Monday, april 23, 2012
9:00 AM – 12:30 PM (registration opens at 8:30 am)
Continental Breakfast will be served
A Hatch-Waxman and BPCIA 101 — A Primer on IP Basics and regulatory Fundamentals
David A. Dow
Director and Senior Counsel
Boehringer Ingelheim USA Corporation (Ridgefield, CT)
Kelly Falconer Goldberg
Senior Corporate Counsel, Regulatory Law
Pfizer Inc (New York, NY)
Ryan L. Marshall
Shareholder
Brinks Hofer Gilson & Lione (Salt Lake City, Utah)
Laura A. Vogel
Partner
Duane Morris LLP (Boston, MA)
Mark A. Perry
Partner
Gibson, Dunn & Crutcher LLP (Washington, DC)
This hands-on workshop will provide you with an in-depth review of the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as well as other IP and regulatory basics relative to small molecules and biologics.
The workshop leaders will lay the necessary foundation for you to comprehend thoroughly the dynamics of the IP and regulatory backdrop underlying each Paragraph IV dispute. They will help you fully appreciate the complexities of the Hatch-Waxman litigation challenges presented during the main conference as well as anticipated conundrums under the biosimilar schematic. Points of discussion will include:
Regulatory Essentials Relative to Hatch-Waxman
- Understanding the link between the FDA approval process and the patenting of drugs and biologics
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)
- what information does it contain?
- labeling, patent information, trade name
- filing requirements
- the FDA review process
- INDA (Investigational New Drug Application) aka “IND”
- how does it differ from an NDA?
- filing requirements
- what does it entitle you to do?
- 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
- Understanding the approval process for a biologic
- how does the approval process for a biologic differ from that of a drug?
- BLA (Biological Licensing Application)
- how does a biologic differ from a drug?
- what application needs to be filed and with whom is it filed?
- which products require BLAs instead of NDAs?
- what does a BLA look like?
- Why is it a “license,” rather than an “approved application”?
- What does the approval process for a ‘biosimilar’ under BPCIA entail and how is it different from the BLA approval process?
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?
- Paragraph IV Certifications and Notice Letters
- Bioequivalence defined
- The Orange Book: what is it and why is it Orange?
Biologics
- Identifying biologics that fall within the purview of Hatch-Waxman
- why are other biologics outside of the Hatch-Waxman rubric?
- Overview of the biosimilar (FOB) law
- Title VII of the Patient Protection and Affordable Care Act (PPACA, P.L. 111-148), i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
- The rationale for safety and efficacy concerns surrounding second generation biologics
The Pharmaceutical Patent Endgame: Hatch-Waxman Explaine
- Overview of Hatch-Waxman and reforms under the Medicare Modernization Act (MMA)
- The role of Orange Book under Hatch-Waxman vis-à-vis the MMA
- Exploring different concepts in exclusivity
- exclusivity (180 day market exclusivity)
- regulatory exclusivity
- 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)
- 30-month stay
- Patent extensions
- The safe harbor
- FD&C 505b2 (an alternate pathway to an ANDA)
Trademark and Trade Dress Issues
- Identifying the PTO and FDA clearances necessary for trade name/trademark approval on your product
Monday, April 23, 2012
2:00 PM – 5:30 PM (Registration opens at 1:15 pm)
B Working Group Session: Assessing The Impact of new PTo Procedures Under the AIA on Paragraph IV Litigation
Kenneth J. Burchfiel
Partner
Sughrue Mion, PLLC (Washington, DC)
Adda C. Gogoris
Partner
Merchant & Gould P.C. (New York, NY)
Deborah L. Lu, Ph.D.
