Day 1 - Wednesday, June 4, 2014

9:00
Biosimilars 101: Comprehensive Deep Dive Into the Relevant Legal, Regulatory and Scientific Factors Companies Must Know
1:30
Biosimilars Around the World: A Regulatory and Patent Cheat Sheet to Maximize Global Biosimilars Market Share and Minimize Risk

Day 2 - Thursday, June 5, 2014

7:15
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks
8:30
Minimizing the Uncertainty Surrounding the Untested Pathway: Insight into FDA’s Current Position and Initiatives Regarding Biosimilars
9:30
Predicting Follow-On Entry and Evaluating the Risk and Commercial Opportunity in the Emerging Biosimilar Landscape
10:15
Morning Coffee Break
10:30
In-house Keynote: New Kid No More: Evolution in Biosimilars Science and Regulations
11:30
The Holy Grail for Biosimilars: Meeting FDA’s Requirements for Biosimilarity and the Heightened Standard of Interchangeability
12:15
Networking Luncheon
1:30
FTC Keynote: Revisiting Competition Issues in the Follow-on Biologics Arena: Substitution and Naming Conventions
2:00
Framing the State Law Issues: Attributing Adverse Events and Applying Interchangeability on the Pharmacy Level
2:30
Afternoon Refreshment Break
2:45
Industry Round Table: Weighing in on the Emerging Controversy on Biosimilars Naming and State Substitution Laws
4:00
The EU Experience: Regulatory and IP Lessons Learned So Far from the First Biosimilar Antibody Approval in Europe
5:00
Conference Adjourns to Day 2

Day 3 - Friday, June 6, 2014

7:45
Registration and Continental Breakfast
8:15
Co-Chairs’ Opening Remarks
8:30
Analyzing the Arguments in the First BPCIA Case, Sandoz Inc. v. Amgen Inc.: Immediate Action Plans for Innovators and Biosimilars to Prepare Before the First Application is Public
9:30
The Most Powerful Tool in Your Arsenal: Using Inter-Partes Review at the PTO to Revamp Branded and Biosimilar Litigation Strategies
10:30
Morning Coffee Break
10:45
Going Beyond the Hatch Waxman Comparisons: Delving into Pre-Suit Due Diligence and Pre-Litigation Tactics for Evaluating Patent Strength and Assertion Strategies
11:45
Platform Patents and Antibodies: Specific Action Plans to Protect or Defend Patents Most Ripe for a Biosimilars First Wave Challenge
12:30
Networking Lunch
1:45
Key IP Case Law Through the Biosimilars Lens: Top 5 Patent Battles to Consider When Updating Your Biosimilars Prosecution and Litigation Strategies
2:30
Case Spotlight: Momenta v. Amphastar and Bioequivalence: Understanding the Implications for the Future of Biosimilars
3:15
Afternoon Coffee Break
3:30
Timing is Everything: Managing the Logistics of the BPCIA Exchange Process and Preparing for “Early” and “Late” Phase Litigation
4:15
Ethics in the Biosimilars Realm: Avoiding Conflicts and Maintaining Confidentiality in the Brave New World
5:15
Conference Adjourns

Day 1 - Wednesday, June 4, 2014

9:00
Biosimilars 101: Comprehensive Deep Dive Into the Relevant Legal, Regulatory and Scientific Factors Companies Must Know

Brian J. Malkin
Senior Counsel
McGuireWoods LLP

Scott M. Lassman
Partner
Kleinfeld, Kaplan & Becker, LLP

Gillian Woollett MA, DPhil
Senior Vice President
Avalere Health (Washington, DC)

Designed for both newcomers to the biosimilars space and for seasoned small molecule attorneys looking to transition into a mixed small and large molecules space, this intensive session will give attendees a chance to get up to speed on the current biosimilars landscape. This session will focus on the scientific challenges inherent to biosimilars development which are essential for both innovators and biosimilars to know when formulating a dynamic regulatory or patent strategy. Setting the stage for the topics to be discussed in-depth through the rest of the conference, our session leaders will give an up-to-the-moment treatise on the significant regulatory and IP developments which will help attendees refine their approach to biosimilars in anticipation of the first applications and litigation. Topics to be discussed include:

Scientific Considerations:

  • Diving into the science of biologics and biosimilars: what attorneys need to know about developing and manufacturing biologics and biosimilars when formulating a multifaceted biosimilars regulatory and patent strategy
    • Overview of the key differences between drugs and biologics
      • Living organisms versus chemically synthesized molecules
      • Types of biologics which may be ripe for a biosimilar including monoclonal antibodies, therapeutic proteins, and vaccines going off patent soon
    • Appreciating the impact of changes in structure, formulation, or impurities on biologic products and understanding how this affects immunogenicity
      • Structure / function relationships
      • Manufacturing issues and drift
      • Drug delivery mechanisms
      • Breaks in cold handling chain
      • Improper patient storage and handling
    • Substituting the biosimilar at the pharmacy level: what will it take to make interchangeability possible?
      • Methods for demonstrating safety and efficacy in a biosimilar product
      • Structuring clinical trials and safety studies
    • Determining what may constitute a “biobetter” and choosing whether to seek pure “biosimilarity” or an improved “biobetters” product or both

Background on legal and regulatory developments:

  • Comparing and contrasting the biosimilar pathway to 505(b)(2) v 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
  • Anticipating how the 12 year exclusivity proposed by the Trans-Pacific Partnership (TPP) trade agreement will interact with biosimilars statutory exclusivity
  • Reading the tea leaves and recapping the statements and guidance issued by FDA post-BPCIA: what are the open questions and when is final guidance expected?
    • August 2011 New England Journal of Medicine article
    • February 2012 three-part guidance pertaining to scientific and quality considerations in demonstrating biosimilarity to a reference product
    • March 2013 guidance regarding closed-door meetings and biosimilars user fees
  • Update on the closed door meetings between manufacturers and FDA and the case-by-case review: anecdotal tales of the FDA’s “totality of the evidence” approach
  • Breakdown of applicable state biosimilars bills affecting substitution at the pharmacy
  • Factoring key cases and legal developments into your biosimilars strategy
    • Sandoz v. Amgen- the first BPCIA case
    • Momenta v. Amphastar and the safe harbor
    • Abbott Citizen’s Petition: is retroactively applying a new set of laws an unconstitutional taking?

9:00am - 12:00pm (Registration begins at 8:30am)

1:30
Biosimilars Around the World: A Regulatory and Patent Cheat Sheet to Maximize Global Biosimilars Market Share and Minimize Risk

Michael J. Wise
Partner
Perkins Coie LLP

Lisa L. Mueller
Partner
Michael Best & Friedrich LLP (Chicago, IL)

In this highly interactive session, leading patent practitioners and patent attorneys on the ground in key markets will give you a comprehensive breakdown to assist you in protecting your IP and minimizing regulatory risk when developing biosimilars internationally. The information our session leaders will provide you in this session is more crucial than ever, as it is still an open question whether and to what extent the FDA will accept foreign safety data, and proactive companies are testing the waters globally as the US biosimilars pathway is fleshed out. Topics to be discussed include:

  • Overview of the nearly $4 billion global biosimilars market and the key players outside of the US and EU which will be the focus of this session:
    • Australia
    • Canada
    • China
    • India
    • Korea
    • Latin America (Brazil, Columbia, Peru)
    • Mexico
    • Nigeria
    • Russia
    • Turkey
  • Navigating the regulatory pathway (or other route to approval) and calculating data exclusivity and patent terms in these countries and regions
  • Going over country-specific definitions: what is a biosimilar? What is a reference product?
  • Selecting a reference product and conducting a comparability study to establish quality, safety, and efficacy
  • Determining which clinical and non-clinical studies will need to be conducted in order to gain marketing approval in that jurisdiction
  • Setting up an appropriate risk management and pharmacovigilance plan
  • What are the applicable GMP rules?
  • Update on the key cases in global biosimilars litigation and preparing your US portfolio to coordinate litigation strategies and positions in a global setting
    • What are the strong arguments and defenses being used in global biosimilars litigation (ie obviousness, patentability, indefiniteness)?
    • Reframing freedom-to-operate analyses to take global positions and decisions into account
    • Exploring the potential role of the ITC in global biosimilars disputes

1:30pm - 4:30pm (Registration begins at 1:00pm)

Day 2 - Thursday, June 5, 2014

7:15
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks
8:30
Minimizing the Uncertainty Surrounding the Untested Pathway: Insight into FDA’s Current Position and Initiatives Regarding Biosimilars

Paul Kim
Partner
Foley Hoag LLP (Washington, DC)

• Recapping the 2012 and 2013 draft guidance and discussing the status of final guidance

• Three years post BPCIA: How are companies communicating with the FDA and handling the open questions from the guidance?
o Demonstrating biosimilarity and interchangeability
o Clinical studies requirements
o Acceptance of foreign-sourced data and extrapolated data
o Naming
• What is the guidance coming out of the closed-door development meetings between industry and FDA?
• Forecasting the future of biosimilars: when will we see the first application?

