In a highly competitive and constantly changing market of today, the pharmaceutical industry is looking for suitable ways to extend the profitability of its products up to and beyond patent expiry, so medical device IP Portfolios are becoming increasingly relevant for pharma. Due to the expensive cost associated with the Research and Development (R&D), it is becoming crucial to implement integrated Life Cycle Management (LCM) strategies that would maximize revenues and extend the lifespan of patent portfolios. In cases where patent extension is not an option, and the product is nearing patent cliff, drug innovators are increasingly relying upon medical device IP to decelerate the pace of revenue loss from generic competition. Without strong product LCM strategies, pharmaceutical companies are more likely to be exposed to legal challenges and revenue risks. In this two-hour LIVE Webcast, a stellar panel assembled by The Knowledge Group will offer a discussion on the most significant issues involving patent portfolio and LCM strategies. The panel will also provide a roadmap through the R&D process and will help the audience understand the best practices in minimizing the risks associated with patent portfolio and lifecycle development. Key Issues: Pharmaceutical and Medical Device Patent Life Cycles – An Overview Patent Term Adjustments for Biotech and Pharma Role of PTA in Medical Device and Pharma Patent Life Cycle Patent Term Extension Patentability and Implications for Life Sciences Innovation Portfolio Strategies Common Risks and Pitfalls Up-to-the-minute Regulatory Updates To view the webcast go to this link: https://youtu.be/moDq0HVku8E To learn more about the webcast please visit our website: http://theknowledgegroup.org

1. Speaker Firms and Organization:
Riley Safer Holmes & Cancila LLP
Taylor Corbitt
Partner
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Presented By:
January 12, 2017
1
Partner Firms:
Weiss & Arons, LLP
Edward Arons, PH.D., Esq.
Founding Partner
Proskauer Rose LLP
Christine G. Espino, PhD
Attorney

2. January 12, 2017
2
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3. January 12, 2017
3
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4. January 12, 2017
4
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5. January 12, 2017
5
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6. Partner Firm:
January 12, 2017
6
Proskauer is a leading international law firm focused on creating value. Founded in 1875 and with over 700+ lawyers active in
virtually every major market worldwide, the firm is recognized not only for its legal excellence, but also its dedication to client
service. Their clients include many of the world’s top companies, financial institutions, investment funds, not-for-profit
institutions, governmental entities and other organizations across industries and borders. They have offices in New York,
Boston, Beijing, Chicago, Hong Kong, London, Los Angeles, Paris, São Paulo and Washington, D.C., as well as Boca Raton,
Newark and New Orleans.
Proskauer's collaborative Life Sciences Patent practice has industry experience in the life sciences area that is second to
none, with members having worked at companies such as Amgen, Chiron, Life Technologies, Affymetrix, Millennium
Pharmaceuticals and Wyeth. The group focuses on partnering with leading pharmaceutical, biotechnology and medical device
clients to meet their business objectives and develop and execute practical solutions to their problems throughout the full life
cycle of the patent process. Their deep knowledge of the most important therapeutic areas, such as immunology, oncology
and neurology, has allowed them to successfully represent their life sciences clients against some of the industry’s most
aggressive companies and institutions, employing comprehensive strategies that draw from their extensive experience with
patent prosecution, patent litigation, contested patent office proceedings, FDA regulations, patent transactions, including
licenses and assignments, and patent litigation.

7. Partner Firms:
January 12, 2017
7
Riley Safer Holmes & Cancila LLP is a diverse, service-oriented and
technically sophisticated national litigation practice committed to providing
legal and client service at the highest levels in the profession. Our partners
offer decades of experience and feature leaders in class action, white collar,
intellectual property, product liability, employment law and general
litigation. Our teams of seasoned and capable attorneys in Chicago, San
Francisco and New York, represent and serve the interests of valued clients
around the world.
Weiss & Arons LLP is an intellectual property law firm that represents clients
that range from small businesses to private equity and from start-ups to
multi-billion dollar international corporations. We provide IP risk management
advice in connection with technology-based transactions, whether
acquisition- or license-based, product development strategy and competitive
market positioning. Our scientific expertise and institutional knowledge cover
the fields of medtech, electrical engineering, telecommunications, software,
material properties, heat transfer and thermodynamics, optics, geophysical
exploration, high-energy particle applications and consumer products. The
firm is entrusted with IP matters that go before the U.S. Patent and
Trademark Office, including the Patent Trials and Appeals Board, the U.S.
District Courts and, through decades of collaboration with trusted foreign
associates worldwide, courts and rightsgranting agencies throughout the
world.

