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Transcription:

May 14, 2013

These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of U.S. intellectual property law. These materials reflect only the personal views of the joint authors and are not individualized legal advice. It is understood that each case is fact-specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, the author and Finnegan, Henderson, Farabow, Garrett & Dunner, LLP cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorneyclient relationship with the author and Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. While every attempt was made to ensure that these materials are accurate, errors or omissions may be contained herein, for which any liability is disclaimed. 2

Supplemental Examination: Basis of SNQP Removed as Basis for Allegation of Inequitable Conduct: The Effect IN GENERAL. A patent shall not be held unenforceable on the basis of conduct relating to information that had not been considered, was inadequately considered, or was incorrect in a prior examination of the patent if the information was considered, reconsidered, or corrected during a supplemental examination of the patent. The making of a request under subsection (a), or the absence thereof, shall not be relevant to enforceability of the patent under section 282. [ 257(c)(1), 125 STAT. 326] Is this a holy grail of a pre-lit purge of inequitable conduct under a but-for materiality standard? 3

Allows submission of prior art in your own patents Restrictions: Does not apply against allegations already raised in district court or ANDA notice para. IV before date of filing request ( 257(c)(2)(A)), or Shall not apply to any defenses raised in ITC litigation/district court litigation unless SE and any reexam ordered there from is finished before the date on which the action is brought ( 257(c)(2)(B)). 4

The second of those two limitations requires a patent owner to think very carefully about the timing of any effort at supplemental examination if there is a desire to enforce the patent in the foreseeable future. A reexamination may need to be appealed to get the patent out. Thus, it may mean delaying any effort to enforce the patent for one or more years. 5

New 257(a): A patent owner may request supplemental examination of a patent in the Office to consider, reconsider, or correct information believed to be relevant to the patent[.] Prior art? Inconsistent positions? Errors? Therasense: Rule 56? Importantly, uses term relevant not material. Request does not mean admission of materiality. 6

Supplemental Examination: Heading South 257(f): Nothing in this section shall be construed (1) to preclude the imposition of sanctions based upon criminal or antitrust laws ; (2) to limit the authority of the Director to investigate issues of possible misconduct and impose sanctions for misconduct in connection with matters or proceedings before the Office; or (3) to limit the authority of the Director to promulgate regulations under chapter 3 relating to sanctions for misconduct by representatives practicing before the Office. 7

Supplemental Examination: The South Pole? Fraud exception [ 257(e)] (e) FRAUD. If the Director becomes aware, during the course of a supplemental examination or reexamination proceeding, that a material fraud on the Office may have been committed in connection with the patent that is the subject of the supplemental examination the Director shall also refer the matter to the Attorney General for such further action as the Attorney General may deem appropriate. 8

78 Fed. Reg. 4,212 (Jan. 18, 2013), effective March 16, 2013 1.20 Post issuance fees (c)(1) Request for ex parte reexamination: $12,0000 ($6000 for small entity; $3000 for micro entity) (k) Supplemental Examination (1) For processing and treating a request for supplemental examination: $4,400.00 ($2200 for small entity; $1100 for micro entity) (2) For ex parte reexamination ordered as a result of a supplemental examination proceeding: $12,100 ($6050 for small entity; $3025 for micro entity) (3) For processing and treating, in a supplemental examination proceeding, a nonpatent document over 20 pages in length, per document: (i) Between 21 and 50 pages: $180 ($90 for small entity; $45 for micro entity) (ii) For each additional 50 pages or a fraction thereof, in addition to the fee specified in paragraph (k)(3)(i) of this section: $280 ($140 for small entity; $70 for micro entity) 9

1.605 Request cannot have more than 12 items believed to be relevant to the patent. May file more than one supplemental examination request at a time. 1.610(b) A request for supplemental examination must include: (5) A separate, detailed explanation of the relevance and manner of applying each item of information to each claim of the patent for which supplemental examination is requested. 1.620 (e) No interviews. (f) No amendments. 10

Probably most practitioners won t change Rule 56 disclosure practices very much for now. 11

As of March 3, 2013: 1 granted, 1 granted-in-part, 1 denied, 1 dismissed.

Another purge opportunity? Amendment to 251, 253: Whenever any patent is, through error without any deceptive intention, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent. [SEC. 20(d) and (e), 125 STAT. 333-334]. Biggest implication no pre-filing due diligence is needed to assess whether any deceptive intent was involved in the error on which the reissue under 251 is based or whether any deceptive intent was involved in a claim being disclaimed under 253??? Would one use a combination of Reissue and Supplemental Examination to insulate reissued claims from allegation of inequitable conduct? Or just reissue? Why? Note: 37 CFR 1.16(e) Basic fee for filing each application for the reissue of a patent is $330! (with small entity reduction available) 13

116(c) CORRECTION OF ERRORS IN APPLICATION. Whenever through error a person is named in an application for patent as the inventor, or through an error an inventor is not named in an application, and such error arose without any deceptive intention on his part, the Director may permit the application to be amended accordingly, under such terms as he prescribes. 184 and 185 FOREIGN FILING LICENSES: without deceptive intent 256(a) CORRECTION. Whenever through error a person is named in an issued patent as the inventor, or through error an inventor is not named in an issued patent and such error arose without any deceptive intention on his part, the Director may, issue a certificate correcting such error. 288 Whenever, without deceptive intention, a claim of a patent is invalid, an action may be maintained for the infringement of a claim of the patent which may be valid. Although not invalid, remaining patent claims may nonetheless be unenforceable based upon the inequitable conduct of an unclean litigant. Precision Instrument Mfg. Co. v. Automotive Maintenance Machinery Co., 324 U.S. 806, 814-15 (1945).?? 14

Thank you. Tom Irving Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 901 New York Avenue, NW Washington, DC 20001-4413 202.408.4082 tom.irving@finnegan.com 15