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Clarifying Recent Case Law, Process Changes, and Other Industry Trends Impacting
Medical Device and Diagnostic Organizations for Improved Preservation of Existing
and Developing Ip and Patents While Expanding Protection Worldwide
MARCH 9-10, 2015 | ALEXANDRIA, VA
SHERATON SUITES OLD TOWN ALEXANDRIA
Ali Ahmed
Chief Intellectual Property Counsel
FRESENIUS KABI
Miles Grody
Senior Vice President, General Counsel
ACELL
Norman Hainer
Patent Attorney
SMITH & NEPHEW
Jeff Hohenshell
Senior Patent Attorney
MEDTRONIC
Matt Doscotch
Senior Patent Counsel
ZIMMER
The Honorable Judge
J. Frederick Motz
United States District Court
DISTRICT OF MARYLAND
Rachel K. Hunnicutt
Of Counsel
WILEY REIN LLP
Les Bookoff
Partner
BOOKOFF & MCANDREWS
Lee Caffin
Senior Consultant
QUESTEL
DISTINGUISHED PRESENTERS INCLUDE:
Elias Domingo
Associate General Counsel,
Intellectual Property
COVIDIEN
Jamie Kemler
VP, IP Business Strategy
STRYKER
Keith Newburry
Chief Counsel, Patent Strategy
EDWARDS LIFESCIENCES
Paul Lee
Patent Counsel
DEXCOM
Mike Cygan
Senior Legal Advisor, Office of
Patent Legal Administration
UNITED STATES PATENT AND
TRADEMARK OFFICE
Michael O’Shaughnessy
Partner
MCDERMOTT WILL & EMERY
Jeremy Lowe
Partner
AXINN, VELTROP & HARKRIDER
Todd Baker
Partner
OBLON
IN-HOUSE COUNSEL
EXTERNAL COUNSEL & FEDERAL PERSPECTIVES
MEDICAL DEVICE AND
DIAGNOSTIC IP/PATENT
STRATEGY CONFERENCE
CONFERENCE SPONSORS:
Ajit Narang
Senior Legal Counsel
MEDTRONIC
Austin Wang
Senior Intellectual Property Counsel
HOLOGIC
Brian Burn
Assistant General Counsel
CR BARD
Kevin Ferguson
Senior Intellectual Property Counsel
COVIDIEN
The Honorable Judge
John F. Anderson
United States District Court
EASTERN DISTRICT OF VIRGINIA
Sonali Gunawardhana
Of Counsel
WILEY REIN, LLP
Hathaway Russell
Partner
FOLEY HOAG
Clark Wilson
Senior Counsel
MERCHANT & GOULD
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com
Senior Vice President, General Counsel	ACELL
Senior Patent Attorney AGA MEDICAL
Senior Associate, Intellectual Property AGAMATRIX
Vice President of Intellectual Property ARCHUS ORTHOPEDICS
VP of Intellectual Property & Legal Affairs ARDIAN, INC.
Associate	ARNOLD & PORTER
VP General Counsel ATRICURE, INC.
Intellectual Property Manager	BAXANO
VP & Associate General Counsel BAYER
Manager of Intellectual Property BAYLIS MEDICAL
Vice President, General Patent Counsel BECKMAN COULTER
Vice President of Intellectual Property BIOFORM
General Counsel BIOMERIEUX INC.
Corporate Counsel BIOMET
Executive Director & Counsel BOEHRINGER-INGELHEIM
Senior Corporate Counsel BOSTON SCIENTIFIC
Senior Counsel BRISTOL-MYERS SQUIBB
Vice President & General Counsel, United States BTG
Senior Corporate Counsel CELGENE
Associate General Counsel- Intellectual Property COVIDIEN
Associate General Counsel COVIDIEN
Principal Patent Engineer DEPUY ORTHOPAEDICS
Vice President Chief IP Counsel EDWARDS LIFESCIENCE
General Counsel Litigation & Legal Compliance ELI LILLY
Assistant General Counsel ENDO PHARMACEUTICALS
General Counsel & VP of Intellectual Property EXPLORAMED
Assistant General Counsel FERRING PHARMACEUTICALS
Senior Counsel FOREST LABORATORIES
Vice President, Associate General Counsel FRESENIUS KABI
Attorney, Healthcare Division FTC
Senior Commercial Counsel GE HEALTHCARE
Vice President & General Counsel GENOMIC HEALTH
Director of Intellectual Property GLOBUS MEDICAL
Patent Attorney GREENBERG TRAURIG LLP
Senior Corporate Counsel GRIFOLS
Corporate Counsel HILL-ROM
Director, Marketing Communications KCURA
Compliance Counsel MAQUET CARDIOVASCULAR
Principal Patent Counsel MEDTRONIC
Chief Patent Counsel MEDTRONIC CARDIOVASCULAR
General Counsel, Americas MOLNLYCKE HEALTH CARE
IP Counsel MYLAN
Director of Intellectual Property NEUROPACE, INC.
Secretary & General Counsel	 NOSTRUM LABORATORIES
Senior Litigation Counsel NOVARTIS
Corporate Counsel	 Novo Nordisk
Corporate Counsel, Intellectual Property	NOVONORDISK
Vice President, Secretary & General Counsel NURON BIOTECH
Partner, Litigation Department PAUL HASTINGS LLP
VP of Intellectual Property & Legal Affairs PULMONX
Patent Counsel REVA MEDICAL
Partner ROPES & GRAY
Partner SIDLEY AUSTIN LLP
Assistant General Counsel TERUMO BCT
Assistant General Counsel ZIMMER
Executives that will find this program of greatest relevance are attorneys currently
working to protect the current and developing intellectual property and owned pat-
ents of medical device and diagnostic corporations. Job titles of those executives
that will find this program to be most applicable to their job functions include:
• Patent Counsel
• Intellectual Property Counsel
• General Counsel
• Patent Strategy
• IP Strategy
• Patent & IP Litigation
• General Litigation
• IP and Patent Paralegal
At this time, there are a variety of sponsorship and exhibition opportunities available
for companies wishing to increase their visibility and participation in the program,
ranging from keynote speaking opportunities through to exhibitor and documenta-
tion sponsors. Organizations most suitable for this type of exposure provide services
and solutions including:
• IP and Patent Management Software
• External Legal Counsel
• IP and Patent Strategy Consultants
• Patent Preparation and Filing Services
• International Patent Filing Consultants
• Global Patent Filing Services
MEDICAL DEVICE & DIAGNOSTIC IP/PATENT STRATEGY
MARCH 9-10, 2015 | ALEXANDRIA, VA
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com
PREVIOUS ATTENDEES INCLUDE:
WHO SHOULD ATTEND:
SPONSORSHIP OPPORTUNITIES:
CONFERENCE LOCATION
PROGRAM OVERVIEW:
In a rapidly evolving landscape of patent/IP approval and counsel, it is becom-
ing even more important for attorneys within medical device and diagnostic com-
panies to be aware of the current events and cases that will impact their filing
strategies. With the passing of the America Invents Act in 2011, there has been
rapid change including the shift to first-to-file approvals and the new IPR challenge
process. With technological advances and continued research conducted on bio-
logical innovations and diagnostic tools, it is becoming very difficult for legal teams
to develop patent and IP strategies. The specific impact that Supreme Court de-
cisions, industry trends and process changes have on the medical device industry
will help in-house counsel more effectively protect owned property and make stra-
tegic decisions for patent filings and responses to challenged claims.
