Day 1 - Wednesday, February 24, 2016

Patents Around the World: A Cheat Sheet on Executing a Cohesive International Patent and Exclusivity Strategy

Anita Varma
Ropes & Gray LLP (Boston, MA)

Lisa L. Mueller
Michael Best & Friedrich LLP (Chicago, IL)

Joel Silver
Corporate Counsel
Gilead Sciences (Foster City, CA)

Jennifer Zarutskie Sieczkiewicz Ph.D., J.D.
Research and Business Development Counsel
Biogen Inc. (Cambridge, MA)

Michael A. Fisher
Chief Intellectual Property Counsel
KaVo Kerr Group, Danaher Corporation (Hatfield, PA)

In this session, leading patent practitioners will give you a comprehensive breakdown to assist you in protecting your IP and minimizing risk when filing patents internationally. Benefit from our session leaders in-depth analysis of patent laws around the world on a region-by-region basis. Topics to be discussed include:

  • Comparing and contrasting the standards of patentability in the US with those at other major patent offices
    • What is patentable?
    • Filing requirements
    • Claim construction
    • Availability of patent extensions
    • IP and regulatory data protection and exclusivity
    • Brand versus generic considerations
    • Pricing factors
    • Compulsory licensing
    • Bolar-type safe harbor provisions
    • Privilege concerns
  • Going through common rejections in the US (subject matter patentability, obviousness, indefiniteness etc.) and determining how they might succeed or fail in other key patent offices
  • Procuring and enforcing life sciences patents worldwide on a cost-effective basis
    • Timing and logistics of filing: When to file to maximize exclusivity and what are the expected costs?
    • Determining the locations where it is most and least important to have patent protection in place
    • Drafting applications that satisfy the requirements of different locations
    • Coordinating between lawyers on the ground internationally and with your U.S. teams
  • Spotlight on the EU: how has the establishment of a Unitary Patent Court affected life sciences IP strategies?
    • How will the Court work?
    • What actions should companies take now to prepare for implementation?
    • Overview of recent EU decisions affecting life sciences
    • Keeping SPCs and PTE in mind

Workshop Adjourns

Day 2 - Thursday, February 25, 2016

Registration and Continental Breakfast
Co-Chairs’ Opening Remarks

Scott P. McBride
McAndrews, Held & Malloy, Ltd.

Jeffrey J. Hohenshell
Senior IP Counsel
Medtronic (Minneapolis, MN)

Karen L. Shannon
VP Intellectual Property
Beckman Coulter (Brea, CA)

In-House Roundtable: Strategic Considerations for Limiting Liability and Managing and Reducing Costs in Medical Device Patent Prosecution and Litigation

Joseph E. Topmiller
Deputy Chief Patent Counsel
Zimmer, Inc.

Paul Lee
Senior IP Counsel
DexCom Inc. (San Diego, CA)

David J. Johns
Intellectual Property Counsel
W.L. Gore & Associates, Inc. (Flagstaff, AZ)

Erik M. Drange
Senior Counsel
3M (St. Paul, MN)


Eligio C. Pimentel
McAndrews, Held & Malloy, Ltd. (Chicago, IL)

  • Considerations involved selecting outside counsel for patent portfolio development
  • Managing costs and maximizing value provided by outside counsel
    • What kind of arrangements with law firms are working to lower the cost of patent protection and litigation?
    • What does in-house counsel expect to get from their outside counsel?
  • Determining countries for patent protection
  • Exploring the troubling steady increase in the size of medical device patent infringement verdicts
  • Selecting a venue for litigation: knowing which district rules favor patent holders and patent challengers
    • Where are the next hotbeds of medical device litigation?
    • Weighing the benefits and drawbacks of PTO procedures versus litigation in the Courts

Morning Networking Break
View From the Bench: The Judicial Perspective on Medical Device Patent Litigation

The Honorable Barbara M.G. Lynn
District Judge
United States District Court, Northern District of Texas (Dallas, TX)

Honorable Jacqueline Wright Bonilla
Lead Administrative Patent Judge Patent Trial and Appeal Board
US Patent and Trademark Office (Alexandria, VA)

Hon. Joy Flowers Conti
Chief District Judge
U.S. Dist. Ct., W.D. Pa.

