TUESDAY, MARCH 5, 2013
7:30 Registration and Continental Breakfast
8:30 Evaluating the State of the Medical Device Industry: Key Developments to Factor into Portfolio Management in a Game-Changing Year
Co-Chairs:
Noreen C. Johnson
Vice President and Chief Patent Counsel
Medtronic Spinal and Biologics, Inc.(Memphis, TN)
Sandra A. Bresnick
Partner
Quinn Emanuel Urquhart & Sullivan, LLP (New York, NY)
Scott McBride
Shareholder
McAndrews, Held & Malloy, Ltd. (Chicago, IL)
In this session, your conference chairs will set the stage for the rest of the conference through a state-of-the-industry analysis of the significant developments in the medical device world in the past year including:
- Patent reform one year later: where are we now?
- Examining the practical effects of the medical device tax
- Overview of key Supreme Court and Appellate case law applicable to device patents:
- Divided infringement post-Akamai
- Method patents post-Prometheus
- Inequitable conduct: the continuing saga of Therasense
- Deconstructing noteworthy medical device patent litigation jury verdicts
9:00 PTO Keynote: update on the Implementation of the American Invents Act: Lessons Learned in the First Six Months of the Post-Patent reform World
Janet Gongola
Patent Reform Coordinator
U.S. Patent and Trademark Office (Alexandria, VA)
10:15 Morning Coffee Break
10:30 Proving or Disproving Joint Infringement: Bracing for the Fallout from Akamai in Device Method Prosecution and Litigation
Adam B. Strauss
Chief Intellectual Property Counsel
Stryker (Kalamazoo, MI)
Maia H. Harris
Partner
Nixon Peabody LLP (Boston, MA)
Mark L. Mathie
Principal
McKool Smith (Dallas, TX)
Lawrence M. Sung, Ph.D.
Partner
Baker & Hostetler LLP (Washington, DC)
- Reconsidering the single entity rule post-Akamai Technologies v. Limelight Networks and McKesson Technologies v. Epic Systems
- What is the future of method claims going forward?
- Under what circumstances can split infringement be found under the new standard?
- Claim drafting strategies to proactively avoid inducement charges with method claims featuring multiple steps
- Supporting 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 and defining agency
- Establishing active infringement: how do you show specific intent and willfulness?
- Seeking opinions of counsel post-Bard v. Gore
- Factoring in the joinder provisions of the AIA: How much more creative do parties have to be to prove infringement?
- Exploring the option of obtaining foreign patent protection to bolster U.S. rights
- 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
- Will large device companies bear the brunt of the fallout here?
12:00 Networking Lunch
1:15 Revolutionizing Medical Device Patent Prosecution and Litigation Strategies Post-Patent reform: Preparing for the Monumental Switch to Validity Assessment in the PTO
Joseph E. Topmiller
Deputy Chief Patent Counsel
Zimmer, Inc. (Warsaw, IN)
Sandra A. Frantzen
Shareholder
McAndrews, Held & Malloy, Ltd. (Chicago, IL)
David L. Cavanaugh
Partner & Vice Chair, Intellectual Property Department
Wilmer Hale LLP (Boston, MA)
- Bracing for the impact of the switch to first-to-file in March 2013
- Deciding when to file: steering clear of the pitfalls of premature disclosure
- What to include: Providing sufficient disclosure in order to define the invention and distinguish from the prior art
- Who to list as a named inventor
- Planning for an uptick of provisional applications
- Factoring in foreign filings
- Adjudicating patent validity at the PTO level
- Deciding whether to forego the clear and convincing standard in litigation in favor of the preponderance of the evidence standard in the post grant review (PGR) process
- Understanding the inherent risks for third party challengers
- Factoring in estoppel considerations for claims which should have been raised in the PGR process
- Contrasting specific strategy considerations for large and small device companies
- Exploring judicial recourse from PTO decisions: who has the final word?
- Dealing with the fallout stemming from new procedural considerations in AIA including joinder and venue
- Understanding the finer points of the inter partes review procedure
- Harnessing the powerful tool reexamination to effectively challenge or uphold a patent
- When does it make sense for a patent holder to request reexamination?
- Lessons learned from the first inter partes reviews which have been filed
- Strategies for disclosing and overcoming prior art
- Planning timing and disclosure of prior art accordingly in light of new §102 standards
- Disclosing best mode in cases of multiple methods of use: which do you have to reveal and what can be kept as a trade secret?
- Determining the viability of a clearance opinion
- Preparing for the expansion of the prior user rights defense and the additional commercial uses exception: how will pre-marketing regulatory review products be affected?
