3rd Annual

Hatch-Waxman Boot Camp

A Primer on IP Basics and Regulatory Fundamentals Relative to Small Molecules and Biologics

Monday, June 25 to Tuesday, June 26, 2012
Hilton San Diego Resort & Spa, San Diego, CA

DAY ONE: JUNE 25, 2012

8:00 Registration and Continental Breakfast

9:00 Co-Chairs’ Opening Remarks

Brian L. Wamsley, Esq.
Patent
Attorney, Sandoz, Inc. (Princeton, NJ)

Marc T. Morley
Partner,
Knobbe Martens Olson & Bear LLP(San Diego, CA)

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

Elaine Tseng
Partner,
King & Spalding LLP (San Francisco, CA)

  • 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 Identifying and Comprehending Pre-Commercialization Concerns Relative to Small Molecules and Biologics

Edward J. Allera
Partner,
Buchanan Ingersoll & Rooney, P.C. (Washington, DC)

The current pre-commercialization landscape:

  • Reviewing the types of products that pharmaceutical, biotechnology and biopharmaceutical companies seeking to develop now
  • Identifying impediments – through patent or regulatory restraint – which prevent these companies from pursuing the development of the desired product
    • FDA hurdles that may not clear even if all patent and other IP hurdles are met
  • Techniques for analyzing the value the product adds to the company’s portfolio, and methods for proving value
  • Assessing the competition and analyzing potential therapeutic interchange considerations

Considerations in light of Health Care Reform:

  • Understanding how the introduction of biosimilars is changing the commercial landscape
  • Examining the role of the Center for Medicare and Medicaid Services (CMS) in the approval process and its impact on R&D
    • the connection between CMS approval and commercial viability via government payor systems and rebates
    • comparative effectiveness

11:15 Exploring the Link between the FDA Approval Process and the Patenting of Drugs and Biologics

Anders T. Aannestad
Partner,
Morrison & Foerster LLP (San Diego, CA)

Richard Berman
Partner,
Arent Fox LLP (Washington, DC)

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
  • 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”?

12:15 Networking Luncheon

1:30 IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trade Dress, and More

Marc T. Morley
Partner,
Knobbe Martens Olson & Bear LLP(San Diego, CA)

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

Biologics

  • Understanding draft biosimilars guidance released by the Food and Drug Administration
    • formulations, routes of administration, and indications
    • interchangeability
    • new regulatory definitions
  • Identifying biologics that fall within the purview of Hatch-Waxman
  • The rationale for safety and efficacy concerns surrounding second generation biologics

Trademark Issues

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

2:45 Paragraph IV Disputes and Litigation: Federal Court, PTO Proceedings & ITC Actions

Robert J. Goldman
Partner,
Ropes & Gray LLP (East Palo Alto, CA)

Herbert D. Hart III
Shareholder,
McAndrews, Held & Malloy, Ltd. (Chicago, IL)

Vicki Norton
Partner,
Duane Morris LLP (San Diego, CA)

District Court (Traditional Paragraph IV Litigation)

  • Paragraph IV Certifications and Notice Letters
  • Presuit considerations
    • Initial pleadings; Multiple ANDA filers; Declaratory judgments
  • 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; patent extensions; the safe harbor
  • 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
  • FD&C 505b2 (an alternate pathway to an ANDA)

Applicable PTO Proceeding Under the America Invents Act

  • Understanding the fundamentals of the AIA and it’s procedures
  • Identifying how the AIA intersects with the Hatch-Waxman rubric
    • supplemental proceedings
    • Third party pre-issuance submission

Post Grant Review

  • Should you challenge an OB-listed patent by petitioning for a post grant review (PGR)?
  • What are the relevant considerations?
    • Would a challenge be timely?
    • Is the basis of the invalidity challenge one suited for resolution in a PGR proceeding?
    • prior art (anticipation and/or obviousness)
    • § 112 insufficient written description or lack of enablement
    • basis of the invalidity challenge; timing; prior art; 112 deficiency under written description; lack of enablement;o obviousness; inherent anticipation; fate of best mode
  • Estoppel considerations relative to Paragraph IV litigation
  • What are the mechanics, protocols, and procedures for PGR?
    • Is a PGR proceedings analogous to district court litigation?
    • What will the procedures be?
    • § the petition
    • § discovery
    • § hearings; motions; settlement
    • The Patent Trial and Appeal Board (PTAB)
  • Analyzing the petitioner’s burden of proof
  • Procedures for appeal

Inter Partes Review

  • Comparing current inter partes reexamination protocols to inter partes review protocols under AIA
  • Examining how current inter partes reexamination procedures are being employed by both patent challengers and patent holders in Hatch Waxman scenarios
    • questions of economics, efficiencies and risk
  • Understanding the fine points of the new inter partes review procedure
    • considerations for choosing this forum
    • timing, cost, speed of resolution
  • Revisions to patent challenger’s burden of proof under current inter partes reexamination and new inter partes review procedures
    • patentability vs. reasonable likelihood that the petitioner will prevail on claim
  • Exploring the scope of review for current and new procedures under 102 and 103
    • patents (prior art) and publications
  • Transition and phase out
    • examining the interplay between the timing for post grant review and inter partes review
    • Central Reexam Unit (CRU) vs. Patent Trial and Appeal Board (PTAB)
    • appeal to CAFC

4:00 Afternoon Refreshment Break

4:15 How the Dynamics of Biosimilars Are Changing the Hatch-Waxman Landscape

Madison Jellins
Partner,
HelixIP LLP (Redwood City, CA)

  • What are biologic drugs and why are they different for purposes of generic competition?
  • When can FDA approve a biosimilar under current law?
  • What kind of abbreviated approval route for biologics is available under the new Act?
  • Exploring concerns over:
    • exclusivity; patentability; interchangeability

5:30 Conference Adjourns to Day Two

DAY TWO: JuNe 26, 2012

8:00 Continental Breakfast

8:45 Co-Chairs’ Opening Remarks and Re-Cap of Day One

9:00 Orange Book Listings, De-Listings and Related Challenges

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

Ellen A. Scordino
Principal,
Fish & Richardson P.C. (Boston, MA)

  • 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

10:00 Morning Coffee Break

10:15 Bioequivalence and the “Same Active Ingredient” vis-à-vis Patentability

Peter Munson
Partner,
Wilson Sonsini Goodrich & Rosati LLP (San Diego, CA)

  • 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
  • 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 litigationo infringement, copying (non-obviousness)

11:15 An In-Depth Look at 180-Day Exclusivity

David G. Adams
Partner,
Venable LLP (Washington, D.C.)

Brian L. Wamsley, Esq.
Patent
Attorney, Sandoz, Inc. (Princeton, NJ)

  • 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”
  • Case law update-
    • Vyvanse (Actavis v. FDA); Sanofi v. Apotex

12:15 Networking Luncheon

1:30 Comprehending the Intricacies of Non-Patent/ Regulatory Exclusivity

George Ng
Partner,
Snell & Wilmer LLP (San Diego, CA)

Len Smith
Principal Intellectual Property Counsel
Medicis Pharmaceutical Corp. (Scottsdale, AZ)

  • 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

2:30 Afternoon Refreshment Break

2:45 Assessing Patent Protections Afforded Under the Safe Harbor

Robin M. Silva
Partner,
Morgan Lewis & Bockius LLP (San Francisco, CA)

  • 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 on safe harbor protections afforded to research tool patents
  • Identifying safe harbor protections relative to:
    • basic R&D; new product screening; optimization; pre-clinical testing; post-approval testing

3:30 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration

Louis C. Cullman
Partner,
K&L Gates LLP (Irvine, CA)

  • Extension of patent term under 35 U.S.C. § 156 and 37 CFR 1.710 – 1.791
  • Exploring the viability of extension applications to:
    • basic and combination compounds; secondary patents
  • Important benchmarks in the drug’s development and patent timelines
  • Eligibility for patent term extension
  • Regulatory review period determinations
  • How to calculate the patent term restored
    • respective roles of the FDA and PTO in granting patent extensions
    • third-party challenges – “diligence”
  • Patent term extensions outside the U.S.
  • Evaluating PTO letters interpreting judicial guidance
  • Photocure ASA v. Kappos
  • Ortho-McNeil Pharmaceutical,
  • Inc. v. Lupin Pharmaceuticals, Inc.
  • Examining patent term adjustment due to delays in prosecution before the USPTO
    • strategies for:
      • diligence in prosecution by the patent applicant
      • calculating the adjustment period
  • Understanding the link between patent extensions and exclusivity
    • extensions obtained through FDA Pediatric Exclusivity and Orphan Drug Exclusivity
  • Obtaining patent coverage for pharmaceuticals through the use of second-generation patents, e.g.,
  • Assessing the impact of the PTO Rule regarding elimination of continuation practice on pharmaceutical patent extensions

4:45 Conference Concludes