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American Conference Institute’s Advanced Summit on
Life Sciences Patents
Earn
CLE
ETHICS
Comprehensive and Practical Prosecution and Non-Hatch-Waxman Litigation
Strategies for Biotechnology, Pharmaceutical, and Diagnostics Companies
Credits
January 13–14, 2015 • DoubleTree Suites by Hilton Times Square • New York, NY
Pre-Conference Master Class: January 13, 2015
Post-Conference Interactive Working Group: January 14, 2015
Refreshed content based on the
insights of top patent counsel
- see page 2 for faculty list
Featuring a Who’s Who of Patent
Counsel and Industry Experts From:
Alexion
BIO
Biogen Idec
Cubist
Eisai
Emergent
BioSolutions
ImmunoGen
MannKind
Mercer University
Merck
Momenta
Myriad Genetics
Pfizer
PhRMA
Novartis
Novo Nordisk
Roche Sequencing
Shire
Hear directly from the USPTO:
Daniel Kolker, Supervisory Patent Examiner
(SPE), Art Unit 1644, United States Patent
and Trademark Office (USPTO)
Zac Lucas, Supervisory Patent Examiner
(SPE), Art Unit 1648
United States Patent and Trademark Office
(USPTO)
Mary C. Till, Senior Legal Advisor
United States Patent and Trademark Office
(USPTO)
Plus, included in your registration,
choose between two new interactive sessions designed to simplify
your day-to-day patent practice
A. They’re Here: Incorporating
Biosimilars into Current Life
Sciences Patent Strategies
B. Working with SPEs:
Best Practices Guide for Life
Sciences Patent Practitioners
New session this year
Policy and Patents: How the Federal Circuit and PTO Can Best Work Together
to Protect Life Sciences Innovation Going Forward
David J. Kappos
Partner, Cravath, Swaine & Moore LLP
(Under Secretary of Commerce and Director
of the United States Patent and Trademark
Office (USPTO), 2009-2013)
The Honorable Paul R. Michel
Chief Judge(Retired), U.S. Court
of Appeals for the Federal Circuit
Esteemed Co-Chairs:
Leslie Fischer, Ph.D.
Senior Patent Attorney
Novartis Pharmaceuticals Corporation
Immac J. Thampoe, Ph.D., J.D. (‘Casey’)
Managing Counsel, Biologics
Merck & Co., Inc.
George W. Johnston
Partner
Gibbons P.C.
(former Vice President & Chief Patent Counsel,
Hoffmann-LaRoche)
Mark E. Waddell
Partner and Chair, Patent Litigation
and Counseling, Loeb & Loeb
Prominent in-house patent counsel and leading attorneys serving the life sciences
industries will provide in-depth analysis on the year’s biggest legal developments
and offer key sessions on:
• Protecting patents in light of increasingly strict § 101 patentability standards post-Myriad
and USPTO patent eligibility guidelines
• Demystifying the doctrine of obviousness-type double patenting and analyzing its interplay
with patent term extension (PTE) post-Gilead
• Using inter partes review (IPR) and post-grant review (PGR) offensively and defensively
in the life sciences space
• Drafting strong claims and protecting patents in light of written description and indefiniteness
challenges post-Abbvie and Nautilus
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Associate Sponsors:
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Amidst crisis over § 101 patentability and fears of an antipatent climate, be a part of the premier life sciences intellectual
property forum designed to provide you with the necessary
skills to adapt to rapidly evolving industry standards.
Distinguished Faculty:
Paul Alloway
Alexion Pharmaceuticals
Jennifer Blount
ImmunoGen, Inc.
Nicholas M. Boivin
Cubist Pharmaceuticals, Inc.
