Patent Reissue: Strategic Use for Pre- and Post-AIA

Transcription

1 Presenting a live 90-minute webinar with interactive Q&A Patent Reissue: Strategic Use for Pre- and Post-AIA Correcting Errors in Patents, Determining Whether and When to Pursue a Reissue Application, and Mastering the Recapture Rule TUESDAY, OCTOBER 21, pm Eastern 12pm Central 11am Mountain 10am Pacific Today s faculty features: Erika H. Arner, Partner, Finnegan Henderson Farabow Garrett & Dunner, Reston, Va. Thomas L. Irving, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C. Donna M. Meuth, Associate General Counsel - Intellectual Property, Eisai, Andover, Mass. Deborah M. Herzfeld, Of Counsel, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C. The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions ed to registrants for additional information. If you have any questions, please contact Customer Service at ext. 10.

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5 Patent Reissue: Strategic Use for Pre- and Post-AIA Correcting Errors in Patents, Determining Whether and When to Pursue a Reissue Application, and Mastering the Recapture Rule by Donna Meuth Erika Arner Deborah Herzfeld Tom Irving Copyright Finnegan, 2014

6 Disclaimer 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 and practice. 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. And not all views expressed herein are subscribed to by each joint author. Thus, the joint authors, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (including Finnegan Europe LLP, and Fei Han Foreign Legal Affairs Law Firm), and EISAI cannot be bound either philosophically or as representatives of various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with the joint authors, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (including Finnegan Europe LLP, and Fei Han Foreign Legal Affairs Law Firm), or EISAI. While every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed. 6

7 Key Questions What factors should be considered in evaluating the possibility of reissue? What are the risks and limitations of using reissue proceedings to resolve patent errors? How have patent reissue implications changed post-aia? If you have a pending patent application, how good an idea is reissue? When is supplemental examination a better idea than reissue and does reissue basically get the owner to the same place a supplemental examination would in a shorter time? 7

8 SNAPSHOT OF REISSUE APPLICATIONS: 64% GRANT RATE (5668/8845)( ) Reissue applications filed Reissue patents issued Source: USPTO 2013 Annual Report , reissue patents =.2% to 3% of total patent applications filed Volume is similar to that of plant patents. 8

9 Reissue Statute AIA 35 U.S.C. 251 (a) IN GENERAL. Whenever any patent is, through error, 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 for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue. (d) REISSUE PATENT ENLARGING SCOPE OF CLAIMS. No reissued patent shall be granted enlarging the scope of the claims of the original patent unless applied for within two years from the grant of the original patent. without any deceptive intention removed by AIA 9

10 Factors To Consider In Evaluating Possibility Of Reissue Avoiding recapture. Mistakes/inaccuracies in specification or drawings. Claims are too broad or narrow: May broaden if filed within 2 years of patent grant May narrow if filed within patent term Missing or improper priority claim (U.S. or foreign). With petition to accept late priority claim. Inventorship (may also be by Certificate of Correction). 10

11 Factors To Consider In Evaluating Possibility Of Reissue (con t) Must be unexpired patent. Patent is reissued for the unexpired part of the term of the original patent. 35 U.S.C Different than reexamination, where proceeding continues after expiration, as long as patent is enforceable. Term of patent cannot be extended by eliminating 35 U.S.C. 120 priority benefits in a reissue; original term remains in effect. Can that be done if a copending application is still pending? Same invention double patenting? Disclaimer under 35 U.S.C. 253? Obviousness type double patenting? 11

12 Other Statutory Requirements Reissue is initiated by patentee or the patentee s assignee. Amended application, fee and offer to surrender original (by operation of law when reissue grants). There must be a statutory error. 12

13 Rules 37 C.F.R a) Contents of a reissue application. An application for reissue must contain the entire specification, including the claims, and the drawings of the patent. No new matter shall be introduced into the application. No reissue patent shall be granted enlarging the scope of the claims of the original patent unless applied for within two years from the grant of the original patent, pursuant to 35 U.S.C C.F.R a) The inventor s oath or declaration for a reissue application, in addition to complying with the requirements of 1.63, 1.64, or 1.67, must also specifically identify at least one error pursuant to 35 U.S.C. 251 being relied upon as the basis for reissue and state that the applicant believes the original patent to be 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 the patentee had the right to claim in the patent. 13

