Day 1 - Monday, June 9, 2014

Registration and Continental Breakfast
Co-Chairs’ Opening Remarks

Jason G. Winchester
Jones Day

Thomas J. Filarski
Steptoe & Johnson LLP

Key Agencies Overview: Understanding the Jurisdiction and Interplay of the FDA and PTO in the Patenting of Drugs and Biologics

Marc T. Morley
Foley & Lardner LLP

Dorothy R. Auth Ph.D.
Cadwalader, Wickersham & Taft LLP

  • Understanding the
    respective roles and interplay of the FDA and PTO in the patenting and approval
    of drugs and biological products


    • FDA overview and

      – Department of Health and Human Services and the Commissioner

      – The 5 FDA Centers and the Office of Regulatory Affairs and their functions
    • CDER (Drug) and CBER
      (Biologic) overview
    • Defining the scope of
      the FDA’s jurisdiction with respect to drugs and biologics
    • Examining how the FDA
      exercises its jurisdiction: 

      – rule making

      – product decisions

      – enforcement

      – informal mechanisms
    • Reviewing the laws that
      the FDA enforces relative to the patenting of drug and biological products

      – Food Drug & Cosmetic Act

      – Prescription Drug Marketing Act

      – Public Health Services Act

      – Hatch-Waxman Act

      – other applicable laws
    • Defining drugs and
    • Labeling: when is a drug
      a drug and not a biologic
    • Working with the FDA
      – Administrative Procedures Act

      – formal and informal dispute resolution mechanisms

    The PTO

    • Review of the
      organizational structure of the PTO
    • Patents: overview of
      drug and biological products that may be patented
    • Who may apply for a

      – agency and
    • What is the PTO’s
      jurisdiction in the patenting of drugs and biologics?
    • What laws and
      regulations does the PTO enforce relative to the patenting of drugs and
    • Patent Reform
    • Trademark and copyrights
      vis-à-vis drugs and biologics

    Morning Coffee Break
    Exploring the Link between the FDA Approval Process and the Patenting of Drugs and Biologics

    Adam Samansky
    Edwards Wildman Palmer LLP

    Rx Drugs (new drugs)

    • Identifying the
      application process for the approval of a new drug, i.e., small molecule, new
      chemical entities, etc.
    • NDA (New Drug
      Application): definition, contents and regulatory overview
    • INDA (Investigational
      New Drug Application) aka “IND”

      – how does it differ from an NDA?
    • Accelerated approvals
      – defining eligibility criteria for accelerated approval and priority reviews 

      – what portions of approval submissions might FDA release and when?
    • Using advisory
      committees in the approval process 


    • How does the approval
      process for a biologic differ from that of a drug?
    • BLA (Biological
      Licensing Application): application and filing

      – how does a biologic differ from a drug?

      – which products require BLAs instead of NDAs?
    •  Why is it a “license,” rather than an “approved


    • What does the approval
      process for a “biosimilar” entail?

      how is it different from the BLA approval process?

    IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trade Dress, and More

    Michael Siem
    Farney Daniels, P.C.

    Bruce C. Haas
    Fitzpatrick, Cella, Harper & Scinto

    Patricia Carson
    Kirkland & Ellis LLP

    IP Protection for Drugs
    and Biologics

    • Analyzing the patenting
      process for drugs and biologics
    • Seeking patent
      protection during the pre-approval process
    • IP and regulatory
      redress for time lost during the pre-approval process
    • Distinguishing the
      patenting process for drugs from that of biologics

       which biologics are treated as drugs and why?
    • Identifying the
      respective roles of the FDA and the PTO in the patenting of drugs and
      biological products


    • Exploring the
      differences between a NDA and an ANDA (Abbreviated New Drug Application)
    • ANDA:  what does it
    • Bioequivalence defined
    • The Orange Book: what is
      it and why is it Orange?

