Maximizing Pharmaceutical Patent Lifecycles

Wednesday, October 10 to Thursday, October 11, 2012

New York Marriott Downtown, New York, NY

​8:30 Registration and Continental Breakfast

9:00 a.m – 12:30 p.m.

Working Group Session: Assessing the Impact of New PTO Procedures Under the AIA on Hatch-Waxman Strategies Relative to Patent Life Cycle Management

Allen R. Baum
Shareholder
Brinks, Hofer, Gilson, & Lione, P.C. (Research Triangle Park, NC)

Kenneth J. Burchfiel
Partner
Sughrue Mion, P.L.L.C. (Washington, DC)

John Murnane
Partner
Fitzpatrick, Cella, Harper, & Scinto (New York, NY)

Christine A. Dudzik
Partner
Edwards Wildman Palmer L.L.P. (Chicago, IL)

Through its creation of new and amending of existing PTO procedures the America Invents Act (AIA) has opened the door to new controversies. While these developments create new challenges, they also present opportunities to cure past errors. Knowledge of these procedures is essential to life cycle planning strategies in the pharmaceutical industry. 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 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 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)
– question of prior art
• 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 looking ahead to potential 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

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1:15 Registration

2:00 p.m. – 5:30 p.m.
PTA-PTE Boot Camp: Basic Training in the Essentials of Patent Term Adjustment and Patent Term Restoration for Patent Lawyers Serving the Biopharmaceutical Industry

Barton Giddings
Partner
Stoel Rives, L.L.P. (Salt Lake City, UT)

J. Eric Thies
Assistant Counsel, Intellectual Property Group
Merck & Co., Inc. (Rahway, NJ)

Mary C. Till
Legal Advisor, Office of Patent Legal Administration
United States Patent and Trademark Office (Alexandria, VA)

Patent Term Adjustment (PTA) and Patent Term Extensions (PTE) are essential to patent life cycle longevity — especially in the pharmaceutical and biotechnology industries. Biopharmaceutical companies invest numerous resources into preserving the patent life and the subsequent profits of products which take years to produce. Each day of patent life equals millions of dollars in profits. A loss of even one day can have substantial impact on a company’s profit margin.

Recent court decisions and the creation of an abbreviated pathway for follow-on biological products have made knowing the “ins and outs” of PTE and PTA a critical competency for every patent practitioner servicing the pharmaceutical and biotechnology industries.

This intensive half–day workshop will help you master the skills you need to face your greatest PTA and PTE challenges head on. A faculty of PTA and PTE experts will offer practical solutions and in-depth instruction for everything from eligibility requirements to calculation to the application and reconsideration processes to the interplay of these mechanisms.

Points of discussion will include:

• Overview of Patent Term Adjustment (PTA)and Patent Term Extension (PTE)
– statutory authorities
• Patent Act
• Hatch-Waxman Act
• Understanding the unique role of PTA and PTE in the longevity of patent life cycles in the life sciences industries
• PTA vs. PTE
– seeking redress for PTO delays
– seeking redress for FDA delays
• Which point of patent life does each of these devices extend?
– full scope of patent vs. full scope of patent life of patent product

PTA

• Review of 35U.SC. 154(b) and 37 C.F.R. 1.702 -1.705
• Comprehending the criteria for PTA eligibility
• Reconciling discrepancies in certain PTA and PTO Rules
• Seeking PTA
– starting point and the Notice of Allowance
– addressing dispute with PTO’s initial PTA calculation
• request for Reconsideration /Application for Correction
– when can PTA be corrected after the issuance
of the patent
• PTO delays v. applicant delays
• A-Delays: what are they and when are they granted?
– understanding the PTO’s 14 – 4 – 4 clock
• 14 months: first action response time
– how to measure the initial 14 month delay
• 4 months: response/appeal
• 4 months: patent issuance
– identifying the point in time when A delays accumulate?
• B-Delays: what are they and what are the criteria for their issuance?
– triggers: PTO 3 year patent issuance deadline
• starting point for B-Delay accumulation
• how are B-Delays measured?
• C- Delays: how are they different for A and B-Delays
– triggering events:
• interferences
• secrecy orders
• notices of appeal
– when are they granted?
– how are they calculated?
• Identifying events which stop the 3 year B-Delay clock and their relation to C-Delays
– other clock stoppers
• RCE- Request for Continued Examination
• Analyzing and solving A and B Delay overlap dilemmas
– Wyeth v. Dudas
– Japan Tobacco

PTE

• Overview of PTE
– 35 USC 156
– 37 CFR 1.710 – 1.791
• Identifying important benchmarks in a drug’s development and patent timelines relative to seeking PTE
– what is the patent term restored and to what does it apply?
• defining “drug product” under PTE provisions of
Hatch-Waxman Act
• salts
• esters
• enantiomers
– regulatory review period determinations
• testing phase
• review phase
• Understanding why PTE provisions in the Hatch-Waxman Act extend to products outside the scope of Hatch-Waxman, i.e., biologics and certain medical devices
– the importance of PTE in the newly ratified follow-on biologic scenario
– exploring PTE applicability relative to:
• antibiotics
• animal drugs
• food/color additives
• combination products
• Reviewing eligibility requirements/prerequisites for patent
term extension
• Calculating the patent term restored
– FDA/ PTO interplay
• Criteria and eligibility for interim extensions
• The PTE application
– strategies for preparation and submission

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Location:
New York Marriott Downtown
New York, NY