Day 1 - Tuesday, February 24, 2015

Registration and Networking Breakfast
Co-Chairs’ Introductory Remarks

Mercedes K. Meyer Ph.D.
Drinker Biddle & Reath LLP (Washington, DC)

Virginia A. Gibson
Hogan Lovells US LLP (Former Executive Assistant U.S. Attorney, Eastern District of Pennsylvania)

Establishing Ethical Document Production Practices: Avoiding Ethical Landmines and Spoliation Charges in Discovery

Stephen D. Brody
O'Melveny & Myers LLP

Michael Siem
Farney Daniels, P.C.

K. Shannon Mrksich Ph.D.
Senior IP Counsel
Danaher Corporation

  • Having policies in place before any potential litigation: appropriate confidentiality policies, document retention policies, and IT policies (who can access what, where is it stored, and ensuring employee understanding)
  • Understanding the duties of a life sciences attorney during document production in the digital age: applying traditional ethical analysis under the Model Rules to a previously unimaginable amount of electronic data
    • Competency and electronically stored information (ESI): What life sciences attorneys need to know about preserving and storing info
    • Ethically handling sensitive data in highly regulated life sciences industries
  • Balancing the somewhat-at-odds duties of zealous advocacy to the client and duty of cooperation between producing and receiving parties in the discovery context
    • Case study: Understanding what led to billions in spoliation punitive damages in the Actos litigation
  • Interpreting the grey areas in document production requests: what is meaningful discovery and what is gamesmanship?
    • Knowing what to collect from the client and what to turn over to an opponent
    • Deciding what to put in the privilege log
    • Conducting the responsiveness review with the duty of good faith in mind: making plausible and legitimate objections versus engaging in frivolous or dilatory litigation techniques
    • Case study: Lauren Stevens, individual corporate responsibility, and the advice of counsel
  • Formulating corporate policies to mitigate spoliation accusations stemming from a litigation hold
    • Determining when and whether to put a hold in place in light of litigation sometimes anticipated years in advance
    • Training employees on their obligations regarding record keeping, note taking, and email usage during a litigation hold

Zealous Advocacy for Life Sciences Corporate Attorneys and Law Firm Counsel: Understanding and Fulfilling Your Ethical Duty to the Client

Gael Diane Tisack
Cardiovascular Group Vice President of Legal Affairs & Terumo Americas Vice President of Intellectual Property
Terumo Medical Corporation (Ann Arbor, MI)

Ginger Pigott
Shareholder and Vice-Chair, Pharmaceutical, Medical Device & Health Care Litigation Group
Greenberg Traurig LLP

Brien T. O’Connor
Ropes & Gray, LLP (Boston, MA)

David M. Jacobs
Assistant General Counsel, Commercial Brands Legal Affairs
Daiichi Sankyo, Inc.

  • Balancing the mandate to act in the best interests of the client and the duty to adhere strictly to the responsibilities and duties owed to the court
  • Special concerns for in-house life sciences counsel regarding potentially conflicting interests: Who is the client? What is your duty to shareholders? To the Board? Duty to patients?
    • Understanding when you are giving legal advice or business advice
    • Serving two masters: representing specific business units who may wish to push the envelop while keeping your broader duty to the corporate entity in mind
    • Factoring in additional complexity regarding privilege issues for legal and compliance in life sciences companies operating under CIAs
    • Determining when to bring in outside counsel
  • Walking the fine line between zealous advocacy and making potential misstatements: how far is too far in the post-Lauren Stevens world?
    • Parsing language too finely: when have you crossed the line from truthfulness to falsity?
    • Understanding the potential ramifications for individual responsibility for both in-house and law firm counsel when there is a “bad call”
  • Ripped from the headlines: Going through hypothetical situations to formulate best practices on how life sciences attorneys should respond to potential ethical issues
    • Dealing with improper behavior by a high-ranking executive
    • Counseling a client who is acting against the advice of counsel regarding disclosures to a government agency
    • Jointly representing both a corporate client and a named employee defendant (current or former), particularly in the sales and marketing context
  • Maintaining the integrity of the profession: understanding your duty to report ethical violations

Morning Coffee Break
Protecting Attorney-Client Privilege and Avoiding Inadvertent Waivers of Privilege