14 Error According to 35 U.S.C. 251 While we have acknowledged that 251 is based on fundamental principles of equity and fairness, and should be construed liberally we have also stated that the remedial function of the statute is not without limits.. Indeed, [t]he reissue statute was not enacted as a panacea for all patent prosecution problems, nor as a grant to the patentee of a second opportunity to prosecute de novo his original application. Thus, not every event or circumstance that might be labeled error is correctable by reissue. In re Serenkin, 479 F.3d 1359, 1362 (Fed. Cir. 2007) Prior to 1952, the reissue statute specifically provided that defects correctible through reissue were those that had resulted from inadvertence, accident, or mistake. 35 U.S.C. 64 (1946); When it enacted section 251, the current reissue provision, Congress intended to retain the inadvertence, accident, or mistake standard that had existed under the earlier statute. In re Rosuvastatin Calcium Patent Litigation, 703 F.3d 511, (Fed. Cir. 2012) 14

15 Failure to File Divisional Is Not an Error Under 251 If claims were non-elected in the application (that became the patent) and the non-elected claims were not re-filed in a divisional, they cannot be recovered via reissue. Rationale: Failure to file a divisional application on the nonelected claims is not considered to be an error correctable under 35 U.S.C. 251 by reissue of the original patent. In re Orita, 550 F.2d 1277, 1280 (CCPA 1977) and In re Watkinson, 900 F.2d 230 (Fed. Cir. 1990). Cited by In re Serenkin, 479 F.3d 1359, 1364 (Fed. Cir. 2007): The distinction is between a genuine error, or mistake, and a deliberate, but subsequently found to be disadvantageous, choice. 15

16 Withdrawing Terminal Disclaimer Not an Error In re Dinsmore, 757 F.3d 1343 (Fed. Cir. 2014) During prosecution of 568 patent, recorded a TD to overcome a ODP rejection. Reissue application to modify the recorded terminal disclaimer to delete the common-ownership provision, and to modify the claims that gave rise to the disclaimer, because the two patents are not and never have been commonly owned. A FC: Affirmed rejection of application; no error within the meaning of statute. 16

17 Withdrawing Terminal Disclaimer Not an Error Dinsmore (con t) FC: Section 251 requires not only that the original patent be wholly or partly inoperative or invalid, and that the inoperativeness or invalidity be by reason of a defective specification or drawing or unduly broad or narrow claiming, but that error be the cause of the infirmity. Section 251 often applies to applicants' choices, i.e., their deliberate decisions about what to say in their patents, not just slips of the pen. But not every choice that produces inoperativeness or invalidity by reason of a specification, drawing, or claiming problem (within the meaning of section 251) can qualify. Only choices based on error count. Most reissue cases involve no dispute about this basis of error the court has noted that the typical situations are (for a broadening reissue) the post-issuance discovery of attorney error in understanding the scope of the invention and (for a narrowing reissue) the belated discovery of partially invalidating prior art. On the other hand, we have held reissue unavailable in several cases where the applicants identified no deficient understanding behind a choice,. In such cases, the reissue application was held inadequate as being no more than an effort to reverse a later-regretted choice made in obtaining the original patent. 17

18 Reissue Cannot Be Used To Withdraw Terminal Disclaimer In re Yamazaki, 702 F.3d 1327 (Fed. Cir. 2012) Yamazaki filed terminal disclaimer to overcome obviousness-type double patenting rejection. Amended claims. Yamazaki filed to withdraw TD, but PTO did not decide before patent issued. Petition dismissed Recorded terminal disclaimer could not be withdrawn after a patent has issued. Yamazaki sought to rescind by filing a reissue application. "error" identified was applicant's failure to ensure the proper disposition of the Petition to Withdraw during prosecution, failure to withdraw the application from issuance before and/or after payment of the issue fee. During pendency of the reissue application, both patents expired. 18