2:15 Demystifying the Current Standards for Device Obviousness: Defeating rejections at the PTO and Combating Challenges in the Courts
Jeremy C. Lowe
Partner
Axinn, Veltrop & Harkrider LLP (Hartford, CT)
Noreen C. Johnson
Vice President and Chief Patent Counsel
Medtronic Spine, Inc. (Memphis, TN)
- Survey of post-KSR case law: lessons learned from how Courts are interpreting § 101 patentability standards in an area where technology traditionally evolves incrementally
- Showing novelty when combining known elements
- Emphasizing unexpected results
- Detailing the substantial evolution of the technology and more
- Factoring in the increased importance of secondary considerations
- Delineating the scope of § 102 prior art
- 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
- Determining how statements made in the FDA approval process could affect subsequent obviousness litigation
3:15 Afternoon Coffee Break
3:30 Practical Strategies for Dealing with the Written Description / Enablement Dichotomy: Satisfying Ever-Evolving § 112 Standards for Validity
Sean Edman
Principal Patent Counsel
Medtronic CardioVascular (Mounds View, MN)
Eric W. Dittmann
Partner
Paul Hastings LLP (New York, NY)
Kevin W. McCabe
Director
Sterne Kessler (Washington, DC)
- Understanding the heightened conflict between the USPTO's § 112 guidelines and the Federal Circuit's mandates
- Meeting the PTO's requirements for sufficient written description and enablement
- Reviewing specification requirements and showing the claims are fully supported by the specs
- Reaffirming the distinction between written description and enablement in Ariad v. Lilly and comprehending the specific application to medical devices
- Analyzing the Federal Circuit's current trend of using the specification to either narrow or invalidate claims
- Exploring the intersection between written description and future invalidity challenges
- Potential utility / enablement attacks on new uses
- Balancing the unpredictability needed to overcome obviousness with the level of disclosure necessary to satisfy § 112
4:30 Vigilantly Protecting Device IP Globally: Developing a Plan for International Medical Device Patent Life Cycle Management
John R. Fuisz
The Fuisz-Kundu Group, LLP (Washington, DC)
Dr. Ulrike Till
Partner
Wildanger Kehrwald Graf von Schwerin & Partners (Dusseldorf, Germany)
- Securing patent protection in the EU: a cheat sheet on best practices for international patent prosecution and litigation to remain competitive on the global stage
- Understanding how American standards for obviousness carry over to the European patent prosecution offices and Courts
- Pinpointing which European courts traditionally give stronger patent protection: Deciding where to file
- How will the Unitary Patent Court affect device IP strategies?
- Claim drafting strategies to ensure patentability of device diagnostic patents abroad
- Exploring strategies to extend medical device patent life in BRIC countries: update on key developments affecting device IP
- Compulsory licensing rulings in Brazil
- Changes in Indian IP law
- Status of Russian proposed customs legislation –Border wars in China
- The rise of the ITC action: Deciding whether your medical device is ripe for an ITC challenge
- Overview of recent key ITC decisions and extrapolating the holdings to the medical device context
- Employing ITC litigation offensively to prevent entry of alleged infringing products into the U.S. market
- Factoring in the public interest defense in the case of a potentially life saving medical device
5:30 Conference Adjourns to Day Two
WEDNESDAY, MARCH 6, 2013
7:30 Continental Breakfast
8:15 Co-Chairs’ Opening remarks
8:30 View From the Bench: The Judicial Perspective on Medical Device Patent Litigation
The Honorable James F. Holderman
Chief Judge, U.S. District Court
Northern District of Illinois (Chicago, IL)
The Honorable James L. Robart
District Judge, U.S. District Court
Western
District of Washington (Seattle, WA)
The Honorable Sue L. Robinson
District Judge, U.S. District Court
District of Delaware (Wilmington, DE)
Moderator:
Scott McBride
Shareholder
McAndrews, Held & Malloy, Ltd. (Chicago, IL)
Both patent prosecutors and litigators will benefit from this unique interactive opportunity to 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 fluent in the nuances of medical device litigation who will provide guidance into the hot-button issues affecting medical device patent litigation, including the effects of patent reform and the new PTO dispute resolution process on litigation, the rise of the NPE, implementation of Judge Rader’s rules for discovery in patent cases, conducting Markman hearings, granting temporary and permanent injunctions, and calculating damages in the device infringement context.
10:00 Morning Coffee Break
10:15 Protecting Method and Diagnostic Claims: Tailoring Medical Device Patents to Comply with Increasingly Strict § 101 Patentability Standards
David J. Dykeman
Patent Attorney & Shareholder
Greenberg Traurig LLP (Boston, MA)
Suzannah K. Sundby
Partner
Smith, Gambrell & Russell LLP (Washington, DC)
- Exploring the shifting landscape of method and diagnostic claims: How will Mayo v. Prometheus and Myriad impact patent eligibility under 35 U.S.C. §101 for medical devices?
- Reviewing recent court decisions related to other technologies and their influence on patent eligibility for medical devices and diagnostics: Will claims reciting limitations to device structure be sufficient for patent eligibility?
- Anticipating the future of patent eligibility for claims to medical devices, diagnostic tools, and methods employing such devices and tools: Can they survive in the Post-Mayo world?
