Day 1 - Monday, June 13, 2016

8:00
Registration and Continental Breakfast – Sponsored by:
9:00
Co-Chairs’ Opening Remarks
9:15
Strengthening Your Regulatory Biosimilars Strategy for Interchangeability, Naming, and More in an Uncertain Landscape
10:30
Morning Refreshment Break – Sponsored by:
10:45
Case Study: Amgen Inc. v. Sandoz Inc. and the Impact on the Patent Dance and the Notice of Commercial Marketing
12:15
Networking Luncheon – Sponsored by:
1:30
Charting State Regulation: Sailing Through the Murky Waters of State Laws Affecting Biosimilars
2:30
Demystifying IPRs for Effective Use in the Biosimilars Landscape
4:00
Afternoon Refreshment Break – Sponsored by:
4:15
Spotlight on the Judiciary: Lessons Learned for Biosimilars Litigation
5:15
Conference Adjourns to Day TwoCocktail Reception – Sponsored by:

Day 2 - Tuesday, June 14, 2016

7:45
Continental Breakfast – Sponsored by:
8:15
Co-Chairs’ Opening Remarks and Recap of Day 1
8:30
FTC Keynote Address
9:00
New Considerations for Practical Commercial Strategies and Debating the Economic Viability of Biosimilars
10:00
Morning Refreshment Break – Sponsored by:
10:30
Mapping Out the BPCIA Process: A Cheat Sheet on Navigating the Biosimilars Pathway
12:00
Networking Luncheon – Sponsored by:
1:45
Exploring the Strategic Implications of the Transition from NDA Approval to BLA Licensure
2:00
Section 101 and Written Description issues in Biologic Products – Prosecutor and Litigator Perspectives
3:15
Afternoon Refreshment Break – Sponsored by:
3:30
Developing Real World Strategies for Marketing and Promoting a Biosimilar: Distinguishing the Biosimilar From the Reference Product
4:30
Comparing and Contrasting the US and Global Biosimilars Experience
5:30
Conference Adjourns

Day 3 - Wednesday, June 15, 2016

9:00
Legal Ethics and Professional Responsibility: Avoiding Conflicts of Interest, Maintaining Confidentiality, and Other Special Concerns for the Biosimilars Space

Day 1 - Monday, June 13, 2016

8:00
Registration and Continental Breakfast – Sponsored by:

9:00
Co-Chairs’ Opening Remarks

Betty Ryberg
Senior Counsel, Patents & IP
West Pharmaceutical Services, Inc. (Exton, PA)

Donald R. Ware
Partner and Chair of Intellectual Property Department
Foley Hoag LLP (Boston, MA)

9:15
Strengthening Your Regulatory Biosimilars Strategy for Interchangeability, Naming, and More in an Uncertain Landscape

Bruce A. Leicher
Senior Vice President and General Counsel
Momenta Pharmaceuticals (Cambridge, MA)

John Klimek R.Ph.
Senior VP, Standards and Information Technology
National Council for Prescription Drug Programs (“NCPDP”) (Scottsdale, AZ)

Thomas Felix MD
Medical Director, R&D Policy Global Regulatory Affairs and Safety
Amgen Inc. (Washington, DC)

Moderator:

Lisa Barclay
Partner
Boies, Schiller & Flexner, LLP (Washington, DC)

  • Status of current FDA regulations affecting biosimilars
  • Examining the FDA’s potential requirements for interchangeability
    • Analyzing citizen petitions from the industry on interchangeability
      and similarity requirements
  • Resolving whether a biosimilar must be interchangeable for all of the
    indications that a reference product is approved for by the FDA
  • Dissecting FDA’s draft guidance on the Nonproprietary Naming of
    Biological Products
    • Exploring industry comments to the draft guidance
    • Reviewing the FTC’s comments on the FDA’s naming guidance
    • Forecasting the impact on the global market
    • Identifying the impact of FDA’s draft guidance on the name of the
      first U.S. biosimilar—filgrastim-sndz
    • Evaluating the benefits and drawbacks of using a distinct nonproprietary name to distinguish biosimilars from reference products
    • Comprehending the WHO’s approach to naming of biosimilars and
      how it differs from the FDA’s draft guidance
    • Understanding the risks and benefits of having the biosimilar separately identifiable by its name from the reference product
  • Developing best practices for moving ahead despite uncertainty
    stemming from draft FDA guidances
  • Distinguishing the various stages of the Biosimilar Product Development Program meetings and what happens in each stage
  • Preparing for an Advisory Committee meeting for biosimilar review

10:30
Morning Refreshment Break – Sponsored by:

10:45
Case Study: Amgen Inc. v. Sandoz Inc. and the Impact on the Patent Dance and the Notice of Commercial Marketing

Jonathan Bachand
Partner
Knobbe, Martens, Olson & Bear, LLP (Washington, DC)

Mark I. Bowditch
Vice President of Intellectual Property and Litigation
Coherus BioSciences, Inc. (Redwood Shores, CA)

Robert S. Schwartz Ph.D.
Partner
Fitzpatrick, Cella, Harper & Scinto (New York, NY)

Donald R. Ware
Partner and Chair of Intellectual Property Department
Foley Hoag LLP (Boston, MA)

In July 2015, the Federal Circuit held in Amgen Inc. v. Sandoz Inc. that the BPCIA did not require the biosimilar applicant and the reference product sponsor to engage in the patent dance. The court also found that the notice of commercial marketing was required where the biosimilar applicant did not engage in the patent dance and that such notice could only be given after FDA approval of the biosimilar product. Despite the Federal Circuit’s ruling, much uncertainty still exists in the industry regarding the patent exchange process and the 180-day notice of commercial marketing. After the Federal Circuit’s denial of petitions for an en banc rehearing in October, a petition for certiorari was filed with the Supreme Court. Meanwhile, the industry is left assessing the repercussions of the Federal Circuit’s decision.

This case study of the Amgen Inc. v. Sandoz Inc. decision will explore the ramifications on the patent process in the biosimilars industry. Points of discussion shall include:

  • Reviewing the Federal Circuit’s final holding in Amgen Inc. v.
    Sandoz Inc.
  • Delving into other biosimilars cases interpreting the BPCIA
    • Amgen Inc. v. Apotex Inc. and Janssen Biotech Inc. v. Celltrion Healthcare Co. Ltd.: is the 180-day notice of commercial marketing mandatory where the parties engaged in the patent dance?
      • If mandatory, when is the earliest that a biosimilar applicant can give notice to the reference product sponsor?
    • Amgen Inc. v. Hospira Inc.: if participating in the patent dance, how much information must you provide in order to be compliant with the BPCIA provisions
    • Janssen Biotech Inc. v. Celltrion Healthcare Co. Ltd. and Immunex v. Sandoz: is it mandatory to complete all steps of the patent dance, once started?
  • What are the risks and benefits for both parties of engaging in the patent dance?
  • Exploring various strategies to minimize litigation risk if you are filing a biosimilars application

12:15
Networking Luncheon – Sponsored by:

1:30
Charting State Regulation: Sailing Through the Murky Waters of State Laws Affecting Biosimilars

John J. Lewis
Senior Vice President, Policy & Public Affairs
Association of Clinical Research Organizations (“ACRO”) (Washington, DC)

Brynna Clark
Senior Director, State Affairs
Generic Pharmaceutical Association (“GPhA”) (Washington, DC)

  • Revisiting the relationship between FDA’s upcoming guidance on interchangeability and state substitution laws and understanding the types of biosimilars that would and would not be eligible for substitution
  • Identifying the different states with legislation regulating biosimilars especially pertaining to substitution and interchangeability
  • Monitoring other states that are expected to pass laws impacting the biosimilars landscape
  • Addressing how states have determined whether physicians should be notified in case of a substitution by the pharmacy
    • Understanding whether pharmacists can automatically substitute a prescription for a biosimilar
    • How should the pharmacist notify the physician of the substitution?
    • Exploring pharmacist record keeping requirements under various state substitution laws

2:30
Demystifying IPRs for Effective Use in the Biosimilars Landscape

Barbara A. Fiacco
Partner
Foley Hoag LLP

Mark E. Waddell
Partner and Chair, Patent Litigation and Counseling
Loeb & Loeb LLP (New York, NY)