The Q1 Productions Medical Device & Diagnostic IP and Patent Strategy Conference
is a unique educational program that will bring together experienced attorneys and
counsel within industry groups to discuss workable strategies for conquering chal-
lenges. Focusing exclusively on issues within the medical device & diagnostic com-
munity, this conference program will provide high value to attendees through case
study presentations on current, relevant topics including Inter Partes Review pro-
cess, recent case law such as CLS Bank vs. Alice and Mayo vs. Prometheus, global
patent protection strategies, in-house budget management and technological in-
novation, as well as general patent filing and extension strategies. This program
will certainly provide attendees with an improved understanding of the changing
landscape of the industry and applicable strategies for continued success.
Sheraton Suites Old Town Alexandria
801 N Saint Asaph Street
Alexandria, VA 22314
MEDIA PARTNERS:
7:00 REGISTRATION & MORNING COFFEE
7:50 CHAIRPERSON’S OPENING REMARKS
Clark Wilson, Senior Counsel, MERCHANT & GOULD
8:00 RECENT SUPREME COURT CASE LAW & IMPLICATIONS FOR
MEDICAL DEVICE AND DIAGNOSTIC INDUSTRIES
Understanding the impact that recent Supreme Court decisions have on device
and diagnostic patent approvals and cases is essential for legal teams to dis-
cover trends that will affect the industry moving forward. Clarifying decisions of
highly publicized Supreme Court cases, reviewing cases that are currently un-
der way and predicting potential trends in future decision making can aid in the
development of legal strategy for patent and IP. Notable cases related to subject
matter patentability, obviousness, indefiniteness, damages, claim construction
and patent infringement will be discussed, as these topics are most closely
connected to medical device and diagnostic patent protection and strategy.
• Alice vs. CLS Bank, Teva vs. Sandoz, Mayo v. Prometheus and more
• Strategies for continued success in patent protection after publicized decisions
• Trends within medical device/diagnostic IP and patent strategy
Hathaway Russell, Partner, FOLEY HOAG
Brian Burn, Assistant General Counsel, CR BARD
Mike Cygan, Senior Legal Advisor, Office of Patent Legal Administration
UNITED STATES PATENT AND TRADEMARK OFFICE
8:45 THE INNOVATIVE WORLD OF 3D PRINTED MEDICAL DEVICES, IP
AND FDA CONSIDERATIONS- WHAT YOU NEED TO KNOW
3D printing technologies have opened up the capabilities for customization
in a wide variety of applications in the medical field. 3D printing turns tradi-
tional manufacturing on its head, moving from mass production to individual
production and mass customization as some believe it is the perfect model
for personalized medicine. Using bio-compatible and drug-contact materials,
medical devices can be produced that are perfectly suited for a particular indi-
vidual giving rise to many regulatory challenges for the FDA. The FDA is working
through some of the technical issues that 3D printing poses and has begun to
receive numerous submissions using 3D printing for both traditional and pa-
tient-matched devices. This presentation will discuss the current FDA regulatory
landscape as well as the impact of 3D printing on forms of intellectual property
and address strategies for protecting intellectual property.
• Considerations when developing an IP protection strategy for 3D printing
• Reviewing the current regulatory landscape for 3D printed medical devices
• Challenges ahead for FDA clearance/ approval of these innovative devices
• Understanding takeaway messages from the recent FDA stakeholder meeting
Sonali Gunawardhana, Of Counsel, WILEY REIN, LLP
Rachel K. Hunnicutt, Of Counsel, WILEY REIN LLP
9:30 COFFEE & NETWORKING BREAK
10:00 UNDERSTANDING CHALLENGES OF INNOVATION AND
PATENTABLE SUBJECT MATTER
As companies research and develop innovative medical devices and diagnostic
tools, internal legal teams must understand the aspects of a product that are
patentable and in need of protection to ensure profitability and to minimize
competition. With recent Supreme Court decisions like Alice vs. CLS Bank indi-
cating new challenges to patent claims and subject matter, it is vital for IP and
patent counsel to comprehend how patents for influential products involving
abstract ideas and natural principles are reviewed and scrutinized by the patent
office and federal judges. Clarification of subject matter patentability and Su-
preme Court rationale for decision-making will assist attorneys in successfully
protecting exceptional products developed by medtech companies.
• Reviewing eligible properties for patent under Section 101 of Title 35
• Alice vs. CLS Bank and Association for Molecular Pathology vs. Myriad Genetics
• Patentability of abstract ideas and naturally occurring principles/products
Miles Grody, Senior VP, General Counsel, ACELL
Clark Wilson, Senior Counsel, MERCHANT & GOULD
11:00 UTILIZATION OF IPR AND POST-GRANT PROCEEDINGS
Resulting from the America Invents Act, the final rule for Inter Partes Review (IPR)
went into effect in September 2012 and development continued until March
2013, offering IP and patent counsel a new tool for protecting and challenging
patents in post-grant proceedings. As the utilization of IPRs remains in its infan-
cy, attorneys in the device and diagnostic space should evaluate the benefits
of utilizing IPR proceedings, including a statistically pro-petitioner Patent Trial
and Appeal Board (PTAB), faster trial timing and potential cost savings, as well
as the risks including the potential that a claim amendment made as a result
of an IPR could complicate future proceedings for the challenging party. Under-
standing practice tips after the past years of IPR use, application of certain pro-
vision of the rules, and prosecution of patents to increase the difficulty of being
taken out on an IPR is extremely important as this space continues to evolve.