8. Brief Speaker Bios:
Christine G. Espino, PhD
Christine is an associate in the Litigation Department, and a member of the Life Sciences Patent practice. She works with clients at all
stages of product development, from early-stage R&D through clinical trials and product commercialization. She brings the dual
perspectives of scientist and attorney to her role as counsel on US and foreign patent prosecution, transactional due diligence, and
freedom-to-operate and patentability analyses.
January 12, 2017
8
Taylor Corbitt
Taylor Corbitt is an intellectual property and patent litigator at Riley Safer Holmes & Cancila LLP. Taylor has nearly a decade of
experience with patent portfolio planning and counselling, managing prosecution of chemical, biotech and pharmaceutical portfolios,
clearance and freedom-to-operate opinions, IP due diligence, pre-litigation analysis, litigation, and proceedings before the Patent Trials
and Appeal Board of the U.S. Patent and Trademark Office. Taylor’s practice focuses on chemical and pharmaceutical technologies,
but she also represents clients in patent litigation concerning technologies related to consumer products, mechanical devices, and
computer methods. Taylor is a graduate of DePaul University College of Law. She received a degree in molecular biology from the
University of Virginia. Taylor has been named an Emerging Lawyer in Intellectual Property Law and Patent Law by Law Bulletin
Publishing Company’s Leading Lawyers in 2015 and 2016.
► For more information about the speakers, you can visit: https://theknowledgegroup.org/event-homepage/?event_id=1959
Edward Arons, PH.D., Esq.
Ted Arons' distinctive combination of law and engineering expertise is invaluable to his clients. With 15 years of highly technical
experience in engineering and applied mathematics prior to his legal career, Ted brings a high level of knowledge and practical
solutions to every case. Clients can count on his immediate and thorough understanding of their advanced technology products as
well as their short- and long-term business needs.

9. In a highly competitive and constantly changing market of today, the pharmaceutical industry is looking for suitable ways to extend the
profitability of its products up to and beyond patent expiry, so medical device IP Portfolios are becoming increasingly relevant for pharma. Due
to the expensive cost associated with the Research and Development (R&D), it is becoming crucial to implement integrated Life Cycle
Management (LCM) strategies that would maximize revenues and extend the lifespan of patent portfolios. In cases where patent extension is
not an option, and the product is nearing patent cliff, drug innovators are increasingly relying upon medical device IP to decelerate the pace of
revenue loss from generic competition.
Without strong product LCM strategies, pharmaceutical companies are more likely to be exposed to legal challenges and revenue risks. In this
two-hour LIVE Webcast, a stellar panel assembled by The Knowledge Group will offer a discussion on the most significant issues involving
patent portfolio and LCM strategies. The panel will also provide a roadmap through the R&D process and will help the audience understand the
best practices in minimizing the risks associated with patent portfolio and lifecycle development.
Key Issues:
• Pharmaceutical and Medical Device Patent Life Cycles – An Overview
• Patent Term Adjustments for Biotech and Pharma
• Role of PTA in Medical Device and Pharma Patent Life Cycle
• Patent Term Extension
• Patentability and Implications for Life Sciences Innovation
• Portfolio Strategies
• Common Risks and Pitfalls
• Up-to-the-minute Regulatory Updates
January 12, 2017
9

10. Featured Speakers:
January 12, 2017
10
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP
SEGMENT 2:
Taylor Corbitt
Partner
Riley Safer Holmes & Cancila LLP

11. Introduction
Ted Arons' distinctive combination of law and engineering expertise is invaluable to his clients. With 15 years of highly technical experience in
engineering and applied mathematics prior to his legal career, Ted brings a high level of knowledge and practical solutions to every case. Clients can
count on his immediate and thorough understanding of their advanced technology products as well as their short- and long-term business needs.
He is highly regarded for providing new ways of looking at technical issues and client advice regarding their products, product pipeline development,
acquisitions and licensing. Drawing on his wide-ranging experience in technical areas, guides companies through IP aspects of transactions,
including fundraising, renders legal opinions, provides product clearance advice and helps businesses achieve optimal IP positions for corporate
growth and fundraising.
Ted's combination of broad and deep scientific background and extensive legal experience enables him to respond to the many intellectual property
concerns of his clients. His practice is fully supported by an outstanding staff that works collaboratively on cutting- edge legal issues.
Key to his success are strategies to protect the value of IP assets in today's business and legal climate, whether in the U.S. or abroad. Ted brings
this integrated approach to transactional work including due diligence, patent portfolio strength assessment and risk management counseling.
January 12, 2017
11
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP

12. A Patent View of Medical Device
Product Lifecycle Management
Or
WHEN THE ONLY CONSTANT IS CHANGE
January 12, 2017
12
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP

13. A Patent View of Medical Device Product Lifecycle Management
January 12, 2017
13
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
I. Drug candidate screening vs device conception and
proving
II. Modeling device technology under constant change
III. Hanging onto the priority date
IV. Patent drafting techniques for constant change

14. A Patent View of Medical Device Product Lifecycle Management
January 12, 2017
14
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
I. Drug candidate screening vs device conception and
proving

15. January 12, 2017
15
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
Time
Intensity
Pharma:
Rate of Innovation--new drug

16. January 12, 2017
16
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
Time
Intensity
Pharma:
Rate of Innovation--new drug
Medical Device:
Rate of Innovation

17. A Patent View of Medical Device Product Lifecycle Management
January 12, 2017
17
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
II. Modeling device technology under constant change

18. January 12, 2017
18
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
Cell Phone Microneedle
Array
Peristaltic Pump

19. January 12, 2017
19
(A)
Electronic Control
Circuit
(B)
Housing
(C)
Medicament Supply
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP

20. January 12, 2017
20
Technology
Model
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
(A)
Electronic Control
Circuit
(C)
Medicament Supply
(B)
Housing

21. January 12, 2017
21
Technology model development timeline
(A)
(B)
(C)
Exit?
SEGMENT 1:
Edward Arons, Ph.D., Esq.
Founding Partner
Weiss & Arons, LLP
Milestones
Financing

22. January 12, 2017
22
(A)
Electronic Control
Circuit
(B)
Housing
(C)
Medicament Supply
?
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP

23. January 12, 2017
23
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
(A)
Electronic Control
Circuit
(C)
Medicament Supply
(B)
Housing
Technology
Model

24. January 12, 2017
24
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
(A)
Electronic Control
Circuit
(C)
Medicament Supply
(B)
Housing
Technology
Model

25. January 12, 2017
25
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
(A)
Electronic Control
Circuit
(C)
Medicament Supply
(B)
Housing
Technology
Model

26. January 12, 2017
26
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
(A)
Electronic Control
Circuit
(B)
Housing
(C)
Medicament Supply

27. January 12, 2017
27
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
(A)
Electronic Control
Circuit
(C)
Medicament Supply
(B)
Housing
Technology
Model

28. January 12, 2017
28
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
Time
Intensity
Medical Device:
Rate of Innovation
End of Technology
Model (Vers. 1)

29. January 12, 2017
29
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
(A)
Electronic Control
Circuit
(B’)
Housing
(C)
Medicament Supply

30. January 12, 2017
30
Technology
Model Vers. 2
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
(A)
Control
Software
(B’)
Tissue Penetrator
(C)
Medicament Supply
(B)
Tissue Penetrator

31. A Patent View of Medical Device Product Lifecycle Management
January 12, 2017
31
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
III. Hanging onto the priority date

32. January 12, 2017
32
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
(A)
Electronic Control
Circuit
(B’)
Housing
(C)
Medicament Supply
(B)
Housing
Technology
Model Vers. 1
Technology
Model Vers. 2

33. January 12, 2017
33
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
Time
Intensity
End Vers. 1
Commercial Vers.
Medical Device:
Rate of Innovation

34. January 12, 2017
34
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
(A)
Electronic Control
Circuit
(B’)
Housing
(C)
Medicament Supply
(B)
Housing
Technology
Model Vers. 1
Technology
Model Vers. 2

35. January 12, 2017
35
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
(C)
Medicament Supply
Technology
Model Vers. 1
Technology
Model Vers. 2
(A)
Electronic Control
Circuit
(B’)
Housing
(B)
Housing

36. January 12, 2017
36
Medical Device:
Rate of Innovation
Medical Device:
Number of new indications
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
Time
Intensity
Begin Rev. 2
Commercial Rev.

