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Supplemental Examination Under the AIA

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Knobbe attorneys presented "Supplemental Examination Under the AIA" at a recent seminar held in Japan.

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Supplemental Examination Under the AIA

  1. 1. Supplemental Examination Under the AIA Irfan A. Lateef October 19, 2012 TokyoThe recipient may only view this work. No other right or license is granted. knobbe.com
  2. 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. 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. 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. 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. 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. 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. 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
  9. 9. 2040 Main Street, 14th Floor Irfan A. Lateef Irvine, California 92614 Irfan.Lateef@knobbe.comOrange County San Diego San Francisco Silicon Valley Los Angeles Riverside Seattle Washington DC knobbe.com

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