Dear Colleague,
In response to the daunting IP challenges currently before the biotechnology, pharmaceutical,
and diagnostics industries, ACI has designed its Life Sciences Patents Summit as a gathering
place for key stakeholders — in-house IP counsel, patent prosecutors and litigators, the
PTO, and policy experts — to share their collective intellectual property knowledge. This is
the leading forum for both life sciences industry-specific networking and masters-level strategy
sharing. Attend this event and learn winning strategies to file patents flawlessly and protect
patents vigorously.
Facing a double whammy of challenges in both the Federal Courts and
the USPTO, life sciences patents have never been more vulnerable.
Decisions like Myriad and Prometheus have left specific types of patents subject to an
onslaught of challenges, while decisions like Gilead and developments in USPTO procedures
have left entire patent portfolios hanging in the balance. Attend this event and walk away with
tailored patent strategies you can immediately incorporate into your practice regarding §101
patentability, double patenting type obviousness, and written description and indefiniteness
challenges.
Our accomplished faculty — a veritable “Who’s Who” of the
life sciences patent bar — have united to provide comprehensive
updates and strategic solutions to protect life sciences patents.
Our unparalleled faculty — including multiple speakers from the USPTO and in-house
representatives from Merck, Novartis, Biogen, Roche, and many more — will share the
methods that have worked for them in recent battles, and provide specific advice to protect
your patent portfolio cost-effectively. Furthermore, this year’s conference features a new
session in which former leaders from the USPTO and the Federal Circuit — including
David Kappos and The Honorable Paul Michel — discuss patentability and the role of both
agencies in the future of continued investment in life sciences R&D. Do not miss this unique
opportunity to learn from leading members of the life sciences patent bar who are setting the
standards in the trenches of life sciences patent prosecution and litigation.
I hope you will join us in New York City in January and be a part of a community of peers
with the goal of protecting life sciences intellectual property. Call 1-888-224-2480, fax your
registration to 1-877-927-1563, or visit us online at americanconference.com/maxbiopharma.
Very truly yours,
Heather Boussios
Emergent BioSolutions
Maureen A. Bresnahan
Eisai, Inc.
Krista Hessler Carver
Covington & Burling LLP
David Diamond
MannKind Corporation
Leslie Fischer, Ph.D.
Novartis Pharmaceuticals
Corporation
Barton W. Giddings, Ph.D., J.D.
Stoel Rives LLP
Reza Green
Novo Nordisk, Inc.
Elizabeth F. Holowacz
Fitzpatrick, Cella, Harper
& Scinto
David Hricik
Mercer University
John P. Iwanicki
Banner & Witcoff, Ltd.
Benjamin G. Jackson
Myriad Genetics
Patrice P. Jean, Ph.D.
Kenyon & Kenyon LLP
George W. Johnston
Gibbons P.C.
David J. Kappos
Cravath, Swaine & Moore LLP
Olga Kay, J.D., Ph.D.
Roche Sequencing
Yelee Kim
Arent Fox LLP
Daniel Kolker, Ph.D.
United States Patent and
Trademark Office
Nicole M. Cutrufello-Turner, J.D.
Legal Analyst and Senior Conference Director
Plus, when making your travel arrangements, plan on attending two new sessions designed for
heightened networking and in-depth strategizing:
A. They’re Here: Incorporating Biosimilars into Current Life Sciences Patent Strategies
B. Working with SPEs: Best Practices Guide for Life Sciences Patent Practitioners
Who You Will Meet:
• Patent attorneys, patent agents, and patent litigators
(in-house and law firm) who represent:
- Biotechnology Companies
- Diagnostics Companies
- Pharmaceutical Companies
2
Join the Conversation
ACI: Pharma / Biotech / Life Sciences
David E. Korn
Pharmaceutical Research and
Manufacturers of America
(PhRMA)
Zac Lucas
United States Patent and
Trademark Office
Raymond R. Mandra
Fitzpatrick, Cella, Harper
& Scinto
The Honorable Paul R. Michel
Chief Judge(Retired) U.S.
Court of Appeals for the Federal
Circuit
Randall Morin
Shire
Kevin E. Noonan, Ph.D.