• Examples and situations where IPR is effective
• Understanding success of recent IPR proceedings
• Managing IPR’s efficiently as an alternative to traditional litigation
Todd Baker, Partner, OBLON
11:45 PRIORITIZING BUDGETS IN-HOUSE TO STRATEGICALLY MANAGE
PATENT PROTECTION AND LITIGATION SPEND
Protecting intellectual property in device and diagnostic organizations can result
in challenges with staying within budget constraints while appropriately investing
in a patent portfolio and litigation opportunities to maximize the value of the com-
pany’s intellectual property. Understanding how strategic choices can be made
regarding the number of claims needed to protect a product, the global locations
where it may be vital to hold patents, and prioritization of intellectual property
assets can help reduce cost and increase the value of the portfolio. Techniques
to streamline litigation must also be understood so that legal teams can con-
tinue to work effectively within financial constraints. It is essential that teams
work to optimize current budgets, manage senior management expectations,
and continue adding value to organizations by protecting intellectual assets.
• Eliminating low value properties and maximizing budget value
• Understanding locations where it is most/least important to hold patents
• Best practices for budget management and cost tracking
Matt Doscotch, Senior Patent Counsel, ZIMMER
12:30 LUNCHEON FOR ALL DELEGATES, SPEAKERS & SPONSORS
1:30 CLEAR IP OWNERSHIP IN ACADEMIC RESEARCH PARTNERSHIPS
Partnering with academic programs to research and develop new devices and
diagnostic tools supports educational programs, the development of innovative
technologies, and can decrease costs. However, it is essential that ownership of
any developed property and responsibility for any necessary litigation is clearly
outlined prior to the start of contracted research, ensuring that all parties under-
stand the license rights. Unclear communication of responsibilities and owner-
ship expectations can lead to future litigation over rights if a property becomes
valuable, which can cost organizations time and money. Clarifying strategies that
are usable for different types of university partnerships will aid attorneys support-
ing organizational goals of innovation and high-value intellectual property through
the development of clear contracts with university partners.
• Understanding impact of different partnership types on contract development
• Developing agreements for contracted researchers within academic programs
• Licensing created property from universities and student researchers
Jamie Kemler, VP, IP Business Strategy, STRYKER
Les Bookoff, Partner, BOOKOFF & MCANDREWS
2:15 BRIDGING THE GAPS IN UNIVERSITY-INDUSTRY COLLABORATIONS
Partnering with academic institutions to research and develop new devices and
diagnostic tools has many benefits, including supporting educational programs,
developing innovative technologies, and obtaining access to expertise and facili-
ties at a decreased cost. The differences in missions and perspectives of indus-
try and academic institutions, however, can lead to many challenges, including
challenges in the negotiation of the IP issues. For example, it is essential that the
parties clarify ownership of developments, rights of prosecution of the intellectual
property, confidentiality and publication issues, and appropriate financial terms.
This presentation will discuss the various IP issues that arise within industry-aca-
demic research partnerships.
• Trends in university/medical device industry interaction;
• Understanding differences in mission and objectives of the organizations; and
• How those differences can affect IP ownership, prosecution, publication, and
other issues
Jeff Hohenshell, Senior Patent Attorney, MEDTRONIC
Lee Caffin, Senior Consultant, QUESTEL
3:30 COFFEE & NETWORKING BREAK
4:00 INTERPRETING INDEFINITENESS IN ORDER TO IDENTIFY AND
PROTECT VULNERABLE INTELLECTUAL PROPERTY
With recent cases garnering attention in the Supreme and Federal courts, it has
become increasingly important for in-house attorneys to develop knowledge on
how properties could be targeted for infringement with a claim of indefiniteness.
Proving a patent claim to be definite and valid relies on the clarity of the writ-
ten claim and the subsequent ability of subject matter experts to determine the
boundaries of each patent. Patents issued years prior to the time of enforcement
have an increased risk of lacking this clarity as a result of increased innovation and
technological advances within the device and diagnostic industries, among other
complications. Understanding recent trends and decisions made by the courts
related to patent term ambiguity will be extremely valuable as indefiniteness con-
tinues to be an area of high focus to competitors and patent assertion entities.
• Impact of recent cases on patent litigation and prosecution
• Identifying patents that may be of greater risk for invalidation
• Predicting future trends related to patent term validity
Jeremy Lowe, Partner, AXINN, VELTROP & HARKRIDER
4:45 REVIEWING SUCCESSFUL PATENT CLAIM TYPES TO DEVELOP
EFFECTIVE STRATEGIES AND INCREASE ASSETS
Developing IP that will serve as an asset to an organization is traditionally viewed
as the responsibility of R&D operations, but legal teams must also continually
provide input on which aspects of the developed properties are patentable to en-
sure that no items of value are overlooked or unprotected. Reviewing the common
and uncommon types of claims utilized to patent new products and technologies
is essential, especially as medical devices and diagnostic tests become more
technologically advanced and claims are under greater scrutiny. With recent and
notable cases challenging method claim construction and subject matter patent-
ability, it is even more important to understand the value that can be created from
a developed product, the claims most useful to protect these products, and the
role that in-house counsel plays in the protection of developed assets.
• Collaborating with R&D teams to discover patentable assets internally
• Selecting filing types for an increased likelihood of patent grant
• Understanding the success of different filing methods worldwide
Norman Hainer, Patent Attorney, Advanced Surgical Devices, SMITH & NEPHEW
5:30 END OF DAY ONE
MEDICAL DEVICE & DIAGNOSTIC IP/PATENT STRATEGY
DAY ONE | MONDAY, MARCH 9
7:30 REGISTRATION & MORNING COFFEE
7:50 DAY ONE RECAP & DAY TWO OPENING REMARKS
8:00 STRATEGIC SELECTION OF PATENT LITIGATION VENUES TO
IMPROVE OUTCOMES
As legal teams prepare for litigation, many considerations can improve the prob-
ability of a positive outcome, including the selection of a venue for the litigation
to take place that will have optimal favorability with judges familiar with med-
ical device patent cases. Selecting the preferred location out of the available
options, usually given based upon the location of the defending organization,
requires analysis of court favorability, judge familiarity with patent or medical
device cases, and ability to persuasively argue that the chosen court is the best
suited to hear the claim. Understanding these different factors and scenarios
where certain courts are preferable will aid attorneys in decision making when
given the opportunity to select litigation venues, and will help teams adapt if
litigation is transferred to an alternate venue.
