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?
- 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?
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-
- 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
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