Main Conference – Day One Tuesday, October 4, 2011
7:15 Registration and Continental Breakfast
8:15 Co-chairs’ Opening Remarks
Chairmen:
George W. Johnston
Vice President & Chief Patent Counsel
Hoffmann-La Roche(Nutley, NJ)
Mark E. Waddell
Partner
Loeb & Loeb LLP(New York, NY)
Chairman Emeritus:
John C. Vassil
(Formerly Of Counsel to Morgan & Finnegan LLP)
(New York)
8:30 Understanding How the Patent Cliff Will Re-Define the Endgame
George W. Johnston
Vice President & Chief Patent Counsel
Hoffmann-La Roche(Nutley, NJ)
Christopher A. Vellturo, Ph.D.,
President,
Quantitative Economic Solutions, LLC(Cambridge, MA)
Mark E. Waddell
Partner
Loeb & Loeb LLP(New York, NY)
- Defining the patent cliff
- How will the patent cliff impact the future of the pharmaceutical industry?
- brand-name and generic perspectives
- Understanding how the patent cliff could unravel the balance of power established by Hatch-Waxman between brand names and generics
- Exploring modes of innovation that will make up for patent cliff losses
- drug delivery modalities
- combination products
- combined drugs
- combined drug and device therapies
- the future of gene patenting
- other section 101 controversies
- Identifying the role of biosimilars in the era of the small molecule patent cliff
9:30 USPTO Keynote: The Impending Reality of Patent Reform and Its Potential Impact on Pharmaceutical Patents
Teresa Stanek Rea (Invited)
Deputy Under Secretary of Commerce for Intellectual Property and Deputy
Director United States Patent and Trademark Office
(Alexandria, VA)
On March 8, 2011, the Senate by a 95-5 vote passed S. 23, i.e., The America Invents Act or Patent Reform Act of 2011. A little more than a month later, the House Judiciary Committee voted to approve its own version of the Patent Reform Act, i.e., H.R. 1249. It is anticipated that this bill will go to a full House vote sometime in mid-June. If passed, proceedings would begin to reconcile both the Senate and House versions of this legislation.
In light of these developments, Patent Reform is now an impending reality of which the biopharmaceutical industry must become well acquainted.
Teresa Stanek Rea will address the provisions of the proposed Patent Reform legislation and its implications for the pharmaceutical and biotechnology industries. Points of discussion will include:
- First to file vs. first to invent
- Proposed changes in PTO practice
- False marking
- The future of reexamination practice
- Post Grant Review proceedings
- The Goodlatte Supplemental Proceeding Amendments
10:30 Morning Coffee Break
10:45 Potential Life Cycle Management Controversies Posed By the Implementation of the Biosimilars Act
Stephen R. Auten
Vice President, IP
Sandoz, Inc.(Princeton, NJ)
David Korn
Senior Assistant
General CounselPhRMA(Washington, DC)
Hans Sauer, Ph.D., J.D.
Deputy General Counsel for Intellectual Property
Biotechnology Industry Organization(Washington, DC)
Moderator:
Gregory J. Glover, MD, JD
Principal
Pharmaceutical Law Group PC(Washington, DC)
It has been more than a year since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) which established a pathway for biologics to be approved as biosimilars under section 351k of the Public Health Service Act. Although the FDA still has not issued regulations which would allow the industry to make critical determinations in pursuing the development of these products, the statutory structure suggests several life cycle management issues that are likely to arise from FDA’s regulations and the implementation of BPCIA. In this session, our panelists will explore the regulatory, patent, and exclusivity issues raised by BPCIA as well as the status and anticipated content of FDA rulemaking in this area. Points of discussion will include:
- FDA regulatory issues in the implementation of BPCIA
- highly similar
- interchangeability
- user fees for expedited review
- FDA waiver
- analytical studies
- animal studies
- human clinical studies
- what can we glean from FDA’s individual meetings with would-be biosimilar manufacturers?
- regulatory lessons learned from Europe
- Market protection issues raised by the patent exchange procedures
- benefits and risks of the patent exchange procedures
- disclosure of the biosimilars application
- question of what constitutes infringement
- perspective of the reference product sponsor
- list exchanges conundrum
- weighing economic and cost considerations of the biosimilars pathway and the full BLA
- The potential impact and practical implications of the exclusivity provisions
- 12-year exclusivity
- nature of the exclusivity
- criteria for eligibility
- importance of “sameness” definitions
- interchangeability exclusivity
- uncertain duration
- potential need for “at-risk” launch
- pediatric exclusivity
- orphan drug exclusivity
11:45 Patent term Adjustment and patent term extensions update: strategies and considerations for small and large molecules
Barton W. Giddings, Ph.D
Partner
Stoel Rives LLP(Salt Lake City, UT)
Mary C Till (Invited)
Legal Advisor, Office of Patent Legal Administration
United States Patent and Trademark Office(Alexandria, VA)
- Assessing the impact of evolving PTA and PTE precedents in pharmaceutical patent life cycle management strategies
PTA
- Re-examining A and B overlaps in a post-Wyeth world
- equitable tolling
- Schering v. Kappos (D.C. Cir.)
- Post-Wyeth PTO procedures and calculations
- PTO’s PTA computer program overhaul
- proposed changes by the PTO to the PTA Rules
- factoring-in BPAI appeals
- holidays
- Identifying circumstances when filing a District Court complaint before the DC Circuit is still your best option for PTA redress
PTE
- Examining substantive and procedural PTE controversies impacting not only drugs but biological products as well
- The Medicines Company v. PTO (E.D. Va.)
- denying PTE application filed on day 62
- potential legislative solution to Medicines Company dilemma under Patent Reform
- Genetics & IVF Institute v. Kappos (E.D. Va.)
- Schering Corp. v. Mylan Pharmaceuticals, Inc., (D.N.J. 2011)
- duty to disclose prior art
12:30 Networking Luncheon
1:45 Exploring Post-Issuance PTO Procedures in the Era of the Patent Cliff: focus on reexam and reissue proceedings
Robert M. Gould, Ph.D.
Partner
Duane Morris LLP (Chicago, IL)
Kevin W. McCabe
Director
Sterne, Kessler, Goldstein & Fox P.L.L.C.(Washington, DC)
Len S. Smith
Principal Intellectual Property Counsel
Medicis Pharmaceutical Corporation(Scottsdale, AZ)
Jean F. Vollano, Ph.D (Invited)
Quality Assurance, Specialist
United States Patent and Trademark Office (Alexandria, VA)
- Examining the recent upswing in reexam and reissue proceedings and what their implications are for patent life cycle strategies
- Understanding how reexam proceedings are being used by both patent challengers and patent holders
- ex-parte and inter-partes proceedings
- economics and efficiencies of reexam
- what are the inherent risks for third party challengers
- when does it make sense for a patent holder to file for reexam?
- Assessing the future of reexam proceedings in light of pending Patent Reform legislation
- Current reexam proceeding vs. proposed post-grant review under Patent Reform
- Evaluating the risks and benefits of reissue proceedings in patent life cycle management
- Exploring the significance of In Re Tanaka on reissue filings in the pharmaceutical industry- addition of narrow claim- preservation of original claim
2:45 Afternoon Refreshment Break
3:00 The Combined Impact of Prior Art Obviousness and Obvious-type Double Patenting on Pharmaceutical Patent Life Cycle Strategies
Margaret “Peg” M. Buck
Head of Section, US Legal Affairs & Patents
Lundbeck Research USA, Inc.(Paramus, NJ)
Thomas J. Kowalski
Shareholder
Vedder Price P.C.(New York, NY)
Steven J. Lee
Partner
Kenyon & Kenyon(New York)
Brian P. Murphy
Partner
Edwards Angell Palmer and Dodge LLP(New York, NY)
Brian V. Slater
Partner
Fitzpatrick, Cella, Harper & Scinto(New York, NY)
- Comparing obviousness based on prior art to obvious-type double patenting and understanding their collective impact on pharmaceutical patent and portfolio strategies
Prior Art obviousness
- Prior art obviousness revisited: lessons learned from KSR and its progeny and In Re Kubin relative to life cycle and portfolio strategies for large and small molecules
- Reaffirmation of KSR through In Re Kao (Fed. Cir. 2011)
- Understanding the impact of KSR and its progeny on primary compound and composition claims vis-à-vis generic challenge
- impact on secondary patents
- enantiomers
- isomers
- new formulations
- new indications
- crystallizations
- salts
- Anticipated obviousness challenges to proteins and biosimilars
- Examining the USPTO 2010 Revisions to its obviousness guidelines
Obviousness-type Double Patenting
- Analyzing the evolving state of the law on obviousness-type double patenting
- Sun Pharm. Indus. v. Eli Lilly & Co., No. 2010-1105 (Fed. Cir. 2010): how denial of both en banc review and certiorari by the Supreme Court has resulted in a culmination of a new double patenting standard
- deciphering the Federal Circuit’s rationale regarding an extension of a prior art analysis to a double patenting controversy
- exploring why the Federal Circuit strayed from prior Federal Circuit precedent holding that double-patenting is based upon that which is already claimed
- understanding the importance of the dissent in this opinion
- examining the heretofore used “obvious variant” standard
- Boehringer Ingleheim Int’l, et al. v. Barr Labs, Inc., et al., 592 F.3d 1340 (Fed. Cir. 2010)
- exploring the respective roles of patent term extensions and terminal disclaimers in the double patenting controversy
- Brand-name and generic strategies for navigating the new double patenting landscape
- examining the link between double patenting and inequitable conduct
- Understanding the impact of the Sun and Boehringer cases on pharmaceutical patent life cycle strategies
4:15 personalized medicine and patent life cycle considerations Vis-à-Vis sections 101, 112, and Allowable research exceptions
Patricia Carson
Partner
Kaye Scholer LLP(New York, NY)
Michael A. Davitz
Partner
Axinn, Veltrop & Harkrider LLP(New York, NY)
Denise L. Loring
Partner
Ropes & Gray LLP(New York, NY)
- Patent controversies relative to research on genetic material
- Section 101 Patentability
- exploring the patentability of genes and related diagnostic claims patentable – should they be patentable?
- patent drafting and claiming strategy to protect the genetic and diagnostic inventions.
- Examining Section 112 written description and enablement vis-à-vis personalized medicine
- recap of Ariad v. Lilly and its current application by the Federal Circuit to Centocor Ortho Biotech Inc. v. Abbott Laboratories
- reaffirming the distinction between written description and enablement- reviewing specification requirements
- understandability
- inventorship
- Examining Abbott’s impact on future written description challenges regarding antibodies and other biological products
- anticipating written description challenges relative to biosimilars
- what level of description is required to satisfy the Patent Office to meet the written description and enablement requirements?
- how much information is sufficient for diagnostic claims to an expert in the field, i.e., one skilled in the art
- revisiting the role of written description in patent life cycle strategies for the biopharmaceutical industry
- assessing how written description will be used as a means of invalidity challenges in light of this jurisprudence
- Scope of patent Infringement exception under § 271(e)(1) as it applies to genetic research and development
5:15 CAFC and Supreme Court Watch: three cases that may have radical Impact on pharmaceutical patent life cycle strategies
John M. (Jack) Griem, Jr.
Partner
Milbank, Tweed, Hadley & McCloy LLP
(New York, NY)
Edward T. Lentz
Patent
Attorney
(New Lisbon, NY)
Rashad L. Morgan
Patent Attorney
Brinks Hofer Gilson & Lione
(Research Triangle Park, NC)
Colleen Tracy
Partner
Fitzpatrick, Cella, Harper & Scinto(New York, NY)
There are currently three matters before the Federal Circuit and U.S. Supreme Court that may greatly impact patent life cycle strategies in the biopharmaceutical industry. These matters go to the very heart of patent validity, the subject matter of that which is patentable, and the ethical considerations affecting the manner in which patents are obtained. Our panel will address the legal and strategic implications raised by these matters as they discuss:
- Microsoft Corporation v. i4i Limited Partnership (Supreme Court ___)
- Association for Molecular Pathology v. Myriad (Fed. Cir. __)
- Therasense, Inc. v. Becton, Dickinson and Co. (Fed. Cir. ___)
6:15 Conference Adjourns to Day Two
Day Two - Wednesday, October 5, 2011
7:15 Continental Breakfast
8:15 Co-Chairs’ Opening Remarks and Recap of Day One
8:30 FTC Keynote: Analysis of Competitive Behaviors in Pharmaceutical Patent Life-Cycle Management Strategies
Suzanne Munck
Counsel for Intellectual Property
Federal Trade Commission (Washington DC)
The FTC continues to vigorously use its enforcement and policy tools to prevent anticompetitive business practices in the pharmaceutical industry. The Commission remains steadfast in its position that certain industry behaviors concerning patent settlements are anticompetitive. In this session, Suzanne Munck will discuss the FTC’s position in these matters, including:
- The FTC’s current stance on “pay-for-delay” settlements
- enforcement of MMA reporting requirements
- FTC and DOJ alignment on “pay-for-delay”
- status of pending legislation regarding settlements
- Analysis of the competitive implications of other pharmaceutical life cycle management strategies
- FTC Report on the IP Market Place
- The FTC’s Report on Follow-On Biologic Drug Competition
9:15 Morning Coffee Break
9:30 Rems Studies and Generic Entry: Exploring the Latest Regulatory Conundrum Affecting Pharmaceutical Patent Life Cycle Strategies
Guy Donatiello
Vice President, Intellectual Property
Endo Pharmaceuticals(Chadds Ford, PA )
Kurt R. Karst
Director
Hyman, Phelps & McNamara, P.C. (Washington, DC)
- Understanding how REMS (Risk Evaluation and Mitigation Strategies) studies are impacting the generic entry of certain drugs
- cost of REMS study
- obligation of generic to continue or mimic REMS study
- The FDA prohibition against using REMS as a blocking strategy: fact vs. reality
- Exploring the patentability of a REMS study
- the incorporation of certain REMS elements in Orange Book listings
- Exploring the potential use of a 505(b)(2) application as a design around REMS obligations by the generic
- Novel questions of sample request under and ANDA as posed by Thalidomide
- New Orange Book Strategies and Controversies
10:15 Part A: Carve-outs, skinny labeling and use codes: understanding their role in orange Book listing strategies and life cycle management
Nicolas G. Barzoukas
Partner
Weil, Gotshal & Manges LLP(Huston, TX)
Bruce A. Pokras
Senior Corporate Counsel, Intellectual Property
Pfizer Inc.(Madison, NJ)
Richard T. Ruzich
Partner
Duane Morris LLP(Chicago, IL)
- Exploring the relationship between a drug’s label, patents and Orange Book listings
- Defining Section viii carve –outs and understanding their significance to Orange Book listings
- Therapeutic equivalence evaluation codes
- the role of AB ratings and OB use codes in the Orange Book and how they impact pharmaceutical patent life cycle strategies
- Examining delisting strategies based on use codes and labeling controversies vis-à-vis Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2010)
- when can use codes be altered?
- will seeking permission from the FDA to carve-out patent protected language allow for generic entry?
- significance of Solicitor General’s filing of an invitation brief in this matter
11:15 Part B: Inducement Actions and Divided Infringement: How Method of Use Claims Controversies Are Influencing Orange Book Listings
Aaron F. Barkoff, Ph.D.
Partner
McAndrews, Held & Malloy, Ltd.(Chicago, IL)
Michael P. Dougherty
Special Counsel
Cadwalader, Wickersham & Taft LLP(New York)
Ted J. Ebersole, Ph.D.
Assistant General Patent Counsel
Eli Lilly and Company(Indianapolis, IN)
Elizabeth Weiswasser
Partner
Weil, Gotshal & Manges LLP(New York, NY)
- Examining inducement challenges to methods of use claims listed in the Orange Book
- Defining inducement of infringement and divided infringement under current law
- how the Supreme Court’s ruling in Global Tech v. SEB has altered the standard for inducement findings
- mens rea requirements
- º willful blindness vs. deliberate indifference
- indirect vs. direct infringement
- the concept of divided and joint infringement vis-à-vis Akamai Technologies, Inc. v. Limelight Networks, Inc., (Fed. Cir. 2011)
- Exploring the relationship between inducement actions and divided infringement and how they apply to methods of use claims in pharmaceutical patents
- AstraZeneca LP v. Apotex, Inc.: the role of Section viii carve-outs and the inducement controversy
- Orange Book listed methods of use patents vs. that which is actually listed in the label
- Indentifying the indirect infringer in these circumstances
- how might a similar rationale be used in a matter of divided infringement?
12:30 Networking Luncheon
1:45 Exclusivities and Forfeitures: New Developments, Controversies and Concerns
Allen R. Baum
Shareholder and Chair, Chemical Practice Group
Brinks Hofer Gilson & Lione(Research Triangle Park, NC)
Thomas D. Hoffman
Consultant – Patent Counsel
Sandoz,Inc.(East Hanover, NJ )
Brian J. Malkin
Partner
Frommer Lawrence & Haug LLP(New York, NY)
Shashank Upadhye
Vice President – Global Intellectual Property
Apotex, Inc.(Toronto, ON)
- Forfeiture provisions: circumstances under which exclusivity is forfeited
- identifying circumstances under which forfeiture of another’s exclusivity may occur?
- Deciphering the FDA’s stance on pre and post–MMA 180-day exclusivity
- Interpreting the “earlier of”, later of” language in making a forfeiture determination
- Evaluating the strength of “the failure to market” provision post-Lipitor
- Exploring simultaneous qualification for and forfeiture of exclusivity for failure to obtain tentative approval
- Evaluating the impact of “delisting” on forfeiture
- Forfeiture relative to patent expiration
- When can the 180-day exclusivity period be transferred to another ANDA applicant?
- Evaluating when the 180-day exclusivity period can be relinquished, and exploring the consequences
- When can a brand “park” a generic’s exclusivity?
- Defining “shared exclusivity”
- How have authorized generics changed the playing field relative to 180-day exclusivity?
- Exploring regulatory bars to exclusivity
- Revisiting the relationship between exclusivity, forfeiture and the 30 month stay
- circumstances under which a second stay may be granted impact on grant of exclusivity
3:00 Afternoon Refreshment Break
3:15 FDA Keynote: Update on FDA Activities Impacting Pharmaceutical Patent Life Cycles for Small and Large Molecules
Elizabeth Dickinson (Invited)
Associate Chief Counsel,
Office of the Chief Counsel
U.S. Food and Drug Administration (Rockville, MD)
The FDA’s jurisdiction over the Orange Book and listed patents; its decision-making powers concerning the consequences of de-listing patent; and its recent determinations regarding forfeitures are indicative of the agency’s critical role in the patent endgame. The discretionary Rule Making authority allowed to the agency over follow-on biologics under BPCIA further enhances this role. This session will cover the present state of the FDA’s authority in Orange Book listings, forfeiture decisions and other Hatch-Waxman and biosimilar-related matters.
4:15 Safe Harbor or Stormy Port?: Calming the Legal Tempest Left by Proveris
Nick Goombridge
Partner and Co-Chair Patent Litigation
Paul Weiss (New York)
Brian D. Coggio
Senior Principal
Fish & Richardson, P.C.(New York)
- Analyzing the pivotal role that the Hatch-Waxman safe harbor plays in patent portfolio management and life cycle management
- Overview of the safe harbor exemption to patent infringement
- Identifying “research tools” under Proveris?
- if a patent can be extended under § 156, does Proveris still apply?
- does Proveris control “compounds” used as research tools (e.g., comparators)?
- Under which circumstances does the safe harbor protect general screening (high through-put screening)?
- if not, where is the dividing line between unprotected screening and protected research?
- what is a “reasonable basis for believing” a compound or compounds “may work” for their intended purposes under Merck v. Integra
- when is post-approval testing protected under the safe harbor?
- can aspects of the research be “farmed-out” and still be protected?
- special considerations for antibodies vis-à-vis the safe harbor?
- exploring the applicability of the safe harbor in ITC actions?
5:00 Conference Ends
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