19 Reissue Cannot Be Used To Withdraw Terminal Disclaimer Yamazaki (con t) Reissue was rejected as premised on a defective basis for reissue. Board rejected for lack of error correctable under 35 U.S.C. 251; reissue proceedings cannot be used to withdraw a terminal disclaimer from an issued patent. terminal disclaimer s effect on patent term must apply to the term of the original patent, as recited in 251 (prohibits the reissue of an expired patent and precludes expanding a reissued patent's term beyond the original term set at issuance). 253 interpreted as meaning that disclaimed claims never existed in the original patent, the same holds true for Yamazaki s disclaimer of patent term. 19

20 Reissue Cannot Be Used To Withdraw Terminal Disclaimer Yamazaki (con t) FC: Upheld Board's decision. "...when the '991 patent issued with its terminal disclaimer in effect, that disclaimer became part of the original '991 patent and served to define its term, regardless of any further term that might have been otherwise available in the absence of the disclaimer." 20

21 What If You Forget A Claim? In re Tanaka, 640 F.3d 1246 (Fed. Cir. 2011) Tanaka filed a reissue declaration containing the original claims plus an added claim dependent on original claim 1. Examiner rejected the claims because there was no error identified that broadened or narrowed the scope of the issued claims. Board held that it is not reissue error under 35 U.S.C. 251 to add a subgeneric claim where all existing claims in the patent are maintained, both broader and narrower than the added claim. FC: Reversed and remanded. adding dependent claims as a hedge against possible invalidity of original claims is a proper reason for asking that a reissue be granted. In re Handel, 50 CCPA 918, 312 F.2d 943, 946 n. 2 (1963). the omission of a narrower claim from a patent can render a patent partly inoperative by failing to protect the disclosed invention to the full extent allowed by law. 21

22 What Are The Risks And Limitations Of Using Reissue Proceedings To Resolve Patent Errors? New Narrow Claims New prior art discovered, e.g., in pre-litigation diligence Old prior art not disclosed during original examination, e.g., to hedge inequitable conduct (AIA changes) New Dependent Claims New prior art; hedge against possible invalidity attack New Broader Claims New products (patent owner or third-party) Unclaimed embodiments or species 22

23 What Are The Risks And Limitations Of Using Reissue Proceedings To Resolve Patent Errors? Provoke Interference Add new claims to reissue application. Still need to identify an error; which can be the addition of the new claims. Cannot re-file patent claims and suggest an interference If broadened; must be filed within 2 years. Intervening Rights Applies to past infringement. Consider scope of likely amendment. The greater the difference between patent claims and reissue claims the more likely intervening rights will be triggered. 23

24 BROADENING REISSUE Only allowed within two years from patent grant. Reissue application filed within two years for reasons other than broadening may not be later broadened during prosecution outside of two years. Intent to broaden must be established in the reissue application within two years In re Graff, 111 F.3d 874, 877 (Fed. Cir. 1997). Subject also to 112 written description requirement. But if you are driven to reissue by IPR/PGR, broadening may not be at issue. 24

25 CONTINUATION AFTER 2-YEAR BROADENING DEADLINE In re Staats, 671 F.3d 1350 (Fed. Cir. 2012) Issue: Does 251 allow a continuing reissue application to add broadened claims after 2-year limit where the broadened claims are unrelated to the broadened claims filed within the 2-year limit? 1996 file patent application 2 embodiments described, claims only to 1st patent issues 2001 timely filed first broadening reissue application relating to 1 st embodiment May nd broadening reissue application filed as continuation of first broadening reissue application, relating to 1 st embodiment Oct 2004 RE38,641 issues (from first broadening reissue application) Aug 11, 2006 Third broadening reissue application filed as continuation of second broadening reissue application, relating to 2 nd embodiment Aug 2007 RE39,763 (from second broadening reissue application) Note: each reissue application filed while previously filed one still pending. 25

26 CONTINUATION AFTER 2-YEAR BROADENING DEADLINE Staats (con t) Board: Rejected third reissue application because new broadened claims were not related in any way to what was covered in the original broadening reissue. PTO: the language of the statute does not suggest that the first broadening reissue can serve as a kind of placeholder for later applications. FC: Reverse rejection. Case controlled by In re Doll, 419 F.2d 925 (CCPA 1970): 251's 2-year time limit applies to the filing date only of the first broadening reissue application. No distinction between related and unrelated claims. [N]o basis for limiting Doll to situations where later broadened claims are related to, or are directed to the same embodiment as in the original application. 26