McDonnell Boehnen Hulbert
& Berghoff LLP
Bruce A. Pokras
Pfizer Inc
William B. Raich, Ph.D.
Finnegan, Henderson, Farabow,
Garrett & Dunner, LLP
Kathleen A. Ranney
Eisai Inc.
Nabeela Rasheed, Ph.D., J.D.
McAndrews, Held, & Malloy
Teresa “Terry” Stanek Rea
Crowell & Moring LLP
Michelle S. Rhyu, Ph.D., J.D.
Cooley LLP
Keisha Hylton-Rodic, Ph.D., J.D.
Nevrivy Patent Law Group
P.L.L.C.
Hathaway P. Russell
Foley Hoag LLP
Hans Sauer, Ph.D., J.D.
Biotechnology Industry
Organization (BIO)
Jennifer Zarutskie Sieczkiewicz,
Ph.D., J.D.
Biogen Idec Inc.
Suzannah K. Sundby
canady + lortz LLP
Immac J. Thampoe, Ph.D., J.D.
(‘Casey’)
Merck & Co., Inc.
Mary C. Till
United States Patent and
Trademark Office (USPTO)
John C. Todaro
Merck
Thomas J. Kowalski
Vedder Price
Leda Trivinos
Momenta Pharmaceuticals
Jeffrey P. Kushan
Sidley Austin LLP
Anita Varma
Ropes & Gray LLP
Jeremy Lowe
Axinn, Veltrop & Harkrider LLP
Mark E. Waddell
Loeb & Loeb
Deborah L. Lu, Ph.D.
Vedder Price
@ACI_Pharma / #LSPatents
Pre-Conference Master Class
Day 1: Tuesday, January 13, 2015
9:00 a.m. to 12:00 p.m. (Registration begins at 8:30 a.m.)
A
They’re Here: Incorporating Biosimilars into
Current Life Sciences Patent Strategies
12:30
Main Conference Registration Begins
1:00
Co-Chairs’ Opening Remarks
Kathleen A. Ranney
Senior Patent Counsel
Eisai Inc. (Andover, MA)
Leslie Fischer, Ph.D.
Senior Patent Attorney
Novartis Pharmaceuticals Corporation (East Hanover, NJ)
Krista Hessler Carver
Partner
Covington & Burling LLP (Washington, DC)
Immac J. Thampoe, Ph.D., J.D. (‘Casey’)
Managing Counsel, Biologics
Merck & Co., Inc. (Rahway, NJ)
George W. Johnston
Partner
Gibbons P.C.
(former Vice President & Chief Patent Counsel,
Hoffmann-LaRoche)
Jeffrey P. Kushan
Partner
Sidley Austin LLP (Washington, DC)
Nabeela Rasheed, Ph.D., J.D.
Shareholder
McAndrews, Held, & Malloy (Chicago, IL)
Mark E. Waddell
Partner and Chair, Patent Litigation and Counseling
Loeb & Loeb (New York, NY)
Michelle S. Rhyu, Ph.D., J.D.
Partner
Cooley LLP (Palo Alto, CA)
1:15
In anticipation of the first wave of applications, this intensive
session will give attendees a chance to get up to speed on the current
biosimilars landscape and will give attendees an up-to-the-moment
treatise on the significant regulatory and IP developments. Topics to
be discussed include:
David J. Kappos
Partner
Cravath, Swaine & Moore LLP (New York, NY)
(Under Secretary of Commerce and Director of the United States
Patent and Trademark Office (USPTO), 2009-2013)
Regulatory Considerations:
The Honorable Paul R. Michel
Chief Judge (Retired)
U.S. Court of Appeals for the Federal Circuit (Washington, DC)
• FDA’s interpretation of biosimilarity and methods for showing
it, including discussion of recent draft guidance
• Substituting the biosimilar at the pharmacy level: what will it
take to make interchangeability possible?
• Nonproprietary naming and labeling of biosimilars
•“Bio-betters”
• Full BLA route versus biosimilar route
• Reference product exclusivity and the Purple Book
David E. Korn
Vice President, Intellectual Property and Law
Pharmaceutical Research and Manufacturers of America
(PhRMA) (Washington, DC)
Hans Sauer, Ph.D., J.D.
Deputy General Counsel for Intellectual Property
Biotechnology Industry Organization (BIO) (Washington, DC)
IP Strategies and Product Life Cycle Considerations:
• Comparing and contrasting the biosimilar pathway to 505(b)(2)
v and BLA pathways
• Relevant considerations for innovators and (k) applicants with
respect to timing, costs, and IP litigation considerations, and
exclusivity
• Crafting a winning biologic patenting strategy
• Devising claim drafting methods for and against biosimilars:
strategies to head off biosimilar development or to work around
narrowly written biopharmaceutical patents
• 101, 112, and double patenting recent developments at PTO
Proceedings and in case law
• Effective use of Patent Office Proceedings
Litigation Considerations:
• Patent litigation and exchange provisions
• BPCIA litigation provisions in practice – review of Sandoz/
Amgen and Celltrion v. Kennedy etc.
• Strategic forum choices for disputes: District Court, ITC, PTO
Policy and Patents: How the Federal Circuit
and PTO Can Best Work Together to Protect Life
Sciences Innovation Going Forward
In the past year, there has been a tension between the life sciences
industry and the Federal Courts and the USPTO with regards to the
patentability of life sciences inventions. This discord poses a threat to
innovation, risking both human health and economic consequences.
In this session, esteemed former leaders from the Federal Circuit and
the USPTO unite with leading life sciences industry patent policy
experts to discuss possibilities for easing tensions through judicial
and administrative channels while recognizing the necessity for
continued advancement of life sciences research and development.
2:15
Crisis in the Industry: Protecting Life Sciences
Patents in Light of Increasingly Strict § 101
Patentability Standards
Paul Alloway
Senior Director and Patent Counsel
Alexion Pharmaceuticals (Cheshire, CT)
Benjamin G. Jackson
Vice President, Legal Affairs
Myriad Genetics (Salt Lake City, UT)
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3
Leslie Fischer, Ph.D.
Senior Patent Attorney
Novartis Pharmaceuticals Corporation (East Hanover, NJ)
3:30
Leda Trivinos
Chief Patent Counsel
Momenta Pharmaceuticals (Cambridge, MA)
Thomas J. Kowalski
Shareholder
Vedder Price (New York, NY)
• Exploring the shifting landscape of what is patentable postMyriad and Prometheus
o Update on Alice Corp, v. Cls Bank International, 134 S.
Ct. 1537 (Supreme Court March 21, 2014): applying the
two-step test in the life sciences context and examining its
potential chilling effects on patents
o Establishing realistic expectations for the scope of patent
protection that can be obtained going forward
o Assessing the strength of your current portfolio and
competitors’ portfolios for FTO and licensing purposed
o Formulating patent disclosure strategies in light of the
differing standards in the U.S. and abroad where more claims
are still allowed
o Factoring increased IPRs into the mix post-Myriad IPRs:
prior art, obviousness, and novelty challenges
• Update on the USPTO’s position on subject matter eligibility
and guidelines on examination under these decisions
o Examining the breadth of the USPTO’s interpretation
of the case law and subsequent guidance
o Evaluating the possibility of respite post-comment period
from either the USPTO or from Congress
o § 101 rejections and pulled notices of allowance: dealing with
proper and potentially erroneous office actions post-guidance
o Understanding the appeals process: PTAB and District Courts
• Specific claim drafting and enforcement strategies for
recombinant antibodies, naturally occurring products,
personalized medicine, methods of treatment, clinical and
companion diagnostics, biomarkers, and bioinformatics to avoid
§ 101 rejections
o Writing in transformative steps to show the “hand of man”
while simultaneously avoiding divided infringement issues
o Determining what constitutes a law of nature or product
of nature
o Showing structural and form changes
o Going beyond well-known techniques for assays for natural
products
o Avoiding mental and abstract steps
• Working around these decisions and the current seemingly
anti-patent climate
o Alternative routes to build patent exclusivity
o Exploring the use of trade secret protection as an alternative
to traditional IP protection
• The economics of the narrowing scope of § 101: Understanding
the public policy concerns at play on both sides
o What is the incentive to invest in continued R&D?
3:15 4
Practical Strategies for Dealing with the Shifting
Landscape of Obviousness-Type Double Patenting
Nicholas M. Boivin
Associate General Counsel and
Senior Director, Intellectual Property Counsel
Cubist Pharmaceuticals, Inc. (Lexington, MA)
Heather Boussios
Senior Intellectual Property Counsel
Emergent BioSolutions (Rockville, MD)
Yelee Kim
Partner
Arent Fox LLP (Washington, DC)
Jeremy Lowe
Partner
Axinn, Veltrop & Harkrider LLP (Hartford, CT)
• Portfolio management in light of the Gilead Sciences Inc. v.
Natco Pharma Ltd. decision
o Redefining how patents qualify for obviousness type double
patenting
o Strategies for avoiding or overcoming obviousness type double
patenting
o Examining how this decision breaks from existing case law
in the arena
o Being aware of traps in your earlier-filed but later-issues
patents which can cost you PTA down the line
• Understanding the application of inherency in the obviousness
context post Bristol-Myers v. Teva
o Grasping the growing importance of unpredictable
or unexpected results
o Resolving the tension between written description
requirements and unexpected results
• Demystifying the evolving jurisprudence of obviousness: lessons
learned from how Courts and the USPTO have interpreted §
103 patentability standards post-KSR
o What claims and arguments have been successful in
countering obviousness and which haven’t?
o Practice tips and specific language and claim drafting
strategies in the USPTO to head an expensive obviousness
rejection off at the pass
- Showing novelty
- Emphasizing unexpected results
- Detailing the substantial evolution of the technology
and more
- Factoring in the increased importance of secondary criteria
of nonobviousness including commercial success
• Relying on the prior art to show non-obviousness in the life
sciences context
o Understanding the ramifications of the expanded prior art
under patent reform
o When have you searched enough? Strategically planning
for the new prior art which may be used against you
o Updating prior art searches to factor in third party
submissions and global submissions
Afternoon Coffee Break
Join the Conversation
ACI: Pharma / Biotech / Life Sciences
@ACI_Pharma / #LSPatents
4:30
It’s All about How Many Days, Months, Years are
Left. . . Patent Term Adjustment and Patent Term
Extension: Understanding the Practical Impact of
this Year’s Game Changing Cases
• Examining the impact of AIA Inter Partes Review (IPR)
procedures so far in the life sciences space:
o Update on the statistics and grant rate from the first wave
o Under what circumstances has this been an effective tool?
o Surviving IPRs: are the quasi-litigation procedures in the
PTO a killing field for patents?
o Using IPRs to clear freedom to operate
o Understanding how the standards of claim construction
(broadest reasonable interpretation versus ordinary meaning)
impact life sciences IPRs
• Timing is everything: how the rigid timeframes and accelerated
deadlines under the AIA can work for or against life sciences
companies
o Choosing your forum factoring in the clear and convincing
standard in litigation versus preponderance of the evidence
standard in the USPTO proceedings
o Fighting a war on two fronts: Factoring in estoppel
considerations in parallel proceedings
o Strategic considerations when appearing before the PTAB
o Exploring the effects of declaratory judgment actions and stays
• Update on Post-Grant Review (PGR): how will this play out
in the life sciences space?
o Invalidating patents: understanding how life sciences patents
are particularly vulnerable to attack to challenges based on
subject matter, written description, lack of enablement and
more
• Other PTO proceedings to watch
o Third party re-issuance submissions
o Supplemental examination
Mary C. Till
Senior Legal Advisor
United States Patent and Trademark Office (USPTO)
Raymond R. Mandra
Partner
Fitzpatrick, Cella, Harper & Scinto (New York, NY)
Kevin E. Noonan, Ph.D.