• Trending US locations for medical device patent litigation
• Considering alternatives to the Federal District court system
• Reacting to venue transfers by district courts
Ali Ahmed, Chief Intellectual Property Counsel, FRESENIUS KABI
8:45 UNDERSTANDING STRATEGIES TO DEVELOP AND MAINTAIN IP
STRATEGIES FOR COMBINATION PRODUCTS
With advances in technology allowing for highly innovative medical devices
and diagnostic tools, there are an increasing number of combination products
integrating devices or diagnostic tools with computerized parts, software sys-
tems, and computer systems, which can make the navigation of licensing and
patent processes challenging. Working within this intersection requires a clear
understanding of claims that can be utilized to patent technologies, navigating
a potentially complex web of product clearance assessments, and/or executing
appropriate agreements to allocate risk. Understanding the risks and uncer-
tainty associated with developing a combination product enables in-house at-
torneys to better prepare filings and licenses in order to prevent costly and time
consuming litigation in the future.
• Developing an IP strategy proactively for combination products
• Maintaining partnerships that benefit both stakeholders
• Understanding scope of competitive IP space in new areas
Austin Wang, Senior Intellectual Property Counsel
HOLOGIC
9:30 COFFEE & NETWORKING BREAK
10:00 PANEL DISCUSSION: JURIST FEEDBACK ON ATTORNEY
PRACTICE IN MEDICAL DEVICE PATENT CASES
Evolving trends and laws as a result of the America Invents Act make IP and
patent cases challenging to litigate, and it can be difficult to select the most
effective strategy to utilize within a court. Even after a case has been com-
pleted, attorneys should look to understand what aspects of litigation worked
well and what aspects could have used revision in order to ensure the success
of future cases. This panel of jurists with expertise in patent and intellectual
property cases will share perspectives regarding successful strategies utilized
in courtrooms to manage witnesses and maintain time limitations, and provide
feedback on current trends utilized by practicing attorneys that will help attend-
ees better prepare for patent litigation.
MODERATOR:
Artem Sokolov, IP Litigation Attorney, MCDERMOTT WILL & EMERY
PANELISTS:
The Honorable Judge J. Frederick Motz, United States District Court
DISTRICT OF MARYLAND
The Honorable Judge John F. Anderson, United States District Court
EASTERN DISTRICT OF VIRGINIA
Keith Newburry, Chief Counsel, Patent Strategy
EDWARDS LIFESCIENCES
Michael O’Shaughnessy, Partner
MCDERMOTT WILL & EMERY
10:45 GLOBAL PATENT FILINGS TO REDUCE COST AND INCREASE
PRODUCT PROTECTION
As medical device and diagnostic corporations grow internationally more rapidly
than ever before, it is essential to maintain a strong global patent strategy to
decrease potential infringements and maintain exclusive revenue from owned
intellectual property. Understanding the most important countries to file in will
help in-house attorneys to prioritize patent filings, reducing expenses and se-
curing patent protection. In countries like China, there has been some progress
related to the protection of intellectual property rights, which is valuable for
legal teams to understand as organizations look to enter international markets.
• Best practices & tools for developing and maintaining a global patent strategy
• Strategic value of securing patents for intellectual property in different countries
• Changing laws impacting patent protection in key markets such as Asia, India
and Europe
Elias Domingo, Associate General Counsel, IP
COVIDIEN
11:30 FUNCTIONAL LANGUAGE IN MEDICAL DEVICE PATENT CLAIMS
AND OTHER TOOLS FOR CLAIM CONSTRUCTION
Drafting patent claims can be challenging as attorneys must balance risks of
claim infringement with maintaining the high value of a patent claim. Contrast-
ing to claims that describe a device or component that “performs” a function,
some claims are now reciting that devices or components are “configured” or
“adapted” to perform a function which can increase the number of potential
infringements for making or selling the device. Understanding recent ways that
specific language has been interpreted by courts during post-grant proceedings
will help legal teams better develop patent claims to escape patent rejection
and increase protection of developed products.
• Utilizing specific language for exceptional claim construction
• Understanding potential responses from the patent office
• Interpreting court decisions related to functional claim terms and other
language
Paul Lee, Patent Counsel
DEXCOM
12:15 LUNCHEON FOR ALL CONFERENCE DELEGATES, SPEAKERS &
SPONSORS
1:15 ASSESSING INNOVATIVE TECHNOLOGIES FOR IMPROVED IP
ASSET MANAGEMENT
Managing IP assets can be a complex undertaking due to the quantity of in-
formation and the number of documents associated with each individual IP
record, especially as organizations grow their IP portfolio and are granted new
patents for medical devices and diagnostic tools. Evaluating alternatives to
traditional docketing systems for efficiency gains and ease of use can be eye
opening and can identify direct benefits to adopting a technologically advanced
system that offers greater functionality, including automating workflow and
improving efficiency. There are many full life-cycle IP asset management tools
and systems available for in-house legal teams that can store and manage IP
records from the opening an invention disclosure record all the way through
to managing annuity payments for issued patents. Selecting the right system
for your team’s needs can improve visibility to your portfolio, enhance matter
management, increased detail and reliability of automated system reminders,
and streamline workflow required to accomplish tasks.
• Understanding effectiveness of current IP asset management processes and
programs
• Identifying costs and benefits of potential new systems and functionalities to
aid decision making
• Implementation considerations for managing the change to a new asset
management systems
Kevin Ferguson, Senior IP Counsel, Surgical Solutions Group
COVIDIEN
2:00 CASE STUDY: STRATEGIC CONSIDERATIONS FOR POTENTIAL
PATENT LITIGATION
Depending on the company size, number of marketed products, patent value
and internal budget there are many different choices that legal teams can
make when it comes to developing a strategy for asserting patents against po-
tential infringers. Understanding current statistics on royalty rates, lost profits,
business dynamics and case results is important for teams to take into account
when developing a strategy to assert infringement claims Start-up or smaller
companies may wish to always assert potential infringement claims, but larger
corporations may have more flexibility in procedures and can evaluate situa-
tions based on business climate and economics to decide what choice is most
profitable, fair, and safe for a patent.
• Understanding business risk and resource allocation needs
• Creating a workable strategy to benefit unique company circumstances &
and goals
• Choosing to consult/partner with external counsel to maximize budgets line-
of-sight and improve outcomes
Ajit Narang, Senior Legal Counsel
MEDTRONIC
2:45 M&A DUE DILIGENCE ON PATENTS AND INTELLECTUAL
PROPERTY: VALUATION & LIABILITY
As the medical device industry continues to utilize acquisition activity as a strat-
egy for corporate growth and development, patent teams are increasingly called
upon to provide insight and guidance on both patent and intellectual property
value as well as potential liabilities. Ensuring due diligence is carried out in an
effective manner will provide organizations with the certainty that investments
are being made at an appropriate value, as well as confirming freedom to op-
erate once the transaction has completed. This process can be streamlined
through formulating operating procedures for the assessment of IP and patent
value in order to provide a clear picture of the value as well as any potential
challenges that may exist.
3:30 CLOSING REMARKS & CONCLUSION OF CONFERENCE ACTIVITIES
MEDICAL DEVICE & DIAGNOSTIC IP/PATENT STRATEGY
DAY TWO | TUESDAY, MARCH 10

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Agenda- Device IP Patent Conference

  • 1. Clarifying Recent Case Law, Process Changes, and Other Industry Trends Impacting Medical Device and Diagnostic Organizations for Improved Preservation of Existing and Developing Ip and Patents While Expanding Protection Worldwide MARCH 9-10, 2015 | ALEXANDRIA, VA SHERATON SUITES OLD TOWN ALEXANDRIA Ali Ahmed Chief Intellectual Property Counsel FRESENIUS KABI Miles Grody Senior Vice President, General Counsel ACELL Norman Hainer Patent Attorney SMITH & NEPHEW Jeff Hohenshell Senior Patent Attorney MEDTRONIC Matt Doscotch Senior Patent Counsel ZIMMER The Honorable Judge J. Frederick Motz United States District Court DISTRICT OF MARYLAND Rachel K. Hunnicutt Of Counsel WILEY REIN LLP Les Bookoff Partner BOOKOFF & MCANDREWS Lee Caffin Senior Consultant QUESTEL DISTINGUISHED PRESENTERS INCLUDE: Elias Domingo Associate General Counsel, Intellectual Property COVIDIEN Jamie Kemler VP, IP Business Strategy STRYKER Keith Newburry Chief Counsel, Patent Strategy EDWARDS LIFESCIENCES Paul Lee Patent Counsel DEXCOM Mike Cygan Senior Legal Advisor, Office of Patent Legal Administration UNITED STATES PATENT AND TRADEMARK OFFICE Michael O’Shaughnessy Partner MCDERMOTT WILL & EMERY Jeremy Lowe Partner AXINN, VELTROP & HARKRIDER Todd Baker Partner OBLON IN-HOUSE COUNSEL EXTERNAL COUNSEL & FEDERAL PERSPECTIVES MEDICAL DEVICE AND DIAGNOSTIC IP/PATENT STRATEGY CONFERENCE CONFERENCE SPONSORS: Ajit Narang Senior Legal Counsel MEDTRONIC Austin Wang Senior Intellectual Property Counsel HOLOGIC Brian Burn Assistant General Counsel CR BARD Kevin Ferguson Senior Intellectual Property Counsel COVIDIEN The Honorable Judge John F. Anderson United States District Court EASTERN DISTRICT OF VIRGINIA Sonali Gunawardhana Of Counsel WILEY REIN, LLP Hathaway Russell Partner FOLEY HOAG Clark Wilson Senior Counsel MERCHANT & GOULD 500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com
  • 2. Senior Vice President, General Counsel ACELL Senior Patent Attorney AGA MEDICAL Senior Associate, Intellectual Property AGAMATRIX Vice President of Intellectual Property ARCHUS ORTHOPEDICS VP of Intellectual Property & Legal Affairs ARDIAN, INC. Associate ARNOLD & PORTER VP General Counsel ATRICURE, INC. Intellectual Property Manager BAXANO VP & Associate General Counsel BAYER Manager of Intellectual Property BAYLIS MEDICAL Vice President, General Patent Counsel BECKMAN COULTER Vice President of Intellectual Property BIOFORM General Counsel BIOMERIEUX INC. Corporate Counsel BIOMET Executive Director & Counsel BOEHRINGER-INGELHEIM Senior Corporate Counsel BOSTON SCIENTIFIC Senior Counsel BRISTOL-MYERS SQUIBB Vice President & General Counsel, United States BTG Senior Corporate Counsel CELGENE Associate General Counsel- Intellectual Property COVIDIEN Associate General Counsel COVIDIEN Principal Patent Engineer DEPUY ORTHOPAEDICS Vice President Chief IP Counsel EDWARDS LIFESCIENCE General Counsel Litigation & Legal Compliance ELI LILLY Assistant General Counsel ENDO PHARMACEUTICALS General Counsel & VP of Intellectual Property EXPLORAMED Assistant General Counsel FERRING PHARMACEUTICALS Senior Counsel FOREST LABORATORIES Vice President, Associate General Counsel FRESENIUS KABI Attorney, Healthcare Division FTC Senior Commercial Counsel GE HEALTHCARE Vice President & General Counsel GENOMIC HEALTH Director of Intellectual Property GLOBUS MEDICAL Patent Attorney GREENBERG TRAURIG LLP Senior Corporate Counsel GRIFOLS Corporate Counsel HILL-ROM Director, Marketing Communications KCURA Compliance Counsel MAQUET CARDIOVASCULAR Principal Patent Counsel MEDTRONIC Chief Patent Counsel MEDTRONIC CARDIOVASCULAR General Counsel, Americas MOLNLYCKE HEALTH CARE IP Counsel MYLAN Director of Intellectual Property NEUROPACE, INC. Secretary & General Counsel NOSTRUM LABORATORIES Senior Litigation Counsel NOVARTIS Corporate Counsel Novo Nordisk Corporate Counsel, Intellectual Property NOVONORDISK Vice President, Secretary & General Counsel NURON BIOTECH Partner, Litigation Department PAUL HASTINGS LLP VP of Intellectual Property & Legal Affairs PULMONX Patent Counsel REVA MEDICAL Partner ROPES & GRAY Partner SIDLEY AUSTIN LLP Assistant General Counsel TERUMO BCT Assistant General Counsel ZIMMER Executives that will find this program of greatest relevance are attorneys currently working to protect the current and developing intellectual property and owned pat- ents of medical device and diagnostic corporations. Job titles of those executives that will find this program to be most applicable to their job functions include: • Patent Counsel • Intellectual Property Counsel • General Counsel • Patent Strategy • IP Strategy • Patent & IP Litigation • General Litigation • IP and Patent Paralegal At this time, there are a variety of sponsorship and exhibition opportunities available for companies wishing to increase their visibility and participation in the program, ranging from keynote speaking opportunities through to exhibitor and documenta- tion sponsors. Organizations most suitable for this type of exposure provide services and solutions including: • IP and Patent Management Software • External Legal Counsel • IP and Patent Strategy Consultants • Patent Preparation and Filing Services • International Patent Filing Consultants • Global Patent Filing Services MEDICAL DEVICE & DIAGNOSTIC IP/PATENT STRATEGY MARCH 9-10, 2015 | ALEXANDRIA, VA 500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com PREVIOUS ATTENDEES INCLUDE: WHO SHOULD ATTEND: SPONSORSHIP OPPORTUNITIES: CONFERENCE LOCATION PROGRAM OVERVIEW: In a rapidly evolving landscape of patent/IP approval and counsel, it is becom- ing even more important for attorneys within medical device and diagnostic com- panies to be aware of the current events and cases that will impact their filing strategies. With the passing of the America Invents Act in 2011, there has been rapid change including the shift to first-to-file approvals and the new IPR challenge process. With technological advances and continued research conducted on bio- logical innovations and diagnostic tools, it is becoming very difficult for legal teams to develop patent and IP strategies. The specific impact that Supreme Court de- cisions, industry trends and process changes have on the medical device industry will help in-house counsel more effectively protect owned property and make stra- tegic decisions for patent filings and responses to challenged claims. The Q1 Productions Medical Device & Diagnostic IP and Patent Strategy Conference is a unique educational program that will bring together experienced attorneys and counsel within industry groups to discuss workable strategies for conquering chal- lenges. Focusing exclusively on issues within the medical device & diagnostic com- munity, this conference program will provide high value to attendees through case study presentations on current, relevant topics including Inter Partes Review pro- cess, recent case law such as CLS Bank vs. Alice and Mayo vs. Prometheus, global patent protection strategies, in-house budget management and technological in- novation, as well as general patent filing and extension strategies. This program will certainly provide attendees with an improved understanding of the changing landscape of the industry and applicable strategies for continued success. Sheraton Suites Old Town Alexandria 801 N Saint Asaph Street Alexandria, VA 22314 MEDIA PARTNERS:
  • 3. 7:00 REGISTRATION & MORNING COFFEE 7:50 CHAIRPERSON’S OPENING REMARKS Clark Wilson, Senior Counsel, MERCHANT & GOULD 8:00 RECENT SUPREME COURT CASE LAW & IMPLICATIONS FOR MEDICAL DEVICE AND DIAGNOSTIC INDUSTRIES Understanding the impact that recent Supreme Court decisions have on device and diagnostic patent approvals and cases is essential for legal teams to dis- cover trends that will affect the industry moving forward. Clarifying decisions of highly publicized Supreme Court cases, reviewing cases that are currently un- der way and predicting potential trends in future decision making can aid in the development of legal strategy for patent and IP. Notable cases related to subject matter patentability, obviousness, indefiniteness, damages, claim construction and patent infringement will be discussed, as these topics are most closely connected to medical device and diagnostic patent protection and strategy. • Alice vs. CLS Bank, Teva vs. Sandoz, Mayo v. Prometheus and more • Strategies for continued success in patent protection after publicized decisions • Trends within medical device/diagnostic IP and patent strategy Hathaway Russell, Partner, FOLEY HOAG Brian Burn, Assistant General Counsel, CR BARD Mike Cygan, Senior Legal Advisor, Office of Patent Legal Administration UNITED STATES PATENT AND TRADEMARK OFFICE 8:45 THE INNOVATIVE WORLD OF 3D PRINTED MEDICAL DEVICES, IP AND FDA CONSIDERATIONS- WHAT YOU NEED TO KNOW 3D printing technologies have opened up the capabilities for customization in a wide variety of applications in the medical field. 3D printing turns tradi- tional manufacturing on its head, moving from mass production to individual production and mass customization as some believe it is the perfect model for personalized medicine. Using bio-compatible and drug-contact materials, medical devices can be produced that are perfectly suited for a particular indi- vidual giving rise to many regulatory challenges for the FDA. The FDA is working through some of the technical issues that 3D printing poses and has begun to receive numerous submissions using 3D printing for both traditional and pa- tient-matched devices. This presentation will discuss the current FDA regulatory landscape as well as the impact of 3D printing on forms of intellectual property and address strategies for protecting intellectual property. • Considerations when developing an IP protection strategy for 3D printing • Reviewing the current regulatory landscape for 3D printed medical devices • Challenges ahead for FDA clearance/ approval of these innovative devices • Understanding takeaway messages from the recent FDA stakeholder meeting Sonali Gunawardhana, Of Counsel, WILEY REIN, LLP Rachel K. Hunnicutt, Of Counsel, WILEY REIN LLP 9:30 COFFEE & NETWORKING BREAK 10:00 UNDERSTANDING CHALLENGES OF INNOVATION AND PATENTABLE SUBJECT MATTER As companies research and develop innovative medical devices and diagnostic tools, internal legal teams must understand the aspects of a product that are patentable and in need of protection to ensure profitability and to minimize competition. With recent Supreme Court decisions like Alice vs. CLS Bank indi- cating new challenges to patent claims and subject matter, it is vital for IP and patent counsel to comprehend how patents for influential products involving abstract ideas and natural principles are reviewed and scrutinized by the patent office and federal judges. Clarification of subject matter patentability and Su- preme Court rationale for decision-making will assist attorneys in successfully protecting exceptional products developed by medtech companies. • Reviewing eligible properties for patent under Section 101 of Title 35 • Alice vs. CLS Bank and Association for Molecular Pathology vs. Myriad Genetics • Patentability of abstract ideas and naturally occurring principles/products Miles Grody, Senior VP, General Counsel, ACELL Clark Wilson, Senior Counsel, MERCHANT & GOULD 11:00 UTILIZATION OF IPR AND POST-GRANT PROCEEDINGS Resulting from the America Invents Act, the final rule for Inter Partes Review (IPR) went into effect in September 2012 and development continued until March 2013, offering IP and patent counsel a new tool for protecting and challenging patents in post-grant proceedings. As the utilization of IPRs remains in its infan- cy, attorneys in the device and diagnostic space should evaluate the benefits of utilizing IPR proceedings, including a statistically pro-petitioner Patent Trial and Appeal Board (PTAB), faster trial timing and potential cost savings, as well as the risks including the potential that a claim amendment made as a result of an IPR could complicate future proceedings for the challenging party. Under- standing practice tips after the past years of IPR use, application of certain pro- vision of the rules, and prosecution of patents to increase the difficulty of being taken out on an IPR is extremely important as this space continues to evolve. • Examples and situations where IPR is effective • Understanding success of recent IPR proceedings • Managing IPR’s efficiently as an alternative to traditional litigation Todd Baker, Partner, OBLON 11:45 PRIORITIZING BUDGETS IN-HOUSE TO STRATEGICALLY MANAGE PATENT PROTECTION AND LITIGATION SPEND Protecting intellectual property in device and diagnostic organizations can result in challenges with staying within budget constraints while appropriately investing in a patent portfolio and litigation opportunities to maximize the value of the com- pany’s intellectual property. Understanding how strategic choices can be made regarding the number of claims needed to protect a product, the global locations where it may be vital to hold patents, and prioritization of intellectual property assets can help reduce cost and increase the value of the portfolio. Techniques to streamline litigation must also be understood so that legal teams can con- tinue to work effectively within financial constraints. It is essential that teams work to optimize current budgets, manage senior management expectations, and continue adding value to organizations by protecting intellectual assets. • Eliminating low value properties and maximizing budget value • Understanding locations where it is most/least important to hold patents • Best practices for budget management and cost tracking Matt Doscotch, Senior Patent Counsel, ZIMMER 12:30 LUNCHEON FOR ALL DELEGATES, SPEAKERS & SPONSORS 1:30 CLEAR IP OWNERSHIP IN ACADEMIC RESEARCH PARTNERSHIPS Partnering with academic programs to research and develop new devices and diagnostic tools supports educational programs, the development of innovative technologies, and can decrease costs. However, it is essential that ownership of any developed property and responsibility for any necessary litigation is clearly outlined prior to the start of contracted research, ensuring that all parties under- stand the license rights. Unclear communication of responsibilities and owner- ship expectations can lead to future litigation over rights if a property becomes valuable, which can cost organizations time and money. Clarifying strategies that are usable for different types of university partnerships will aid attorneys support- ing organizational goals of innovation and high-value intellectual property through the development of clear contracts with university partners. • Understanding impact of different partnership types on contract development • Developing agreements for contracted researchers within academic programs • Licensing created property from universities and student researchers Jamie Kemler, VP, IP Business Strategy, STRYKER Les Bookoff, Partner, BOOKOFF & MCANDREWS 2:15 BRIDGING THE GAPS IN UNIVERSITY-INDUSTRY COLLABORATIONS Partnering with academic institutions to research and develop new devices and diagnostic tools has many benefits, including supporting educational programs, developing innovative technologies, and obtaining access to expertise and facili- ties at a decreased cost. The differences in missions and perspectives of indus- try and academic institutions, however, can lead to many challenges, including challenges in the negotiation of the IP issues. For example, it is essential that the parties clarify ownership of developments, rights of prosecution of the intellectual property, confidentiality and publication issues, and appropriate financial terms. This presentation will discuss the various IP issues that arise within industry-aca- demic research partnerships. • Trends in university/medical device industry interaction; • Understanding differences in mission and objectives of the organizations; and • How those differences can affect IP ownership, prosecution, publication, and other issues Jeff Hohenshell, Senior Patent Attorney, MEDTRONIC Lee Caffin, Senior Consultant, QUESTEL 3:30 COFFEE & NETWORKING BREAK 4:00 INTERPRETING INDEFINITENESS IN ORDER TO IDENTIFY AND PROTECT VULNERABLE INTELLECTUAL PROPERTY With recent cases garnering attention in the Supreme and Federal courts, it has become increasingly important for in-house attorneys to develop knowledge on how properties could be targeted for infringement with a claim of indefiniteness. Proving a patent claim to be definite and valid relies on the clarity of the writ- ten claim and the subsequent ability of subject matter experts to determine the boundaries of each patent. Patents issued years prior to the time of enforcement have an increased risk of lacking this clarity as a result of increased innovation and technological advances within the device and diagnostic industries, among other complications. Understanding recent trends and decisions made by the courts related to patent term ambiguity will be extremely valuable as indefiniteness con- tinues to be an area of high focus to competitors and patent assertion entities. • Impact of recent cases on patent litigation and prosecution • Identifying patents that may be of greater risk for invalidation • Predicting future trends related to patent term validity Jeremy Lowe, Partner, AXINN, VELTROP & HARKRIDER 4:45 REVIEWING SUCCESSFUL PATENT CLAIM TYPES TO DEVELOP EFFECTIVE STRATEGIES AND INCREASE ASSETS Developing IP that will serve as an asset to an organization is traditionally viewed as the responsibility of R&D operations, but legal teams must also continually provide input on which aspects of the developed properties are patentable to en- sure that no items of value are overlooked or unprotected. Reviewing the common and uncommon types of claims utilized to patent new products and technologies is essential, especially as medical devices and diagnostic tests become more technologically advanced and claims are under greater scrutiny. With recent and notable cases challenging method claim construction and subject matter patent- ability, it is even more important to understand the value that can be created from a developed product, the claims most useful to protect these products, and the role that in-house counsel plays in the protection of developed assets. • Collaborating with R&D teams to discover patentable assets internally • Selecting filing types for an increased likelihood of patent grant • Understanding the success of different filing methods worldwide Norman Hainer, Patent Attorney, Advanced Surgical Devices, SMITH & NEPHEW 5:30 END OF DAY ONE MEDICAL DEVICE & DIAGNOSTIC IP/PATENT STRATEGY DAY ONE | MONDAY, MARCH 9
  • 4. 7:30 REGISTRATION & MORNING COFFEE 7:50 DAY ONE RECAP & DAY TWO OPENING REMARKS 8:00 STRATEGIC SELECTION OF PATENT LITIGATION VENUES TO IMPROVE OUTCOMES As legal teams prepare for litigation, many considerations can improve the prob- ability of a positive outcome, including the selection of a venue for the litigation to take place that will have optimal favorability with judges familiar with med- ical device patent cases. Selecting the preferred location out of the available options, usually given based upon the location of the defending organization, requires analysis of court favorability, judge familiarity with patent or medical device cases, and ability to persuasively argue that the chosen court is the best suited to hear the claim. Understanding these different factors and scenarios where certain courts are preferable will aid attorneys in decision making when given the opportunity to select litigation venues, and will help teams adapt if litigation is transferred to an alternate venue. • Trending US locations for medical device patent litigation • Considering alternatives to the Federal District court system • Reacting to venue transfers by district courts Ali Ahmed, Chief Intellectual Property Counsel, FRESENIUS KABI 8:45 UNDERSTANDING STRATEGIES TO DEVELOP AND MAINTAIN IP STRATEGIES FOR COMBINATION PRODUCTS With advances in technology allowing for highly innovative medical devices and diagnostic tools, there are an increasing number of combination products integrating devices or diagnostic tools with computerized parts, software sys- tems, and computer systems, which can make the navigation of licensing and patent processes challenging. Working within this intersection requires a clear understanding of claims that can be utilized to patent technologies, navigating a potentially complex web of product clearance assessments, and/or executing appropriate agreements to allocate risk. Understanding the risks and uncer- tainty associated with developing a combination product enables in-house at- torneys to better prepare filings and licenses in order to prevent costly and time consuming litigation in the future. • Developing an IP strategy proactively