DAY ONE: TUESDAY, FEBRUARY 28, 2012
7:15 Registration and Continental Breakfast
8:15 Device Industry State of the Union: Maximizing Device Patent Life and Strategic Portfolio Building in a Game-Changing YearCo-Chairs
Sandra A. Bresnick
Partner
Quinn Emmanuel Urquhart & Sullivan, LLP (New York, NY)
Noreen C. Johnson
Vice President and Chief Patent Counsel
Medtronic Spine, Inc. (Memphis, TN)
8:45 PTO Keynote: Integrating the America Invents Act into Medical Device Patents Practice
Teresa Stanek Rea
Deputy Under Secretary of Commerce for Intellectual
Property and Deputy Director of the United States Patent and Trademark Office (Alexandria, VA)
10:00 Morning Coffee Break
10:15 The Post-AIA World: Tailoring Medical Device Patent Strategies for Litigation and PTO Proceedings
Charles A. Krauss
Chief Patent Counsel,
C.R. Bard, Inc. (Murray Hill, NJ)
Karen D. McDaniel
Partner,
Merchant & Gould (Minneapolis, MN)
Dr. Charles E. Millet
Senior Counsel
Dickstein Shapiro LLP (New York, NY)
Adjunct Professor of Patent Law
St. John’s University School Of Law (New York, NY)
- Comprehending how medical-device companies can cope with the new post-grant administrative patent validity assessment schemes: reexamination, inter partes review, post-grant review, derivation contests, and supplemental prior art citations by third parties
- Court litigation vs. validity-assessment in the PTO
- Understanding the inherent advantages and risks for third-party challengers and for patent owners
- Judicial recourse from PTO decisions
- Contrasting strategy-considerations for large and small medical-device companies
- Harnessing the powerful tool of reexamination to effectively challenge or uphold a patent
- when does it make sense to request or not request reexamination?
- Planning, timing, and disclosure of prior art in light of new § 102 standards
- Factoring in supplemental examination
- How will the USPTO sift through huge new quantities of information constituting prior art
- Strategies for disclosing and overcoming prior art in the PT
- Pre-grant submission of prior art- Disclosing the “best mode” in cases of multiple methods of use: what do you have to reveal and what can be kept as a trade secret?
- Preparing for a prior commercial use defense
11:30 Protecting Diagnostic Method Claims post-Bilski: Lessons for Prosecutors and Litigators to Comply with Increasingly Strict Standards of Patentability
Jeff Cook
Senior Patent Counsel,
Boston Scientific Corporation (Maple Grove, MN)
Lawrence M. Sung, Ph.D.
Partner,
Dewey & LeBoeuf LLP (Washington, DC)
- Anticipating how Bilski’s progeny will apply to device companies\
- Will the Supreme Court’s holding in Mayo v. Prometheus impede the future of innovation with personalized assays and companion diagnostics?
- Factoring in considerations from Classen Immunotherapies v. Biogen and ACLU v. Myriad Genetics which may have analogous application in deciding the patentability of medical device patents
- Understanding the public policies concerns which come into play in determining the limits of the application of a law of nature to a method claim
- Drafting claims to fall within the purview of the machine or transformation test
- Is there transformation of matter or is it merely an idea?
- Writing in transformative steps
- Avoiding mental steps
- Proving that you have effected a reaction: case studies successfully passing the Bilski test so far including injectables and cardiac signals and diagnostics
12:30 Networking Lunch
1:45 Overcoming Obviousness Challenges: Evolving Standards for Evaluating Validity for Devices post-KSR
Matthew J. Becker
Partner,
Axinn, Veltrop & Harkrider LLP (Hartford, CT)
David L. Cavanaugh
Partner and Vice Chair, Intellectual Property Department
Wilmer Hale LLP (Boston, MA)
Christy G. Lea
Partner,
Knobbe Martens Olson & Bear LLP (Irvine, CA)
Douglas S. Portnow
Patent Attorney,
Wilson Sonsini Goodrich & Rosati (Palo Alto, CA)
Claim Construction Strategies to Avoid an Obviousness Rejection
- Showing novelty when combining known elements
- What’s worked for other device companies to defeat obviousness rejections: Emphasizing unexpected results, detailing the substantial evolution of the technology and more
- Delineating the scope of § 102 prior art post-patent reform
- Understanding the ramifications of extending the obviousness standard to nonanalagous art under patent reform
- When have you searched enough? Strategically planning for the new prior art which may be used against you
- Updating prior art searches to factor in technologies outside the device industry, third party submissions and global submissions
- Exploring the risks and benefits of outsourcing this analysis
- Conducting an investigation directly with inventors
- Comparing obviousness based on prior art to new double patenting type obviousness to understand the doctrines’ collective impact on medical device portfolio development as a whole
- Examining the link between double patenting and inequitable conduct
Combating Obviousness Challenges in the Courts
- Survey of post-KSR case law: understanding how the Courts are interpreting § 101 patentability standards in an area where technology traditionally evolves in increments
- Determining how statements made in the FDA approval process could affect subsequent obviousness litigation
- Controlling costs when litigating a post-KSR obviousness case
- How discovery in obviousness cases will drive future success
- Successfully mounting an obviousness defense in the Courts
- Judge or jury? Who should decide the ultimate question of obviousness?
- Use of special interrogatories to facilitate appellate review
3:00 Afternoon Coffee Break
3:15 Resolving the Written Description / Enablement Dichotomy: Practical Claim Drafting Strategies and Litigation Strategies Post-Centocor
Eric W. Dittmann
Partner,
Paul Hastings LLP (New York, NY)
W. Todd Baker
Partner,
Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P. (Alexandria, VA)
- Reaffirming the distinction between written description and enablement set forth in Ariad v. Lilly and comprehending the specific application to medical devices in Centocor Ortho Biotech, Inc. v. Abbott Laboratories
- Understanding the heightened tension between the USPTO guidelines regarding § 112 and the Federal Court’s mandates
- What level of data must be submitted when submitting a new disclosure in order to patent a new use?
- Preventing utility / enablement attacks on new uses of established medical devices
- Does the Janssen holding regarding new uses translate into the medical device context?
- How much info is suffi cient to show one skilled in the art?
- Strengthening IP to prevent against design-arounds
- Designing around competitors predicates
- Exploring the intersection between written description and future invalidity challenges: changes to § 101 patentability post-patent reform
- Balancing costs against the scope of patent protection which can realistically be obtained: gaining alignment between “file early, file often” and successful strategy
4:15 Maximizing Market Share in a Global Economy: Developing a Plan for International Medical Device Patent Life Cycle Management
Dr. Ulrike Till
Partner,
Field Fisher Waterhouse (Dusseldorf, Germany)
John R. Fuisz
The Fuisz-Kundu Group LLP (Washington, DC)
In the increasingly global economy, manufacturers of all sizes must commercialize their products abroad in order to stay competitive and protect market share. In this session, leading device practitioners on the ground in key established and emerging markets will give you a cheat sheet on best practices for international patent prosecution and litigation to assist you in vigilantly protecting your intellectual property on the global stage.
Established Markets
- Securing patent protection in the EU and other established markets
- Understanding how American standards for obviousness are carrying over to the European patent prosecution offices and Courts
- Pinpointing which European courts traditionally give stronger patent protection
- Claim drafting strategies to ensure patentability of device diagnostic patents
- Do Supplementary Protection Certificates (SPCs) apply to patent term extension in the device context?
- Patenting strategies for new uses for a known apparatus
Emerging Markets
- Exploring strategies to extend medical device patent life in: emerging BRIC countries
- Warding off counterfeit products
- Employing ITC litigation to prevent entry of alleged infringing products into the U.S. market
- Deciding whether your medical device is ripe for an ITC challenge
5:15 Conference Adjourns to Day
DAY TWO: WEDNESDAY, FEBRUARY 29, 2012
8:00 Continental Breakfast
8:30 Co-Chairs’ Opening Remarks
8:45 Proving or Disproving Inducement of Infringement: Understanding McKesson’s Consequences for Device Method Patents
Matthew K. Blackburn
Partner,
Locke Lord LLP (San Francisco, CA)
Jeremy C. Lowe
Partner,
Axinn, Veltrop & Harkrider LLP (Hartford, CT)
Mark L. Mathie
Principal,
McKool Smith (Dallas, TX)
Karun D. Naga
Director, Corporate Development
Medtronic, Inc. (Mountain View, CA)
Brent D. Sokol
Partner,
Jones Day LLP (Los Angeles, CA)
- After McKesson Technologies Inc. v. Epic Systems Corp., what facts will support claims of inducement and joint infringement when individual doctors and healthcare providers perform the necessary steps?
- Apportioning responsibility between separate entities each performing separate steps in a method claim
- Determining the scope of contractual obligation
- Establishing active infringement under the heightened proofs of Global Tech
- Claiming strategies to proactively avoid inducement charges with method claims
- Comprehending the downstream consequences of accusing doctors and healthcare providers of infringement in the device context
- Carving out the exception for doctors exercising independent medical judgment
- Putting forth a good faith defense based on the opinion of counsel
- Understanding the privilege implications: when would it be worth it to waive privilege?
- How much more creative do parties have to be to prove infringement post-AIA?