27 Effect of Reissue Patent is deemed wholly or partly invalid or inoperable due to at least one error: the benefits of Tanaka. Unexpired term of the patent: no additional PTA or PTE, but also reissue doesn t adversely affect either. Effective date of claims. Intervening rights. 27

28 Effect of Reissue Opening up design-around possibilities. Delicate balance between avoiding prior art and avoiding patent owner estoppel and still being able to prove infringement. Notice what claims Petition did not challenge in IPG/PGR. Probably didn t challenge claims that raised no infringement concerns. Effects of reissue prosecution history. 28

29 Effect of Reissue Combined with PGR Opening up design-around possibilities particularly since discovery in IPR/PGR is not likely to be robust. Discovery is available but limited. Routine discovery Exhibits cited in paper or testimony; Cross examination of declarants; Relevant information that is inconsistent with a position advanced by a party. 29

30 Non-Routine, Additional Discovery For additional discovery, has as to meet the five Garmin factors: Request is based on more than a mere possibility of finding something useful. Request does not seek the litigation positions of the other party. Information is not reasonably available from other sources. Request is easily understood. Request is not overly burdensome. Very few motions for additional discovery granted through twoyear anniversary of IPR: the signal is that PTAB cannot resolve cases within twelve month requirement if additional discovery is granted. 30

31 AIA Makes No Difference on Doctrine of Intervening Rights No 3 rd party intervening rights for claims substantially identical to original patent. May be 3 rd party intervening rights for changed claims if: Alleged infringer made, used, sold, offered for sale or imported prior to the grant of the reissue. Alleged infringer made substantial preparation to make, use, sale, offer for sale or import prior to the grant of the reissue. Where intervening rights are at issue, going for a reissue in view of an IPR/PGR may not have any practical benefit. 31

32 AIA Does Not affect Existing Rules Against Recapture Precluding Reissue Federal Circuit recapture test. Interplay of the recapture rule and the Orita doctrine. MPEP will be most important to PTO but Federal Circuit decisions could mean more to PTAB. 32

33 Traditional Recapture Subject matter surrendered to obtain the original patent cannot be recaptured by filing a reissue. Consider effect of broadest reasonable claim construction? Surrendered subject matter : 1. The claim scope of the application claims that were canceled/amended in order to obtain the allowance of the patent; or 2. The right to a claim that does not include (in any form) a particular limitation that had been added/argued to overcome a prior art rejection. 33

34 MPEP Recapture of Canceled Subject Matter A reissue will not be granted to "recapture" claimed subject matter which was surrendered in an application to obtain the original patent. THREE STEP TEST FOR RECAPTURE: 1) first, we determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims; 2) next, we determine whether the broader aspects of the reissue claims relate to subject matter surrendered in the original prosecution; A. determine whether applicant surrendered any subject matter in the prosecution of the original application that became the patent to be reissued. B. If yes, determine whether any of the broadening of the reissue claims is in the area of the surrendered subject matter. 3) finally, we determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule. 34

35 Recapture Must Relate To Change In re Youman, 679 F.3d 1335 (Fed. Cir. 2012) Board upheld examiner rejection for improper recapture of subject matter surrendered in the original application. 3-step recapture rule analysis 1. determine whether and in what aspect the reissue claims are broader than the patent claims. 2. determine whether the broader aspects of the reissue claims relate to surrendered subject matter. 3. determine whether the surrendered subject matter has crept into the reissue claim. FC: Vacate and remand for Board to perform 3 rd step. 35

36 Violate Rule Against Recapture MBO Labs., Inc. v. Becton, Dickinson & Co., 602 F.3d 1306 (Fed. Cir. 2010) RE 885 patent teaches a syringe that protects against needle-stick injuries by sheathing a contaminated needle in a flange-covered guard. MBO argued that it never surrendered a guard body that could move relative to the syringe's fixed needle. DC: MBO violated rule against recapture. 36