for combination products • Maintaining partnerships that benefit both stakeholders • Understanding scope of competitive IP space in new areas Austin Wang, Senior Intellectual Property Counsel HOLOGIC 9:30 COFFEE & NETWORKING BREAK 10:00 PANEL DISCUSSION: JURIST FEEDBACK ON ATTORNEY PRACTICE IN MEDICAL DEVICE PATENT CASES Evolving trends and laws as a result of the America Invents Act make IP and patent cases challenging to litigate, and it can be difficult to select the most effective strategy to utilize within a court. Even after a case has been com- pleted, attorneys should look to understand what aspects of litigation worked well and what aspects could have used revision in order to ensure the success of future cases. This panel of jurists with expertise in patent and intellectual property cases will share perspectives regarding successful strategies utilized in courtrooms to manage witnesses and maintain time limitations, and provide feedback on current trends utilized by practicing attorneys that will help attend- ees better prepare for patent litigation. MODERATOR: Artem Sokolov, IP Litigation Attorney, MCDERMOTT WILL & EMERY PANELISTS: The Honorable Judge J. Frederick Motz, United States District Court DISTRICT OF MARYLAND The Honorable Judge John F. Anderson, United States District Court EASTERN DISTRICT OF VIRGINIA Keith Newburry, Chief Counsel, Patent Strategy EDWARDS LIFESCIENCES Michael O’Shaughnessy, Partner MCDERMOTT WILL & EMERY 10:45 GLOBAL PATENT FILINGS TO REDUCE COST AND INCREASE PRODUCT PROTECTION As medical device and diagnostic corporations grow internationally more rapidly than ever before, it is essential to maintain a strong global patent strategy to decrease potential infringements and maintain exclusive revenue from owned intellectual property. Understanding the most important countries to file in will help in-house attorneys to prioritize patent filings, reducing expenses and se- curing patent protection. In countries like China, there has been some progress related to the protection of intellectual property rights, which is valuable for legal teams to understand as organizations look to enter international markets. • Best practices & tools for developing and maintaining a global patent strategy • Strategic value of securing patents for intellectual property in different countries • Changing laws impacting patent protection in key markets such as Asia, India and Europe Elias Domingo, Associate General Counsel, IP COVIDIEN 11:30 FUNCTIONAL LANGUAGE IN MEDICAL DEVICE PATENT CLAIMS AND OTHER TOOLS FOR CLAIM CONSTRUCTION Drafting patent claims can be challenging as attorneys must balance risks of claim infringement with maintaining the high value of a patent claim. Contrast- ing to claims that describe a device or component that “performs” a function, some claims are now reciting that devices or components are “configured” or “adapted” to perform a function which can increase the number of potential infringements for making or selling the device. Understanding recent ways that specific language has been interpreted by courts during post-grant proceedings will help legal teams better develop patent claims to escape patent rejection and increase protection of developed products. • Utilizing specific language for exceptional claim construction • Understanding potential responses from the patent office • Interpreting court decisions related to functional claim terms and other language Paul Lee, Patent Counsel DEXCOM 12:15 LUNCHEON FOR ALL CONFERENCE DELEGATES, SPEAKERS & SPONSORS 1:15 ASSESSING INNOVATIVE TECHNOLOGIES FOR IMPROVED IP ASSET MANAGEMENT Managing IP assets can be a complex undertaking due to the quantity of in- formation and the number of documents associated with each individual IP record, especially as organizations grow their IP portfolio and are granted new patents for medical devices and diagnostic tools. Evaluating alternatives to traditional docketing systems for efficiency gains and ease of use can be eye opening and can identify direct benefits to adopting a technologically advanced system that offers greater functionality, including automating workflow and improving efficiency. There are many full life-cycle IP asset management tools and systems available for in-house legal teams that can store and manage IP records from the opening an invention disclosure record all the way through to managing annuity payments for issued patents. Selecting the right system for your team’s needs can improve visibility to your portfolio, enhance matter management, increased detail and reliability of automated system reminders, and streamline workflow required to accomplish tasks. • Understanding effectiveness of current IP asset management processes and programs • Identifying costs and benefits of potential new systems and functionalities to aid decision making • Implementation considerations for managing the change to a new asset management systems Kevin Ferguson, Senior IP Counsel, Surgical Solutions Group COVIDIEN 2:00 CASE STUDY: STRATEGIC CONSIDERATIONS FOR POTENTIAL PATENT LITIGATION Depending on the company size, number of marketed products, patent value and internal budget there are many different choices that legal teams can make when it comes to developing a strategy for asserting patents against po- tential infringers. Understanding current statistics on royalty rates, lost profits, business dynamics and case results is important for teams to take into account when developing a strategy to assert infringement claims Start-up or smaller companies may wish to always assert potential infringement claims, but larger corporations may have more flexibility in procedures and can evaluate situa- tions based on business climate and economics to decide what choice is most profitable, fair, and safe for a patent. • Understanding business risk and resource allocation needs • Creating a workable strategy to benefit unique company circumstances & and goals • Choosing to consult/partner with external counsel to maximize budgets line- of-sight and improve outcomes Ajit Narang, Senior Legal Counsel MEDTRONIC 2:45 M&A DUE DILIGENCE ON PATENTS AND INTELLECTUAL PROPERTY: VALUATION & LIABILITY As the medical device industry continues to utilize acquisition activity as a strat- egy for corporate growth and development, patent teams are increasingly called upon to provide insight and guidance on both patent and intellectual property value as well as potential liabilities. Ensuring due diligence is carried out in an effective manner will provide organizations with the certainty that investments are being made at an appropriate value, as well as confirming freedom to op- erate once the transaction has completed. This process can be streamlined through formulating operating procedures for the assessment of IP and patent value in order to provide a clear picture of the value as well as any potential challenges that may exist. 3:30 CLOSING REMARKS & CONCLUSION OF CONFERENCE ACTIVITIES MEDICAL DEVICE & DIAGNOSTIC IP/PATENT STRATEGY DAY TWO | TUESDAY, MARCH 10