37. January 12, 2017
37
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
(C)
Medicament Supply
Technology
Model Vers. 2
Technology
Model Vers. 1
(A)
Electronic Control
Circuit
(B’)
Housing
(B)
Housing

38. January 12, 2017
38
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
(C)
Medicament Supply
Technology
Model Vers. 2
Technology
Model Vers. 1
(A)
Electronic Control
Circuit
(B’)
Housing
(B)
Housing

39. January 12, 2017
39
Technology model development timeline
(A)
(B)
(C)
Exit?
SEGMENT 1:
Edward Arons, Ph.D., Esq.
Founding Partner
Weiss & Arons, LLP
Milestones
Financing
Priority Filing

40. January 12, 2017
40
Technology model development timeline
(A)
(B)
(C)
Exit?
SEGMENT 1:
Edward Arons, Ph.D., Esq.
Founding Partner
Weiss & Arons, LLP
Milestones
Financing
Priority Filing

41. A Patent View of Medical Device Product Lifecycle Management
January 12, 2017
41
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
IV. Patent drafting techniques for constant change

42. January 12, 2017
42
APPLICATION FOR UNITED STATES PATENT
WHAT IS CLAIMED IS:
1. Apparatus for drug delivery comprising:
(A) an electronic control circuit that receives a signal having a strength that is
dependent on a patient’s temperature;
(B) a biocompatible housing configured to be placed in fluidic communication with
the patient’s spinal cord; and
(C) a microfluidic discharge reservoir that delivers, through the housing, to the
spinal cord, a quantity of active ingredient corresponding to the signal.
DETAILED DESCRIPTION
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP

43. January 12, 2017
43
APPLICATION FOR UNITED STATES PATENT
WHAT IS CLAIMED IS:
1. Apparatus for drug delivery comprising:
(A) an electronic control circuit that receives a signal having a strength that is
dependent on a patient’s temperature;
(B) a biocompatible housing configured to be placed in fluidic communication with
the patient’s spinal cord; and
(C) a microfluidic discharge reservoir that delivers, through the housing, to the
spinal cord, a quantity of active ingredient corresponding to the signal.
DETAILED DESCRIPTION
[101] An apparatus for drug delivery is provided.
[102] The apparatus may include an electronic control circuit that receives signals having a
strength that is dependent on a patient’s temperature. The apparatus may include a
biocompatible housing configured to be placed in fluidic communication with the patient’s
spinal cord. The apparatus may include a microfluidic discharge reservoir that delivers, through
the housing, to the spinal cord, a quantity of active ingredient corresponding to the signal.
.
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP

44. January 12, 2017
44
APPLICATION FOR UNITED STATES PATENT
DETAILED DESCRIPTION
[101] An apparatus for drug delivery is provided.
[102] The apparatus may include an electronic control circuit that receives signals having a
strength that is dependent on a patient’s temperature. The apparatus may include a
biocompatible housing configured to be placed in fluidic communication with the patient’s
spinal cord. The apparatus may include a microfluidic discharge reservoir that delivers, through
the housing, to the spinal cord, a quantity of active ingredient corresponding to the signal.
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
(A) (B) (C)
“Apparatus” (A) Circuit receives signal from spinal cord
(B) Housing in fluidic communication with spinal cord
(C) Delivers to spinal cord through housing based on signal
Tie-back to apparatus Structural/functional interrelationships

45. January 12, 2017
45
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
(A) (B) (C)
“Apparatus” (A) Circuit receives signal from spinal cord
(B) Housing in fluidic communication with spinal cord
(C) Delivers to spinal cord through housing based on signal
Tie-back to apparatus Structural/functional interrelationships
Iontophoretic
Patch
Microneedle
Array

46. • Technology model based on broad conceptual overlaps between
components.
• Claims and Description clearly articulate the interactions
• Description ties back different embodiments to the interactions
• Stack serial provisional applications
January 12, 2017
46
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
PARTING NOTES

47. Introduction
Taylor Corbitt is an intellectual property and patent litigator at Riley Safer Holmes & Cancila LLP. Taylor has nearly a decade
of experience with patent portfolio planning and counselling, managing prosecution of chemical, biotech and pharmaceutical
portfolios, clearance and freedom-to-operate opinions, IP due diligence, pre-litigation analysis, litigation, and proceedings
before the Patent Trials and Appeal Board of the U.S. Patent and Trademark Office. Taylor’s practice focuses on chemical
and pharmaceutical technologies, but she also represents clients in patent litigation concerning technologies related to
consumer products, mechanical devices, and computer methods. Taylor is a graduate of DePaul University College of
Law. She received a degree in molecular biology from the University of Virginia. Taylor has been named an Emerging
Lawyer in Intellectual Property Law and Patent Law by Law Bulletin Publishing Company’s Leading Lawyers in 2015 and
2016.
January 12, 2017
47
SEGMENT 2:
Taylor Corbitt
Partner
Riley Safer Holmes & Cancila LLP

48. Managing and Monetizing
Your Pharma Patent Portfolio
January 12, 2017
48
SEGMENT 2:
Taylor Corbitt
Partner
Riley Safer Holmes & Cancila LLP

49. IP Asset Life Cycle
January 12, 2017
49
SEGMENT 2:
Taylor Corbitt
Partner
Riley Safer Holmes & Cancila LLP
Patents
Copyrights
Trademarks
Trade Secrets
Licensing

50. IP Asset Life Cycle
January 12, 2017
50
SEGMENT 2:
Taylor Corbitt
Partner
Riley Safer Holmes & Cancila LLP
Patents
Copyrights
Trademarks
Trade Secrets
Licensing

51. Maintaining Your Portfolio
• Strategic portfolio management
• Maintain rights (careful docketing and maintenance fee payments)
• Continuation practice (“evergreening”)
• Patent cliff issues
• Pruning deliberately (abandonment or divestiture)
• Monitor expiration dates to ensure defensive pricing strategies or OTC switch before rights expire
January 12, 2017
51
SEGMENT 2:
Taylor Corbitt
Partner
Riley Safer Holmes & Cancila LLP

52. Maintaining Your Portfolio
• Formulate monetization strategy (compare cost and benefits)
• Minefield model
• Pioneering model
• Identify strategy for each application or apply globally to product group
January 12, 2017
52
SEGMENT 2:
Taylor Corbitt
Partner
Riley Safer Holmes & Cancila LLP

53. Managing Portfolio through M&A
• PwC dubbed 2016 “the year of merger mania” in the pharmaceutical, biotech and healthcare
industries, citing it as #1 of the top health industry issues of 2016. Before that, 2015 was the
record-breaking year, with Mergermarket citing 954 transactions worth nearly $700 billion.
• Managing your portfolio through a merger or acquisition
• Lay of the land during merger or acquisition
• turf insecurities, too many chiefs, pruning difficult, but holistic evaluation of portfolio to
ensure representation of new priorities imperative
• Tips for managing transition and minimizing continued outlay for less profitable patents
• designate external “bad guy” from outside department or organization to manage
process; timeline management; priority consensus; managing IP conflicts
January 12, 2017
53
SEGMENT 2:
Taylor Corbitt
Partner
Riley Safer Holmes & Cancila LLP

54. Maintening Your Portfolio Against External Challenges
• AIA/ Post grant challenges
• Defending IPRs in pharmaceutical cases
• Who is filing, what type of cases
• No first-filers, prospective ANDA filers or 3rd parties, so starts clock for brand name
companies much earlier than usual in H-W cases
• Emerging as good route for patent challenges to biosimilars/BPCIA
• CBM attempts
• Stay vs. stay
• Success Rates
• Roughly 67% institution rate of IPR petition by generic against brand company, and trend is
rate falling
• High settlement rates, low (45%) invalidation rates
• For OB patents, 65% institution and only 40% invalidation
• Hedge Fund IPRs – 50% institution
• Reissue Practice
January 12, 2017
54
SEGMENT 2:
Taylor Corbitt
Partner
Riley Safer Holmes & Cancila LLP

55. Defensive Maintenance
January 12, 2017
55
SEGMENT 2:
Taylor Corbitt
Partner
Riley Safer Holmes & Cancila LLP

56. IP Asset Life Cycle
January 12, 2017
56
SEGMENT 2:
Taylor Corbitt
Partner
Riley Safer Holmes & Cancila LLP
Patents
Copyrights
Trademarks
Trade Secrets
Licensing

57. Monetizing Your Pharma Portfolio
• Monetizing your pharma portfolio
• Litigation, licensing, or divestiture
• Define project scope and end it when over – patents having high value almost always
immediately apparent
• Tax considerations/ advantages for IP ownership, including transfer pricing?
• Use of IP Holding company
• Standing to sue
• Indispensable parties
• Non-OB patents vs. OB patents
January 12, 2017
57
SEGMENT 2:
Taylor Corbitt
Partner
Riley Safer Holmes & Cancila LLP