9:30
Predicting Follow-On Entry and Evaluating the Risk and Commercial Opportunity in the Emerging Biosimilar Landscape

Henry G. Grabowski
Professor Emeritus and Director of Program in Pharmaceutical Health Economics
Duke University, Department of Economics (Durham, NC)

Naomi Pearce
VP, IP Counsel and Director, Global Biologics Centre of Excellence
Mylan (Canonsburg, PA)

Vincent L. Capuano Ph.D.
Partner
Duane Morris LLP

D. Christopher Ohly
Intellectual Property Law Professional
(Washington, DC)

• Which biologics are particularly vulnerable to biosimilar competition?

o How much money is there in the current biologics market?
o Examining the drivers shaping the biosimilars market globally
o Factoring in the “patent cliff ” and shifting industry dynamics which may make biosimilars even more attractive
• Cost-benefit analysis: Determining the potential value of biosimilars revenue based on relevant IP, regulatory, and commercial factors
o Estimated development costs and production capital needed
o Pricing considerations for follow-on products: how similarly will the biosimilar need to be priced to the branded product?
o Estimating market penetration for biosimilar products
o Reimbursement and insurance issues: how will the ACA affect the nascent biosimilars market?
• Which companies are emerging as the key players?
• Exploring the unique alliances forming in the market: who has the manufacturing capability and capital to produce and commercialize a biosimilar?
o Update on the key collaborations to date: which have fallen through and which are still going?
o Let’s make a deal: strategies for both innovators and biosimilars while looking for potential partners or acquisitions to shore up their respective positions

10:15
Morning Coffee Break
10:30
In-house Keynote: New Kid No More: Evolution in Biosimilars Science and Regulations

Joerg Windisch PhD
Chief Science Officer
Sandoz Biopharmaceuticals (Kundl, Austria)

11:30
The Holy Grail for Biosimilars: Meeting FDA’s Requirements for Biosimilarity and the Heightened Standard of Interchangeability

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

Shefali Kakar
Senior Director, Clinical Pharmacology
Novartis (East Hanover, NJ)

• Understanding FDA’s current guidance on biosimilarity and interchangeability: what are the expectations?

o How do the FDA guidelines define “highly similar”?
o Appreciating that the U.S. biosimilars law is the only one with a definition of interchangeability included
o Determining whether a compound is equally effective or biobetter
• Demonstrating biosimilarity: What exactly will a company need to show?
o Putting together a step-wise approach to meet FDA’s totality of the evidence standard
o Showing safety and efficacy through clinical trials: Looking to innovators’ trial design and endpoints
o Extrapolating data: what will be acceptable? (i.e. between populations within indications? Across unrelated indications?)
o To what extent will bridging studies of ex-US data be acceptable?
o What are companies doing in the absence of final guidance?
• Debating whether interchangeability is even possible in light of current technology
o Maintaining an interchangeability determination over time: how will changes to the manufacturing process affect this?

12:15
Networking Luncheon

Sponsored by: 

1:30
FTC Keynote: Revisiting Competition Issues in the Follow-on Biologics Arena: Substitution and Naming Conventions
2:00
Framing the State Law Issues: Attributing Adverse Events and Applying Interchangeability on the Pharmacy Level

Kimberly Greco
Director, Regulatory Affairs
Amgen (Thousand Oaks, CA)

2:30
Afternoon Refreshment Break
2:45
Industry Round Table: Weighing in on the Emerging Controversy on Biosimilars Naming and State Substitution Laws

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

Emily A. Alexander
Director, External Affairs, Biologics Strategic Development
AbbVie, Inc.

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

Kimberly Greco
Director, Regulatory Affairs
Amgen (Thousand Oaks, CA)

Jocelyn Ulrich MPH, RAC
Director, Scientific and Regulatory Affairs
Pharmaceutical Research and Manufacturers of America (PhRMA) (Washington, DC)

Joerg Windisch PhD
Chief Science Officer
Sandoz Biopharmaceuticals (Kundl, Austria)

Moderator:

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

• Analyzing the continued debate and controversy in the biosimilars naming process

o Overview of the Citizen’s Petitions and related docket comments regarding naming
o Overview of current pharmacovigilance practices in U.S.
o The benefits and drawbacks of using a distinct nonproprietary name to distinguish biosimilars from reference products
o Exploring whether the use of a distinct nonproprietary name
will affect biosimilar uptake
o How distinct will the biosimilar product name have to be from
the original in order to facilitate traceability?
o Relationship between naming and product labeling
• Update on state laws regarding interchangeable biosimilar substitution: which states have weighed in to date?
o What should be required for notification?
o Record keeping: to what level should pharmacists be required to keep records?
o Responding to alleged anti-competitive effect of notification provisions
• Additional interchangeability issues related to biologics
o Concept of “drift” or product evolution
o Similarity of device for self-injectable/self-use biologics
o Scope of FDA authority over interchangeability designations (e.g., could a product be interchangeable for only certain indications or patient populations)?

