American Conference Institute’s 4th Advanced Summit on
Medical Device Patents
Comprehensive and Practical Patent Prosecution and Litigation Strategies for an Evolving IP Landscape
Monday, March 24 to Wednesday, March 26, 2014
Intercontinental Chicago, Chicago, IL
Day 1: Monday, Mar 24, 2014
Main Conference Registration Begins
Co-Chairs’ Opening Remarks: Exploring the Key Developments Aff ecting Medical Device IP Strategies for 2014
In 2013, the medical device patent world was riding the crest of a sea change; now, the time has come to brace for the fallout of last year’s game-changers. In this session, the esteemed co-chairs will set the stage for the topics which will be discussed in depth throughout the conference by breaking down the developments which will significantly change prosecution and litigation strategies going forward including:
• Supreme Court, Appellate cases, and legal developments affecting
medical device IP to watch:
- Divided infringement post-Akamai
- 101 patentability post-Myriad
- Post-grant proceedings post-Fresenius v. Baxter
- Burden of proving infringement post-Medtronic v. Boston Scientific
- Patent infringement and the Lanham Act post-Retractable Technologies Inc. v. Becton Dickinson & Co.
- Update on the Goodlatte bill and status of potentially new patent reform
• Overview of the year’s most noteworthy medical device patent litigation jury verdicts and settlements
• The American Invents Act (AIA): What is the impact of the new post-grant review and IPR proceedings?
• Examining the practical effects of the medical device tax under healthcare reform
Keynote: USPTO Update on Patent Reform: Statistical Breakdown and Best Practices Learned from the First Year of Implementation
In this session, a USPTO representative (speaker to be determined) will discuss the specific implications for the device industry now that patent reform is a reality.
Examining the Impact of AIA Post-Grant Review and Inter Partes Review Procedures on Traditional Medical Device Patent Litigation
• Lessons learned from the fi rst inter partes reviews which have been filed in the medical device context
- Under what circumstances is this an effective tool?
- Timing is everything: how the rigid timeframes and accelerated deadlines under the AIA can work for or against device companies
• Using PTO procedures to your advantage in the crowded and litigious medical device patent fi eld
- Deciding whether to forego the clear and convincing standard in litigation in favor of the preponderance of the evidence standard
- Fighting a war on two fronts: Factoring in estoppel considerations in parallel proceedings
- Exploring the effects of declaratory judgment actions and stays
- The judiciary or the PTO: who has the final word in post- grant proceedings in light of Fresenius v. Baxter?
- Dealing with joinder and venue issues under the AIA
- Avoiding procedural pitfalls, including timing requirements
• Understanding the new breadth of prior art
- Timing and disclosure of prior art accordingly in light of new § 102 standards
- Offers of negotiation and trade shows post-Trans Ocean
• Gaining leverage in an NPE / PAE case through PTO procedures
Afternoon Coffee Break
Setting the Stage Pre-Trial: Mock Markman Hearing and Claim Construction Strategy Session
Witness patent trial lawyers take part in a mock Markman hearing and a discussion of key pretrial claim construction strategies, which lay the groundwork for ultimate infringement and validity battles at trial. Learn about successful presentation and argument techniques, including tips on dealing with a hot bench, extrinsic evidence, and creating a record for appeal. Attendees will also learn about avoiding common pitfalls in Markman strategies, including the roles of “plain meaning” and Section 112 validity arguments, and will examine the impact these positions can have at trial.
The Incredible Shrinking Patent World: Protecting Medical Device Patents in Light of Increasingly Strict § 101 Patentability Standards
• Exploring the shifting landscape of what is patentable post-Prometheus and Myriad
- Understanding the public policies concerns at play and the rationales which may apply to certain device diagnostic patents
- Anticipating the future of medical and surgical patent claims: are they safe or is the US likely to fall in line with the rest of the world and restrict patentability?
• Establishing realistic expectations for the scope of patent protection that can be obtained going forward with diagnostics, medical software patents, and bioinformatics
• Drafting diagnostic claims to fall within the purview of increasingly narrow § 101 patentability
- Writing in transformative steps
- Avoiding mental and abstract steps
- Determining what constitutes a law of nature in a method claim
• Exploring the use of trade secret protection as an alternative to traditional IP protection for diagnostics
• Sussing out how much the trend towards decreasing patentability will really affect medical device companies
Conference Adjourns to Day Two
Day 2: Tuesday, Mar 25, 2014
Co-Chairs’ Opening Remarks and Recap of Day 1
The In-House Perspective on Medical Device Patent Litigation: Limiting Liability and Managing and Reducing Costs
• Exploring the troubling steady increase in the size of medical device patent infringement verdicts and analyzing the drivers of the billion dollar infringement verdict in this space
- What’s next after the stent wars and Saffran patents?
- Factoring in the rise of NPE litigation phenomenon and the ensuing increase in the size of verdicts
• Dealing with the tremendous pressure to reduce costs and slash budgets in light of the looming medical device tax under healthcare reform
- What kind of fixed arrangements with law firms are working to lower the cost of patent litigation?
- What does in-house counsel expect to get from their outside counsel?
- Awarding attorney’s fees in exceptional cases post-Octane Fitness: is this an incentive for plaintiffs to bring spurious patent litigation to cause competitive harm?
• Selecting a venue: knowing which district rules favor patent holders and patent challengers
- Where are the next hotbeds of medical device litigation?
- Understanding the interplay with local patent rules
• Weighing the benefits of quasi-litigation in the PTO versus litigation in the Courts: considerations regarding costs, damages, discovery, and complexity of the claims
• Streamlining litigation costs despite heavy discovery burdens: limiting the scope of discovery requests in accordance with Judge Rader’s model rules
Morning Coffee Break
Bracing for the Impact of NPEs and PAEs in the Medical Device Space: How to Defend Against These Entities and What We Can Learn from Them
• Examining the proliferation of non-practicing entities and patent assertion entities in the medical device space: dissecting the outcomes so far
- Investigating the assumption surrounding NPEs, PAEs, and “trolls”
• Exploring the shift towards monetization and creating value in IP beyond your product line
- Understanding how company size affects perspective when deciding to patent what you don’t make or to spin out a portfolio
- Feeding the beast which may eventually eat you: exploring the benefits and drawbacks of selling off patent portfolios to a PAE or NPE
- Case study: Medtronic and the Ortho Phoenix patents
• Proven strategies for defeating NPEs and effective tactics for driving down the cost of a settlement
- Preventing an NPE from obtaining an injunction post-eBay
- Challenging validity in the patent office through inter partes review
• Status of the pending legislation at the federal and state level regarding NPEs
- Do the current proposed fi xes help or hurt industry?
Joint Indirect Infringement Post-Akamai: Bracing for the Fallout on Prosecution and Litigation Strategies
• Update on Limelight Networks v. Akamai: Recap of the en banc opinion and discussion of the potential for Supreme Court review in this case
• Establishing joint infringement and supporting claims of inducement under the current standard 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 proper parties in litigation involving multi-staged transactions
- Showing specific intent and willfulness
• Claim drafting strategies to proactively avoid inducement charges with method claims featuring multiple steps: how can manufacturers protect themselves?
• Factoring in the joinder provisions of the AIA: How much more creative do parties have to be to prove infringement?
• Comprehending the downstream consequences of accusing doctors and healthcare providers of infringement in the device context
Case Spotlight on Medtronic v. Boston Scientific: Determining Who Bears the Burden of Proof in a Declaratory Judgment Action
• Overview of the case and the merits of the various arguments and recapping the procedural history to date
• Reading the tea leaves: how might the Supreme Court come down on who bears the burden of persuasion in the post-Medimmune world in light of November’s oral arguments?
• Understanding the potentially sweeping consequences to licensing agreements depending on the Court’s decision
• Tips for proceeding with declaratory judgment actions in the meantime: what kinds of clauses might licensors include going
Sponsored By: McAndrews Held & Mallot LTD
View From the Bench: The Judicial Perspective on Medical Device Patent Litigation
Hear what arguments and claims Courts fi nd 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 experienced in medical device litigation who will discuss the hot-button issues affecting medical device patent litigation, including:
• The effects of the PTO dispute resolution procedures on patent litigation
• The increase of litigation involving non-practicing entities and patent assertion entities
• Controlling litigation costs in patent cases
• Granting temporary and permanent injunctions with life-saving technology at stake
• The continued debates over exclusive patent jurisdiction in the Federal Circuit and Appellate deference post-Lighting Ballast
Rethinking Medical Device Damages: Updated Strategies for Calculating Damages and Determining Valuation in Light of Evolving Federal Circuit Case Law
• Understanding how much your IP is really worth in light of the fundamental changes to the case law involving damages and remedies for infringement
- Treble damages post-Stryker v. Zimmer
- The demise of the 25 percent rule post-Uniloc v. Microsoft
- Bifurcating cases after Robert Bosch, LLC v. Pylon Manufacturing Corp.
• Recap of medical device patent litigation damage trends in 2013: what were the average verdicts?
• Going beyond the Georgia Pacific factors to develop an unassailable reasonable royalty analysis
- Determining the royalty rate
- Ascertaining the point at which infringement began
• Exploring the value of individual components of complex technology: how does the patented feature drive demand for the entire device?
• Applying the entire market value rule to a medical device
• Working with experts and setting up your damages case early to help drive more realistic settlements in light of the current law
Focus on Bard v. Gore: Exploring the Evolution of the Law of Willful Infringement and Enhanced Damages
• Proving objective willfulness under the heightened standard in Bard
• Demonstrating what it takes to win enhanced damages under Bard
• The two-prong test: determining the timing to proffer arguments of objective and subjective willfulness
• Special tips for handling mixed questions of law and fact
• Figuring in “willful blindness” considerations post Global Tech
Afternoon Coffee Break
Developing a Global Patent Strategy to Protect Medical Device IP in Emerging and Established Markets
• Opposition practice in Europe: making the case, defending it, and ensuring consistency with your U.S. fi lings
• 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 specifi cations 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
• How has the establishment of a Unitary Patent Court affect device IP strategies?
• Claim drafting strategies to ensure patentability of device diagnostic patents abroad
• 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 fi ling internationally: what types of medical device claims are allowed in key BRIC jurisdictions?
- Reviewing the standards for patentability, fi ling 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?
• Utilizing the ITC as a forum for litigating international patent disputes
ETHICS and Medical Device IP: An Update on the Continued Evolution of Inequitable Conduct and Overview of the New PTO Ethical Rules
• Examining the tightening of the inequitable conduct standard in Therasense and its progeny: Is inequitable conduct dead?
- Raising the defense: under what circumstances will anyone litigate now that this is so hard to win?
- Using the totality of the circumstances to show 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
- Determining standards for fraud and unclean hands
• Updated best practices for inequitable conduct: 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
• Analysis of the PTO’s new ethical Rules of Professional Conduct
- Overview of key provisions including sanctions and experts
- How will these work with the ABA model rules and state bar rules?
- Exploring how the PTO has adopted the Therasense standard in inequitable conduct proceedings
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Mon, Mar 24, 2014
Wed, Mar 26, 2014