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Harmonization! Biotech/Chemical/Pharmaceutical Customer Partnership Meeting December 9, 2013. Mark R. Powell Special Advisor to the Commissioner for Patents on International Patent Cooperation. Harmonization. 3 Facets: Technical Procedural Legal. Technical Harmonization. Global Dossier

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harmonization biotech chemical pharmaceutical customer partnership meeting december 9 2013

Harmonization!Biotech/Chemical/Pharmaceutical Customer Partnership MeetingDecember 9, 2013

Mark R. Powell

Special Advisor to the Commissioner for Patents on International Patent Cooperation

harmonization
Harmonization

3 Facets:

  • Technical
  • Procedural
  • Legal
technical harmonization
Technical Harmonization

Global Dossier

  • Concept
  • Initiative
global dossier initiative
Global Dossier Initiative
  • Focus on outcomes: Services to benefit all stakeholders
  • Close out or re-mission projects not leading to those outcomes
  • User-centric principles applied to services development
procedural harmonization
Procedural Harmonization
  • Cooperative Patent Classification (CPC)
  • PCT Reform
  • Patent Prosecution Highway (PPH)
pph state of play
PPH: State of Play
  • Brief recap of PPH from an historical standpoint
  • Favorable statistics still holding; costs halved for users
  • USPTO participates with 27 offices and 41 separate agreements, with others in the pipeline
  • In 2013, EPO promotes IP5-based PPH
    • agreed to, but with stipulations
    • Indicates EPO’s willingness to move beyond Trilateral arrangements, but not beyond IP5 offices
  • Near concurrent introduction of a normalized, “global” PPH system
coming very soon global pph
Coming Very Soon: Global PPH
  • At long last, agreement by a number of offices to harmonize the PPH system
  • Introduction of USPTO’s “Global PPH Principles” document in June of 2013
  • “Agreement”regime
    • Compliance v. formal MOU language
    • Declaration/intent format
    • Offices can sign on at any time
global pph key elements
Global PPH: Key Elements

Global PPH Principles

  • Includes the “Mottainai” concept
  • Plus “PPH 2.0” requirement streamlining
        • Reduced entry needs
        • Use of IT systems where possible
  • No distinction between work available in any filing route, Paris or PCT
  • Positive results from any earlier office available as a basis
leadership offices global pph
Leadership Offices: Global PPH
  • United States
  • Japan
  • Korea
  • United Kingdom
  • Australia
  • Canada
  • Russia
  • Spain
  • Portugal
  • Norway
  • Finland
  • Denmark
  • Nordic Patent Institute
  • Sweden
  • Israel
  • Others in discussions today

~ 90 % of PPH entries to date

legal harmonization examples
Legal Harmonization: Examples

America Invents Act (AIA)

  • First-inventor-to-File
  • Grace Period (regarding prior art)
  • Third party prior art submission
  • Post-grant procedures
  • Three-tier fee structure
legal harmonization examples1
Legal Harmonization: Examples

Patent Law Treaties Implementation Act

  • Title 1 - Hague agreement on registration of industrial designs
  • Title 2 – Patent Law Treaty implementation

U.S. Trade Negotiations (underway)

    • Trans-Pacific Partnership (TPP)
    • Transatlantic Trade & Investment Partnership (TTIP)