From American Conference Institute, the creator of ACI’s

Maximizing Pharmaceutical Patent Life Cycles, Paragraph IV Disputes HATCH-WAXMAN

and Hatch-Waxman Boot Camp comes: s e r i e s

THE LIFE SCIENCES LAWYER’S GUIDE TO

PATENT TERM ADJUSTMENT AND
PATENT TERM EXTENSIONS
Tips, tactics and techniques for attorneys servicing the pharmaceutical,
biotechnology and medical device industries Earn
CLE
Credits
JANUARY 26 - 27, 2011 | DOWNTOWN CONFERENCE CENTER | NEW YORK, NY

DISTINGUISHED FACULTY Leading life sciences patent practitioners having

Co-Chairs in-depth experience in Patent Term Adjustment
Jack Brennan and Patent Term Extensions will help you:
Principal, Fish & Richardson P.C. (New York, NY)
Teresa Stanek Rea
Partner, Crowell & Moring LLP (Washington, DC) • UNDERSTAND the unique role of PTE and PTA in patent life
cycle management for the life sciences industry
SPEAKERS • MASTER the essentials of PTA from questions of eligibility and
Patricia Carson calculation to the application process to procedures for redress
Partner, Kaye Scholer LLP (New York, NY)
• DECIPHER the mysteries of A, B and C-delays
Rebecca L. Dandeker
Of Counsel, K & L Gates LLP (Washington, DC) • LEARN to solve the A and B-delay overlap dilemma and B-delay
Jane T. Gunnison National Stage queries vis-à-vis Wyeth v. Dudas and Japan Tobacco
Partner, Ropes & Gray LLP (New York, NY) • AVOID applicant delays and circumvent “failure to engage” findings
Kurt R. Karst by the PTO
Director
Hyman, Phelps & McNamara, P.C. (Washington, DC) • NAVIGATE the complexities of PTE in terms of substance
and procedure
Deborah L. LU, Ph.D.
Shareholder • COMPREHEND how the key challenges in Wyeth Holdings,
Vedder Price P.C. (New York, NY) Photcure, Lupin and The Medicine Company will affect PTE
Brian J. Malkin determinations in the future
Partner, Frommer Lawrence & Haug LLP (New York, NY)
• APPRECIATE how second generation patents and regulatory
Edward H. Mazer exclusivities factor into patent term extensions
Patent Attorney
(formerly Senior Legal Director, Merck & Co., Inc.) • EXAMINE the significance of Supplemental Protection Certificates
(Kenilworth, NJ) (SPCs) in patent term restoration in the EU
Kevin W. McCabe
Director
Sterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC) Media Partners:
Mary C Till (invited)
Legal Advisor, Office of Patent Legal Administration, USPTO
(Washington, DC)
Raymond R. Mandra
Partner, Fitzpatrick, Cella, Harper & Scinto (New York, NY)

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Your Most Pressing
PTA/PTE Quandaries –
SOLVED!
PTA and PTE are essential to patent life cycle longevity – especially in
the life sciences. The life sciences industries invest numerous resources
into preserving the patent life and 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
your company’s profit margin. Moreover, recent court decisions and
the introduction 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, biotechnology and medical device industries.
Learn from the PTA and PTE Masters.
Hear directly from lawyers at the forefront
of Wyeth and Japan Tobacco.
Fine tune your PTE know-how.
ACI has designed this two day intensive program to 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.
Come and learn everything that you wanted to know about PTA
and PTE and more.
Register now by calling 1-888-224-2480, faxing your
registration form to 1-877-927-1563, or logging on to
www.AmericanConference.com/PTA-PTE.
WHO YOU WILL MEET
In-House Counsel from Pharmaceutical, Biotechnology,
Biopharmaceutical and Medical Device Companies, including:
• Patent Attorneys
• Patent Agents
• FDA & Regulatory Attorneys
Law Firm Attorneys for the Pharmaceutical, Biotech &
Biopharmaceutical Industries whose practices focus on:
• Patent Prosecution
• Patent Litigation
• FDA and Food & Drug Law
Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/PTA-PTE
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ACI, along with our sister organization based in London,
C5 Conferences, works closely with sponsors in order to
create the perfect business development solution catered
exclusively to the needs of any practice group, business line
or corporation. With over 350 conferences in the United
States, Europe, the Commonwealth of Independent States
(CIS) and China, ACI/C5 Conferences provide a diverse
portfolio of first-class events tailored to the senior level
executive spannin-g multiple industries and geographies.
For more information about this program or our global
portfolio of events, please contact:
Wendy Tyler
Head of Sales
American Conference Institute
Tel: 212-352-3220 x242 | Fax: 212-220-4281
w.tyler@AmericanConference.com
CONTINUING LEGAL EDUCATION CREDITS
Accreditation will be sought in those jurisdictions
CLE requested by the registrants which have
Credits continuing education requirements. This course
is identified as nontransitional for the purposes
of CLE accreditation.
ACI certifies that the activity has been approved for CLE
credit by the New York State Continuing Legal Education
Board in the amount of 12.5 hours.
ACI certifies that this activity has been approved for
CLE credit by the State Bar of California in the amount of
10.75 hours.
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opportunities beyond the scope of their
ALUMNI conference experience.
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Expand your Network at www.my-aci.com
 Wednesday, January 26, 2011 11:00 USING A-DELAYS, B-DELAYS AND C-DELAYS
TO YOUR ADVANTAGE

8:00 REGISTRATION AND CONTINENTAL BREAKFAST Deborah L. LU, Ph.D.

Shareholder
9:00 CO-CHAIRS’ OPENING REMARKS Vedder Price P.C. (New York, NY)
EXPLORING THE ROLE OF PTA AND PTE IN • A-delays: what are they and how do they accumulate?
PATENT LIFE CYCLE MANAGEMENT IN THE - understanding the PTO’s 14 – 4 – 4 clock
LIFE SCIENCES INDUSTRY - 14 months: first action response time
P how to measure the initial 14 month delay

Jack Brennan - 4 months: response/appeal

Principal - 4 months: patent issuance
Fish & Richardson P.C. (New York, NY) - identifying the point in time when A-delays accumulate
• B-Delays: what are they and how do they accumulate?
Teresa Stanek Rea - triggers: PTO 3 year patent issuance deadline
Partner - starting point for B-delay accumulation
Crowell & Moring LLP (Washington, DC) - how are B-delays measured?
• Overview of Patent Term Adjustment (PTA)and Patent • C- delays: how are they different from A and B-delays
Term Extension (PTE) - triggering events:
- statutory authorities - interferences
- Patent Act - secrecy orders
- Hatch-Waxman Act - notices of appeal
P provisions for products outside the scope - when do they accumulate?
of Hatch-Waxman - how are they calculated?
• Understanding the unique role of PTA and PTE in the • Identifying events which stop the 3 year B-delay clock and
longevity of patent life cycles in the life sciences industries their relation to C-delays
• PTA vs. PTE - other clock stoppers
- seeking redress for PTO delays - RCE – Request for Continued Examination
- seeking redress for FDA delays
• Identifying which patent rights are extended through PTA
and PTE 12:00 LUNCHEON
- full scope of patent vs. full scope of patent life of patented
product 1:15 WYETH V. DUDAS: ANALYZING AND SOLVING
THE A AND B DELAY OVERLAP DILEMMA
9:45 MORNING COFFEE BREAK
Patricia Carson
Partner
10:00 PTA 101: MECHANICS, ESSENTIALS AND Kaye Scholer LLP (New York, NY)
CONUNDRUMS • Overview of Wyeth v. Dudas
Jane T. Gunnison • Analyzing typical A and B delay overlap dilemmas
Partner pre-Wyeth v. Dudas
Ropes & Gray LLP (New York, NY) - exploring questions and controversies over ‘double dipping’
• Comprehending what Wyeth did in terms of solving
• Overview of the purpose and scope of the 1999 statute the overlap dilemma
instituting PTA • How does the PTO now address the A and B overlap
• Understanding the impetus for amending the original statute period?
• Review of 35 U.S.C.§ 154(b) and 37 C.F.R. 1.702 -1.705 - understanding when A-delays and B-delays are added
• Comprehending the criteria for PTA eligibility and actions together
which stop the PTO clock - identifying when A-delays and B-delays truly overlap
• PTO delays vs. applicant delays • Post-Wyeth PTO procedures
• Reconciling discrepancies in certain PTA and PTO Rules - PTO’s PTA computer program overhaul
• Seeking PTA - expedited procedures – reconsideration requests
- starting point and the Notice of Allowance - eligibility – Wyeth only petitions
- addressing disputes with PTO’s initial PTA calculation - when filing a District Court complaint before the
P Request for Reconsideration / Application for DC Circuit is your best option for PTA redress
Correction
- when can PTA be corrected after the issuance of the patent?
- seeking redress in the District Court 2:15 AFTERNOON REFRESHMENT BREAK
• How often is the PTO correct in its PTA calculations?

Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/PTA-PTE

2:30 JAPAN TOBACCO: REMEDYING B-DELAY ERRORS • Overview of PTE
IN NATIONAL STAGE APPLICATIONS UNDER - 35 USC§ 156
35 U.S.C§ 371 - 37 CFR 1.710 – 1.791
• Identifying important benchmarks in a medical product's
Jack Brennan development and patent timelines relative to seeking PTE
Principal - what is the patent term restored and to what does it apply?
Fish & Richardson P.C. (New York, NY) - defining “drug product” under the PTE provisions of
• Overview of Japan Tobacco and the B-delay question it Hatch-Waxman Act
raised in light of Wyeth vis-à-vis PCT applications - salts
• Measuring the 3 year waiting period for B-delay vis-à-vis - esters
a National Stage application - enantiomers
- determination of application of commencement date - regulatory review period determinations
• Review of post-Japan Tobacco PTO procedures - testing phase
• Reconsideration procedures for National Stage application - review phase
• Understanding why PTE provisions in the Hatch-Waxman
Act extend to products outside the scope of Hatch-Waxman,
3:30 STRATEGIES FOR AVOIDING APPLICANT PTA i.e., biologics and certain medical devices
DELAYS AND OTHER PITFALLS - the importance of PTE in the newly ratified follow-on
biologic scenario
Kevin W. McCabe - exploring PTE applicability relative to:
Director - antibiotics
Sterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC)
- animal drugs
• Preventing delays due to failure to engage - food/color additives
- understanding how the PTO defines ‘failure to engage’ - combination products
• What constitutes late filing under the PTO’s PTA rules? • Reviewing eligibility requirements/prerequisites for patent
- identifying triggers for action date term extension
- defining action date • Calculating the patent term restored
- filing provisions (37 CFR 1.6; 1.8 and 1.10) - FDA/PTO interplay
P which stops clock and which does not? • Criteria and eligibility for interim extensions
• Circumventing PTO findings of an incomplete reply • The PTE application
- what is considered non-responsive and non-compliant? - strategies for preparation and submission
• Explaining delay concerns associated with supplemental
replay and information disclosure statements 10:45 MORNING COFFEE BREAK
• Terminal disclaimers- defining them and avoiding them
11:00 NEW TRENDS AND CHALLENGES IN PTE
4:30 CONFERENCE ADJOURNS TO DAY TWO LITIGATION: KEY CASES TO WATCH
Kurt R. Karst
Director
Thursday, January 27, 2011 Hyman, Phelps & McNamara, P.C. (Washington, DC)
There are 4 recent major Patent Term Extension decisions
8:15 CONTINENTAL BREAKFAST concerning substantive and procedural controversies. We will
examine the challenges presented by these cases and provide
insights as to what they will mean to PTE determinations in
9:00 CO-CHAIRS’ OPENING REMARKS the future.
• Wyeth Holdings v. US
9:15 PTE: LAYING THE GROUNDWORK FOR PATENT - challenging FDA’s determination of when the approval
TERM RESTORATION phase began for a phased submission of an NADA
• PhotoCure v. Kappos
Brian J. Malkin
- challenging ineligibility of ester in light of previously
Partner
approved salt
Frommer Lawrence & Haug LLP (New York, NY)
• Ortho McNeil v. Lupin
Teresa Stanek Rea - challenging validity of PTE to enantiomer in light of
Partner previously approved racemate
Crowell & Moring LLP (Washington, DC) • The Medicines Company v. PTO
- enying PTE application filed on day 62
Mary C Till (invited)
Legal Advisor
Office of Patent Legal Administration, USPTO
12:00 LUNCHEON
(Washington, DC)

Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/PTA-PTE

1:15 SUPPLEMENTING PTE THROUGH THE USE OF • Contemplating whether or not a new SPC can be obtained
SECOND GENERATION PATENTS for new combinations, isomers, etc.
• Identifying what (if any) alternatives exist for obtaining
Raymond R. Mandra an SPC when seeking to extend the patent term on your
Partner product
Fitzpatrick, Cella, Harper & Scinto (New York, NY) • Evaluating differing standards for obtaining an SPC on
• Obtaining patent coverage for pharmaceuticals through the a country-by-country basis
use of second-generation patents, e.g., • Considering issues unique to seeking an SPC when the
- maintaining patent position for second-generation products original Marketing Authorisation (MA) was granted in a
• Approaches taken by pharmaceutical companies in country that is not part of the European Economic Area
obtaining second-generation patents (EEA), i.e. Switzerland
- enforcement of second-generation patents • Obtaining a springboard injunction for marketing and
distribution after patent expiry in case of offering and
- effect of post-KSR obviousness rulings on their validity inclusion in pricelists before patent expiry
Patent Extensions – Outside the EU
2:00 AFTERNOON REFRESHMENT BREAK • Japan
• South Korea, Taiwan, Singapore
2:15 UNDERSTANDING THE INTERPLAY OF PATENT • Israel
TERMS AND FDA REGULATORY EXCLUSIVITIES • Ukraine
Regulatory Exclusivities – EU and elsewhere
Rebecca L. Dandeker
Of Counsel • Regulatory Data Protection
K & L Gates LLP (Washington, DC) • The Paediatric Medicines Regulation
- scope and key obligations
• Overview of various exclusivities that extend patent life - what kind of reward/exclusivity are available (SPC
- new chemical entity extension/patent protected products, orphan drugs,
- new use/new clinical studies off-patent products)?
- orphan drug • The Orphan Drugs Regulation – obtaining orphan
- pediatric market exclusivity
- biologicals
• Criteria for eligibility for these means of exclusivity 4:45 CONFERENCE ENDS
- maximizing opportunities and avoiding pitfalls
• Latest regulatory and legal developments affecting exclusivity
- FDAAA
- Health Care Reform Act of 2010
• Maximizing patent term by properly using the exclusivities
in conjunction with PTE
American Conference Institute:
3:30 EXPLORING PATENT EXTENSIONS The leading networking and information resource
AND EXCLUSIVITIES IN THE EU for counsel and senior executives.

Edward H. Mazer
Patent Attorney
(formerly Senior Legal Director, Merck & Co., Inc.)
(Kenilworth, NJ)
Patent Extensions-EU
• Supplementary Protection Certificates(SPCs) – extension
of patent life in the EU
- scope of the protection
- how do you apply for it?
- interaction between the Pharmaceutical Directive
and the SPC Regulation
• Meeting the requirements to obtain an SPC
- tips for maximizing the patent extension obtained
under an SPC for human medicinal products
- weighing the pros and cons of seeking a pediatric extension
- obtaining a zero term or SPC or quasi patent term
extension
- determining what extension term is best for your
product based on an assessment of the type of rights
you will be granted
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Register now: 888-224-2480 • fax: 877-927-1563 • AmericanConference.com/PTA-PTE

 From American Conference Institute, the creator of Maximizing Pharmaceutical Patent ACI’s

Life Cycles, Paragraph IV Disputes and Hatch-Waxman Boot Camp comes: HATCH-WAXMAN
s e r i e s

THE LIFE SCIENCES LAWYER’S GUIDE TO

PATENT TERM ADJUSTMENT AND PATENT TERM EXTENSIONS
Tips, tactics and techniques for attorneys servicing the pharmaceutical, biotechnology and medical device industries

JANUARY 26 - 27, 2011 | DOWNTOWN CONFERENCE CENTER | NEW YORK, NY

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