4:00
The EU Experience: Regulatory and IP Lessons Learned So Far from the First Biosimilar Antibody Approval in Europe

Eva Geschke
Partner
Wildanger Kehrwald Graf von Schwerin & Partner mbB (Duesseldorf, Germany)

Magdalena Leszczyniecka
President and CEO
STC Biologics (Cambridge, MA)

Lorna Brazell
Partner
Osborne Clarke

• Shedding light on possible FDA guidance based on the biosimilars experience in the EU so far: how might the FDA follow the EMA’s lead?

o Considering whether bridge studies may be appropriate in support of approval of a biosimilar product by the FDA, and if so, to what extent
o Any adverse events or safety signals to date from the biosimilars on market which American companies should prepare to address?
• Recapping the current EMA policies on substitution, interchangeability, and naming: going over the rules, communications by EMA, and product specific guidelines
o The degree of structural differences acceptable for a biosimilar especially differences in the amino acid sequence from the reference product
• Conducting comparability studies with monoclonal antibodies: what it took to gain approval
• How successful have biosimilar launches been in the EU so far, and what is the market uptake?
o Studying approvals to date: what have the actual costs been and what are expected profits?
o What price differentials are being seen in the EU?
• Update on global biosimilars litigation: preparing your US portfolio in light of what defenses and strategies are being used in EU biosimilars litigation
o Reframing freedom-to-operate analyses to take global positions and decisions into account

5:00
Conference Adjourns to Day 2

Day 3 - Friday, June 6, 2014

7:45
Registration and Continental Breakfast
8:15
Co-Chairs’ Opening Remarks
8:30
Analyzing the Arguments in the First BPCIA Case, Sandoz Inc. v. Amgen Inc.: Immediate Action Plans for Innovators and Biosimilars to Prepare Before the First Application is Public

Irene E. Hudson
Principal
Fish & Richardson P.C. (New York, NY)

Seth Fidel PhD
Lead IP Counsel
Merrimack Pharmaceuticals, Inc.

Donald Ware
Partner
Foley Hoag LLP

• Review of the case and Judge Chesney’s decision regarding the ability to bring a declaratory judgment action to invalidate patents pre-suit

o Examining Judge Chesney’s ruling that ruling that the Act
requires biosimilars maker to seek approval before filing suit
o What does this mean for biosimilars manufacturers looking to make early challenges to innovator patents?
o Anticipating a Circuit split: will proactive companies attempt to make this argument in other jurisdictions?
o Should innovators be wary of more “jump the gun” lawsuits like Sandoz v. Amgen to avoid the litigation dance?
• The patent dance macabre: Following the rules of the BPCIA and dealing with the strict litigation timelines and the patent exchange as outlined in the BPCIA
• Understanding what this means to the timing of patent filings: What must companies be doing now in light of Judge Chesney’s interpretation of the litigation timeline?
o Putting contingency plans in place now to comply with the strict timeframes
o Managing the logistics of the IP exchange process, given the extreme deadlines
o When should biosimilars give notice of application post- Sandoz?
o Is it even possible to comply with the rules and resolve litigation pre-launch under the rubric of this argument?
o Is filing a notice of commercial marketing early in the process still a viable strategy?
• Developing patent certainty: What does this mean for companies’
BLA versus biosimilar application analysis and for companies’ choice to bring quasi-litigation at the PTO?