58. Introduction
Christine is an associate in the Litigation Department, and a member of the Life Sciences Patent practice. She works with clients at all stages of
product development, from early-stage R&D through clinical trials and product commercialization. She brings the dual perspectives of scientist and
attorney to her role as counsel on US and foreign patent prosecution, transactional due diligence, and freedom-to-operate and patentability analyses.
Prior to joining Proskauer Christine worked as an intellectual property associate at two leading Boston law firms, where she worked with large
academic, institutional and corporate clients in all phases of product development and patent prosecution strategy. She drafted and prosecuted U.S.
and foreign patent applications, assisted in due diligence for financing, and conducted freedom-to-operate and patentability analyses in the life
sciences area.
Christine’s technical experience includes small molecules, pharmaceutical formulations, crystalline polymorphs, polymers for drug delivery, and
protein-drug and antibody-drug conjugates. She performed her post-doctoral research in organic and polymer chemistry at M.I.T., where she
developed transition-metal mediated strategies for preparing novel conjugated polymers and extended aromatic structures. As a graduate research
fellow at Stanford University, Christine developed a new methodology for synthesizing highly functionalized amine derivatives, which culminated in a
novel, commercially available catalyst. As an undergraduate research assistant at Harvard University, she delineated the substrate scope of the
enantioselective aluminum-catalyzed addition of HCN to imines as a route to non-natural a-amino acids.
Christine has served as an attorney mentor in the Boston Lawyers Group Mentor Program since 2014.
January 12, 2017
58
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

59. Small Molecule Patent Lifecycle Management Post-Gilead
January 12, 2017
59
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

60. US Exclusivity Strategies
Small Molecule Portfolio Strategies
– Composition of matter/method of use
– Solid forms (salts, polymorphs, co-crystals, co-formers)
– Pharmaceutical formulations
– Combination therapy, patient populations
– Manufacturing/synthetic processes
Other Extensions of Exclusivity
– Patent Term Adjustment (PTA)
– Patent Term Extension (PTE)
– Pediatric Exclusivity
– Orphan Designation
January 12, 2017
60
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

61. Portfolio Strategies – Further Considerations
• In addition to multiple patent families, continuing applications (DIVs, CONs, and CIPs) in each family
can be used to develop a portfolio
• Can be used to capture different subject matter disclosed in application or claims of differing scope to
those obtained in earlier-issued patents (e.g., Office rejects broad claims in 1st application and
Applicant accepts narrower claims to expedite prosecution)
• Conventional wisdom: keep important patent families pending for strategic flexibility in, e.g., litigation
and USPTO trials (e.g., largely theoretical ability to amend claims in IPR proceedings) or to capture
subject matter of new commercial interest
January 12, 2017
61
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

62. Flexibility May Have Costs*
• Continuing applications often are examined more quickly compared to parent and fewer days of PTA
likely to accrue: shorter term than parent
• Examiner may levy non-statutory obviousness-type double patenting in child applications over parent
case, which can be addressed via terminal disclaimer (TD)
• Note that TD cannot be filed over an expired patent to remedy OTDP
January 12, 2017
62
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

63. Terminal Disclaimer Practice Prior to Gilead
• Strategic value to keep an application pending in important patent families, even if unlikely to accrue
PTA due to Office delay
• If ODTP rejection raised in continuing application, filing a TD could expedite prosecution
• While the TD requires common ownership, a TD over the earlier-filed but later expiring (due to, e.g.,
PTA) parent patent generally was not thought to adversely affect the parent
January 12, 2017
63
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

64. Gilead Sciences Inc. v. Natco Pharma Ltd.,
753 F.3d 1208 (Fed. Cir. 2014) (1/6)
• Two patents owned by Gilead and having same five inventors, directed to antiviral compounds and
methods for their use:
– 5,952,375, filed Feb. 26, 1996, and issued Sep. 14, 1999
• Earliest priority: Feb. 27, 1995 (US 08/395,245)
• Expiration: February 27, 2015
– 5,763,483, filed Dec. 27, 1996, and issued Jun. 9, 1998
• Earliest priority: Dec. 29, 1995 (US 60/009,306)
• Expiration: December 27, 2016
• Different priorities: not PAR/CON or PAR/DIV or PAR/CIP
• Different expiration dates: due to filing dates and not PTA
January 12, 2017
64
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

65. Gilead Sciences Inc. v. Natco Pharma Ltd.,
753 F.3d 1208 (Fed. Cir. 2014) (2/6)
• Graphical representation of timelines for each patent
• The two applications were before different Examiners
• After the ‘483 patent issued, Gilead filed a TD in the application that led to the ‘375 patent
– Fed. Cir. opinion notes that this appears to be the first time that this seems to be first time that
Gilead informed either Examiner about the other application
January 12, 2017
65
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

66. Gilead Sciences Inc. v. Natco Pharma Ltd.,
753 F.3d 1208 (Fed. Cir. 2014) (3/6)
• Gilead sued Natco for infringement of the ‘483 patent after Natco filed a request with the FDA seeking
approval to market a generic version of one of Gilead’s drugs covered by patent (35 U.S.C. §
271(e)(2))
• Natco argued that the ‘483 patent was invalid for OTDP over earlier-filed but later-issued ‘375 patent
• Gilead argued that ‘375 patent wasn’t available as double patenting reference because of later
issuance
• District Court (NJ): following stipulation of infringement by both parties, agreed with Gilead (citing two
district court cases) and granted final judgment on infringement
January 12, 2017
66
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

