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

American Conference Institute’s 5th Advanced Summit on

Medical Device Patents

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

March 4 – 5, 2015 | InterContinental | Chicago, IL

Pre-Conference Workshop: March 4, 2015 | Post-Conference Workshop: March 6, 2015 Government Insight from:

Tom Barrett

Supervisory Patent Examiner U.S. Patent and Trademark Office

Patricia Bianco

Supervisory Patent Examiner U.S. Patent and Trademark Office

Hon. Elaine Bucklo

Senior Judge

U.S. District Court for the Northern District of Illinois

Janet Gongola

Associate Commissioner for Patent Examination Policy U.S. Patent and Trademark Office

Hon. Faith S. Hochberg

District Judge

U.S. District Court for the District of New Jersey

Hon. James F. Holderman

District Judge

U.S. District Court for the Northern District of Illinois

Hon. James D. Smith (invited)

Chief Administrative Patent Judge Patent Trial and Appeal Board U.S. Patent and Trademark Office

Valuable Industry Insight from:

Eric M. Drange

Senior Counsel – Litigation & Preventive Law 3M

Jeffrey Hohenshell

Senior Patent Counsel Medtronic Inc. Paul Lee Patent Counsel DexCom Inc. Shannon Mrksich, Ph.D. Senior IP Counsel Danaher Corporation Richard L. Rainey

Executive Counsel, IP Litigation General Electric Co.

Peter Socarras

Director, Intellectual Property Nevro Corp.

Gael Diane Tisack

Terumo Cardiovascular Group Vice President of Legal Affairs & Terumo Americas Vice President of Intellectual Property

Tom Wolfe

Senior Patent Counsel

Medtronic Spinal and Biologics

PLUS! Interactive Pre- and Post-Conference Workshops

Wednesday, March 4, 2015:

Patent Prosecution Master Class — Best Practices for Drafting Claims and Prosecuting Medical Device Patents in the Post-AIA Landscape

Friday, March 6, 2015:

Act Locally, Think Globally — Being Mindful of International Forums While Prosecuting Patents in the United States or Considering How to Bring

A

B

Massive changes to patent practice have been wrought by Congress and the Supreme Court. This conference explores and demystifies the most pressing issues facing medical device companies when prosecuting, enforcing, or defending its patents both domestically and abroad. Topics for discussion include:

• What qualifies as obvious in the wake of KSR and Gilead?

• The best methods for using IPRs in parallel to district court litigation

• Understanding the confines of joint infringement and claim drafting techniques to avoid future claims

• Calculating and proving damages

• Being mindful of ethical standards and the doctrine of inequitable conduct

• Advanced prosecution techniques in light of Supreme Court cases and changes wrought by the AIA

Cocktail Hosted by:

Associate Sponsor: Luncheon Sponsored by: Sponsored by:

Earn

CLE ETHICS

The only conference dedicated to the prosecution and litigation

of Medical Device Patents

I

n response to the daunting challenges facing the medical device industry,

ACI’s Advanced Summit on

Medical Device Patents

provides a forum for the key players —

preeminent in-house IP counsel, patent

prosecutors and litigators, the PTO, and judges

— to unite and share their collective intellectual property

knowledge to provide you with cutting-edge patent strategies you can immediately incorporate into your

practice.

The ongoing implementation of the American Invents Act...massive changes in subject matter patentability

post-

Mayo v. Prometheus

...increased vulnerability to allegations of infringements post-

Akamai

...These

developments signal that 2015 will continue to be a period of uncertainty and upheaval for the medical

device patent community.

Amidst pivotal case law changes affecting the patentability of devices and the rollout of landmark patent

reform into actual practice, it is more crucial than ever for medical device companies to diligently protect

intellectual property and maximize device patent life through a cohesive prosecution and litigation strategy.

Featuring first-hand insight from the USPTO and current and former judges in medical device litigation

hotbeds, this conference is the premiere conference for medical device companies to devise strategies to

strengthen patent rights and prevent costly litigation.

By attending this conference you will be armed with the tools to file patents flawlessly and defend patents

vigorously. Strengthen your device patent portfolio as you learn how to use the major developments in

medical device intellectual property from leading members of the patent bar who are setting the standards

in device prosecution and litigation.

In this time of sweeping changes and with such high stakes in the lucrative medical device market, this

industry-specific intellectual property conference will provide you with the certainty in your claiming and

defense strategies which you need more than ever.

Hear what attendees have said about this annual event:

“Excellent conference, as always. High caliber speakers and attendees. Excellent networking opportunities.”

“Good overview of important topic.”

“Very informative.”

