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 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

    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 application”?
    • 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 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) 
    • 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

    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 infringed”
    • 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 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

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

    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 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”

    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

    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 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


    • 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 
    • 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

    Conference Concludes