67. Gilead Sciences Inc. v. Natco Pharma Ltd.,
753 F.3d 1208 (Fed. Cir. 2014) (4/6)
• Appealed to the Federal Circuit
• Panel: Rader, Prost, and Chen
• Divided panel vacated district court judgment, finding ‘483 patent invalid for OTDP and remands to the
district court for further proceedings consistent with opinion
We therefore hold that an earlier-expiring patent can qualify as an obviousness-type double
patenting reference for a later-expiring patent under the circumstances here. In cases where such
obviousness-type double patenting is present, a terminal disclaimer can preserve the validity of
the later-expiring patent by aligning its expiration date with that of the earlier-expiring patent. Id. at
1217.
• Gilead’s petition for en banc rehearing was denied, as was its petition for writ of certiorari
January 12, 2017
67
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

68. Gilead Sciences Inc. v. Natco Pharma Ltd.,
753 F.3d 1208 (Fed. Cir. 2014) (5/6)
• Opinion (Prost, Chen):
This appeal presents a narrow question: Can a patent that issues after but expires before another
patent qualify as a double patenting reference for that other patent? We conclude under the
circumstances of this case that it can and, therefore, that the district court erred in excluding the '375
patent as a potential double patenting reference for the '483 patent. Id. at 1212-13 (emphasis added).
[I]t is a bedrock principle of our patent system that when a patent expires, the public is free to use not
only the same invention claimed in the expired patent but also obvious or patentably indistinct
modifications of that invention…. The double patenting doctrine has always been implemented to
effectively uphold that principle. Id. at 1214.
As discussed above, the primary ill avoided by enforcement of the double patenting doctrine is restriction
on the public's freedom to use the invention claimed in a patent and all obvious modifications of it after
that patent expired. Id. at 1215.
Permitting any earlier expiring patent to serve as a double patenting reference for a patent subject to
the URAA guarantees a stable benchmark that preserves the public's right to use the invention (and its
obvious variants) that are claimed in a patent when that patent expires. Id. at 1216 (emphasis added).
January 12, 2017
68
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

69. Gilead Sciences Inc. v. Natco Pharma Ltd.,
753 F.3d 1208 (Fed. Cir. 2014) (6/6)
• Dissent (Rader):
Id. at 1218:
Immediately prior to the Uruguay Round Agreements Act (URAA) and the General Agreement on
Tariffs and Trade (GATT), a U.S. patent enjoyed a term of 17 years from its issue date….
However, based on changes implemented as part of the GATT and URAA, the term of a patent is
now generally limited to 20 years from its filing date or the earliest claimed filing date under 35
U.S.C. §§ 120, 121 or 365(c). 35 U.S.C. § 154(a)(2). With this change, successive continuations
generally do not result in any additional patent term. Rather, the filing date of the earliest member
of a patent family limits the rest of the related patents. Id. Thus a primary motivation behind the
doctrine—preventing the effective extension of patent term—is largely no longer applicable.
Id. at 1219:
Rather, to obtain a longer patent term, a patentee must forfeit its earlier claim to priority and
subject any new patent to intervening prior art. Gilead followed that precise approved course.
January 12, 2017
69
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

70. Post-Gilead Developments
• AbbVie Inc. v. Kennedy Institute of Rheumatology, 764 F.3d 1366 (Fed. Cir. 2014) (Humira® litigation)
We now make explicit what was implicit in Gilead: the doctrine of obviousness-type double patenting continues to
apply where two patents that claim the same invention have different expiration dates. Id. at 1374.
• Magna Electronics v. TRW et al., 1:12-cv-654 (S.D. Mich. Dec. 10, 2015):
– Claim 41 of parent patent with 418 days of PTA held to be invalid based on OTDP in view of child patent with 20-year
term. Parties settled after decision.
• Janssen Biotech, Inc. v. Celltrion Healthcare Co., C.A. No. 15-10698-MLW (D. Ma Sep. 26, 2016) (Remicade® litigation)
– Gilead motion granted for summary judgment of invalidity of US 6,284,471 (pre-GATT) based on OTDP in view of
6,790,444 (post-GATT, expired): Janssen appealing to Federal Circuit, but Celltrion/Hospira launched Inflectra®
biosimilar)
• Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc., Civil Action No. 14-874-SLR
(D. Del., Nov. 16, 2016) (Nasonex® litigation)
– Merck alleged infringement of US 6,127,353, and Teva alleged ‘353 patent invalid based on OTDP over US
6,180,781. ‘353 found to be valid (but not infringed):
The patents-at-issue are from the same family, indeed the ‘781 patent is a continuation of the ‘353 patent. The
patents were examined by the same examiner at the USPTO. Under the particular circumstances, the oddity
of using the ‘781 patent as a reference patent to cut short the ‘353 patent (the first issued parent patent) term of
exclusivity is rejected. This is not an instance of a patentee seeking to extend the patent term with “sequential”
applications. The ‘353 patent is not invalid for double patenting.
January 12, 2017
70
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