“ACI seminars are the most comprehensive for the medical device industry so I rely on them to stay current.”

“The conference was very well organized and ran smoothly. The speakers were engaging.”

Register today by calling

888-224-2480

, faxing your form to

877-927-1563

or online at

www.AmericanConference.com/DevicePatents

Patent attorneys and litigators (in-house and law firm) who represent:

• Medical device companies • Medical technology companies

PRE-CONFERENCE WORKSHOP

WEDNESDAY, MARCH 4, 2015

9:00 am – 12:00 pm (Registration & Continental Breakfast begins at 8:30 am)

Patent Prosecution Master Class — Best Practices for Drafting Claims and Prosecuting

Medical Device Patents in the Post-AIA Landscape

Tom Barrett

Supervisory Patent Examiner U.S. Patent and Trademark Office Patricia Bianco

Supervisory Patent Examiner U.S. Patent and Trademark Office Paul Lee Patent Counsel DexCom Inc. David Simonelli Shareholder Reising Ethington

In this hands-on, interactive workshop, current PTO examiners and leading patent prosecution counsel will guide you through the new PTO landscape and share best practices on securing and maintaining patent prosecution cost-effectively. Learn successful techniques, identify practice pitfalls, and streamline the process by developing an understanding of how the new PTO operates. Topics for discussion include:

• Analyzing how the AIA has affected and will continue to affect medical device patent practice

- Exploring how the change from “first to invent” to “first to file” has impacted medical device patent practice - Adapting to the expansion of what constitutes “prior art” - Understanding the use of supplemental examination,

ex parte reexamination, or reissue to cure defects before a patent is challenged

• Speaking the language of the PTO — advanced techniques for claim drafting and patent examiner interviews

- Delineating the meaning of claim terms in the specification - Balancing claiming broadly with the risk of validity

challenges down the line

- Claiming through functional language (update on recent cases)

- Maximizing your opportunity to explain the science behind your device at the interview

- Understanding the examiner’s perspective

- Incorporating examiner interviews into your practice - Crafting an effective response to an inquiry or rejection • IDS practice — how the PTO handles supplemental

examination of prior art and third party submissions

Networking Luncheon for Workshop Attendees Only (12:00 pm – 1:00 pm)

A

1:15

Co-Chairs Opening Remarks

Senior Patent Counsel Medtronic Inc.

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

1:30

PTO Keynote Address

Associate Commissioner for Patent Examination Policy U.S. Patent and Trademark Office

In this exclusive address, Ms. Gongola will discuss the impact of the AIA upon the prosecution of medical device patents, as well

2:30

Prosecutor and Litigator Roundtable

— Adapting to the New Landscape of

Patentable Subject Matter, Indefiniteness,

and Willfulness

Matthew K. Blackburn Partner

Locke Lord LLP Jeffrey Hohenshell Senior Patent Counsel Medtronic Inc. Thomas J. Kowalski Shareholder

Vedder Price Michael A. Siem

MAIN CONFERENCE DAY 1

4:30

Exploring the Parallel World of IPR

Proceedings

Matthew Becker Partner

Axinn, Veltrop & Harkrider LLP Eric M. Drange

Senior Counsel – Litigation & Preventive Law 3M

Richard T. McCaulley, Jr. Partner

Ropes & Gray Gregory A. Morris

Of Counsel, Litigation Department Paul Hastings

• Examining the impact of IPR procedures so far on the medical device space

• Knowing when it is strategically prudent to file an IPR • Will District Court Proceedings be stayed in light of IPR

filings?

• Lessons learned from the first IPRs • Pre-IPR filing considerations

• Analysis of key PTAB appeals before the Federal Circuit

5:30

Conference Adjourns to Day 2

Cocktail Reception Sponsored by:

The Supreme Court and Federal Circuit have had much to say of late on the basics of patent issuance. The PTO — examiners and administrative judges alike — and district courts then need to incorporate these standards into their review of existing patents, or those challenged in IPRs or litigation. In this session, experienced medical device patent prosecutors and litigators will draw on examples from cases before the PTO or district courts to explore the effects the major cases identified below have had on (a) evaluating patent portfolios, (b) drafting future claims, and (c) adjusting litigation tactics:

• Mayo v. Prometheus and Assoc. for Molecular Pathology v. Myriad Genetics

• Alice Corp. Pty. Ltd. v. CLS Bank Intern

• Nautilus, Inc. v. Biosig Instruments, Inc.

• Teva v. Sandoz and Octane Fitness v. Icon Health and Fitness 3:30

Afternoon Refreshment Break

3:45

An Obvious Spotlight — Exploring the

Effects of

KSR

and

Gilead

Jeremy Lowe Partner

Axinn, Veltrop & Harkrider LLP Joshua I. Rothman

Partner

Fitzpatrick, Cella, Harper & Scinto Clark A.D. Wilson

Senior Counsel

Merchant & Gould, P.C.

In the wake of KSR v. Teleflex and Gilead v. Natco, what qualifies as obvious has remained murky. The panelists will seek to clarify this standard by diving into how the PTO and various district courts have applied it.

With more than 300 conferences in the United States, Europe, Asia Pacific, and Latin America, American Conference Institute (ACI) provides a diverse portfolio devoted to providing business intelligence to senior decision makers who need to respond to challenges spanning various industries in the US and around the world.

As a member of our sponsorship faculty, your organization will be deemed as a partner. We will work closely with your organization to create the perfect business development solution catered exclusively to the needs of your practice group, business line or corporation.

For more information about this program or our global portfolio of events, please contact: Esther Fleischhacker

Senior Business Development Executive, American Conference Institute Tel: 212-352-3220 x5232 | [email protected]

MAIN CONFERENCE DAY 2

THURSDAY, MARCH 5, 2015

8:30

Continental Breakfast

9:00

Co-Chairs Opening Remarks

PTAB Keynote

Hon. James D. Smith (invited) Chief Administrative Patent Judge Patent Trial and Appeal Board U.S. Patent and Trademark Office

Numerous parties have availed themselves to the various new proceedings created by the AIA, particularly the IPR proceeding. Chief Judge Smith will provide commentary on lessons learned from cases decided to date, including best practices for attorneys appearing before PTAB.

10:00

Joint and Divided Infringement

Post-Akamai

— Adjusting Claim Drafting and

Litigation Techniques

McAndrews Held & Malloy Ltd. Tom Wolfe

Senior Patent Counsel

Medtronic Spinal and Biologics

With the Supreme Court’s decision of Limelight v. Akamai, the landscape of joint or divided infringement has been changed. Lack of attention to divided infringement during claim drafting can defeat the value of patents for a device company. Meanwhile, existing patents may be more susceptible to attack. Drawing from recent case law, this session will identify industry areas or types of medical device patents that are prone to attack. Additionally, the panelists will discuss how to draft claims going forward to safeguard against divided infringement issues, and how to handle all aspects of litigating such a claim.

11:00

Morning Refreshment Break

11:15

Balancing the Costs and Benefits of Patent

Litigation from Injunctions to Damages

Shawn Kolitch, Ph.D., M.S.

Partner, Intellectual Property Attorney Kolisch Hartwell, P.C.

Bradley T. Lennie Partner

Hunton & Williams LLP

Peter Socarras

Director, Intellectual Property Nevro Corp.

Lawrence M. Sung, Ph.D. Partner

Wiley Rein LLP

• Exploring ways to reduce patent litigation costs • When is an injunction likely?

- The impact of eBay on medical device patent litigation - The circumstances in which an injunction is likely - Balancing the public interest with competitive injury • Determining patent infringement damages

- Raising the floor — how to create a high “reasonable royalty” rate

- Conventional and unconventional arguments for lost profits

- Apportionment and the value added by a patented invention

• Achieving settlement with a strong remedies case - Invest early in remedies analysis

- How to present your position directly to the opposing decision maker

12:15

Networking Luncheon

Sponsored by:

1:30

Views from the Benches — Insights from

Multiple Judicial Venues on the Effects of

Parallel Proceedings, Managing Discovery,

Construing Claims, Assessing Damages,

and More

Hon. Elaine Bucklo Senior Judge

U.S. District Court for the Northern District of Illinois Hon. Faith S. Hochberg

District Judge

U.S. District Court for the District of New Jersey Hon. James F. Holderman

District Judge

U.S. District Court for the Northern District of Illinois Moderator:

Scott P. McBride Shareholder

2:45

In-House Perspective — Managing Patent

Prosecution and Litigation Costs and

Budgets; Adapting to the Post-AIA World;

Streamlining Discovery; and More

Eric M. Drange

Senior Counsel – Litigation & Preventive Law 3M

Paul Lee Patent Counsel DexCom Inc. Richard L. Rainey

Executive Counsel, IP Litigation General Electric Co.

Gael Diane Tisack

Terumo Cardiovascular Group Vice President of Legal Affairs & Terumo Americas Vice President of Intellectual Property

Moderator:

Barry E. Bretschneider Partner

BakerHostetler

3:45

Afternoon Refreshment Break

4:00

Testing the NPE Waters — Evaluating

Whether “Trolls” Are Targeting the

Medical Device Space; Discussing Choice

of Venue Issues

Brinks Gilson & Lione

• Evaluating the “threat” of litigation by non-practicing entities or trolls

- Are traditional “trolls” targeting or starting to target medical device companies?