Partner
McDonnell Boehnen Hulbert & Berghoff LLP (Chicago, IL)
• Overview of the Novartis v. Lee decision
o How has the USPTO implemented the decision?
o What repercussions from the rulemaking are impacting
lifecycle management?
• Implementation of the AIA technical amendments to the Patent
Term Adjustment statutes
o Discussion of USPTO rules
o Effect of change on patents granted before applicability date
• Effect of Gilead v. Natco on PTA and subsequently earned PTE
o Analyzing the interplay between Patent Term Extensions
(PTE), changes in double patenting type obviousness case,
and terminal disclaimer
o Laying the groundwork for patent term restoration in light
of evolving case law
o Factoring PTA considerations into the decision whether
or not to file a terminal disclaimer and available PTE
5:30
Conference Adjourns to Day Two
5:30
Cocktail Reception
Sponsored by:
9:45
Day 2: Wednesday, January 14, 2015
7:45 Continental Breakfast
8:15
Co-Chairs’ Opening Remarks and Recap of Day 1
8:30
Lessons Learned From the First IPRs and PGRs:
Best Practices for Offensive and Defensive Use
of AIA Procedures in the Life Sciences Space
Jennifer Blount
Associate Director, Chemistry IP
ImmunoGen, Inc. (Waltham, MA)
Bruce A. Pokras
Senior Corporate Counsel
Pfizer Inc (Peapack, NJ)
Focus on Antibodies: Understanding Tightened §
112 Standards for Written Description
Maureen A. Bresnahan
Senior Patent Counsel
Eisai, Inc. (Andover, MA)
Deborah L. Lu, Ph.D.
Shareholder
Vedder Price (New York, NY)
William B. Raich, Ph.D.
PartnerFinnegan, Henderson, Farabow, Garrett & Dunner, LLP
(Washington, DC)
Analysis of Recent Case Law and PTO Guidance
• Supporting your claim and securing antibody coverage through
adequate written description after Abbvie v. Janssen and
Novozymes decisions, which have confirmed the strong Ariad
written description requirement
• Factoring in the resurgence of indefiniteness and preparing for
the fallout post-Nautilus relative to antibody claims
• The PTO Mayo-Myriad Guidance and § 112
Current Drafting Considerations and Best Practices
Jennifer Zarutskie Sieczkiewicz, Ph.D., J.D.
Director of IP Strategy and Operations
Biogen Idec Inc. (Cambridge, MA)
Teresa “Terry” Stanek Rea
Partner
Crowell & Moring LLP (Washington, DC)
(Former Deputy Director, U.S. Patent and Trademark Office)
• Preparing patents to maximize the scope of allowable antibody
claims in light of recent decisions and the recent PTO MayoMyriad Guidance
• Determining appropriate claim scope for your antibody and
how broadly to describe the antibody invention using structural
and functional characteristics
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5
• What is the future of functional claims?
• Describing a process while avoiding functional claiming
• Leveraging unpredictability: balancing the inherent tension
between the need to demonstrate unpredictability to avoid
obviousness and producing an adequate written description
10:45
Morning Coffee Break
11:00
Bracing for the Fallout from Inducement and
Divided Infringement on Method of Treatment
Claims for Pharmaceutical, Biotechnology, and
Diagnostic Patents
Randall Morin
Lead, Business Development Transactions
Shire (Lexington, MA)
Patrice P. Jean, Ph.D.