      – listings and de-listings
    • The patent endgame
      (Hatch-Waxman Overview)

      – overview of Hatch-Waxman and reforms under MMA

      – the role of Orange Book under Hatch-Waxman vis-à-vis the MMA

      – exclusivity (180 day);  30-month stay

      – regulatory exclusivity

      – patent extensions

      – the safe harbor
    • FD&C 505b2 (an
      alternate pathway to an ANDA) 


    • Identifying biologics
      that fall within the purview of Hatch-Waxman

       why are other biologics outside of the Hatch-Waxman rubric?
    • Overview of the
      Biologics Price Competition and Innovation Act of 2009 (BPCIA), 
      biosimilars legislation

      – status of pending FDA
      guidance and regs

      – the rationale for safety
      and efficacy concerns surrounding second generation biologics

    Trademark, Trade Name
    and Trade Dress Issues

    • Identifying the PTO and
      FDA clearances necessary for trade name/trademark approval on your product

    Networking Luncheon
    ANDA Litigation 101: Paragraph IV Disputes Primer

    Gregory A. Morris
    Honigman Miller Schwartz and Cohn LLP

    Jason G. Winchester
    Jones Day

    Thomas J. Filarski
    Steptoe & Johnson LLP

    • Paragraph IV Certifications and Notice Letters
    • Presuit considerations
       initial pleadings
      – multiple ANDA filers

      declaratory judgments
    • Typical Paragraph IV
      litigation scenarios

      – “invalid or will not be
    • Hot button issues in
      Hatch-Waxman litigation

      – settlements

      – damages

      – double-patenting

      – inducement of infringement

    Afternoon Refreshment Break
    Orange Book Listings, De-Listings and Related Challenges

    Jonathan E. Grossman
    Patent Attorney
    Fresenius Kabi USA

    Shashank Upadhye
    Amin Talati & Upadhye, LLC

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

    • Understanding the role of Orange Book listings in
      patent life cycle management and patent portfolio management
    • Exploring
      the continuing dilemma of which patents should be listed, delisted and held in
    • Assessing the effect of de-listing/disclaiming a patent on 180-day exclusivity
    • Examining  the  FDA’s position on not
      listing a patent
    • Overcoming
      challenges associated with listing patented information in the product label
      and indications discovered in clinical testing

      – incorporating long term
      patent listing strategies into label negotiations with FDA

      – skinny labeling and carve –outs
    • Reviewing antitrust considerations relative to Orange Book listings
    • Assessing the scope of potential Orange Book listing controversies
      relative to:

      – device patents

      – product-by-process

      – metabolites; 
      polymorphs; intermediates

      – patents
      on unapproved uses

      – old
      antibiotics under QI Act

      – use

    Conference Adjourns to Day Two

    Day 2 - Tuesday, June 10, 2014

    Continental Breakfast
    Co-Chairs’ Opening Remarks and Re-Cap of Day One
    Bioequivalence and the “Same Active Ingredient” vis-à-vis Patentability

    Gary Veron
    Hogan Lovells US LLP

    Gary J. Speier
    Schwegman, Lundberg & Woessner, P.A.

    • Defining bioequivalence
      in drugs and biologics

       drugs v. biologics
    • What an ANDA-filer must
      demonstrate for bioequivalence?

       bioequivalence and dosage form – oral tablet/capsule, injection,
      nasal sprays, topical, nasal sprays
    • Exploring bioequivalence
      controversies related to biosimilars
    • How does bioequivalence
      relate to patents

       patenting of bioequivalence characteristics – extended-release
      drug products

       bioequivalence v. Doctrine of Equivalents – what is the

       arguments about bioequivalence raised in Paragraph IV patent

      – infringement, copying

    Morning Coffee Break
    An In-Depth Look at 180- Day Exclusivity

    Scott B. Howard
    Patterson Belknap Webb & Tyler LLP

    • Understanding 180-day generic market exclusivity under the Hatch-Waxman

       what are the qualifying
      criteria for exclusivity?
    • How can an ANDA applicant
      really determine who is “first-to-file” and win 180 –day exclusivity?
    • Identifying triggers for
      the running of the 180-day exclusivity period
    • Deciphering the FDA’s new
      interpretation of pre- and post- MMA 180 day exclusivity

       what are the implications
      of this interpretation for products having ANDA’s filed prior to the enactment
      of the MMA?
    • Exploring the interplay
      between the 30-month stay and 180-day exclusivity