Karen D. McDaniel
Briggs and Morgan

Jonathan A. Harris
Axinn Veltrop & Harkrider LLP

Judith A. Waltz
Foley & Lardner LLP

Colleen Tracy James
Mayer Brown LLP

Mark Rachlin
Senior Patent Counsel

  • Understanding the standard for a common interest where privilege may kick in
  • Making it clear that you are giving or seeking legal advice in the digital world of emails and texts
    • Business advice versus privileged attorney communications
    • Keeping confidential information private in an age when oversharing is commonplace
    • Case studies: Vioxx litigation and non-privileged email communications
  • Providing information in the discovery context without breaching attorney-client privilege
    • Creating a privilege log
    • Good document practices and confidentiality agreements
    • Setting up your systems so that confidentiality is protected
    • Knowing when to exercise the clawback provision
  • Conducting witness interviews during litigation with privilege to the client in mind
  • Protecting privilege across jurisdictions and across borders: choice of law and applicable rules both internationally and within different states
  • Putting protective orders in place and avoiding inadvertent waivers with privileged info during discovery
    • Rule 502(d) orders
    • Samsung v. Apple
  • Understanding the situations where an attorney either is permitted to or has a duty to make a disclosure which defeats privilege
    • Sarbanes Oxley mandates
    • SEC disclosures
    • Crime fraud exception

Understanding Judicial and Government Expectations for Life Sciences Counsel Regarding Civility and Ethical Practice of the Law

The Honorable Timothy S. Black U.S.D.J.
United States District Judge
Southern District of Ohio

Do not miss this unique opportunity to hear about Judicial expectations regarding life sciences counsels’ conduct under the Model Rules and how to best maintain civility in a high-stakes arena.

Lunch: Networking Roundtables

Learn informally during lunch about different ways of handling ethical challenges as you sit at the table of your choice. Network and discuss the specific ethical concerns within your practice that are most applicable to your daily life in a more informal setting. Attendees will have an opportunity to reserve their table at the beginning of the conference.

  1. IP
  2. Compliance
  3. Regulatory
  4. Transactional
  5. Products liability litigation

Building Competence: Updates on the Substantive Legal Developments Affecting Life Sciences Companies in 2015 and Beyond

Rachel Clark Hughey
Partner and Co-Chair, Appellate Practice
Merchant & Gould P.C.

Loren H. Brown
Partner and Co-Chair, US Litigation Group
DLA Piper

The best life sciences attorneys understand not only the ins-and-outs of their daily practice, but also have the most well-rounded and up to date information on the most pressing legal developments facing life sciences companies as a whole. In this session, leading attorneys will go through the top 10 Supreme Court, Appellate Court, and District Court cases affecting life sciences practice to give you the information necessary to protect the interests of your life sciences clients.

Afternoon Coffee Break
Identifying and Avoiding Ethical Conflicts of Interest for Life Sciences Attorneys

Timothy H. Kratz
McGuireWoods LLP

Douglas S. Portnow
Patent Attorney
Wilson Sonsini Goodrich & Rosati

Bruce S. Weintraub
Senior Corporate Counsel, Intellectual Property, Legal Division
Pfizer Inc.

John T. Vaughan
Vice President and Regulatory Counsel

Rajan Sharma
General Counsel
Dynamic Biologics, Inc.

  • Best practices for doing conflicts checks for adverse interests in the closely related life sciences world, particularly in light of increased mergers and acquisitions between companies
    • Identifying actual conflicts and making sure appropriate waivers are in place
    • Subject matter conflicts: representing competitors and maintaining product related confidentiality
  • The revolving door: Factoring in high employee turnover between companies
    • Hiring an ex-government attorney (FDA, SEC etc): what are the restrictions when dealing with the agency going forward?
  • In-house perspective: choosing a law firm in light of potential conflicts
    • Knowing the limitations of an ethics screen: when should a firm be disqualified?
    • Making a decision whether to waive a law firm conflict
    • Understanding when a conflict cannot be waived
  • Addressing conflicts in a collaboration or licensing situation: understanding the competing interests at play and addressing ethical dilemmas proactively contractually
  • Understanding the ethical requirements during a joint representation: considerations for in-house and law firm counsel
    • Determining whether the named employee was acting in the scope of his or her employment
    • Making the decision if the employee requires special counsel
    • Preparing for testimony and depositions at trial
    • Ethical concerns related to potential settlements involving claims against individuals

An Ethical Guide to Conducting Internal Investigations for Life Sciences Attorneys

Carol Ann Poindexter
Norton Rose Fulbright US LLP (Washington, DC)

Laura Laemmle-Weidenfeld
Jones Day (Washington, DC)

Robert K. Kelner
Covington & Burling LLP

Conference Adjourns to Day Two Working Groups

Day 2 - Wednesday, February 25, 2015

ETHICS and Life Sciences IP: Inequitable Conduct, New PTO Ethical Rules, BPCIA Litigation and Special Concerns for the IPR Space

Kevin E. Noonan Ph.D.
McDonnell Boehnen Hulbert & Berghoff LLP (Chicago, IL)

Barton W. Giddings
Stoel Rives LLP (Salt Lake City, UT)

Barbara A. Fiacco
Foley Hoag LLP

Donna M. Meuth
Associate General Counsel, Intellectual Property
Eisai Inc. (Andover, MA)

William R. Covey
Deputy General Counsel and Director of the Office of Enrollment and Discipline (OED)
United States Patent and Trademark Office (USPTO)

Mercedes K. Meyer Ph.D.
Drinker Biddle & Reath LLP (Washington, DC)

  • USPTO spotlight: What are OED’s expectations of attorneys in this space?
  • Understanding when to raise the inequitable conduct defense under the continually evolving Therasense standard
    • Rule 36 affirmations of inequitable conduct cases
    • Update on recent relevant inequitable conduct cases
    • Complying with the USPTO duty of disclosure: what to submit and how much?
  • Analysis of the PTO’s 2013 Rules of Professional Conduct
    • Overview of key provisions including conflicts, sanctions and experts
    • How do these work with the ABA model rules and state bar rules?
  • Avoiding ethical quagmires in the IPR / PGR space for life sciences companies
    • What conflict of interest rules apply with parallel litigation
    • Duty of candor and good faith owed by petitioner challenging the patent
    • Avoiding putting forth inconsistent information in different proceedings
    • Concerns for Supplemental Examination
  • Navigating the tricky conflicts and confidentiality issues inherent in BPCIA pre-litigation procedures
    • Protecting confidential information in the dossier exchange process
    • Applying traditional conflicts analysis and principles when agreeing to work for a client: Are ABA comments to the model rules instructional?

​9:00 am – 12:00 pm

Networking Lunch for Workshop C Attendees

12:15 – 1:30

Diversity, Inclusion and Well Being in the Life Sciences Bar: Ethical Considerations in Building a Better Life Sciences Legal Community

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

George Ng
Senior Vice President & General Counsel
BioDelivery Sciences International, Inc.

Marianne Slivkova
Director – Legal
Acorda Therapeutics, Inc. (Ardsley, NY)

In this session, our esteemed panel will explore the challenges and opportunities for in-house and law firm retention of diverse talent and how the bar as a whole will benefit by having a diverse group comprised of individuals of different races, genders, sexual orientations, and generations, with a wealth of perspectives and personal experience. Topics to be discussed will include:

  • Taking a look at the current statistics of diverse representation in executive positions at life sciences companies and in leadership positions at law firms
    • Keeping up morale in the face of a reputed “old boys’ club” and pay gap
    • Getting a seat at the table: increasing the prominence of diversity in power positions in the life sciences world
  • Designing and implementing sustainable policies and procedures that will truly effect change and promote a diverse workforce
    • What recruitment, retention, and advancement initiatives are working and which are merely academic?
    • Advocating for diversity and inclusion policies and procedures at your company and firm
    • Staying respectful of non-traditional family structures
  • Identifying actions and solutions that can help overcome stereotypes and implicit and explicit bias in law firms and companies
  • Fostering relationships with colleagues to work towards a mutually respectful and beneficial working relationship
  • Rainmaking and business development
  • Communication strategies for leaders: “bossy” does not need to be a bad thing
  • In-house perspective: Understanding how much diversity matters when vetting and choosing law firm counsel

Spotlight on Law Firm Culture and the Lawyers’ Epidemic”: Substance Abuse, Depression and Suicide

Work related stress in the high-stakes life sciences legal community is more intense then ever, with clients and colleagues having virtually 24/7 access to attorneys through technology. Perhaps as a result of job pressures and a quest for perfectionism at all costs, the statistics show that lawyers are more than twice as likely than other professions to suffer from substance abuse and depression. In this session, our leaders will discuss the high incidence of depression and substance abuse in the legal profession and solutions for best helping our peers facing these challenges.

  • Understanding the nexus between substance abuse and character and fitness to practice law
    • Encouraging attorneys to seek help and minimizing stigma
    • When is the duty to report another attorney’s mental health or substance abuse triggered?
  • The physiology of addiction and depression: a clinical look
  • Strategies for coping and cultivating a full and healthy life outside the office while balancing the intensive commitment of a life sciences legal career and 24/7 availability through technology
    • Participating in social events, often involving alcohol, without overdoing it
    • Understanding the benefits of meditation, yoga, and exercise
    • Putting an effective support system in place to lighten the load
  • Overcoming any hesitation to take advantage of corporate policies promoting work life balance and encouraging mental well being
  • Walking away from professional and personal guilt in the quest for perfection and learning to be okay when you can’t give 110% on every front

​2:00 pm – 5:00 pm