Day 1 - Monday, June 9, 2014

8:00
Registration and Continental Breakfast
9:00
Co-Chairs’ Opening Remarks

Jason G. Winchester
Partner
Jones Day

Thomas J. Filarski
Partner
Steptoe & Johnson LLP

9:15
Key Agencies Overview: Understanding the Jurisdiction and Interplay of the FDA and PTO in the Patenting of Drugs and Biologics

Marc T. Morley
Partner
Foley & Lardner LLP

Dorothy R. Auth Ph.D.
Partner
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
    • FDA overview and organization
      – 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 biologics
    • 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 patent?
      – agency and inventorship
    • 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 biologics?
    • Patent Reform Legislation
    • Trademark and copyrights vis-à-vis drugs and biologics

    10:15
    Morning Coffee Break
    10:30
    Exploring the Link between the FDA Approval Process and the Patenting of Drugs and Biologics

    Adam Samansky
    Partner
    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 
    Biologics
    • 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 application”?
    Biosimilars
    • What does the approval process for a “biosimilar” entail?
      how is it different from the BLA approval process?

    11:30
    IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trade Dress, and More

    Michael Siem
    Partner
    Farney Daniels, P.C.

    Bruce C. Haas
    Partner
    Fitzpatrick, Cella, Harper & Scinto

    Patricia Carson
    Partner
    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
    Drugs
    • Exploring the differences between a NDA and an ANDA (Abbreviated New Drug Application)
    • ANDA:  what does it require?
    • 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) 
    Biologics
    • 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), i.e., 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

    1:00
    Networking Luncheon
    2:15
    ANDA Litigation 101: Paragraph IV Disputes Primer

    Gregory A. Morris
    Partner
    Honigman Miller Schwartz and Cohn LLP

    Jason G. Winchester
    Partner
    Jones Day

    Thomas J. Filarski
    Partner
    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 infringed”
    • Hot button issues in Hatch-Waxman litigation
      – settlements

      – damages

      – double-patenting

      – inducement of infringement

    3:30
    Afternoon Refreshment Break
    3:45
    Orange Book Listings, De-Listings and Related Challenges

    Jonathan E. Grossman
    Patent Attorney
    Fresenius Kabi USA

    Shashank Upadhye
    Partner
    Amin Talati & Upadhye, LLC

    Kurt R. Karst
    Director
    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 reserve
    • 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 claims

      – metabolites;  polymorphs; intermediates

      – patents on unapproved uses

      – old antibiotics under QI Act

      – use codes

    5:00
    Conference Adjourns to Day Two

    Day 2 - Tuesday, June 10, 2014

    8:00
    Continental Breakfast
    9:00
    Co-Chairs’ Opening Remarks and Re-Cap of Day One
    9:15
    Bioequivalence and the “Same Active Ingredient” vis-à-vis Patentability

    Gary Veron
    Partner
    Hogan Lovells US LLP

    Gary J. Speier
    Partner
    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 difference?
       arguments about bioequivalence raised in Paragraph IV patent litigation
      – infringement, copying (non-obviousness)

    10:15
    Morning Coffee Break
    10:30
    An In-Depth Look at 180- Day Exclusivity

    Scott B. Howard
    Partner
    Patterson Belknap Webb & Tyler LLP

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

    11:30
    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 exclusivity
      – small molecules v. biologics
    • The different modes and methods of regulatory exclusivity (non-patent)
      – 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 exclusivity?
    • When are each of these methods sought?
    • Using trade dress as means of exclusivity

    12:30
    Networking Luncheon
    1:45
    Assessing Patent Protections Afforded Under the Safe Harbor

    Paul S. Tully Ph.D.
    Partner
    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
       optimization
       pre-clinical testing
      –  post-approval testing

    2:45
    Afternoon Refreshment Break
    3:00
    Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration

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

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

      – Patent Act

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

    PTA

    • 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 PTA
      – 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 
    PTE
    • Overview of PTE
      – 35 USC 156

      – 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 phase

      – review phase
    • 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 interplay
    • Criteria and eligibility for interim extensions

    4:00
    Conference Concludes