General Session Day 1
1:00 Co-Chairs’ Opening Remarks
Vice President of Intellectual Property
Molecular Templates (Newark, NJ)
Mercedes Meyer, Ph.D.
Drinker, Biddle, & Reath, L.L.P. (Washington, DC)
1:15 USPTO Keynote Address: The USPTO’s Efforts to Implement AIA Provisions Impacting Patent Prosecution
Patent Reform Coordinator
United States Patent and Trademark Office (Alexandria, VA)
In this exclusive keynote address detailing the AIA’s effects on patent prosecution, Deputy Rea will outline the PTO’s thought process in developing the regulations covering the first-to-file system, the changes to declaration and assignment provisions of 35 U.S.C. § 118, public disclosures and prior art, and the new best mode standard. In addition, Deputy Rea will discuss the protocols to be applied to help examiners navigate what are effectively two sets of rules for the foreseeable future. Other topics to be discussed will include how AIA implementation has worked so far and Deputy Rea’s thoughts on how provisions to be implemented March 16, 2013 date will impact the PTO.
2:00 Preparing Your Company for the Looming Implementation of the First-to-File Regime and Preparing Strategies to Exploit the Coming Changes for Maximum Benefit
Director Intellectual Property Counsel
Cubist Pharmaceuticals (Lexington, MA)
Eric J. Sosenko
Brinks, Hofer, Gilson, & Lione, P.C. (Ann Arbor, MI)
Harold C. (Hal) Wegner
Foley & Lardner, L.L.P. (Washington, DC)
- Timing your filing – which rules do you want?
- Explaining the difference between the pre- and post-March 16, 2013 filing date
- Ensuring that every claim is supported by a pre-AIA priority filing
- What is sufficient to support a pre-AIA filing?
- Why is it important to amend prior to March 16, 2013?
- Filing strategies in light of the March 16, 2013, change:
- Focusing on the statutory requirements (enabled embodiment for § 112(a) support), claims of varying scope
- Rolling provisionals to supplement exemplary support and provide additional subgeneric definitions
- Avoiding prior art mention or characterization in a Background of the Invention (while identifying prior art in an Information Disclosure Statement)
- Avoiding “objects”, “gist” and other MPEP-mandated elements. Grasping the changes to the grace period under the AIA
- Eliminating the ability to swear behind
- Including layers of protection into an application
- Specifying particular embodiments
- Elaborating on alternative embodiments to establish enablement for broader claims
- Determining why documentation of invention date is still important
- Establishing prior user rights
- Rebutting a derivation proceeding
- Initiating a derivation proceeding
- Barring a third party application with strategic publication
- Recognizing loss of foreign rights
- Outlining usefulness in a university setting
- Eliminating a third party’s ability to file for species not included in your publication
- Maintaining a heightened vigilance for third party publications
- Filing prior to March 16, 2013 when third party publications are found
- Preserving the ability to swear behind third party art
- Discussing the sufficiency and insufficiency of trade secret protection in lieu of patent filing
- Adapting to the shift towards derivation practice
- Defining differences between derivation and previous opposition proceedings
- What are the limitations and benefits of derivation proceedings
- Proving or disproving that a disclosure was actually derived from the inventor
- Why is maintenance of meticulous notebook-keeping still important?
3:15 Afternoon Refreshment Break
3:30 Identifying What Constitutes Prior Art Under the AIA and Planning a Patenting Strategy Around the New Standards
Managing Counsel - Patents
Merck (Rahway, NJ)
Michele A. Cimbala, Ph.D.
Sterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC)
Merchant & Gould, P.C. (Washington, DC)
- Coping with the increased amount of public information that can be used against an applicant
- Preparing for the shift to include prior art based on the “effective filing date” and not the date of invention
- Eliminating the ability to swear back
- Nonobvious subject matter under revisions to § 103
- Applying “disclosure” exceptions to the new prior art requirements
- How is “disclosure” defined under the regulations?
- Understanding what will constitute disallowed “disclosures” and avoiding inadvertent mistakes
- When can on-sale and public use activity be considered prior art?
- Has secret § 102(f) prior art been eliminated?
- Exploring changes to § 102(e) practice and the apparent elimination of the Hilmer Doctrine
- Appreciating the expanded prior user rights doctrine under the AIA
- Grasping the exception to this doctrine for universities
- Updating prior art searches to include third party prior art
- Obtaining guidance for conducting global prior art searches
- Comparing what constitutes prior art in the US vs. abroad and the potential risks of inadvertent creation of prior art impacting patent application approvals globally
- Determining the implications of changes to novelty and nonobviousness in the AIA in comparison to absolute novelty in Europe
4:30 Slipping the Gordian Knot – How to Avoid Ethical Conundrums Presented by the AIA’s Inconsistent Best Mode Requirements
Patent Counsel, Diabetes/Endocrinology
Eli Lilly & Co. (Indianapolis, IN)
Mercedes Meyer, Ph.D.
Drinker, Biddle, & Reath, L.L.P. (Washington, DC)
35 U.S.C. § 282 has been amended to disallow failure to include best mode as a basis for invalidating a patent; nevertheless, 35 U.S.C. § 112 still requires inclusion of best mode as a requirement to obtain a patent. Practitioners are left scratching their heads over this inconsistency and fearing charges of inequitable conduct in the face of likely pressure from clients to avoid giving away an invention’s “special sauce” when drafting a patent application. During this panel, our faculty of experts will discuss how to deal with clients demanding that practitioners conceal key elements of best mode, how to respond to an examiner’s demand for proof of best mode under 37 CFR 1.105, overcoming this inherent conflict of interests, and more.
5:30 Conference Adjourns to Day 2
8:45 Co-Chair’s Opening Remarks
9:00 USPTO Address: Detailing the New Post Grant Opposition Procedures, How They Will Impact Patenting, and More
Patent Administrative Judge
United Stated Patent & Trademark Office (Alexandria, VA)
This exclusive address by Judge Giannetti will outline the regulations covering the brand new post grant review, inter partes review, supplemental examination, and third party pre-issuance submission procedures and how they will affect patent prosecution and litigation. Judge Giannetti will discuss the PTO’s thought process in crafting these regulations, especially with regard to discovery rules and standards of evidence, and take questions from attendees on utilizing or defending against them.
9:45 Learning the Sweet Science: Win the New Boxing Match Known as Inter Partes Review
Hoffman-LaRoche, Inc. (Nutley, NJ)
Allen R. Baum
Chair of the Chemical Practice Group
Brinks, Hofer, Gilson & Lione, P.C. (Morrisville, NC)
McAndrews, Held, and Malloy, Ltd. (Chicago, IL)
- Identifying which patents are most susceptible to IPR
- Understanding how the proceedings are limited to prior art
- Examining how inter partes reexamination procedures are being employed by both patent challengers and patent holders in different scenarios
- Questions of economics, efficiencies, and risk
- What can we glean from these current behaviors relative to the future utilization of inter partes review?
- Preparing for potential IPR review of patents granted prior to November 1999
- How to bunt the IPR process for “crown jewel” patents
- When to file a third party parallel IPR
- What are the discovery rules for IPR?
- Utilizing the discovery rules to defend against an IPR proceeding
- How and when to use expert witnesses
- How do re-issuance proceedings and reexam impact IPR strategy?
- Understanding the fine points of the new inter partes review procedure
- Considerations for choosing this forum
- Timing, cost, speed of resolution
- Grasping revisions to patent challenger’s burden of proof under inter partes review procedures
- Substantial new question of patentability vs. reasonable likelihood that the petitioner will prevail on claim
- Exploring the scope of review for current and new procedures under § 102 and § 103
- Patents (prior art) and publications
- Comprehending the relationship between scope of review and estoppel
- Transition and phase out
- Examining the interplay between the timing for post grant review and inter partes review
- Transition in presiding forums
- Choosing between the Central Reexam Unit (CRU) vs. Patent Trial and Appeal Board (PTAB)
11:00 Morning Coffee Break
11:15 Preparing for the Eventual Employment of the Post Grant Review Procedure in Opposition Practice
Associate General Counsel IP
Covidien Surgical Solutions (Boulder, CO)
Baker Botts, L.L.P. (New York, NY)
- Weighing considerations for when a challenge should be brought under post grant review (PGR)
- Exploring start dates, timing and basis of the application – questions to ask
- Is the challenge brought within nine months of patent issuance?
- What is the basis of the invalidity challenge
- Estoppel considerations looking ahead to potential litigation
- Raising all bases for invalidity lest you be precluded from raising them in other PTO or district court proceedings
- Examining the mechanics, protocols and procedures for PGR
- Filing of petition
- Analogous nature of proceeding to district court litigation
- appearing before the Patent Trial and Appeals Board (PTAB)
- Analyzing the petitioner’s burden of proof
- Proving that it is “more likely than not that one of the claims challenged in the petition is unpatentable”
- Procedures for appeal
12:15 Networking Lunch
1:30 Deciding When to Use Supplemental Examination to Cure Defects in a Patent: Balancing the Risks and Rewards
Maggie Shafmaster, Ph.D.
Vice President, Chief Patent Counsel
Sanofi Pasteur (Cambridge, MA)
Frank W. Forman
Senior Patent Counsel
Astellas Pharma US, Inc. (Farmingdale, NY)
- Understanding the risks associated with employing this procedure
- Preclusion of recovery for past damages
- Protocols and procedures for supplemental proceedings
- Defining a substantial new question of patentability (SNQP)
- Exploring relationship between supplemental proceedings and inequitable conduct
- Circumstances in which supplemental reexam can be used as a means to circumvent questions of inequitable conduct
- Failure to disclose - presence of mind
- Intent v. mistake – does it make a difference in the findings?
- Findings of fraud in aftermath of proceedings and possibility of criminal prosecution
2:30 Gambit: Utilizing Third Party Prior Art Submissions in the Pre-Issuance Chess Match
Vice President of Intellectual Property
Molecular Templates (Newark, NJ)
Smith, Gambrell, & Russell, L.L.P. (Washington, DC)
Bryan C. Diner
Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P. (Washington, DC)
This panel session will enhance your understanding how pre-issuance submissions can be used to as pawn pieces in a completely new chess game. As a competitor, grasp how a pre-issuance submission can be used to direct an examiner to weaknesses and vulnerabilities in a patent application and manipulate an applicant to make certain moves and sacrifices. As an applicant, learn how to defend your position and plan for the moves of competitors post-grant and in the marketplace.
- The chess board and rules of the game:
- Timing and formal requirements
- Patents, applications, and printed publications: anticipatory and obviousness-type prior art; “of potential relevance to the examination”, i.e. need not be prior art
- A “concise statement of relevance” – How much and what is acceptable
- Playing the game – Competitor moves:
- Evaluating the strengths and weaknesses of prior art in one’s arsenal
- Determining whether to use the entire arsenal of art or keep some for later use during a post-grant proceeding
- Submissions that may force narrowing amendments and/or arguments and admissions thereby resulting in narrow claim construction and prosecution history estoppel
- Using submissions to attack the sufficiency of the specification to prevent allowable claims to certain subject matter
- Planning for future moves – possible claims an applicant may pursue and post-grant proceedings
- Playing the game or walking away – Applicant moves:
- Evaluating scenarios in which a pre-issuance submission might actually strengthen rather than weaken an applicant/patentee’s position
- Analyzing what result your competitor is trying to achieve by the pre-issuance submission
- Keeping your moves open and avoiding being manipulated into a corner
- Determining whether commenting on a pre-issuance submission is harmful or helpful and whether a copy of the pre-issuance submission should be provided in related applications along with any comments
- Making moves to minimize the ability of competitors to submit pre-issuance submissions
- Using the pre-issuance submission to evaluate your competitor’s products and future R&D
3:30 Afternoon Refreshment Break
3:45 Examining the Ramifications of Patent Reform for Hatch-Waxman Litigation and the Brand/Generic Wars
Mary Catherine DiNunzio
Head of Global Patent Alliances
H. Lundbeck, A/S (Copenhagen, Denmark)
Lisa Barons Pensabene
Fitzpatrick, Cella, Harper & Scinto, L.L.P. (New York, NY)
Given the myriad strategic considerations that companies need to take into account prior to engaging in Paragraph IV litigation, the addition of patent reform has further complicated already complex brand/generic wars. Both branded and generic companies are analyzing the AIA to ascertain the effect on Hatch-Waxman ltigation and debating how post-grant review could potentially impact the playing field for life sciences companies. Add the potential for biosimilars litigation into the mix, and this chess match enters three dimensions, representing nothing less than a geometric increase in complexity. In this session, our expert faculty will use hypothetical situations to explore the implications of patent reform for Paragraph IV and biosimilars litigation and provide guidance on what you should be doing now to prepare for the costly and convoluted litigation that is likely to come.
4:30 Investigating the Changes to Declarations and Assignments and Understanding How These New Provisions Can Be Used to Keep Prosecution on Track
Kenneth F. Mitchell, Ph.D.
AstraZeneca (Wilmington, DE)
Intellectual Property Counsel
Novo Nordisk, Inc. (Princeton, NJ)
- Outlining the revisions to 35 U.S.C. § 118
- Eliminating the statement of citizenship requirement
- How do these provisions give applicants more time to file the oath or declaration or a substitute statement?
- Including an inventor’s declaration on an assignment document
- Filing on behalf of inventor w/o showing of refusal or failure to reach an inventor
- The difference between a substitute statement and filing by an assignee
- What is “appropriate” in this case under 35 USC § 118?
- Exploring the effects of PTO regulations covering this new section
- Do the regulations restrict the statute?
- Determining when you must file a 3.73b form
- Considering the impact of these changes on employment agreements
- How should employment agreements’ wording change in light of this provision?
5:15 Conference Concludes