The Honorable Elaine E. Bucklo
Senior Judge
United States District Court, Northern District of Illinois (Chicago, IL)


Scott P. McBride
McAndrews, Held & Malloy, Ltd.

Hear what arguments and claims Courts find most effective and persuasive when determining who owns the intellectual property at stake in a dispute. Formulate your medical device patent strategies based upon the insights of renowned jurists experienced in medical device litigation who will discuss the hot-button issues affecting medical device patent litigation, including:

  • The effects of the USPTO dispute resolution procedures on patent litigation
  • The increase of litigation involving non-practicing entities and patent assertion entities
  • Controlling litigation costs in patent cases
  • Granting temporary and permanent injunctions with life-saving technology at stake

Update on Pending Patent Reform: Evaluating the Continually Evolving Impact of Non-Practicing Entities, Patent Assertion Entities, and Other Monetizers

Brad Lane
Brinks Gilson & Lione

Mary-Olga Lovett
Texas Co-Regional Operating Shareholder and Houston Co-Managing Shareholder
Greenberg Traurig LLP (Houston, TX)

  • Overview of the proposed bills making their way through Congress, including the Protecting American Talent and Entrepreneurship Act, or PATENT Act, the Innovation Act, and the STRONG Patents Act: what are the key provisions affecting medical device companies?
  • Dissecting the cases and outcomes so far in the medical device context from threats of litigation by “trolls”
    • Investigating the assumptions surrounding NPEs, PAEs, and holding groups
    • The new threat: hedge fund investors who aim to short stocks
    • What segments of the device industry are being targeted and what are the nature of the claims?
    • Where are these entities filing?
  • Exploring the complicated shift towards medical device company monetization and creating value in IP beyond your current product line
    • Weighing the strategic benefits and drawbacks of monetization
    • Case study: Medtronic and the Ortho Phoenix patents
  • Proven strategies for protecting IP against challengers and effective tactics for driving down the cost of a settlement
  • Update on the practical impact of the Supreme Court’s Octane Fitness and Highmark decisions: sanctioning nonpracticing entities and others that pursue meritless patent cases, getting attorney’s fees awarded, and collecting the fees

Networking Lunch
Protecting Medical Device Patents in Light of Increasingly Strict Subject Matter Patentability, Written Description, and Obviousness Standards

David J.F. Gross
Faegre Baker Daniels LLP (Silicon Valley, CA)

Michael P. Kahn
Akin Gump Strauss Hauer & Feld LLP (New York, NY)

Suzannah K. Sundby
Canady + Lortz LLP (Washington, DC)

David J. Simonelli
Reising Ethington P.C. (Detroit, MI)

  • Patentability: Exploring the shifting landscape of what is patentable post-Prometheus, Myriad, and Alice
    • Determining whether providing language in medical device claims is sufficient to meet the patent eligibility requirements in Alice
    • Establishing realistic expectations for the scope of patent protection that can be obtained going forward with medical devices and medical diagnostics
    • Drafting claims to fall within the purview of increasingly narrow § 101 patentability
    • Writing in transformative steps
    • Avoiding mental and abstract steps
    • Determining what constitutes a law of nature in a method claim
    • Exploring the use of trade secret protection as an alternative to traditional IP protection for diagnostics
  • Written description: Strategies for satisfying ever-evolving § 112 standards for sufficient written description and enablement
    • Reviewing specification requirements and showing the claims are fully supported by the specs
    • Avoiding potential indefiniteness challenges post-Nautilus: what is the future of functional claims?
    • Balancing the unpredictability needed to overcome obviousness with the level of disclosure necessary to satisfy § 112
  • Obviousness: Combating rejections and the USPTO and mounting a challenge in the Courts
    • Showing novelty when combining known elements: What makes your structure different and non-obvious in an area replete with improvement patents?
    • Emphasizing unexpected results
    • Detailing the substantial evolution of the technology
    • Factoring in the increased importance of secondary indicia of non-obviousness including commercial success
    • Relying on the prior art to show non-obviousness in a medical device patents case