9:30
The Most Powerful Tool in Your Arsenal: Using Inter-Partes Review at the PTO to Revamp Branded and Biosimilar Litigation Strategies

Eli A. Loots Ph.D.
Partner
Knobbe Martens Olson & Bear LLP

Raymond R. Mandra
Partner
Fitzpatrick, Cella, Harper & Scinto

Dorothy P. Whelan
Principal
Fish & Richardson P.C. (Minneapolis, MN)

Filko Prugo
Partner
O'Melveny & Myers LLP

Moderator:

Moderator: Teresa “Terry” Stanek Rea
Partner
Crowell & Moring LLP (Washington, DC)

• Anticipating how the complex patent resolution provisions in the BPCIA will interplay with the administrative patent validity proceedings at the PTO including:

o Inter-partes review (IPR)
o Post-grant review (PGR)
o Reexamination
o Supplemental examinations
o Derivation proceedings
• Adjudicating patent validity at the PTO level
o Deciding whether to forego the clear and convincing 
litigation standard in favor of the preponderance of the evidence standard
o Factoring in collateral estoppel considerations
o Parallel litigation in two forums: Creating a record in the patent office and managing multiple concurrent proceedings
• Making the timing work: Complying with the tricky timelines in the AIA while factoring in both the complex timeframes under the BPCIA and its statutory mandate that litigation be resolved prior to approval
• Lessons learned from the first life sciences IPRs which have been
filed: what are the benefits in the biosimilars context?
• The second wave of patent reform: understanding how the new
proposals modifying the AIA may affect the biosimilars strategies
you already have in place

10:30
Morning Coffee Break
10:45
Going Beyond the Hatch Waxman Comparisons: Delving into Pre-Suit Due Diligence and Pre-Litigation Tactics for Evaluating Patent Strength and Assertion Strategies

Matthew J. Becker
Partner
Axinn Veltrop & Harkrider LLP

Kenneth J. Dow
Assistant General Counsel- Patents
Johnson & Johnson (New Brunswick, NJ)

John D. Garretson
Partner
Shook, Hardy & Bacon L.L.P.

Mr. Mark Bowditch
Patent Atorney
(Former Exec. Dir., Head, Product Support Intellectual Property, Sandoz, Inc.)

Filko Prugo
Partner
O'Melveny & Myers LLP

​Innovators’ Considerations:

• Anticipating and preparing for first biosimilars challenges: what pre-litigation posturing should you be doing to fight the battle in advance of the notice letter?
• Evaluating the patents in your portfolio which may be the subject
of litigation and doing the required due diligence now
• Vetting your patents to determine which ones to assert in the first
wave versus the second
• Communicating with the relevant inventors and preparing them for potential litigation
• Understanding the importance of Patent Term Extension in a biosimilars scenario
• Creating your “slates” of suggested patents in the absence of an Orange Book
• Disclosing information about the patent manufacturing process in your future patent applications
o To what extent is the biologic reverse engineerable and how
will this affect interchangeability?
• Obtaining an injunction to shut down a potential biosimilar:
successful arguments for satisfying the elements of the four- prong test post-ebay
Biosimilars Considerations: Making the Decision to Navigate the Abbreviated Pathway
• Researching the patent landscape surrounding a particular drug: Real world patent search strategies for biosimilars to find weak claims
• Deciding which patents to challenge: Can the lack of an Orange Book work for you?
• Getting the timing right: how far in advance should you begin preparing for litigation?
• Avoiding contributory infringement when the FDA requires conducting trials, submitting studies, and requesting inclusion in
approval labels of indications that may be covered by 3rd party IP
• Minimizing confidentiality issues inherent in the statutory private
list exchange process

11:45
Platform Patents and Antibodies: Specific Action Plans to Protect or Defend Patents Most Ripe for a Biosimilars First Wave Challenge

Michael J. Brignati, Ph.D.
Associate General Counsel
The Pennsylvania State University Office of the General Counsel

Gregory A. Morris
Partner
Honigman Miller Schwartz and Cohn LLP

• Which types of patents are particularly vulnerable to a biosimilar

challenge?
o Early determination of which patents may be strategically asserted
o Beyond Cabilly: what are the next generation platform patents impacting the ability to bring antibodies to the market?
• Successful and practical strategies for developing and commercializing monoclonal antibodies
o Optimizing patent exclusivity for antibodies: figuring in PTE
considerations
o Determining appropriate claim scope and how broadly you
will have to claim to show interchangeability: functional / nonstructural claims and structurally defined claims
o Satisfying written description and enablement requirements in light of shifting 102 case law
o Figuring in post-KSR obviousness analysis while protecting
against designs-around or designing around key patents
o Figuring in an inventive step
• Having appropriate licensing agreements in place post-Cabilly to strengthen your portfolio in anticipation of biosimilars
o Defining biosimilars for a license agreement and determining the scope of the license
o Out-licensing and in-licensing considerations
o Selecting comparable licenses and establishing their relationship to the biologic at issue
o Investigating the possibility of authorized biologics and complying with applicable FTC policies on settlements
o Reassessing and renegotiating existing university licensing agreements

12:30
Networking Lunch
1:45
Key IP Case Law Through the Biosimilars Lens: Top 5 Patent Battles to Consider When Updating Your Biosimilars Prosecution and Litigation Strategies

David Pauling
IP Counsel
Sutro Biopharma, Inc. (San Mateo, CA)

Barbara A. Fiacco
Partner
Foley Hoag LLP

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

• Analyzing how current IP case law will shape claiming and litigating biosimilars 

o 101 patentability post-Myriad- establishing realistic expectations for the scope of patent protection in view of patent eligibility
o 112 issues and patent claim indefiniteness post-Biosig Instruments, Inc. v. Nautilus, Inc.: anticipating and defending against biosimilars attacks premised on written description and enablement
o Induced infringement post-Akamai v. Limelight
o “Exceptional case” award standards post-Octane Fitness
o Claim construction deference and trial court record keeping
post-Lighting Ballast Control v. Philips

2:30
Case Spotlight: Momenta v. Amphastar and Bioequivalence: Understanding the Implications for the Future of Biosimilars

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

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

• Overview of the case and procedural history

o Examining the significance of FDA’ statement that this case is instructional in how they will handle biosimilars
o Understanding the ramifications of the Supreme Court’s denial of Cert
o Figuring in the implications of the Court’s decision in Classen:
can the cases be reconciled?
• Delineating the parameters of the 271(e) safe harbor: when and to what extent does the safe harbor exception apply to pre-approval
and post-approval activities?
o Developing and submitting info under a federal law versus reporting routinely to the FDA after marketing approval
o Understanding the impact on Roche Bolar
• Exploring Judge Rader’s dissent and contention that the majority
decision essentially renders manufacturing method patents worthless
o Does this significantly limit the types of patents available
for biosimilars?
o Is this a research disincentive for the first biosimilar 
applicants?

3:15
Afternoon Coffee Break
3:30
Timing is Everything: Managing the Logistics of the BPCIA Exchange Process and Preparing for “Early” and “Late” Phase Litigation

Brian V. Slater
Partner and Chair, Life Sciences
Kramer Levin Naftalis & Frankel LLP (New York, NY)

Thomas F. Poché PhD
Senior Counsel, Intellectual Property
Actavis, Inc. (Washington, DC)

James K. Stronski
Partner
Crowell & Moring LLP (New York, NY)

• Understanding how the BPCIA timelines will play out in the real world and preparing to move swiftly once the subsection (k) filing

triggers the patent dance
• Understanding how remedies vary under the timelines
• “Designing around” the timelines
• Whether to provide a (k) application and, if so, determining what other information to provide
• Preparing in advance the initial patent list and who can review the (k) application
• Preparing in advance non-infringement and invalidity contentions
and determining how detailed a response to RPS’ initial patent list
should be
• Understanding the potential consequences of an RPS not responding with a detailed, claim-by-claim response
• Mandatory negotiations: strategic considerations for deciding whether to limit the number of patents RPS can assert in the “early phase” litigation
• Deciding which patents for each side to respectively include on final list
• Early phase litigation: making the decision from an Applicant’s standpoint whether to engage or defer litigation to the later phase
• Appreciating the ramifications of an applicant filing a late phase
declaratory judgment action
• Countermeasures for an RPS if faced with a late phase declaratory
judgment action

4:15
Ethics in the Biosimilars Realm: Avoiding Conflicts and Maintaining Confidentiality in the Brave New World

Susan H. Griffen
Partner
Finnegan‚ Henderson‚ Farabow‚ Garrett & Dunner‚ LLP

David Hricik
Professor of Law
Mercer University

Beth D. Jacob
Partner
Kelley Drye & Warren LLP

• Navigating the tricky confidentiality issues inherent in the dossier exchange process under the BPCIA

o How do you use the information that you get access to during the patent dance?
o Maintaining required confidentiality while advocating for your
company or client
o What are the limitations of disclosure of biosimilar applications?
o Obtaining the help of an outside expert or technical specialist
• Avoiding conflicts of interest as the lines between branded
companies and generic companies blur in the biosimilars space
o Overview of the Rule 11 mandates
o What is the duty of care required?
o Law firms representing both reference products and biosimilars: will the arguments you made in one case come back to haunt you in another?
o Applying traditional conflicts analysis and principles when agreeing to work for a client: Are ABA comments to the model
rules instructional?

5:15
Conference Adjourns