Stacie L. Ropka PhD
Counsel
Axinn, Veltrop & Harkrider LLP (Hartford, CT)

Gregory A. Morris
Partner
Honigman Miller Schwartz and Cohn LLP

Moderator:

J. Patrick Elsevier Ph.D.
Partner
Jones Day (San Diego, CA)

  • Cuozzo Speed Technologies, LLC v. Lee: examining the proper standard to construe patent claims
    • Reviewing the differences between the broadest reasonable interpretation standard and the Phillips standard and how each standard impacts biosimilar strategies
  • Analyzing IPR trends and statistics in the pharmaceutical industry
    • Are IPRs the “death squad” for life sciences patents?
    • When are IPRs an effective tool for the life sciences industry?
  • Preparing strategies for an IPR versus litigating in federal court
    • What are the pros and cons of using an IPR in the biosimilar context?
    • Understanding how IPR proceedings affect patent practice before the USPTO while also serving as a parallel or alternate administrative venue to district court litigation
    • Choosing your forum wisely: comprehending how estoppels, timing, and costs can cause IPRs to work for or against the biosimilars industry
  • Exploring IPR cases in the life sciences context where PTAB has declined to review to develop strategies for successful arguments
  • Best practices for appearing before the PTAB

4:00
Afternoon Refreshment Break – Sponsored by:

4:15
Spotlight on the Judiciary: Lessons Learned for Biosimilars Litigation

Honorable Faith S. Hochberg (ret.)

U.S. District Court, District of New Jersey

Honorable Jacqueline Wright Bonilla
Lead Administrative Patent Judge Patent Trial and Appeal Board
US Patent and Trademark Office (Alexandria, VA)

Moderator:

Irena Royzman Ph.D.
Partner & Co-Chair of Biotechnology Practice
Patterson Belknap Webb & Tyler LLP

In this session, distinguished judges experienced in pharmaceutical patent litigation will provide their insights concerning claim construction, seeking injunctions, parallel USPTO proceedings, motion practice, settlement

5:15
Conference Adjourns to Day TwoCocktail Reception – Sponsored by:

Day 2 - Tuesday, June 14, 2016

7:45
Continental Breakfast – Sponsored by:

8:15
Co-Chairs’ Opening Remarks and Recap of Day 1

Betty Ryberg
Senior Counsel, Patents & IP
West Pharmaceutical Services, Inc. (Exton, PA)

Donald R. Ware
Partner and Chair of Intellectual Property Department
Foley Hoag LLP (Boston, MA)

8:30
FTC Keynote Address

Elizabeth A. Jex
Attorney Advisor, Office of Policy Planning
Federal Trade Commission (Washington, DC)

9:00
New Considerations for Practical Commercial Strategies and Debating the Economic Viability of Biosimilars

Patrick C. Woolley
Partner and Practice Group Chair
Polsinelli PC (Kansas City, MO)

Gabriel Kleiman
Assistant General Counsel
Pfizer Inc. (New York, NY)

Joseph P. Fuhr Jr., Ph.D.
Professor, Economics
Widener University (Chester, PA)

  • Exploring the different financial incentives to develop biosimilars in Europe and taking away key lessons for the U.S. market
  • Comparing different partnerships, collaborations, and joint ventures with other biotech or pharmaceutical companies to develop a biosimilar
  • Analyzing the current U.S. innovator biologics products pipeline and revenue
    • Discussing which biologics are particularly vulnerable to biosimilars competition going forward
  • Scrutinizing the numbers: how much does a biosimilar need to make in order to be profitable?
    • Determining the potential value of biosimilars revenue based on relevant IP, regulatory, and commercial factors
    • Reviewing estimated development costs and amount of production capital needed
  • Pricing considerations: biosimilar prices versus reference product prices
  • Comprehending CMS guidance documents relating to payment, pricing, and reimbursement policies for biosimilars
  • Investigating the economic implications of CMS allowing one J code for biosimilars and reference products

10:00
Morning Refreshment Break – Sponsored by:

10:30
Mapping Out the BPCIA Process: A Cheat Sheet on Navigating the Biosimilars Pathway

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

Anita Varma
Partner
Ropes & Gray LLP (Boston, MA)

Carol Pitzel Cruz
Partner
Knobbe, Martens, Olson & Bear, LLP (Seattle, WA)

Chad A. Landmon
Partner
Axinn, Veltrop & Harkrider LLP (Hartford, CT & Washington, DC)

Christine Willgoos
Special Counsel
Kramer Levin Naftalis & Frankel LLP (New York, NY)

  • Making the decision to navigate the pathway by comparing and contrasting the biosimilars pathway under the statute to 505(b)(2) and BLA pathways including timing, costs, IP litigation considerations, and exclusivities
  • Evaluating the patents in your portfolio which may be the subject
    of litigation
    • Performing the required due diligence ahead of time
  • Understanding the Purple Book provisions on biosimilar and interchangeable products
    • Using the Purple Book to create “slates” of suggested patents
      or deciding which patents to challenge
  • Exploring whether to provide a (k) application and if so, determining
    what other information to provide
    • Preparing the initial patent list and non-infringement and validity
      contentions in advance
    • Comprehending the potential consequences of the Reference Product Sponsor not responding with a detailed claim-by-claim response
  • Updating the BPCIA timeline
    • Comprehending what has worked for biosimilars applicants and the RPS in the first wave of litigation and analyzing what to expect in the second wave
    • Identifying strategic considerations for deciding whether to limit the
      number of patents the RPS can assert in the early phases of litigation
    • Vetting your patents to decide which ones to assert in the first wave
      of litigation versus the second wave of litigation
  • Examining whether it is possible to litigate patents prior to filing
    a biosimilars application
  • Review of most recent at-risk launches in the Hatch-Waxman context to glean lessons for the biosimilars landscape
    • Are at-risk launches possible for biosimilars?
    • Conducting a benefits analysis of launching at risk during the trial
      or appeal period
    • Asserting damages in an at-risk scenario for biosimilars
    • Mitigating factors impacting damage award

12:00
Networking Luncheon – Sponsored by:

1:45
Exploring the Strategic Implications of the Transition from NDA Approval to BLA Licensure

Gregory J. Glover MD
Principal
Pharmaceutical Law Group PC (Washington, DC)

Under the provisions of the BPCIA, a number of products that are currently approved under NDAs and ANDAs will be deemed to have approved BLAs in March 2020. The introduction of new versions of these products will now require licensure under a full BLA or as a biosimilar. FDA has recently issued a guidance regarding this transition, including the agency’s interpretation of the application of exclusivity provisions to products deemed to have an approved BLA. This session will explore the implications of the transition for exclusivities, generic drugs, and biosimilars. The discussion will highlight the need for careful strategic analysis to understand exclusivity issues and the opportunities for competitive product entry.

2:00
Section 101 and Written Description issues in Biologic Products – Prosecutor and Litigator Perspectives

Leslie Fischer Ph.D., J.D.
Senior Patent Attorney
Novartis Pharmaceuticals Corporation (East Hanover, NJ)

John J. Molenda Ph.D., J.D.
Partner and Co-Chair, Healthcare & Life Sciences Industry Group
Steptoe & Johnson LLP (New York, NY)

Kathleen A. Ranney J.D.
Senior Patent Counsel
Eisai, Inc. (Andover, MA)

Moderator (and Speaker):

Betty Ryberg
Senior Counsel, Patents & IP
West Pharmaceutical Services, Inc. (Exton, PA)

  • Section 101 Issues in Biologics Patent Applications
  • The scope of patent protection that can be obtained in the biosimilars context in light of the USPTO’s July 2015 guidance on patent subject matter eligibility
    • USPTO’s Current Guidance
    • Examples
    • Overcoming rejections
  • Section 101 Issues in Litigation
    • Compounds, Compositions
    • Methods of Administration, Diagnostic Methods
  • Abbvie v. Janssen and Implications for Written Description in Biologics Patent Applications
    • Comprehending and applying the current standard for written description in view of the AbbVie case
    • Demonstrating structural diversity
  • Strategic considerations in litigating written description issues in
    biologics litigation
    • Formulating written description arguments, with a focus on
      monoclonal antibodies
      • How many examples are enough to demonstrate representative species
      • Challenges in showing common structural features
    • Key evidentiary issues arising in the written description context