Partner
Kenyon & Kenyon LLP (New York, NY)
• Working with lawyers on the ground internationally and with
your U.S. teams to manage IP portfolios globally and coordinate
standards
o Focus on patentability: how are companies dealing with
the broad denial of natural products and diagnostics in the
US while those inventions are still patentable in the EPO?
o Deciding which claims to file in which countries
• How has the establishment of a Unitary Patent Court affected
life sciences IP strategies?
o Keeping SPCs and PTE in mind
• Preparing for and implementing a patent strategy for emerging
markets in light of access to previously untapped markets
• Coordinating strategies for patent term extension and patent
listing requirements worldwide
2:00 Afternoon Coffee Break
2:15
ETHICS and Life Sciences IP: Inequitable
Conduct, New PTO Ethical Rules, and Special
Concerns for Contested Matters Before the PTO
Mark E. Waddell
Partner and Chair, Patent Litigation and Counseling
Loeb & Loeb (New York, NY)
David Hricik
Professor of Law
Mercer University (Macon, Georgia)
• Comprehending the new standard for establishing joint
infringement and supporting claims of inducement
post-Limelight Networks v. Akamai
o Apportioning responsibility between separate entities
each performing separate steps in a method claim
o Determining the proper parties in litigation involving
multi-staged transactions
o Showing specific intent and willfulness
• Claim drafting strategies to proactively avoid inducement
charges with method claims featuring multiple steps: how can
life sciences manufacturers protect themselves?
• Factoring in the joinder provisions of the AIA: How much more
creative do parties have to be to prove infringement?
12:00
Networking Lunch
1:00
In-House Round Table: Strategically Executing a
Cohesive International Life Sciences Patent Strategy
for Established and Emerging Markets
Barton W. Giddings, Ph.D., J.D.
Partner
Stoel Rives LLP (Salt Lake City, UT)
Elizabeth F. Holowacz
Partner
Fitzpatrick, Cella, Harper & Scinto (New York, NY)
• Keeping up-to-date on the pendulum swing of the doctrine of
inequitable conduct: from narrow to broad and now expanding again
o Rule 36 affirmations of inequitable conduct cases
o Update on relevant life sciences cases post-Therasense
• Understanding when to raise the inequitable conduct defense
under the continually evolving Therasense standard
• Updated best practices for inequitable conduct in the life sciences
space: what is reasonable to turn over to the PTO going forward?
o Meeting the requirements for disclosure to the PTO during
prosecution
o Disclosing related prosecution applications in the US and abroad
o Disclosing foreign language documents post-patent reform
• Analysis of the PTO’s 2013 ethical Rules of Professional Conduct
o Overview of key provisions including conflicts, sanctions and
experts affecting life sciences practitioners
o How will these work with the ABA model rules and state bar rules?
o Exploring how the PTO has adopted the Therasense standard
in inequitable conduct proceedings
o Steering clear of discipline at the patent office through OED
• Understanding the new ethics rules in the IPR space for life
sciences companies
o Duty of candor and good faith owed by petitioner challenging
the patent
o Avoiding putting forth information inconsistent with a position
Reza Green
Vice President of Intellectual Property
Novo Nordisk, Inc. (Princeton, NJ)
Olga Kay, J.D., Ph.D.
Patent Counsel
Roche Sequencing (Pleasanton, CA)
John C. Todaro
Managing Counsel – Patents, Office of General Counsel –
Intellectual Property Group
Merck (Rahway, NJ)
David Diamond
Vice President, Intellectual Property
MannKind Corporation (Valencia, CA)
Moderator:
Anita Varma
Partner
Ropes & Gray LLP (Boston, MA)
3:15
Main Conference Adjourns
• Procuring and enforcing life sciences patents worldwide
on a cost-effective basis: where to file and why?