- Determining what constitutes a law of nature, a natural phenomenon, or an abstract idea that will likely result in a claim being directed to patent ineligible subject matter
- Establishing realistic expectations for the scope of patent protection in view of claim limitations that may be necessary for patent eligible subject matter
- Understanding the public policy concerns related to patent eligibility
- Drafting claims to fall within the purview of §101 which is becoming increasingly narrow
- Writing in transformative steps
- Avoiding mental and abstract steps
- Claim limitations that may help aid in the survival of patent claims to medical devices and diagnostics in this uncertain time
11:30 Calculating and Proving Medical Device Damages: Analyzing Drivers of the Billion Dollar Infringement Verdict
Matthew K. Blackburn
Partner
Locke Lord LLP (San Francisco, CA)
Sarah Cooleybeck
Partner
Foley Hoag LLP (Boston, MA)
Karen D. McDaniel
Partner
Merchant & Gould (Minneapolis, MN)
- Exploring the troubling steady increase in the size of medical device patent infringement verdicts
- Survey of key verdicts in the last year including an update on the Saffran patents
- Reigning in the damages award: Understanding the circumstances under which a Court may set aside a jury verdict
- Factoring in the rise of NPE litigation phenomenon and the ensuing increase in the size of verdicts
- Developing an unassailable reasonable royalty analysis
- Determining the royalty rate
- Ascertaining the point at which infringement began
- Formulating a licensing strategy at the outset of a case
- Selecting comparable licenses and establishing their relationship to the product at issue
- Determining the scope of the license
- xtrapolating the developments in compulsory licensing in the software context to medical devices
- Applying the entire market value rule to a medical device
- Apportioning damages: how does the patented feature drive demand for the entire device?
- Making the case for lost profit damages
- How much can be reasonably assessed?
- Showing the inexorable flow of profits in the case of subsidiaries
- Obtaining an injunction: successful arguments for satisfying the elements of the four-prong test post-Ebay
- Examining the Federal Circuit split regarding the standards for preliminary injunctions
12:30 Networking Lunch
1:45 Establishing Freedom-to-Operate: Mitigating Patent Infringement risks When Commercializing Medical Devices
Suneel Arora
Shareholder
Schwegman Lundberg & Woessner (Minneapolis, MN)
Louis C. Cullman
Partner
K&L Gates, LLP (Irvine, CA)
Justin J. Oliver
Partner
Fitzpatrick, Cella, Harper & Scinto (Washington, DC)
- Formulating the elaborate search necessary to determine whether you have freedom-to-operate in a field which is both crowded and litigious
- Comprehending how the AIA will change your freedom to operate search
- Performing the freedom-to-operate search in the international context: what is relevant?
- Creating a living freedom-to-operate map: Making design changes to device products without returning to square one
- Keeping up with the current case law on willful infringement
- When do you need an opinion of counsel in the freedom-to-operate context?
2:45 Preparing your Device Portfolio for Litigation: Limiting Liability and Managing and reducing Costs
Mark Gorman
Assistant General Counsel of Intellectual Property
Smith & Nephew, Inc (Memphis, TN)
Bradley G. Lane
Shareholder
Brinks Hofer Gilson & Lione (Chicago, IL)
Sheila Swaroop
Partner
Knobbe Martens Olson & Bear (Irvine, CA)
Richard T. McCaulley, Jr.
Partner
Ropes & Gray LLP (Chicago, IL)
- Selecting a venue: knowing which district rules favor patent holders and patent challengers
- Weighing the benefits of quasi-litigation in the PTO versus litigation in the Courts: considerations regarding damages, discovery, and complexity of the claims
- 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
- How hard is the product to design-around?
- Delineating the scope of the safe harbor exemption for post-approval device products
- How far along do you have to be in the development process to fall into the infringement safe harbor?
- What can take you out of the safe harbor?
- Influencing the timing of a Markman hearing and recognizing its impact on litigation strategies
- Taking a realistic approach to discovery: limiting the scope of discovery requests in accordance with Judge Rader’s model rules
- Avoiding common pitfalls when working with experts
- 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
- Understanding the extent to which device combination products fall under the Hatch-Waxman litigation scheme
3:45 Afternoon Coffee Break
4:00 Is Inequitable Conduct Dead? Updating Medical Device Prosecution and Litigation Strategies Post-Therasense
Sona De
Partner
Ropes & Gray LLP (New York, NY)
Janet Pioli
Shareholder
Brinks Hofer Gilson & Lione (Chicago, IL)
Once deemed the "plague" of patent cases by the Federal Circuit, the defense of inequitable conduct was often pled and caused patent prosecutors 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; some analysts even deem the once ubiquitous defense to be "dead." In this session, leading practitioners will examine the practical effect of Therasense and the ethical ramifications of the decision:
- Examining the tightening of the inequitable conduct standard in Therasense and its progeny: Is First Media the final nail in the coffin for inequitable conduct?
- Raising the defense: under what circumstances will anyone litigate inequitable conduct now that this is so hard to win?
- Is the defense too narrow now for the courts to police misconduct?
- Showing the threshold level of intent to deceive
- Working within the context of the materiality-intent balancing test set by Court the in Therasense
- Exploring the “but-for” test for materiality
- Meeting the “deliberately planned and carefully executed” exception
- Best practices going forward: what is reasonable to turn over to the PTO going forward?
- 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?
5:00 Conference Adjourns
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