Lessons Learned from the First Medical Device Patent IPRs

Jeffrey J. Hohenshell
Senior IP Counsel
Medtronic (Minneapolis, MN)

Julianne M. Hartzell
Partner and Chair, Medical Devices
Marshall, Gerstein & Borun LLP (Chicago, IL)

Jeremy C. Lowe
Axinn, Veltrop & Harkrider LLP

Jason W. Schigelone
Brinks Gilson & Lione (Chicago, IL)

John C. O’Quinn
Kirkland & Ellis LLP (Washington, DC)

  • Under what circumstances have AIA procedures been an effective tool?
    • Exploring the trends and statistics regarding invalidity in the medical device context: inherency, obviousness, and more
    • Update on the growing use of PTAB procedures by hedge funds investors and how those challenges by outsiders may complicate medical device patents strategies
    • Understanding how the standards of claim construction (broadest reasonable interpretation versus ordinary meaning) impact life sciences IPRs
  • Utilizing IPR amendment practice, procedurally and strategically
  • Best practices while appearing before the PTAB: avoiding procedural pitfalls including timing and page limit requirements
  • Preparing for the first medical device Post-Grant Review (PGR) challenges: understanding how these patents are particularly vulnerable to attack to challenges based on prior art, subject matter, written description, lack of enablement and more
  • Factoring in other strategic considerations, including better use of reexam procedures, parallel proceedings with District Courts, and seeking judicial review

Afternoon Networking Break
Joint and Divided and Direct Infringement Post-Akamai: Understanding the Impact on Prosecution and Litigation Strategies

Norman F. Hainer Jr.
Patent Attorney
Smith & Nephew (Andover, MA)

Matthew J. Becker
Axinn Veltrop & Harkrider LLP

  • Understanding the expanded parameters for what constitutes direct infringement post-Limelight Networks v. Akamai: conditioning participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishing the manner or timing of that performance
    • Apportioning responsibility between separate entities each performing separate steps in a method claim
    • Determining the proper parties in litigation involving multi-staged transactions
    • Showing specific intent and willfulness
  • Claim drafting strategies to proactively avoid divided infringement with method claims featuring multiple steps
    • How can patent drafters who bear the brunt of the burden protect themselves?
    • Avoiding writing claims in a way that mandates actions by multi parties
    • Exploring the filing of continuation patent application to mitigate risk
  • Exploring Judge Moore’s argument in the Akamai dissent regarding the loophole for alleged infringers to avoid liability by performing some steps and inducing another party to perform the other steps: how well has the loophole been plugged by the en banc decision?

ETHICS and Medical Device IP: Special Concerns for PTAB Practice, Inequitable Conduct, and More

Karen L. Shannon
VP Intellectual Property
Beckman Coulter (Brea, CA)

Clark A.D. Wilson
Senior Counsel
Merchant & Gould P.C. (Atlanta, GA)

  • Overview of the new proposed rules for PTAB practice regarding potential sanctions for attorneys
    • Adequate prefiling investigation
    • Making representations to the board for an improper purpose
  • Understanding how the proposed rules interplay with the already existing duties of candor and duties of good faith for both applicants and petitioners
  • Comprehending how the duty of disclosure in an IPR differs from the duty of disclosure during prosecution
    • Who is liable?
    • Providing information inconsistent with a position
    • No IDS-Type Filings
  • Establishing ethical document production practices: Avoiding ethical landmines and spoliation charges in PTAB discovery
    • Understanding the parameters of limited routine discovery and when additional discovery will be allowed
  • Inequitable conduct: Update on relevant life sciences cases post-Therasense
    • Rule 36 affirmations of inequitable conduct cases
    • Understanding when to raise the inequitable conduct defense under the continually evolving standard
    • What is reasonable to disclose to the PTO going forward?

Conference Adjourns to Cocktail Party Hosted by: