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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.

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

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  • 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. 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
  • 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