- Is litigation commonly brought by non-practicing entities? - If so, what segments of the industry are being targeted

and what are the nature of the claims? • Analyzing venue considerations

- Where are non-practicing entities and other plaintiffs fi ling?

- Does the AIA preclude forum shopping?

- Are rocket dockets being sought to avoid the possibility of IPRs?

4:30

ETHICS and Medical Devices IP:

Inequitable Conduct and New PTO

Ethical Rules

Bradford J. Badke Partner

Ropes & Gray

Shannon Mrksich, Ph.D. Senior IP Counsel Danaher Corporation Trevor Copeland Shareholder

Brinks Gilson & Lione

• 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 affi rmations 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 ethical Rules of Professional Conduct

- Overview of key provisions including confl icts, sanctions and experts affecting life sciences practitioners

- 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 confl icts of interest rules apply with parallel litigation: USPTO or District Court?

- Duty of candor and good faith owed by petitioner challenging the patent

- Avoiding putting forth information inconsistent with a position

- Applying traditional confl icts analysis and principals when agreeing to work for a client: Are ABA comments to the model rules instructional?

5:30

Conference Concludes

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identifi ed as nontransitional for the purposes of CLE accreditation.

ACI certifi es that the activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

ACI certifi es that this activity has been approved for CLE credit by the State Bar of California.

You are required to bring your state bar number to complete the appropriate state forms during the conference. CLE credits are processed in 4 – 8 weeks after a conference is held.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

Questions about CLE credits for your state? Visit our online CLE Help Center at www.americanconference.com/CLE

Continuing Legal Education Credits Earn

CLE ETHICS

9:00 am – 12:00 pm (Registration & Continental Breakfast begins at 8:30 am)

Act Locally, Think Globally — Being Mindful of International Forums While Prosecuting

Patents in the United States or Considering How to Bring an Infringement Challenge

Louis C. Cullman Partner K&L Gates Kieran Power Partner Griffith Hack Sinan Utku Special Counsel

Covington & Burling LLP Michael Wise

Partner

Perkins Coie LLP

Disclosures made while prosecuting a patent in the United States could have wide ranging consequences when attempting to prosecute the same patent in a foreign jurisdiction. In addition, foreign jurisdictions or the International Trade Commission in the United States provide alternative venues to protect your company from infringement. This interactive workshop will provide an overview of major issues abroad, including:

Established Markets

• Opposition practice in Europe: making the case, defending it, and ensuring consistency with your U.S. filings

• Understanding how American standards for obviousness, anticipation, and written description carry over to the EPO and the Courts

• Choosing the right words for your claims and specifications as the EPO seemingly takes a more literal look at patents under select basis: withstanding challenges and maintaining meaningful claim scope

• Coordinating freedom-to-operate globally

• Claim drafting strategies to ensure patentability of device diagnostic patents abroad

• Preparing for the future

- How has the establishment of the Unitary Patent Courts affect device IP strategies?

- What are the pros and cons of obtaining a unitary patent?

Emerging Markets

• Preparing for and implementing a patent strategy for emerging markets as there is a huge paradigm shift towards increased healthfulness and well-being: Where are the medical device patents being filed?

• Finding blue water (new markets, new industry) in a crowded space

• Cheat sheet on filing internationally: what types of medical device claims are allowed in key BRIC jurisdictions? - Reviewing the standards for patentability, filing

requirements, claim construction, and obviousness or inventive step in major emerging markets

- Addressing foreign inventor payment laws and resolving employee-inventor payment issues in China and Russia - What is the litigation climate?

• Discussing the benefits of Commonwealth nations such as Canada and Australia

• Summarizing key advantages and disadvantages to pursuing patents in India, Singapore, and Brazil

ITC

• Utilizing the ITC as a forum for litigating international patent disputes

• Knowing when and how to employ the new, accelerated procedures for determining threshold questions, such as the domestic industry guidelines

• Strategic discussion on obtaining an exclusion order • Exploring the public interest standard and its effect

B

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The leading networking and information resource for counsel and senior executives.

POST-CONFERENCE WORKSHOP

American Conference Institute’s 5th Advanced Summit on

Medical Device Patents

March 4 – 5, 2015 | InterContinental | Chicago, IL

R E G I S T R AT I O N F O R M

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Venue: InterContinental Chicago

Address: 505 North Michigan Avenue, Chicago, IL 60611 Reservations: (800) 628-2112 or (312) 944-4100

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