3:15
Afternoon Refreshment Break – Sponsored by:

3:30
Developing Real World Strategies for Marketing and Promoting a Biosimilar: Distinguishing the Biosimilar From the Reference Product

Jenevieve J. Maerker
Attorney
Foley Hoag LLP (Boston, MA)

Sarah K. Frederick
Partner
Goodwin Procter LLP (New York, NY)

Jennifer Zarutskie Sieczkiewicz Ph.D., J.D.
Research and Business Development Counsel
Biogen Inc. (Cambridge, MA)

  • Distinguishing one biosimilar from another biosimilar treating the same condition through innovative marketing and promotion principles
    • What is the impact of Amarin Pharma, Inc. v. FDA on off-label marketing of biosimilars?
  • Preparing for products liability claims based on the marketing and promotion of biosimilars
  • Best practices for preserving trademark rights for biosimilar products

4:30
Comparing and Contrasting the US and Global Biosimilars Experience

Dominic Adair
Partner
Bristows LLP (London, UK)

Christopher P. Borello
Partner
Fitzpatrick, Cella, Harper & Scinto (New York, NY)

Rachel Moodie
European Patent Attorney, Biologics
Teva Pharmaceuticals (Basel, Switzerland)

Julia Pike
Vice President of IP, North America
Sandoz Inc. (Munich, Germany)

Siegmund Y. Gutman
Partner
Proskauer Rose LLP (Los Angeles, CA)

As established and emerging markets look increasingly towards the biosimilar landscape as a way of cutting costs, the U.S. process can be drastically different from the way that major international markets regulate biosimilars. Given the lack of international harmonization, there has never been a more important time to master the finer points of global biosimilars compliance.

  • Regional updates:
    • Asia – Japan and South Korea
    • Australia
    • Europe
    • Latin America
  • How is interchangeability treated outside of the United States?
  • How do different nations try to replicate the brand drug-generic drug relationship with biosimilars?
  • Preparing your global biosimilars portfolio to coordinate regulatory and litigation strategies and positions in a global setting
  • Examining key international biosimilars litigation to take away strong arguments and defenses
  • Surveying biosimilars approvals to date in the global market
  • Exploring lessons learned in the international framework:
    • Regulatory policies
    • Commercial and economic strategies

5:30
Conference Adjourns

Day 3 - Wednesday, June 15, 2016

9:00
Legal Ethics and Professional Responsibility: Avoiding Conflicts of Interest, Maintaining Confidentiality, and Other Special Concerns for the Biosimilars Space

Michael E. McCabe Jr.
Member
Funk & Bolton P.A. (Baltimore, MD)

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

  • Avoiding conflicts of interest as the lines between branded companies and generic companies blur in the biosimilars space
    • Overview of the Rule 11 mandates
    • What is the duty of care required?
    • Law firms representing both reference products and biosimilars: will the arguments you made in one case come back to haunt you in another?
    • Applying traditional conflicts analysis and principles when agreeing to work for a client: are ABA comments to the model rules instructional?
  • Navigating the tricky confidentiality issues inherent in the dossier exchange process under the BPCIA
    • How do you use the information that you get access to during the patent dance?
    • Maintaining required confidentiality while advocating for your company or client
    • What are the limitations of disclosure of biosimilar applications?
    • Obtaining the help of an outside expert or technical specialist
  • USPTO spotlight: What are OED’s expectations of attorneys in this space?
    • Understanding when to raise the inequitable conduct defense under the continually evolving Therasense standard
    • Rule 36 affirmations of inequitable conduct cases
    • Update on recent relevant inequitable conduct cases
    • Complying with the USPTO duty of disclosure: what to submit and how much?
    • Analysis of the PTO’s 2013 Rules of Professional Conduct
    • Overview of key provisions including conflicts, sanctions and experts
    • How do these work with the ABA model rules and state bar rules?

​9:00 am – 12:00 pm (registration starts at 8:30 am)