10:15 Morning Coffee Break
10:30 Conducting Effective Freedom-to-Operate Searches: Guaranteeing the Right to Commercialize with Certainty
Noreen C. Johnson
Vice President and Chief Patent Counsel
Medtronic Spine, Inc. (Memphis, TN)
Kevin W. McCabe
Director,
Sterne Kessler (Washington, DC)
Andrew E. “Andy” Rawlins
Partner,
Foley & Lardner LLP (Washington, DC)
- Formulating the elaborate search necessary to determine whether your research has been preempted in a field which is both crowded and litigious
- Comprehending how patent reform will change your freedom to operate search
- Making design changes to device products without returning to square one
- Keeping up with the changing law post-Festo and Medimmune: what is willful infringement?
- When do you need an opinion of counsel in the freedom-to-operate context?
12:00 Networking Lunch
1:15 Calculating and Proving Medical Device Damages and Minimizing Damages Liability
David K. Callahan
Partner,
Kirkland & Ellis LLP (Chicago, IL)
- Developing an unassailable reasonable royalty analysis
- Selecting comparable licenses and establishing their relationship to the product at issue
- Survey of recent cases interpreting comparables
- Tracing the calculation back to the point infringement began
- How do you apply the entire market value rule in the device context?
- When should you start thinking about damages?
- Increasing the size of the base for damages
- Drafting claims that are better suited to ensure larger systems sales
- Making the case for lost profit damages- how much can be reasonably assessed?
- Preserving the right to challenge a plaintiff’s damages request
- Conducting an analysis of when to settle: Exploring motivations and strategy considerations for how long to fight
- Presenting a settlement arrangement to the Court with a clear licensing strategy
- Determining the scope of the license including product pipeline and tax consequences
- Weighing the pros and cons between different stipulated settlements
2:15 Preparing Your Device Portfolio for Litigation: Limiting Liability and Managing and Reducing Costs
Chad Everingham
Partner,
Akin Gump Strauss Hauer & Feld (Longview, TX)
Former Magistrate Judge, United States District Court for the Eastern District of Texas
David G. Henry, Sr.
Partner,
Dykema Gossett PLLC (Dallas, TX)
Scott P. McBride
Shareholder,
McAndrews Held & Molloy, Ltd. (Chicago, IL)
- Accurately evaluating your patent portfolio vis-à-vis your competitor’s portfolio to determine which claims to assert or which patents may be ripe for a challenge
- Selecting a venue: knowing which district rules favor patent holders and patent challengers
- Influencing the timing of a Markman hearing and recognizing its impact on litigation strategies
- Factoring in Judge Rader’s proposed model discovery rules and limiting the scope of your discovery requests accordingly
- Avoiding common pitfalls when working with experts
- Developing successful arguments for obtaining a permanent injunction
- Considering the pros and cons from a cost perspective of alternatives to litigation, particularly in light of the concurrent administrative actions in the PTO post patent reform
- Weighing the costs and benefits of effective infringement
- Understanding the Hatch-Waxman regulatory scheme to prepare for litigation on drug and device combination products
- Are drugs used in combination products new drugs?
- Delineating the scope of the safe harbor for combination products
3:30 Afternoon Coffee Break
3:45 Inequitable Conduct: Navigating the Crowded Field of Prior Art for Medical Devices Technology
Bradford “Jim” Badke
Partner,
Ropes & Gray LLP (New York, NY)
Richard S. Meyer
Partner,
Kilpatrick Townsend & Stockton LLP (Washington, DC)
Once deemed the “plague” of patent claims by the Federal Circuit, the defense of inequitable conduct was often pled and caused practitioners to submit reams of prior art to the PTO. After the Federal Circuit’s decision in Therasense, the inequitable conduct defense has become much more difficult to prove. In this session, leading practitioners will examine the practical effect of Therasense and what the future of inequitable conduct will be now that Rule 56 has been discarded, the sliding scale is gone, and the bar has been raised for both prongs of the test for inequitable conduct:
- Analyzing the application of the inequitable conduct doctrine in the PTO and District Courts now that Therasense has been decided
- Will anyone litigate the defense now that it is so hard to win?
- Working within the context of the materiality-intent-balancing test set by Court the in Therasense
- Exploring the new “but-for” test for materiality
- Meeting the “deliberately planned and carefully executed” exception
- Showing a threshold level of intent
- Determining standards for fraud and unclean hands
- Meeting the requirements for disclosure to the PTO during prosecution
- Disclosing related prosecution applications in the US and abroad
- Disclosing foreign language documents post-patent reform changes
- When can disclosure be excessive and be considered burying prior art?
4:45 Conference Adjourns
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