Shareholder
Vedder Price (New York, NY)
Matthew A. Smith
Senior Counsel
Foley & Lardner LLP (Washington, DC)
Patrick C. Woolley
Shareholder
Polsinelli Shughart (Kansas City, MO)
Through its creation of new and amending of existing PTO Procedures, the America Invents Act (AIA) has opened the door to parallel and/or alternate administrative avenues to Paragraph IV proceedings in the District Courts. These PTO Procedures go directly to the heart of an invalidity challenge and also provide administrative mechanisms which in some instances could cure errors in the file history. There are also mechanisms that could stop the issuance of a patent during the pendency of its application. However, the use of these mechanisms may carry unintended consequences and bring about the opposite of their intended purpose. The workshop leaders will address these procedures as well as specific concerns for brands and generics. Points of discussion will include:
Third Party Pre-Issuance Submissions
- Understanding when the pre-issuance submission of prior art to the PTO by a third party challenger as outlined by this procedure would be used in a Hatch-Waxman scenario
- Examining scenarios in which the application of a pending pharmaceutical patent might actually be strengthened as opposed to diminished by the invocation of this procedure
Supplemental Proceedings
- Exploring Paragraph IV scenarios in which it makes sense for a patent holder to pursue supplemental reexamination
- Protocols and procedures for supplemental proceedings
- Defining a substantial new question of patentability (SNQP)
- Exploring relationship between supplemental proceedings and inequitable conduct- circumstances in which supplemental reexam can be used as a means to circumvent questions of inequitable conduct - failure to disclose - presence of mind - intent v. mistake – does it make a difference in the findings?- findings of fraud in aftermath of proceedings and possibility of criminal prosecution- materiality
Post Grant Review
- Weighing considerations for when a challenge should be brought under post grant review (PGR) in a Hatch-Waxman setting
- Exploring start dates, timing and basis of the application – questions to ask
- is the challenge brought within nine months of patent issuance?
- what is the basis of the invalidity challenge
- prior art
- 112 deficiency under written description
- lack of enablement
- obviousness
- inherent anticipation
- fate of best mode
- Estoppel considerations relative to Paragraph IV litigation- have you raised all bases for invalidity lest you be precluded from raising them in other PTO or district court proceedings?
- Examining the mechanics, protocols and procedures for PGR
- filing of petition
- analogous nature of proceeding to district court litigation
- discovery
- hearings; motions; settlement
- appearing before the Patent Trial and Appeals Board (PTAB)
- Analyzing the petitioner’s burden of proof
- proving that it is “more likely than not that one of the claims challenged in the petition is unpatentable”
- 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
- what can we glean from these current behaviors relative to the future utilization of inter partes review?
- 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
- substantial new question of patentability vs. reasonable likelihood that the petitioner will prevail on claim
- understanding the immediate repercussions of this shift on inter partes reexam and strategies for inter partes review for pharmaceutical patent litigation
- Exploring the scope of review for current and new procedures under 102 and 103
- patents (prior art) and publications
- comprehending the relationship between scope of review and estoppel
- Transition and phase out
- examining the interplay between the timing for post grant review and inter partes review
- transition in presiding forums
- Central Reexam Unit (CRU) vs. Patent Trial and Appeal Board (PTAB)
- appeal to CAFC
Thursday, April 26, 2012
9:00 AM - 12:30 PM (registration opens at 8:30 am)
CONTINENTAL BREAKFAST WILL BE SERVED
C The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Names and Generic – A Hands-On, Practical Approach
Christopher J. Kelly
Partner
Mayer Brown LLP (Palo Alto, CA)
Steven A. Maddox
Partner
Knobbe Martens Olson & Bear LLP(Washington, DC)
The MMA mandated that pharmaceutical companies provide the FTC with advance notice of proposed settlements of pharmaceutical patent disputes. The FTC and state attorneys general and private plaintiffs have challenged a number of settlements on antitrust grounds. The DOJ has also lent its support to the FTC in also challenging the legality of these settlements.
Both brand names and generic drug companies have expressed their frustration with the FTC in attempting to come to an agreeable resolution in this matter. There is also fear in the pharmaceutical industry over proposed legislation – introduced term after term- which may, in certain circumstances deem these types of settlements to be per se illegal and eviscerate 180-day exclusivity.
This hands-on, interactive workshop will examine how in the current environment, parties to a Paragraph IV dispute can resolve their differences and receive the government’s blessing. The workshop leaders will explore best practices to reach and finalize successful and sound settlements. Through the use of a hypothetical, they will help you:
- Draft and structure an agreement that will receive FTC approval
- Identify and avoid red flags that may lead to FTC scrutiny
- Anticipate possible requirements regarding patent settlements under proposed legislation
- Preserve Access to Affordable Generics Act
- The Fair Generics Act
- Understand the role of authorized generics in these agreements and the FTC’s view on this topic
- Incorporate elements in the agreement that emphasize the preservation of competition
- Devise strategies to employ pending completion of the FTC’s review
Conference Details