Supplemental Examination Under the AIA

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Supplemental Examination Under the AIA

October 19, 2012

Irfan A. Lateef

Tokyo

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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


Inequitable Conduct Immunization

• Information considered, reconsidered, or corrected

during supplemental examination cannot be the basis

for rendering a patent unenforceable

• There are Exceptions…


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


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


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


Costs – Proposed as of Sept. 10, 2012

• PTO Filing Fees

• Refund if ex parte reexamination not

ordered (i.e., no SNQ raised)

Large Small Micro

$18,000 $9,000 $4,500

Large Small Micro

$13,600 $6,800 $3,400


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

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Supplemental Examination Under the AIA

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