       What steps must be taken
      when a Paragraph IV certification is issued?
    • Forfeiture provisions:
      identifying circumstances under which exclusivity is forfeited

      other circumstances that
      may trigger the loss of 180-day exclusivity
    • When can the 180-day
      exclusivity period be transferred to another ANDA applicant?
    • Evaluating when the 180-day
      exclusivity period can be relinquished, and exploring the consequences
    • Defining “shared

    Comprehending the Intricacies of Non-Patent/ Regulatory Exclusivity

    John E. Haugen
    Senior Counsel, IP
    Takeda Pharmaceuticals U.S.A., Inc.

    • Understanding which drug products are eligible for regulatory

      – small molecules v. biologics
    • The different modes and methods of regulatory exclusivity

      – NCE
      (new chemical entity): 5 years marketing exclusivity/5 years data exclusivity

      – indication
      (new indication or use): 3 years marketing exclusivity

      – NDF
      (new dosage formulation)

      – ODE (orphan drug exclusivity)

      – PED (pediatric exclusivity)
    • FD&C 505b2 (alternate pathway to ANDA) a/k/a paper NDA
    • What role does the FDA play in regulating these modes of
    • When are each of these methods sought?
    • Using trade dress as means of exclusivity

    Networking Luncheon
    Assessing Patent Protections Afforded Under the Safe Harbor

    Paul S. Tully Ph.D.
    McDonnell Boehnen Hulbert & Berghoff LLP

    • Exploring the safe
      harbor of the Hatch-Waxman Act 35 USC § 271(e)(1)
    • Understanding the safe
      harbor’s scope of protection for otherwise infringing activities
    • Examining the impact of Proveris,
      Classen and Momenta 
      on safe harbor protections
    • Identifying safe harbor
      protections relative to:

       basic R&D
        new product screening
       pre-clinical testing
      –  post-approval testing

    Afternoon Refreshment Break
    Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration

    Scott P. McBride
    McAndrews, Held & Malloy, Ltd.

    • Overview
      of Patent Term Adjustment (PTA)and Patent Term Extension (PTE)

      – statutory

      – Patent

      – Hatch-Waxman
    • Understanding
      the unique role of PTA and PTA in the longevity of patent life cycles in the
      life sciences industries
    • PTA vs.

      – seeking
      redress for PTO delays vs. seeking redress for FDA delays
    • Which
      point of patent life does each of these devices extend?

      – full
      scope of patent vs. full scope of patent life of patented product

    • Review
      of 35U.SC. 154(b) and 37 C.F.R. 1.702 -1.705
    • Comprehending
      the criteria for PTA eligibility
    • Reconciling
      discrepancies in certain PTA and PTO Rules
    • Seeking

      – starting
      point and the Notice of Allowance

      – addressing
      dispute with PTO’s initial PTA calculation

      – request
      for Reconsideration /Application for Correction

      – when
      can PTA be corrected after the issuance of the patent
    • PTO
      delays v. applicant delays
    • A, B and
      C-delays and overlaps
    • RCE-
      Request for Continued Examination 


    • Overview
      of PTE

      – 35 USC

      – 37 CFR
      1.710 – 1.791
    • Identifying
      important benchmarks in a drug’s development and patent timelines relative to
      seeking PTE

      – what
      is the patent term restored and to what does it apply?

      – defining
      “drug product” under PTE provisions of Hatch-Waxman Act

      – salts

      – esters

      – enantiomers

      – regulatory
      review period determinations

      – testing

      – review
    • Understanding
      why PTE provisions in the Hatch-Waxman Act extend to products outside the scope
      of Hatch-Waxman
      , i.e., biologics and
      certain medical devices

      – the
      importance of PTE in a biosimilars scenario
    • Reviewing
      eligibility requirements/prerequisites for patent term extension
    • Calculating
      the patent term restored

      – FDA/ PTO
    • Criteria
      and eligibility for interim extensions

    Conference Concludes