ACI’s Hatch Waxman Series:Hatch-Waxman Boot CampA Primer on IP Basics and Regulatory Fundamentals Relative to Small Molecules and BiologicsMonday, 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 |
Brochure
- click image for pdf - Dates: Mon, Jul 18, 2011 Tue, Jul 19, 2011 Location:
Hilton San Diego Resort & Spa San Diego, CA |
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