Hatch-Waxman Boot Camp

Monday, July 18 to Tuesday, July 19, 2011

Hilton San Diego Resort & Spa, San Diego, CA

Day 1: July 18, 2011

8:00 Registration and Continental Breakfast

9:00 Co-Chairs’ Opening Remarks

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

George K. Ng
Partner
Gordon & Rees 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

Kenneth E. Jenkins, JD, PhD
Partner
Kilpatrick Townsend & Stockton LLP
(San Diego, CA)

Elaine H. 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

John E. Peterson, Ph.D.
Of Counsel
Perkins Coie LLP (Los Angeles, CA)

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

Robert Church
Partner
Hogan Lovells US LLP (Los Angeles, CA)

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”?

12:15 Networking Luncheon

1:30 IP Overview for Drugs and Biologics:

Hatch-Waxman, BPCIA, Trade Dress, and More

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

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
• 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
• 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?
• 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

Jeremy C. Lowe
Partner
Axinn Veltrop & Harkrider LLP (Hartford, CT)

• Paragraph IV Certifications and Notice Letters
• Presuit considerations
- Initial pleadings
- Multiple ANDA filers
- Declaratory judgments
• Typical Paragraph IV litigation scenarios
• Hot button issues in Hatch-Waxman litigation
- settlements
- damages
- double-patenting
- inducement of infringement

3:45 Afternoon Refreshment Break

4:00 How the Dynamics of Biosimilars Are Changing the Hatch-Waxman Landscape

Renee Kosslak, Ph.D.
Senior Counsel
Patent and Trademark Dept.

Abbott Biotherapeutics Corp. (Redwood City, CA)
Matthew J. Becker
Partner
Axinn Veltrop & Harkrider LLP (Hartford, CT)

David C. Doyle
Partner
Morrison & Foerster LLP (San Diego, 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

5:00 Conference Adjourns to Day 2

Day 2: July 19, 2011


8:00 Continental Breakfast

8:45 Co-Chairs’ Opening Remarks and Re-Cap of Day 1

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

Jessica Wolff
Partner
Cooley Godward Kronish LLP (San Diego, CA)

• 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

Jeffrey W. Guise
Partner
Wilson Sonsini Goodrich & Rosati (San Diego, CA)

Anders T. Aannestad
Partner
Morrison & Foerster 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 litigation
        o infringement, copying (non-obviousness)

11:00 An In-Depth Look at 180- Day Exclusivity

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

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

• 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

12:00 Networking Luncheon

1:15 Comprehending the Intricacies of Non-Patent/

Regulatory Exclusivity

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

George K. Ng
Partner
Gordon & Rees LLP (San Diego, CA)

• 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

2:15 Afternoon Refreshment Break

2:30 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 Extension

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:
     o diligence in prosecution by the patent applicant
     o 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.,
- maintaining patent position for second-generation products
- approaches taken by pharmaceutical companies
in obtaining second-generation patents
- enforcement of second-generation patents
• Assessing the impact of the PTO Rule regarding elimination
of continuation practice on pharmaceutical patent extensions

4:30 Conference Concludes

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Location:
Hilton San Diego Resort & Spa
San Diego, CA