© American Conference Institute, 2014
6
Join the Conversation
ACI: Pharma / Biotech / Life Sciences
@ACI_Pharma / #LSPatents
Post-Conference Interactive Working Group
o Working through impasses with examiners: crafting
your response to an inquiry or rejection
• Additional tools for your arsenal: Incorporating continued
USPTO initiatives to reduce the backlog into your patent
practice to maximize patent life
o Controlling costs and reducing risks in the Accelerated
Examination Process
o Weighing the advantages and disadvantages of the Patent
Prosecution Highway
• Update on the pendency of patent applications post-AIA and what
this means to the timing of your applications and potential Patent
Term Adjustment (PTA): how fast are patents getting through?
3:30 p.m. to 5:30 p.m.
B
Working with SPEs: Best Practices Guide for Life
Sciences Patent Practitioners
Daniel Kolker, Ph.D.
Supervisory Patent Examiner (SPE), Art Unit 1644
United States Patent and Trademark Office (USPTO)
Zac Lucas
Supervisory Patent Examiner (SPE), Art Unit 1648
United States Patent and Trademark Office (USPTO)
John P. Iwanicki
Attorney
Banner & Witcoff, Ltd. (Boston, MA)
Media Partners:
Keisha Hylton-Rodic, Ph.D., J.D.
Partner
Nevrivy Patent Law Group P.L.L.C. (Washington, DC)
Hathaway P. Russell
Partner
Foley Hoag LLP (Boston, MA)
Suzannah K. Sundby
Partner
canady + lortz LLP (Washington, DC)
In this hands-on, highly interactive session, current USPTO
Supervisory Patent Examiners (SPEs) working in the life sciences
space unite with leading patent counsel to guide you through the
new and constantly evolving USPTO landscape. Revamp your
intellectual property strategies based on the experiences of USPTO
examiners who will discuss what has been working and what hasn’t
been working under the new patent reform procedures and under
the post-Myriad guidance regarding subject matter patentability.
Secure and maintain patent protection cost-effectively based on the
insights of the SPEs themselves:
• Update on the USPTO guidance regarding subject matter
patentability
o What are examiners looking for based on the current guidance?
o Overview of the comments received to date and reading
the tea leaves on how this might affect examination
o Claim drafting strategies to avoid a rejection: Concrete ideas
for addressing patentability issues going forward regarding
claim structure and form with natural products
o Where are we seeing rejections?
o Amending the claims after a rejection
• Analyzing how first-to-file under the AIA has affected
and will continue to affect patent practice
o USPTO perspective: how are examiners responding
to the resulting increases in complexity?
o Large and small companies perspectives on the risks
and benefits of filing often, filing early
• Speaking the language of the PTO: what do PTO examiners
look for in claims and interviews to streamline the patent
approval process?
o Clarifying the scope of claim terms
o Clarifying the meaning of claim terms in the specification
o Include the right prior art in your disclosures
o Avoiding obviousness rejections: updates on USPTO
standards as post-KSR doctrine continually evolves
Global Sponsorship Opportunities
With more than 300 conferences in the United States, Europe, Asia Pacific, and
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development solution catered exclusively to the needs of your practice group,
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contact:
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Tel: 212-352-3220 x5232
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7
Network with a stellar faculty featuring
representative from:
American Conference Institute’s Advanced Summit on
Life Sciences Patents
Comprehensive and Practical Prosecution and Non-Hatch-Waxman
Litigation Strategies for Biotechnology, Pharmaceutical, and
Diagnostics Companies
Alexion Pharmaceuticals Momenta
Pharmaceuticals
BIO
Myriad Genetics
Biogen Idec Inc.
Novartis
Cubist Pharmaceuticals, Pharmaceuticals
Inc.
Corporation
Eisai Inc.
Novo Nordisk, Inc.
January 13–14, 2015 • DoubleTree Suites by Hilton Times Square • New York, NY
ImmunoGen, Inc.
Emergent BioSolutions
Pre-Conference Master Class: January 13, 2015 | Post-Conference Interactive Working Group: January 14, 2015
PhRMA
MannKind Corporation Roche Sequencing
Mercer University
Shire
Merck & Co., Inc.
R E G I S T R AT I O N F O R M
Pfizer Inc
USPTO
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