71. Post-Gilead: MPEP § 804
The doctrine of double patenting seeks to prevent the unjustified extension of patent exclusivity beyond
the term of a patent. The public policy behind this doctrine is that
The public should . . . be able to act on the assumption that upon the expiration of the patent it will
be free to use not only the invention claimed in the patent but also modifications or variants which
would have been obvious to those of ordinary skill in the art at the time the invention was made,
taking into account the skill in the art and prior art other than the invention claimed in the issued
patent.
In re Zickendraht, 319 F.2d 225, 232, 138 USPQ 22, 27 (CCPA 1963) (Rich, J., concurring). Double
patenting results when the right to exclude granted by a first patent is unjustly extended by the grant of a
later issued patent or patents. In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982). Note that in
Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 110 USPQ2d 1551 (Fed. Cir. 2014), the
court found an earlier-expiring patent, which was issued after the later-expiring patent, may be
used to invalidate the later-expiring patent.
• Language in MPEP seems to interpret Gilead to encompass cases where continuation can
serve as a double patenting reference against a parent
January 12, 2017
71
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

72. Current Post-Gilead Landscape
• Still much strategic benefit/value in keeping important patent families pending by continuing
application practice or filing new applications directed to different aspects of the commercial product
• Protecting exclusivity gains (e.g., from PTA/PTE or benefit of a later filing date) from OTDP rejections
requiring a terminal disclaimer
• Current interpretations of Gilead appear to unsettle the expectations of patent applicants/owners
regarding patent term (e.g., PTA)
• Protecting patents from invalidity challenges based on alleged OTDP (see especially biosimilars
litigation)
January 12, 2017
72
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

73. Post-Gilead Strategies (1)
• Divisional Practice and §121 Safe Harbor
– Draft claim set featuring different classes of claims
– Obtain Restriction Requirement in parent case
– Continuing applications: Divisional not continuation applications
• Consonance of claims with original Restriction Requirement
• Proper priority is key (DIV not CON) even if consonance is maintained
• Consider relative benefits of rejoinder in parent case (e.g., PTE) versus subject matter to be
pursued in a DIV
January 12, 2017
73
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

74. Post-Gilead Strategies (2)
• Prosecution Strategies
– Submit all possibly related applications in Information Disclosure Statements
– Consider relative merits of not accepting narrow (but allowable) claims versus broad claims in
order to expedite prosecution
January 12, 2017
74
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

75. Post-Gilead Strategies (3)
• For pending applications not entitled to the §121 safe harbor, consider claims and possible Gilead risk
– If OTDP rejection made, consider if any benefit in strategically filing new application to avoid
possibly adverse characterization of key issued claims
January 12, 2017
75
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

76. Conclusion
• Gilead presents new considerations for lifecycle management
• Filing new applications directed to new aspects of product or continuing applications in a patent family
will continue to be important
• Similarly important to manage Gilead risk
January 12, 2017
76
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP

77. January 12, 2017
77
Contact Info:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP
E: cespino@proskauer.com
T: +1.617.526.9632
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
E: earons@weissarons.com
T: 845.362.6100
Taylor Corbitt
Partner
Riley Safer Holmes & Cancila LLP
E: tcorbitt@rshc-law.com
T: 312.471.8670

78. ► You may ask a question at anytime throughout the presentation today. Simply click on the question mark icon located on the floating tool bar on the bottom right side of your screen. Type
your question in the box that appears and click send.
► Questions will be answered in the order they are received.
Q&A:
January 12, 2017
78
SEGMENT 1:
Edward Arons, PH.D., Esq.
Founding Partner
Weiss & Arons, LLP
SEGMENT 3:
Christine G. Espino, PhD
Attorney
Proskauer Rose LLP
SEGMENT 2:
Taylor Corbitt
Partner
Riley Safer Holmes & Cancila LLP

79. January 12, 2017
79
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