Wiley Rein LLP

Events & Speeches

Wiley Rein's attorneys regularly speak before legal and industry groups on a wide variety of issues, and often serve as panelists, keynote speakers and moderators for law-related events, seminars, symposiums and workshops.  If you are interested in having a Wiley Rein attorney share their expertise with your group, please contact Patricia O'Connell at poconnell@wileyrein.com.

  • Best Practices to Secure Allowance of Patent Application Claims Using Evidence

    Matthew J. Dowd, Panelist
    American Intellectual Property Law Association
    March 3, 2015 at 12:30pm - 2:00pm | Webinar | More Information
  • Oops, My Policy Limits Are Gone. Who Do I Sue Next?

    Mary E. Borja, Panelist
    ABA's 2015 Insurance Coverage Litigation Committee CLE Seminar
    March 4 - March 7, 2015 | Tucson, AZ
  • Balancing the Costs and Benefits of Patent Litigation from Injunctions to Damages

    Lawrence M. Sung, Speaker
    ACI's 5th Advanced Summit on Medical Device Patents
    March 5, 2015
  • CLE Plenary Session: Cyber Attacks and Privacy Perils: Understand and Mitigate Your Risk Through Insurance

    Laura A. Foggan, Speaker
    ABA's Insurance Coverage Litigation Committee CLE Seminar
    March 6, 2015 | Tucson, AZ | More Information
  • Drone Technology, Utilization and Risks

    Benjamin C. Eggert, Speaker
    AGRiP's 2015 Governance & Leadership Conference
    March 8 - March 11, 2015 | Las Vegas, NV | More Information
  • The Innovative World of 3D Printed Medical Devices, IP and FDA Considerations - What You Need To Know

    Sonali P. Gunawardhana, Speaker and Rachel K. Hunnicutt, Speaker
    Overview of Event

    3D printing technologies have opened up the capabilities for customization in a wide variety of applications in the medical field. 3D printing turns traditional 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 individual giving rise to many regulatory challenges for the FDA. The FDA is working through some of the technical issues that 3-D printing poses and has begun to receive numerous submissions using 3-D printing for both traditional and patient-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.

    • Identifying factors related to 3D printing that IP counsel should consider when developing a IP protection strategy

    • Reviewing the current regulatory landscape for 3D printed medical devices and what challenges lie ahead for those seeking FDA clearance/ approval of these innovative devices?

    • Understanding key takeaway messages and questions still posed from the recent FDA stakeholder meeting regarding 3D printing of medical devices.

    Q1 Conferences' Medical Device and Diagnostic IP/Patent Strategy Conference
    March 9 - March 10, 2015 | Alexandria, VA | More Information
  • Personal Jurisdiction in ANDA Litigation Post-Daimler: A Critical Review of the Courts' Response

    A. Claire Frezza* and Eric H. Weisblatt
    Overview of Event

    Listeners will hear:

    ·         An overview of the unique circumstances framing when personal jurisdiction may be asserted over Abbreviated New Drug Application (ANDA) filers

    ·         How Daimler changed the game for asserting personal jurisdiction in ANDA litigation

    ·         A review and critique of recent ANDA jurisdiction decisions post-Daimler 

    Wiley Rein Webinar
    March 10, 2015 | Register Now
  • The OECD: Pioneering Effective Stakeholder Consultation and Participation

    Richard C. Beaird, Moderator
    Joint USCIB/BIAC/OECD Conference on “Promoting Inclusive Growth in the Digital Economy: The OECD Evidence and Practice Base”
    March 10, 2015 | Washington, DC
  • Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics

    James N. Czaban, Speaker
    ACI's 24th FDA Boot Camp
    March 11, 2015 | New York, NY | More Information
  • Ineligibility of Abstract Ideas, Business Methods, and Naturally-Occurring Substances

    James H. Wallace, Jr., Moderator
    Overview of Event

    In its third case dealing with Section 101 since 2010, the Court has continued to question the patentability of business methods, most recently in Alice v. CLS Bank . The Federal Circuit has issued dozens of decisions on Section 101. The discussion will include a brief history of prior Supreme Court patent ineligibility decisions including Gottschalk v. Benson ,Parker v. FlookDiamond v. DiehrBilski v. Kappos , Mayo v. Prometheus , and Molecular Pathology v. Myriad . Also addressed will be post-Alice CAFC cases including Digitech Image Technologies v. Electronics for Imaging, Inc. and the important contrasting decisions by Judge Pfaelzer (CDCa) in Enfish and Cal Tech. Also discussed during this session will be the USPTO's patent eligibility guidelines. 

    Impact of the Supreme Court on Patent Enforcement
    March 12, 2015 | San Francisco, CA | More Information
  • Recovery of Attorney Fees

    Brian H. Pandya, Moderator
    Overview of Event

    Two decisions - Highmark v. Allcare and Octane Fitness v. Icon Health and Fitness - have given trial courts more discretion to award attorney fees under 35 U.S.C. § 285 and made it more difficult for reviewing courts to disturb a trial court's discretion. Lower courts are also broadening recovery opportunities.

    Also discussed during this first portion of the conference will be Innovative Biometric Technology, LLC v. Toshiba (recovery under Rule 41(a)(2), 35 U.S.C. § 285, Rule 56 and 28 U.S.C. § 1927); Straight Path IP Group, Inc. v. Blackberry Ltd. (third-party Netflix recovers for bad faith subpoena enforcement under Rule 45(d)(1)); Medtrica Solutions Ltd. v. Cyagnus Medical LLC (on reconsideration, district court reversed its pre-Highmark denial of attorney fees in light of lower threshold set by Supreme Court); Lee v. Mike's Novelties, Inc. (in a post-Highmark ruling district could would not award attorney's fees despite litigation misconduct and willful infringement).

    Impact of the Supreme Court on Patent Enforcement
    March 12, 2015 | San Francisco, CA | More Information
  • Privacy for Government Contractors Is a Whole New Ballgame in the Age of Information Sharing: Safeguarding Government Data

    Kirk J. Nahra, Panelist
    2015 Section of Public Contract Law 21st Annual Federal Procurement Institute and Midyear Council Meeting
    March 13, 2015 | Annapolis, MD | More Information
  • Preparing for and Responding to an OCR Privacy and Security Audit

    Kirk J. Nahra, Speaker
    The 23rd National HIPAA Summit
    March 17, 2015 | Washington, DC | More Information
  • DOJ Enforcement Actions Regarding Noncompliance with FDA cGMPs - What You Need To Know

    Sonali P. Gunawardhana
    IVT's Validation Week Europe
    March 18, 2015 | Amsterdam, The Netherlands | More Information
  • State Government Affairs Council National Summit

    Carol A. Laham, Speaker
    Complying with State Lobby Laws
    March 19, 2015 | Nashville, TN | More Information
  • Delving into the Mechanics of the USFDA Biosimilars Approval Process and Section 351(k) Applications Under the Pathway

    James N. Czaban
    Overview of Event
    • Going over important definitions in the Act including "biological" and "biosimilars" and "reference product"
      - Exploring key provisions in the Act
      - Criteria for biosimilarity and interchangeability
      - Clinical trials and safety studies
      - Exclusivity provisions
      - Patent litigation and exchange provisions: Understanding the major differences between small molecule Hatch-Waxman litigation and biosimilars litigation as outlined in the statute
    • Recapping the statements and guidance issued by USFDA post-BPCIA: what are the open questions?
      - February 2012 three-part guidance pertaining to scientific and quality considerations in demonstrating biosimilarity to a reference product
      - March 2013 guidance regarding closed-door meetings and biosimilars user fees
      - May 2014 Guidance on Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
      - August 2014 Guidance on Reference Product Exclusivity for Biological Products
      - Submitting an application under 351(k): what must be included in its content?
      - Examining the specific provisions for patent resolution under the statute
      - Certification procedures
      - Procedures for patent identification
      - Mechanisms of negotiation and engaging in good faith negotiations
      - Settlement processes
      - Calculating data and patent exclusivities under the Act
      - Comparing and contrasting the biosimilars pathway under the statute to 505(b)(2) and BLA pathways
      - Breakdown of relevant considerations with each route including timing, costs, IP litigation considerations, and exclusivities
    ACI's Summit on U.S. Biosimilars
    April 20, 2015 | Munich, Germany | More Information
  • Minimizing the Uncertainty Surrounding the Pathway: Insights Into USFDA's Current Initiatives Regarding the First Wave of Biosimilars Applications

    James N. Czaban
    Overview of Event

    Topics covered include:

    • Understanding the USFDA's "totality of the evidence" and case-by-case approach to biosimilar approval
    • Update on the closed-door meetings between manufacturers and USFDA
    • Meeting USFDA's standards for biosimilarity and the heightened standard for interchangeability: how are companies moving forward in light of lingering open questions from draft guidance?
    • Demonstrating biosimilarity: What exactly will a company need to show?
      - Putting together a step-wise approach
      - Showing safety and efficacy through clinical trials: Looking to innovators' trial design and endpoints
      - Extrapolating data: what will be acceptable? (i.e. between populations within indications? Across unrelated indications?)
      - To what extent will bridging studies of ex-US data be acceptable?
      - What are companies doing in the absence of final guidance?
    • Anticipating when final USFDA guidance regarding biosimilarswill be issued in light of the first applications being public
    • Substituting the biosimilar at the pharmacy level: what will it take to make interchangeability a reality and how can manufacturers maintain this over time?
    ACI's Summit on U.S. Biosimilars
    April 21, 2015 | Munich, Germany | More Information
  • The New Paradigm for Health Care Privacy & Why It Matters to You

    Kirk J. Nahra
    2015 Blue National Summit
    April 21, 2015 | Phoenix, AZ | More Information
  • Top Ten Healthcare Privacy and Security Developments to Watch

    Kirk J. Nahra
    2015 Blue National Summit
    April 21, 2015 | Phoenix, AZ | More Information
  • The Wild Wild West: Cyber Risks, Data Security and Privacy

    Kirk J. Nahra
    2015 PLUS Professional Risk Symposium
    April 28, 2015 | Atlanta, GA | More Information
  • Domain Name Registry and Registrar Liability: Recent Developments, Cases and Best Practices

    David E. Weslow, Moderator
    INTA Annual Meeting
    May 4, 2015 | San Diego, CA | More Information
  • The Coming New World Order on Health Care Privacy and Data Security

    Kirk J. Nahra, Speaker
    Third Annual Medical Informatics World Conference 2015
    May 5, 2015 | Boston, MA | More Information
  • The New Paradigm for Health Care Privacy

    Kirk J. Nahra, Moderator
    Third Annual Medical Informatics World Conference 2015
    May 5, 2015 | Boston, MA | More Information
  • Drones are Coming: Are You Ready for Unmanned Aircraft?

    Benjamin C. Eggert, Speaker
    PRIMA 2015 Annual Conference
    June 7 - June 10, 2015 | Houston, TX | More Information
  • State of Existing Allocation Law, With a Focus on Asbestos, Environmental, and Other Long-Tail Claims

    Laura A. Foggan, Panelist
    ACI's 2nd National Forum on Insurance Allocation
    June 25 - June 26, 2015 | Chicago, IL







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