American Conference Institute’s 6th Advanced Summit on

Medical Device Patents

Comprehensive and Practical Prosecution and Litigation Strategies for an Evolving IP Landscape

Thursday, February 25, 2016
Doubletree Times Square, New York, NY

Thursday, Feb 25, 2016

Registration and Continental Breakfast
Co-Chairs’ Opening Remarks
  • Jeffrey J. Hohenshell
    Senior IP Counsel
    Medtronic (Minneapolis, MN)
  • Karen L. Shannon
    VP Intellectual Property
    Beckman Coulter (Brea, CA)
  • Scott P. McBride
    McAndrews, Held & Malloy, Ltd. (Chicago, IL)
In-House Roundtable: Strategic Considerations for Limiting Liability and Managing and Reducing Costs in Medical Device Patent Prosecution and Litigation
  • Erik M. Drange
    Senior Counsel
    3M (St. Paul, MN)
  • David J. Johns
    Intellectual Property Counsel
    W.L. Gore & Associates, Inc. (Flagstaff, AZ)
  • Paul Lee
    Patent Counsel
    DexCom Inc. (San Diego, CA)
  • Joseph Topmiller
    Deputy Chief Patent Counsel
    Zimmer Biomet (Warsaw, IN)
  • 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 Jacqueline Wright Bonilla
    Administrative Patent Judge, Patent Trial and Appeal Board
    United States Patent and Trademark Office (Alexandria, VA)
  • The Honorable Elaine E. Bucklo
    Senior Judge
    United States District Court, Northern District of Illinois (Chicago, IL)
  • The Honorable Joy Flowers Conti
    Chief Judge
    United States District Court for the Western District of Pennsylvania (Pittsburgh, PA)
  • The Honorable Barbara M.G. Lynn
    District Judge
    United States District Court, Northern District of Texas (Dallas, TX)
  • Scott P. McBride
    McAndrews, Held & Malloy, Ltd. (Chicago, IL)

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 (Chicago, IL)
  • 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)
  • David J. Simonelli
    Reising Ethington P.C. (Detroit, MI)
  • Suzannah K. Sundby
    Canady + Lortz LLP (Washington, DC)
  • 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 (Hartford, CT)
  • John C. O’Quinn
    Kirkland & Ellis LLP (Washington, DC)
  • Jason W. Schigelone
    Brinks Gilson & Lione (Chicago, IL)
  • 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 (Hartford, CT)
  • 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: