Register Now • 888-224-2480 • AmericanConference.com/PTA-PTE

Earn

CLECredits

HATCH-WAXMANs e r i e s

ACI’sFrom American Conference Institute, the creator of Maximizing Pharmaceutical Patent Life Cycles, Paragraph IV Disputesand Hatch-Waxman Boot Camp comes:

Tips, tactics and techniques for attorneys servicing the pharmaceutical, biotechnology and medical device industries

THE LIFE SCIENCES LAWYER’S GUIDE TO PATENT TERM ADJUSTMENT AND PATENT TERM EXTENSIONS

Media Partners:

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

DISTINGUISHED FACULTY

Co-ChairsJack Brennan Principal, Fish & Richardson P.C. (New York, NY)

Teresa Stanek Rea Partner, Crowell & Moring LLP (Washington, DC)

SPEAKERS

Patricia CarsonPartner, Kaye Scholer LLP (New York, NY)

Rebecca L. Dandeker Of Counsel, K & L Gates LLP (Washington, DC)

Jane T. GunnisonPartner, Ropes & Gray LLP (New York, NY)

Kurt R. KarstDirectorHyman, Phelps & McNamara, P.C. (Washington, DC)

Deborah L. LU, Ph.D.ShareholderVedder Price LLP (New York, NY)

Brian J. MalkinPartner, Frommer Lawrence & Haug LLP (New York, NY)

Edward H. MazerPatent Attorney (formerly Senior Legal Director, Merck & Co., Inc.) (Kenilworth, NJ)

Kevin W. McCabeDirectorSterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC)

Mary C Till (invited)Legal Advisor, Offi ce of Patent Legal Administration, USPTO (Washington, DC)

Raymond R. Mandra Partner, Fitzpatrick, Cella, Harper & Scinto (New York, NY)

Leading life sciences patent practitioners having in-depth experience in Patent Term Adjustment and Patent Term Extensions will help you:

• UNDERSTAND the unique role of PTE and PTA in patent life cycle management for the life sciences industry

• MASTER the essentials of PTA from questions of eligibility andcalculation to the application process to procedures for redress

• DECIPHER the mysteries of A, B and C-delays

• LEARN to solve the A and B-delay overlap dilemma and B-delay National Stage queries vis-à-vis Wyeth v. Dudas and Japan Tobacco

• AVIOD applicant delays and circumvent “failure to engage” fi ndings by the PTO

• NAVIGATE the complexities of PTE in terms of substance and procedure

• COMPREHEND how the key challenges in Wyeth Holdings, Photcure, Lupin and The Medicine Company will affect PTE determinations in the future

• APPRECIATE how second generation patents and regulatory exclusivities factor into patent term extensions

• EXAMINE the signifi cance of Supplemental Protection Certifi cates (SPCs) in patent term restoration in the EU

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

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 profi ts of products which take years to produce. Each day of patent life equals millions of dollars in profi ts. A loss of even one day can have substantial impact on your company’s profi t 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.

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 fi rst-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

GLOBAL SPONSORSHIP OPPORTUNITIES

CONTINUING LEGAL EDUCATION CREDITS

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identifi ed as nontransitional for the purposes of CLE accreditation.

ACI certifi es 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 certifi es that this activity has been approved for CLE credit by the State Bar of California in the amount of 10.75 hours.

You are required to bring your state bar number to complete the appropriate state forms during the conference. CLE credits are processed in 4-8 weeks after a conference is held.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

Questions about CLE credits for your state? Visit our online CLE Help Center at www.americanconference.com/CLE

CLECredits

The complimentary ACI Alumni Program is designed to provide returning delegates with unique networking and learning opportunities beyond the scope of their conference experience.

Highlights include:

• Instantly access thousands of free presentations, PowerPoints and other event resources - Online!

• Make direct contact with fellow conference alumni• Post a question or look for answers in our Industry

Forums • Join a live Industry Chat in progress• Earn Forum points towards free conferences

& workshops

Expand your Network at www.my-aci.com

Expand Your Network

ALUMNI

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

Wednesday, January 26, 2011

8:00 REGISTRATION AND CONTINENTAL BREAKFAST

9:00 CO-CHAIRS’ OPENING REMARKSEXPLORING THE ROLE OF PTA AND PTE IN PATENT LIFE CYCLE MANAGEMENT IN THE LIFE SCIENCES INDUSTRY

Jack Brennan Principal Fish & Richardson P.C. (New York, NY)

Teresa Stanek Rea PartnerCrowell & Moring LLP (Washington, DC)

• Overview of Patent Term Adjustment (PTA)and Patent Term Extension (PTE)- statutory authorities

- Patent Act- Hatch-Waxman Act

provisions for products outside the scope of Hatch-Waxman

• 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

• Identifying which patent rights are extended through PTA and PTE- full scope of patent vs. full scope of patent life of patented

product

9:45 MORNING COFFEE BREAK

10:00 PTA 101: MECHANICS, ESSENTIALS AND CONUNDRUMS

Jane T. GunnisonPartnerRopes & Gray LLP (New York, NY)

• Overview of the purpose and scope of the 1999 statute instituting PTA

• Understanding the impetus for amending the original statute• Review of 35 U.S.C.§ 154(b) and 37 C.F.R. 1.702 -1.705• Comprehending the criteria for PTA eligibility and actions

which stop the PTO clock• PTO delays vs. applicant delays• Reconciling discrepancies in certain PTA and PTO Rules• Seeking PTA

- starting point and the Notice of Allowance- addressing disputes with PTO’s initial PTA calculation

Request for Reconsideration / Application for Correction

- when can PTA be corrected after the issuance of the patent?- seeking redress in the District Court

• How often is the PTO correct in its PTA calculations?

11:00 USING A-DELAYS, B-DELAYS AND C-DELAYS TO YOUR ADVANTAGE

Deborah L. LU, Ph.D.ShareholderVedder Price LLP (New York, NY)

• A-delays: what are they and how do they accumulate?- understanding the PTO’s 14 – 4 – 4 clock

- 14 months: fi rst 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 how do they accumulate?

- triggers: PTO 3 year patent issuance deadline- starting point for B-delay accumulation- how are B-delays measured?

• C- delays: how are they different from A and B-delays- triggering events:

- interferences- secrecy orders- notices of appeal

- when do they accumulate?- 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

12:00 LUNCHEON

1:15 WYETH V. DUDAS: ANALYZING AND SOLVING THE A AND B DELAY OVERLAP DILEMMA

Patricia CarsonPartnerKaye Scholer LLP (New York, NY)

• Overview of Wyeth v. Dudas• Analyzing typical A and B delay overlap dilemmas

pre-Wyeth v. Dudas- exploring questions and controversies over ‘double dipping’

• Comprehending what Wyeth did in terms of solving the overlap dilemma

• How does the PTO now address the A and B overlap period?- understanding when A-delays and B-delays are added

together- identifying when A-delays and B-delays truly overlap

• Post-Wyeth PTO procedures- PTO’s PTA computer program overhaul- expedited procedures – reconsideration requests

- eligibility – Wyeth only petitions- when fi ling a District Court complaint before the

DC Circuit is your best option for PTA redress

2:15 AFTERNOON REFRESHMENT BREAK

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

2:30 JAPAN TOBACCO: REMEDYING B-DELAY ERRORS IN NATIONAL STAGE APPLICATIONS UNDER 35 U.S.C§ 371

Jack Brennan Principal Fish & Richardson P.C. (New York, NY)

• Overview of Japan Tobacco and the B-delay question it raised in light of Wyeth vis-à-vis PCT applications

• Measuring the 3 year waiting period for B-delay vis-à-vis a National Stage application- determination of application of commencement date

• Review of post-Japan Tobacco PTO procedures• Reconsideration procedures for National Stage application

3:30 STRATEGIES FOR AVOIDING APPLICANT PTA DELAYS AND OTHER PITFALLS

Kevin W. McCabeDirectorSterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC)

• Preventing delays due to failure to engage- understanding how the PTO defi nes ‘failure to engage’

• What constitutes late fi ling under the PTO’s PTA rules?- identifying triggers for action date

- defi ning action date- fi ling provisions (37 CFR 1.6; 1.8 and 1.10)

which stops clock and which does not?• Circumventing PTO fi ndings of an incomplete reply

- what is considered non-responsive and non-compliant?• Explaining delay concerns associated with supplemental

replay and information disclosure statements• Terminal disclaimers- defi ning them and avoiding them

