DAY 1:Wednesday, November 30, 2011
12:00 Registration
1:00 Co-Chairs’ Opening Remarks
Immac Thampoe, Ph.D.
Managing IP Counsel, Biologics
Merck & Co., Inc. (Kenilworth, NJ)
Brian Coggio
Senior Principal
Fish & Richardson, P.C. (New York, NY)
1:15 Protection v. Exploitation: Preparing for the Next Chapter in the Development of Biosimilars
Graham Jones, Ph.D., D.Sc.
Professor and Chair
Barnett Institute of Chemical and Biological Analysis, Northeastern University (Boston, MA)
Gerald Flattmann
Partner
Paul, Hastings, Janofsky & Walker, L.L.P. (New York, NY)
Jeffrey Kushan
Partner
Sidley Austin, L.L.P. (Washington, DC)
- An update on FDA regulations and guidance
- discussing the most recent news from the FDA on regulations promulgated under the BPCI
- analyzing the implications of FDA regulations for patenting biosimilars
- determining the size and composition of the biosimilar market deriving from likely FDA requirements
- Devising claim drafting methods for and against biosimilars
- crafting a claim strategy to head-off biosimilar development
- writing claims to work around narrowly written biopharmaceutical patents
- drafting claims to stymie the creation of second-generation biologics or “bio-betters”
- Preparing for the torrent of litigation that will result from biosimilar approval
- discussing the differences between the patent dispute resolution procedure in the biosimilars legislation and those found in the Hatch-Waxman Act
- planning for the burdensome exchange requirements in absence of an Orange-Book requirement
- Assessing the possible impact from the doctrine of equivalents on biosimilars
- under what circumstances will the doctrine of equivalents adversely affect a patented protein sequence?
- tips on drafting to avoid a doctrine of equivalents rejection by examiners
2:30 KEYNOTE: Examining the Potential Effect of Patent Reform on PTO Practices and Its Impact on Biotech Patents
Teresa Rea
Deputy Under Secretary of Commerce for Intellectual Property and Deputy
Director, US Patent & Trademark Office (Alexandria, VA)
3:30 Refreshment Break
3:45 Preparing for A Radical Overhaul of the U.S. Patent System: The Impact of Reform on Biotech Patent Strategies
Matthew Beaudet, Ph.D.
Patent Attorney
Novartis Institutes for BioMedical Research, Inc. (Cambridge, MA)
John Iwanicki
Partner
Banner & Witcoff, Ltd. (Boston, MA)
Peter Ludwig
Principal
Fish & Richardson, P.C. (New York, NY)
Gonzalo Merino, Ph.D.
Associate General Counsel
Columbia University (New York, NY)
At press time, both the House of Representatives and the Senate have passed substantially similar versions of the America Invents Act. The Senate has yet to reconcile the House version with their own and send it to the President for his signature and passage into law. Nevertheless, the very high likelihood that this bill, containing the biggest changes to 35 U.S.C. in more than fi fty years, becomes law requires discussion of its impact on biotech patent practice.
- Investigating the ramifications of the proposed first-to-file provision
- what does a first-to-file regime mean for smaller entities?
- how to prepare innovators and companies for a first-to-file scenario
- Describing the likely fallout from creation of an opposition procedure
- reviewing the proposed opposition proceeding
- considering the effect opposition practice may have on patent value
- Assessing the strategic considerations entities and inventors must entertain following patent reform
- ascertaining the impact of proposed changes to best mode disclosure requirements
- considering the effects of eliminating the one year grace period on prior art disclosure
5:00 Conference Adjourns
Day 2: Thursday, December 1, 2011
7:15 Continental Breakfast
8:00 Co-Chairs’ OPENING REMARKS
8:15 Examining 35 U.S.C. 101 Subject Matter Patentability in the Wake of Myriad and Prometheus
Rochelle Seide, Ph.D.
Former Vice President,
Intellectual Property Biovail Laboratories International SRL (Barbados, West Indies)
Hans Sauer, Ph.D., J.D.
Deputy General Counsel for Intellectual Property
Biotechnology Industry Organization (Washington, DC)
Steven Lendaris
Special Counsel
Baker Botts, L.L.P. (New York, NY)
The CAFC’s and Supreme Court’s decisions in Myriad and Prometheus will have a profound impact on the way innovations in the biotech sector are created and protected. Our panel will contemplate questions arising from these developments, including:
Myriad
- Considering the role of “isolation,” purification,” and “enlargement of utility” when claiming naturally-sourced substances
- Discussing the CAFC’s reasoning on the patentability of isolated gene sequences
- Divining the possible outcomes of a Supreme Court decision in Myriad
- Preparing for a scenario where the Supreme Court finds that genes are not patentable subject matter
- Debating the possibility of creating a gene sequence that can be claimed as novel and non-obvious
- What is the fall-out for the biotech industry if the court rules that isolated genes are not patentable subject matter?
- Discussing the patentability of diagnostic methods
Prometheus
- Examining the CAFC’s decision in Prometheus Laboratories, Inc. v. Mayo Collaborative Services
- what might be the Supreme Court’s decision?
- Discussing the state of the machine or transformation test in light of Bilski and its progeny and their implications for diagnostic method patents
- Investigating the involvement of mental step clauses in claims
- Determining the limits of the “application of a law of nature” to method claims
9:15 Microsoft v. i4i and Stanford v. Roche: Understanding Their Collective Implications for the Biotechnology Industry
Paul Wolfson
Partner
Wilmer Cutler Pickering Hale & Dorr, L.L.P. (Washington, DC)
Christopher Verni
Senior Patent Counsel
Genzyme Corporation (Waltham, MA)
- Evaluating the Microsoft v. i4i decision
- dissecting the court’s “clear and convincing” standard for having a patent declared invalid
- determining what level of evidence meets the reaffirmed “clear and convincing” standard
- addressing the effect Microsoft will have on biotech patent litigation
- Considering the issues raised in Stanford v. Roche
- exploring the implications of assigning rights to things not yet invented
- how do universities deal with rogue professors?
- examining the effect Stanford will have on application of the Bayh-Dole Act
- what implication does Stanford have for biotech innovations?
- how does it affect start-ups with innovators who work for universities?
10:00 Morning Coffee Break
10:15 Confronting the Written Description Requirement Post-Centocor and Evaluating Its Impact on Biotech Patent Practices
Nicholas Boivin
Director, Intellectual Property Counsel
Cubist Pharmaceuticals, Inc. (Lexington, MA)
Heather Boussios
Intellectual Property Counsel
Emergent Biosolutions, Inc. (Rockville, MD)
Joshua Elliott
Shareholder
Brinks Hofer Gilson & Lione (Research Triangle Park, NC)
- Considering the implications of Centocor Ortho Biotech, Inc. v. Abbott Laboratories
- discussing the heightened tension between the USPTO’s guidelines and the Federal Circuit following Centocor
- resolving written description concerns under §112
- practical strategies for navigating the written description requirement after Centocor
- Reviewing the impact of Ariad v. Eli Lilly and Univ. of Rochester v. G.D. SEARLE
- determining the impact of Ariad on the USPTO’s examination procedure
- assessing practical implications in patent claim drafting that have emerged since these decisions
- Investigating the effect of changes in the written description requirement post-Lilly and Centocor on patenting antibodies
- what is now required in describing an antibody in a patent?
- possible changes in USPTO guidelines for patenting an antibody post-Centocor
- measuring the tension between Centocor and Noelle v. Lederman in antibody patenting
11:15 The Emergence of the New Obviousness Standard and Its Impact on Biotech Patenting: Taking a Closer Look at Obvious-Type Double Patenting
Jeffrey Kopacz
Senior Patent Counsel
Alnylam Pharmaceuticals (Cambridge, MA)
Leora Ben Ami
Partner, Co-chair, Intellectual Property Practice
Kaye Scholer, L.L.P. (New York, NY)
Kevin Noonan, Ph.D.
Partner
McDonnell Boehnen Hulbert & Berghoff, L.L.P.(Chicago, IL)
- Double patenting and obviousness: the impact on patenting of biotechnology
- utilizing obvious-type double patenting claims as a litigation tool
- investigating the policy implications of patents whose terms are extended well-past twenty years and are vulnerable to invalidation by a double patenting finding
- what are the genus/species issues that may influence an obviousness rejection?
- Discussing the double patenting standard following Sun Pharm. Indus., Ltd. v. Eli Lilly & Co.
- understanding the implications of disclosures in the specification for double patenting
- considering the public policy implications of double patenting following Amgen v. Roche
- dissecting the dichotomy between strict statutory interpretation and policy considerations following Sun v. Lilly
12:15 Networking Lunch
1:30 Inequitable Conduct following Therasense: Assessing Its Signifi cance for Biotech Patent Litigation
Cameron Weiffenbach
Of Counsel
Miles & Stockbridge, P.C. (McLean, VA)
Warren D. Woessner, Ph.D.
Founding Shareholder
Schwegman Lundberg & Woessner, P.A. (Minneapolis, MN)
- Reviewing the implications of Therasense, Inc. v. Becton, Dickinson & Co. on biotech patent disputes
- what is the impact of the “but for” rule articulated in Therasense?
- determining materiality in light of the new standard
- analyzing the possible impact of the strong dissent in Therasense
- what does this decision do to “bury the reference” arguments in patent litigation?
- Considering the impact of Therasense on disclosure standards for biotech patents
- what will this do to MPEP Chapter 2000?
- determining how much must now be disclosed
- what constitute best practices in light of this decision?
- Exploring possible avenues of PTO enforcement of the new inequitable conduct standard and it effects on biotech patent litigation
- how will the PTO enforce this new standard?
- how will egregious conduct be codified in the regulations?
- will the PTO reestablish its long-dormant “fraud squad”?
- An overview of the proposed PTO materiality rules in the view of Therasense and future of the duty of disclosure: safe harbor or dangerous waters?
- what is the “but-for-plus” standard?
2:30 International Filing: Strategic Considerations and Advanced Tactics for Patenting Biotech Inventions Abroad
Bert Oosting
Partner
Hogan Lovells, L.L.P. (Amsterdam, Netherlands)
- Patenting procedures in the EU
- lessons from Europe’s biosimilar approval pathway
- detailing the latest developments on prosecution in Europe
- handling the relative expense of fi ling biotech patents in European nations
- Outlining patent litigation in the EU
- which countries see the most litigation?
- what is procedure in those jurisdictions?
- Filing under the PCT: new developments
- what has changed in filing under the PCT?
- describing strategic advantages and disadvantages of filing under the PCT in today’s international landscape
- investigating why biotechnology filings under the PCT dropped last year
3:00 Refreshment Break
3:15 Analyzing and Resolving the Difficulties of Claiming Joint Infringement After Akamai and McKesson
David Resnick
Partner; Co-Pratice Group Leader
Nixon & Peabody, L.L.P. (Boston, MA)
Margaret M. Buck
Head of Section, US Legal Affairs & Patents
Lundbeck Research USA, Inc. (Paramus, NJ)
- Describing the implications of the upcoming en banc hearing in Akamai Technologies, Inc. v. Limelight Networks, Inc. for biotech patent enforcement
- discussing Akamai in light of Bilski v. Kappos
- what could this decision mean for claiming infringement on diagnostic method patents?
- how does this affect claims of joint infringement following Federal Circuit opinions BMC Resources, Inc. v. Paymentech, L.P. and Muniauction, Inc. v. Thomson Corp. and I-Deal?
- limiting the possibility of joint infringement through more careful claim drafting techniques
- Dissecting McKesson Technologies Inc. v. Epic Systems Corp.: Consequences for diagnostic method patents
- what does the McKesson opinion do to enforcement of diagnostic method patents?
- are there any circumstances where actions of patients could create a joint infringement scenario?
4:15 Creating Favorable Patent Tactics in Developing Countries
Gillian Fenton
Vice President of Intellectual Property
Emergent Biosolutions, Inc. (Rockville, MD)
Krishna Sarma
Attorney
Corporate Law Group (New Delhi, India)
Michael Wise
Chair, China Intellectual Property Practice
Perkins Coie, L.L.P. (Los Angeles, CA)
- Filing biotech patent applications in BRIC countries and developing markets
- is it worth the expense to file in these jurisdictions?
- is the market for biotech products robust enough to justify the expense of filing there?
- will these countries live up to their obligations of enforcement?
- Developing a global biotech patenting strategy
- what you need to know to successfully overcome patent challenges abroad
- resolving conflicts between local and international law
- Engaging the intricacies and gaining patent protection in each country
- resolving questions related to international patenting practices in multiple jurisdictions
- prioritizing patent filing among numerous jurisdictions
5:15 Conference Concludes
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