37 Violate Rule Against Recapture MBO Labs. (con t) FC: Affirm. MBO clearly and unmistakably surrendered claiming a guard body that moved relative to a fixed needle. MBO twice overcame the examiner's rejections by emphasizing that the prior art disclosed a type of guard that moved relative to a fixed needle. In contrast, MBO stressed that its needle moved relative to the guard by slidably retracting. Also, note: a patentee may violate the rule against recapture by claiming subject matter in a reissue patent that the patentee surrendered while prosecuting a related patent application. 37

38 More on Reissue-Recapture AIA Engineering Ltd. v. Magotteaux Intern. S/A, 657 F.3d 1264 (Fed. Cir. 2011) Magotteaux replaced homogeneous solid solution in original claim 1 with homogeneous ceramic composite in reissue claims. DC: reissue claims had broader scope than original claims, and are invalid under 35 U.S.C. 251 for impermissibly recapturing subject matter surrendered during reissue examination. FC: Reverse and remand. Error in claim construction lead to error in conclusion of impermissible recapture. With the correct construction (two phrases are synonymous according to patentee s lexicography) there was no broadening, and therefore recapture issue is moot. 38

39 More on Reissue-Recapture In re Mostafazadeh, 643 F.3d 1353 (Fed. Cir. 2011) FC: Affirmed. the reissue application impermissibly attempted to recapture subject matter surrendered during prosecution of the original patent application Parties agree that the reissue claims are broader than the patented claims and that the broader aspects relate to the surrendered subject matter. Did the surrendered subject matter creep into the reissue claim? Violation of the rule against recapture may be avoided under this final step of the analysis if the reissue claims materially narrow the claims relative to the original claims such that full or substantial recapture of the subject matter surrendered during prosecution is avoided. To avoid violation of the rule against recapture in this way, the narrowing must relate to the subject matter surrendered during the original prosecution. Here, the reissue claims are broader than the patented claims. Where this is the case, the recapture rule is avoided only if the claims are materially narrowed in a way that avoids recapture of the surrendered subject matter. While these limitations certainly narrow the reissue claims relative to the original claims, the narrowing limitations are unrelated to the surrendered subject matter and thus insufficient to avoid recapture. 39

40 How Have Patent Reissue Implications Changed Post-AIA? Reissue applications can be merged with ex parte reexaminations. Reissue rules govern merged proceeding. Timing with concurrent PGR/IPR. PGR/IPR instituted before reissue reissue likely stayed. PGR/IPR filed before reissue reissue likely stayed. PGR/IPR filed/instituted after reissue reissue likely stay. PGR/IPR PGR applicable for 9 months after reissue on new reissue claims. Reissue effective filing date is patent filing date. IPR is available as normal. What may the role of reissue be in these PGR/IPR proceedings? 40

41 Reissue In View of AIA Post-Grant Options Other Than Supplemental Examination Ex Parte Reexam Post-Grant Review When After grant Within nine months of grant (only AIA patents) Threshold showing Grounds SNQ Patents/printe d publications 102, 103 More likely than not claim is unpatentable or novel legal question 101, 102, 103, 112 Covered Business Methods PGR After grant, for covered business method patents More likely than not PLUS sued or charged with infringement Inter Partes Review After 9 months of grant (AIA patents) or terminated PGR Reasonable likelihood of success 101, 102, 103, 112 Patents/printed publications 102, 103 Time at PTO Years months months months Anonymity Yes No No No 41

42 Reissue in View of AIA Post-Grant Options Other Than Supplemental Examination Ex Parte Reexam Post-Grant Review Covered Business Methods PGR Inter Partes Review Estoppel None Issues raised or reasonably could have been raised Before whom Discovery/ evidence Appeal PTO: raised or could have raised Dist Ct: raised Issues raised or reasonably could have been raised CRU PTAB PTAB PTAB Declaration Only patent owner may appeal to PTAB then Federal Circuit Declaration and discovery Both parties may appeal to Federal Circuit Declaration and discovery Both parties may appeal to Federal Circuit Declaration and discovery Both parties may appeal to Federal Circuit 42

43 But: IPR/PGR Weighted Against the Patent Owner Burden of proof ISSUE PGR/TPGR/IPR DISTRICT COURT Preponderance of the evidence Clear and convincing evidence Presumption of Validity? No Yes Claim construction Broadest reasonable construction Philips/Markman framework: analyze claims, specification, and prosecution history to determine how claims would be understood by one of ordinary skill in the art Decision maker Patent Trial and Appeal Board (APJs) District court judge or jury 43

