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Supplemental Examination Under the AIA                                                       Irfan A. Lateef
                                                                               October 19, 2012   Tokyo




The recipient may only view this work. No other right or license is granted.                                knobbe.com
Request
    •    Patent owner may request supplemental examination of a patent to
         consider, reconsider, or correct information believed to be
         relevant to the patent
          – If multiple owners, must be collective body of all owners

    •    Request may address any condition for patentability (e.g.,
         patentable subject matter, anticipation, obviousness, double
         patenting, definiteness)

    •    Information is not limited to patents and printed publications

    •    No third party involvement


© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved.            2
Inequitable Conduct Immunization
    • Information considered, reconsidered, or corrected
      during supplemental examination cannot be the basis
      for rendering a patent unenforceable

    • There are Exceptions…




© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved.   3
Inequitable Conduct Immunization: Exceptions

    • Benefit of supplemental examination does not apply to:
           – PRIOR ALLEGATIONS
              • Allegations pled in a civil action prior to date of
                supplemental examination request
              • Notice (for abbreviated drug application) received by
                patentee prior to date of supplemental examination request
           – PATENT ENFORCEMENT
              • Defenses in civil action or ITC proceeding, unless
                supplemental examination and any resulting ex parte
                reexamination is completed before the civil action is
                brought



© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved.         4
Contents of Request
    • Identification of patent and each claim of patent for
      which supplemental examination is requested

    • List of items to be reviewed
           – No more than 12 per supplemental examination request


    • Detailed explanation and manner of applying items to
      claims




© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved.      5
Procedure
    • Within 3 months of request
      – PTO determines whether the items of information
        raise a substantial new question of patentability
        (SNQ)

    • If no SNQ is raised
       – Supplemental examination certificate will issue

    • If an SNQ is raised by one or more items
       – Ex parte reexamination is ordered

© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved.   6
Costs – Proposed as of Sept. 10, 2012

    • PTO Filing Fees
             Large                                   Small       Micro
             $18,000                                 $9,000      $4,500


    • Refund if ex parte reexamination not
      ordered (i.e., no SNQ raised)
              Large                                   Small      Micro
              $13,600                                 $6,800     $3,400




© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved.            7
Practical Considerations
    •    Therasense decision likely decreased the importance of supplemental
         examination

    •    Declaratory Judgment Actions (DJ)
          – If aware of possible DJ against patent, consider filing before DJ is filed

    •    ANDA Litigation
          – If patent will be listed in Orange Book, consider filing supplemental
            examination as part of due diligence; or at a minimum, prior to
            receiving notice

    •    Enforcement
          – If planning to enforce the patent, consider filing supplemental
            examination with sufficient time to complete any ex parte
            reexamination before filing suit
© 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved.                     8
2040 Main Street, 14th Floor
                             Irfan A. Lateef                               Irvine, California 92614
                                                                           Irfan.Lateef@knobbe.com




Orange County   San Diego   San Francisco   Silicon Valley   Los Angeles      Riverside     Seattle   Washington DC




                                                                                           knobbe.com

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Supplemental Examination Under the AIA

  • 1. Supplemental Examination Under the AIA Irfan A. Lateef October 19, 2012 Tokyo The recipient may only view this work. No other right or license is granted. knobbe.com
  • 2. Request • Patent owner may request supplemental examination of a patent to consider, reconsider, or correct information believed to be relevant to the patent – If multiple owners, must be collective body of all owners • Request may address any condition for patentability (e.g., patentable subject matter, anticipation, obviousness, double patenting, definiteness) • Information is not limited to patents and printed publications • No third party involvement © 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 2
  • 3. Inequitable Conduct Immunization • Information considered, reconsidered, or corrected during supplemental examination cannot be the basis for rendering a patent unenforceable • There are Exceptions… © 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 3
  • 4. Inequitable Conduct Immunization: Exceptions • Benefit of supplemental examination does not apply to: – PRIOR ALLEGATIONS • Allegations pled in a civil action prior to date of supplemental examination request • Notice (for abbreviated drug application) received by patentee prior to date of supplemental examination request – PATENT ENFORCEMENT • Defenses in civil action or ITC proceeding, unless supplemental examination and any resulting ex parte reexamination is completed before the civil action is brought © 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 4
  • 5. Contents of Request • Identification of patent and each claim of patent for which supplemental examination is requested • List of items to be reviewed – No more than 12 per supplemental examination request • Detailed explanation and manner of applying items to claims © 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 5
  • 6. Procedure • Within 3 months of request – PTO determines whether the items of information raise a substantial new question of patentability (SNQ) • If no SNQ is raised – Supplemental examination certificate will issue • If an SNQ is raised by one or more items – Ex parte reexamination is ordered © 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 6
  • 7. Costs – Proposed as of Sept. 10, 2012 • PTO Filing Fees Large Small Micro $18,000 $9,000 $4,500 • Refund if ex parte reexamination not ordered (i.e., no SNQ raised) Large Small Micro $13,600 $6,800 $3,400 © 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 7
  • 8. Practical Considerations • Therasense decision likely decreased the importance of supplemental examination • Declaratory Judgment Actions (DJ) – If aware of possible DJ against patent, consider filing before DJ is filed • ANDA Litigation – If patent will be listed in Orange Book, consider filing supplemental examination as part of due diligence; or at a minimum, prior to receiving notice • Enforcement – If planning to enforce the patent, consider filing supplemental examination with sufficient time to complete any ex parte reexamination before filing suit © 2012 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 8
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