4:30 CONFERENCE ADJOURNS TO DAY TWO

Thursday, January 27, 2011

8:15 CONTINENTAL BREAKFAST

9:00 CO-CHAIRS’ OPENING REMARKS

9:15 PTE: LAYING THE GROUNDWORK FOR PATENT TERM RESTORATION

Brian J. MalkinPartnerFrommer Lawrence & Haug LLP (New York, NY)

Teresa Stanek ReaPartnerCrowell & Moring LLP (Washington, DC)

Mary C Till (invited)Legal AdvisorOffi ce of Patent Legal Administration, USPTO (Washington, DC)

• Overview of PTE- 35 USC§ 156- 37 CFR 1.710 – 1.791

• Identifying important benchmarks in a medical product's development and patent timelines relative to seeking PTE- what is the patent term restored and to what does it apply?

- defi ning “drug product” under the 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 ratifi ed 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

10:45 MORNING COFFEE BREAK

11:00 NEW TRENDS AND CHALLENGES IN PTE LITIGATION: KEY CASES TO WATCH

Kurt R. KarstDirectorHyman, Phelps & McNamara, P.C. (Washington, DC)

There are 4 recent major Patent Term Extension decisions 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 the future.

• Wyeth Holdings v. US - challenging FDA’s determination of when the approval

phase began for a phased submission of an NADA• PhotoCure v. Kappos

- challenging ineligibility of ester in light of previously approved salt

• Ortho McNeil v. Lupin - challenging validity of PTE to enantiomer in light of

previously approved racemate• The Medicines Company v. PTO

- enying PTE application fi led on day 62

12:00 LUNCHEON

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

1:15 SUPPLEMENTING PTE THROUGH THE USE OF SECOND GENERATION PATENTS

Raymond R. MandraPartnerFitzpatrick, Cella, Harper & Scinto (New York, NY)

• 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- effect of post-KSR obviousness rulings on their validity

2:00 AFTERNOON REFRESHMENT BREAK

2:15 UNDERSTANDING THE INTERPLAY OF PATENT TERMS AND FDA REGULATORY EXCLUSIVITIES

Rebecca L. Dandeker Of Counsel K & L Gates LLP (Washington, DC)

• Overview of various exclusivities that extend patent life- new chemical entity- new use/new clinical studies- orphan drug- pediatric- biologicals

• Criteria for eligibility for these means of exclusivity- 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

3:30 EXPLORING PATENT EXTENSIONSAND EXCLUSIVITIES IN THE EU

Edward H. MazerPatent Attorney (formerly Senior Legal Director, Merck & Co., Inc.) (Kenilworth, NJ)

Patent Extensions-EU• Supplementary Protection Certifi cates(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

• Contemplating whether or not a new SPC can be obtained for new combinations, isomers, etc.

• Identifying what (if any) alternatives exist for obtaining an SPC when seeking to extend the patent term on your product

• Evaluating differing standards for obtaining an SPC on a country-by-country basis

• Considering issues unique to seeking an SPC when the original Marketing Authorisation (MA) was granted in a country that is not part of the European Economic Area (EEA), i.e. Switzerland

• Obtaining a springboard injunction for marketing and distribution after patent expiry in case of offering and inclusion in pricelists before patent expiry

Patent Extensions – Outside the EU• Japan• South Korea, Taiwan, Singapore• Israel• Ukraine

Regulatory Exclusivities – EU and elsewhere• Regulatory Data Protection • The Paediatric Medicines Regulation

- scope and key obligations- what kind of reward/exclusivity are available (SPC

extension/patent protected products, orphan drugs,off-patent products)?

• The Orphan Drugs Regulation – obtaining orphan market exclusivity

4:45 CONFERENCE ENDS

Each year more than 21,000 in-house counsel, attorneys in private practice and other senior executives participate

in ACI events – and the numbers keep growing.

Guaranteed Value Based on Comprehensive ResearchACI’s highly trained team of attorney-producers are dedicated, full-time, to developing the content and scope of our conferences based on comprehensive research with you and others facing similar challenges. We speak your language, ensuring that our programs provide strategic, cutting edge guidance on practical issues.

Unparalleled Learning and NetworkingACI understands that gaining perspectives from – and building relationships with – your fellow delegates during the breaks can be just as valuable as the structured conference sessions. ACI strives to make both the formal and informal aspects of your conference as productive as possible.

American Conference Institute: The leading networking and information resource for counsel and senior executives.

