PTAB
    • IPR vs. PGR vs. CBM
    • Altaire Pharmaceuticals, Inc. v. Paragon BioTeck Inc.
  • Examining statistics for types of challenges bought and types of patents challenged
  • Developing parallel proceedings protocols
  • Analyzing Federal Circuit decisions relative to pharmaceutical patent challenges brought at the PTAB
    • understanding the impact of Cuozzo affirming broadest reasonable interpretation
  • Exploring impact of PTAB rules package and status of pending cases impacting new rules
    • In re Aqua; motion to amend
  • Update on activity of reverse patent trolls
  • Status of pending patent reform legislation

11:00
Examining the ITC as an Alternate Forum in an ANDA Challenge

Brian Anderson
V.P. & Assist. General Counsel – IP Litigation
Allergan (Parsippany, NJ)

Wanda French-Brown
Counsel
Baker & Hostetler LLP (New York, NY)

Sheila N. Swaroop
Partner
Knobbe, Martens, Olson & Bear, LLP (Irvine, CA)

  • Analyzing the pro and cons of using the ITC in a Hatch-Waxman related pharmaceutical patent challenge
  • Examples of such proceedings and other lifesciences related proceedings where the ITC has been utilized
  • Determining if ITC 337 petitions are a viable means of protecting the patent life of pharmaceutical products in a Hatch-Waxman scenario

11:30
A Magistrate Judge’s Insights on ANDA Practice

Honorable Christopher J. Burke, U.S.M.J.
United States District Court
District of Delaware (Wilmington, DE)

Honorable Tonianne Bongiovanni, U.S.M.J.
United States District Court
District of New Jersey (Trenton, NJ)

Honorable Roy Payne, U.S.M.J.
United States District Court
Eastern District of Texas (Marshall, TX)

Moderator:

James M. (Jim) Lennon
Partner
Young Conaway Stargatt & Taylor, LLP (Wilmington, DE)

Robert D. Rhoad
Partner
Dechert LLP (Princeton, NJ)

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.

Magistrate Judges also work closely with District Judges on these matters. This panel of esteemed Magistrate Judges will offer their insights on these  matters and the art of Paragraph IV practice.

12:30
Networking Luncheon
1:30
FTC Keynote: Update on Reverse Payment Settlements and Other Antitrust Developments Concerning Brand Name and Generic Interests

Daniel Butrymowicz
Staff Attorney
Federal Trade Commission (Washington, DC)

It now been almost four years since the Supreme Court issued its seminal decision in Federal Trade Commission v. Actavis. which made it clear that pharmaceutical patent settlement agreements can violate the antitrust laws. Since the Actavis decision, There have been more than twenty government and private plaintiffs’ actions working their way through the courts, including the Federal Courts of Appeal and the California State Supreme Court.

This session will reflect on the lessons from the last four years. What are the key issues in analyzing settlement agreements post-Actavis? Which, if any, of these issues has been resolved? What issues remain in dispute? What are the arguments on each side of the issues? In sum, what’s the current state of play on “pay for delay”?

We will hear the perspectives of the FTC staff on these questions and more.

2:15
Reverse Payment Settlements: The Industry Response

Mark W. Ryan
Partner
Mayer Brown LLP (Washington, DC)

Jennifer C. Tempesta
Partner
Baker Botts LLP (New York, NY)

Don J. Mizerk
Partner
Husch Blackwell LLP (Chicago, IL)

In this interactive session, leading antitrust attorneys for brand name and generic drug manufacturers will respond to the FTC and explore industry challenges in light of recent court decisions and the Commission’s stance with respect to designing settlement agreements which will withstand FTC scrutiny, benefit the parties and receive a judicial blessing.

3:00
Networking Coffee Break
3:15
The REMS Conundrum: Exploring Challenges for Both Brands and Generics

Alan B. Clement
Partner
Locke Lord LLP (New York, NY)

Katharine R. Rice
Corporate Counsel
Gilead Sciences (Foster City, CA)

Tedd W. Van Buskirk
Partner
Lerner David Littenberg Krumholz & Mentlik, LLP (Westfield, NJ)

  • Overview of the REMS process and analysis of obstacles it poses to both brand name and generic manufacturers in a Hatch-Waxman scenario
  • Examining scenarios in which patent infringement can be alleged not only on the drug which is the subject of a REMS but on the REMS process itself
  • Exploring scenarios of FDA intervention in brand and generic discord in REMS design
  • Understanding antitrust implications
  • Status of pending legislative fix

4:00
Case Studies in New Ethical Developments Impacting Paragraph IV Practice

Aron Fischer
Partner
Patterson Belknap Webb & Tyler LLP (New York, NY)

James Kellerman
Vice President, Intellectual Property
Astellas (Northbrook, IL)

Mark Rachlin
Senior Patent Counsel-Litigation
GlaxoSmithKline (King of Prussia, PA)

David G. Conlin
Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (Boston, MA)

Moderator:

Benjamin C. Hsing
Partner
Baker & Hostetler LLP (New York, NY)

  • Exploring the status and significance of the USPTO’s proposed Rule to adopt the duty of disclosure under Therasense as an amendment to Rule 56
    • understanding the impact of this proposed Rule on Paragraph IV practice
  • Examining the new willfulness standard under Halo and understanding its application in a Hatch-Waxman scenario

5:00
Conference Ends

Workshop A – IPR Strategies and Parallel Proceedings Master Class: Devising Strategies for IPR Best Practices and Navigating Dual Forums in Hatch-Waxman Litigation

Apr 26, 2017 8:30am - 12:00pm

$600

Speakers

Vishal C. Gupta
Partner
Steptoe & Johnson LLP (New York, NY)

Laura A. Vogel
Partner
Barclay Damon LLP (Boston, MA)

Ha Kung Wong
Partner
Fitzpatrick, Cella, Harper & Scinto (New York, NY)

Alyson L. Wooten PharmD
Attorney
Kilpatrick Townsend & Stockton LLP (Atlanta, GA)

What is it about?

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 dual proceedings in both the District Court and PTAB.

 

  • 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
    • stay pros and cons
  • 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 forward

Workshop B – Biosimilars 2.0 for the Paragraph IV Litigator

Apr 26, 2017 1:00pm - 4:30pm

$600

Speakers

Corey M. Casey
Shareholder
Polsinelli PC (Kansas City, MO)

Erin Ator Thomson
Counsel
Vinson & Elkins LLP (Austin, TX )

What is it about?

Despite the fact that BPCIA litigation has been filed and that a few decisions have been rendered notably in one case, Amgen v. Sandoz, we are still only at the beginning of beginning.

In this hands-on session, we will walk you through the first of the biosimilars cases which have been filed and will also take a look at the approval process and other key points of regulation.

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:

  • Reviewing the BPCIA cases filed to date and analyzing the substantive arguments in the first cases
    • Sandoz v. Amgen
    • Celltrion v. Janssen
  • 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
  • Analyzing the use of PTO Proceedings in biosimilars litigation
  • Developing patent certainty: factoring the decisions in the BPCIA case into BLA versus biosimilar application analysis and into forum choice between District Courts, USPTO, and the ITC

 

* Luncheon will be served at 12:00 PM for delegates who are attending both Workshop A and Workshop B.

ELITEPASS: Both Workshops

Apr 26, 2017 8:30am -

$1,200