44 Rocket Docket Procedure/Timeline for Post-Grant Options: An Opening for Reissue? months Petition PO Prelim. Response Decision/ Institution PO Response/ Motion to Amend Petitioner Reply/ Opposition PO Reply Oral Hearing Final Written Decision PO Discovery on Real Parties in Interest (3 months) PO Discovery (3 months) Petitioner Discovery (3 months) PO Discovery (1 month) Period for Observation & Motions (2 months) Sample timeline from USPTO. 44

45 Statistics: Post-Grant Options (as of Oct. 2, 2014) Petitions filed Inter partes review Trials instituted Petition denied Settlements Final Written Decisions Source: 74% of petitions granted (731/983). 45

46 PGR/IPR/Reissue Timing Requirements Related to Litigation Cannot file if challenger also filed civil action challenging validity of patent. Petitioner, real party, or privy of petitioner. Does not include counterclaim. Cannot file IPR more than 12 months after the petitioner is served with a complaint alleging infringement of patent. No such timing requirements on Reissue other than the normal ones. 46

47 Petitioner Estoppel: PGR and IPR PGR and IPR Becomes effective once the Board issues a final written decision Applies to any ground that petitioner raised or reasonably could have raised Estoppel applies in subsequent proceedings before the PTO, in civil actions, and in ITC proceedings 47

48 No Estoppel On Petitioner if 317(a) and 327(a). IPR/PGR Is Settled If IPR/PGR is terminated with respect to a petitioner in view of a settlement, no estoppel attaches to petitioner. If no petitioner remains in the IPR/PGR, then Office may terminate the IPR or proceed to final written decision. 48

49 But: Patent Owner Estoppel Could Make Reissue Interesting Patent owner estoppel. Substantive rule making? 42.73(d)(3) A patent applicant or owner is precluded from taking action inconsistent with the adverse judgment, including obtaining in any patent: i. A claim that is not patentably distinct from a finally refused or canceled claim; or ii. An amendment of a specification or of a drawing that was denied during the trial proceeding, but this provision does not apply to an application or patent that has a different written description. 49

50 In IPR/PGR, Patent Owner Can Theoretically Make Limited Amendments Once Patent Owner must confer with the Board before filing a motion to amend the claims. Motion to Amend requirements Only get a reasonable number of substitute claims one-to-one correspondence. Identify the patentable distinction Provide technical facts and reasoning. Provide any construction for any new claim terms. Some representation should be made about the specific technical disclosure of the closest prior art known to the patent owner. 50

51 Restrictions on Patent Owner Claim Amendments in IPR/PGR Motion to Amend requirements (con t) For amended claims, citations to the specification for written description support for not only the patent-at-issue, but also all parent applications. Address basic skill set possessed by one with ordinary skill in the art [I]f a feature Z is proposed to be added to an independent claim to render it patentably distinct from the prior art,... it would be helpful for the patent owner to first focus on feature Z and indicate whether feature Z was known in any context, and if so, then explain why that context is so remote or different from that of the claimed invention that one with ordinary skill in the art would not have applied that teaching to arrive at the claimed invention. IPR , Oracle v. Clouding IP, LLC, paper 15 (July 15, 2013). 51

52 Claim Amendments in PGR/IPR International Flavors & Fragrances Inc. v. The United States Of America, As Represented By The Secretary Of Agriculture, IPR , Paper 12 (PTAB May 20, 2014) No Preliminary Response filed. IPR instituted. No Patent Owner Response, instead Motion to Amend. (unopposed) cancel all claims substitute new claims First ever motion to amend granted (not just canceled). 52

53 Let s Look at the Old Claims Old claim 1: A method for repelling arthropods, said method comprising treating an object or area with an arthropod repelling effective amount of at least one isolongifolenone analog and optionally a carrier or carrier material; wherein said at least one isolongifolenone analog has the following formula: wherein. Old claim 8: The method according to claim 1, wherein said at least one isolongifolenone analog is selected from the group consisting of [6 specific analogs] and mixtures thereof. 53