© American Conference Institute, 2010

R E G I S T R A T I O N F O R M

CONTACT DETAILS NAME POSITION

APPROVING MANAGER POSITION

ORGANIZATION

ADDRESS

CITY STATE ZIP CODE

TELEPHONE FAX

EMAIL TYPE OF BUSINESS

Registration FeeThe fee includes the conference, all program materials, continental breakfasts, lunches, refreshments and complimentary membership of the ACI Alumni program.

Payment PolicyPayment must be received in full by the conference date. All discounts will be applied to the Conference Only fee (excluding add-ons), cannot be combined with any other offer, and must be paid in full at time of order. Group discounts available to individuals employed by the same organization.

Cancellation and Refund PolicyYou must notify us by email at least 48 hrs in advance if you wish to send a substitute participant. Delegates may not “share” a pass between multiple attendees without prior authorization. If you are unable to find a substitute, please notify American Conference Institute (ACI) in writing up to 10 days prior to the conference date and a credit voucher valid for 1 year will be issued to you for the full amount paid, redeemable against any other ACI conference. If you prefer, you may request a refund of fees paid less a 25% service charge. No credits or refunds will be given for cancellations received after 10 days prior to the conference date. ACI reserves the right to cancel any conference it deems necessary or remove/restrict access to the ACI Alumni program and will not be responsible for airfare, hotel or other costs incurred by registrants. No liability is assumed by ACI for changes in program date, content, speakers, venue or arising from the use or unavailability of the ACI Alumni program.

Hotel InformationConference will be held at:Downtown Conference Center157 William StreetNew York, NY 10038(212) 618-6990

Incorrect Mailing InformationIf you would like us to change any of your details please fax the label on this brochure to our Database Administrator at 1-877-927-1563, or email data@AmericanConference.com.

ATTENTION MAILROOM: If undeliverable to addressee, please forward to:Corporate counsel-patents; Patent attorney

CONFERENCE CODE: 695L11-NYC YES! Please register the following delegate for PTA - PTE

PRIORITY SERVICE CODE695L11_INH

SPECIAL DISCOUNTWe offer special pricing for groups and government employees.

Please email or call for details. Promotional Discounts May Not Be Combined. ACI offers financial

scholarships for government employees, judges, law students, non-profit entities and others. For more information,

please email or call customer care.

To reserve your copy or to receive a catalog of ACI titles go to www.aciresources.com or call 1-888-224-2480.

CONFERENCE PUBLICATIONS

5 Easy Ways to RegisterMAIL American Conference Institute 41 West 25th Street New York, NY 10010

PHONE 888-224-2480

FAX 877-927-1563

ONLINE AmericanConference.com/PTA-PTE

EMAILCustomerService@AmericanConference.com

℡

FEE PER DELEGATE Register & Pay by Nov 23, 2010 Register & Pay by Dec 21, 2010 Register after Dec 21, 2010

Conference Only $1895 $1995 $2195

I would like to add __ copies of the conference documentation to my order - $299 each

I cannot attend but would like information regarding conference publications

Please send me information about related conferences

✃

PAYMENTPlease charge my VISA MasterCard AMEX Please invoice me

NUMBER EXP. DATE

SIGNATURE(for credit card authorization and opt-in marketing)

I have enclosed my check for $_______ made payable to American Conference Institute (T.I.N.—98-0116207)

ACH Payment ($USD)Please quote the name of the attendee(s) and the event code 695L11 as a reference.For US registrants:Bank Name: HSBC USAAddress: 800 6th Avenue, New York, NY 10001Account Name: American Conference InstituteUPIC Routing and Transit Number: 021-05205-3UPIC Account Number: 74952405Non-US residents please contact Customer Service for Wire Payment information

I would like to receive CLE accreditation for the following states: ___________________. See CLE details inside.

HATCH-WAXMANs e r i e s

ACI’sFrom American Conference Institute, the creator of Maximizing Pharmaceutical Patent Life Cycles, Paragraph IV Disputes and Hatch-Waxman Boot Camp comes:

Tips, tactics and techniques for attorneys servicing the pharmaceutical, biotechnology and medical device industries

THE LIFE SCIENCES LAWYER’S GUIDE TO

PATENT TERM ADJUSTMENT AND PATENT TERM EXTENSIONS

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

Sleeping rooms are available at:Best Western Seaport Inn33 Peck SlipNew York, NY 10038(212) 766-6600