54 Let s Look at the New Claims 54

55 Int l Flavors (con t) PTAB: Motion to Amend Granted Patent Owner showed written description support for amended claims. We conclude that Patent Owner has made a sufficient showing that each of proposed independent claims 27 and 45, as well as each of proposed dependent claims 28-44, as a whole, has written description support in the application as filed. Patent Owner must overcome prima facie case of obviousness patent owner bears the burden of proof to demonstrate patentability of the proposed claims over the prior art in general, and thus entitlement to the proposed claims. the patent owner should discuss, as well as present evidence, if appropriate, as to the level of ordinary skill in the art, and what was known regarding the features being relied upon to demonstrate patentability of the proposed claims. 55

56 Int l Flavors (con t) PTAB: Motion to Amend Granted Patent Owner provides several publications, as well as the Declaration of Dr. Aijun Zhang (Ex. 2005; Zhang Declaration ), to demonstrate the level of ordinary skill in the art, as well as the unobviousness of features being relied upon to demonstrate patentability of the proposed claims. Although Patent Owner s statement that Behan is the apparent closest prior art may appear conclusory, Patent Owner goes beyond that statement to demonstrate the level of ordinary skill in the art, as well as providing evidence regarding what would have been understood by the ordinary artisan as to those features being relied upon to demonstrate patentability of the proposed claim. 56

57 Int l Flavors (con t) PTAB: Motion to Amend Granted Specifically, Dr. Zhang concludes, based on the results presented in the Declaration, that the ordinary artisan would not expect that minor structural changes to a known insect, tick, or mite repellent would result in a modified compound having the same repellency as the parent compound. Ex According to Dr. Zhang, such activity cannot be predicted based on structure alone, but must be determined by experiment. Because the prior art does not provide a reason to modify isolongifolanone to arrive at the modified isolongifolanone compounds of proposed claim 27, nor does it provide a reasonable expectation that such modifications would result in a compound having the desired insect repellent activity, we conclude that the preponderance of the evidence supports the patentability of claim 27. As to dependent claims 28-44, because those claims incorporate all of the limitations of claim 27, they would be patentable for the same reasons. 57

58 Int l Flavors (con t) Motion to Amend Granted Comments Use case as guide in ex parte matters Way to win on nonobviousness at the PTO in ex parte matters, which of course should be strongly guided by PTAB. The claim: selected from the group consisting of but better to say wherein said at least one analog is chosen from and mixtures thereof is strange in juxtaposition with at least one in context of this case 58

59 So, Consider Having Patent Owner in IPR/PGR Go to Reissue As seen, only able in IPR/PGR to amend once, and only if Motion to Amend requirements are met. As seen, Patent Owner Estoppel can be quite severe, reminiscent of the body of law of interference estoppel. Bad environment in inter partes IPR/PGR. Particularly the inter partes part of it and the PTOimposed patent owner estoppel. 59

60 So, Consider Having Patent Owner in IPR/PGR Go to Reissue So maybe Patent Owner doesn t amend claims in IPR/PGR and rather provides a patentably distinct but useful claim amendment in reissue. Reissue likely stayed pending disposal of IPR/PGR within the one year period from institution. If claims of patent canceled in IPR/PGR, look for patentably distinct claims in reissue that are enforceable and still infringed. 60

61 So, Consider Having Patent Owner in IPR/PGR Go to Reissue In other words, pursue reissue to get Orange Book listable claims that are separately patentable over patent claims lost in the IPR/PGR. Generic has to certify against claims. Institute new Hatch Waxman litigation with narrower claims. But how realistic will this be, particularly if PGR/IPR patent owner estoppel sticks? Would the reissue be stayed? 61

62 Litigation and Reissue Litigation A reissue application will be stayed if there is concurrent litigation unless The litigation is stayed The litigation is terminated There are no significant overlapping issues The applicant requests examination to continue Will that last point generally be quite likely? If reissue examination continues, NO extension of times are permitted. See MPEP A reissue can be needed because of litigation, irrespective of any AIA considerations. 62

63 USPTO Claim Construction Standard MPEP 2111: Applies to Both IPR/PGR and Reissue During patent examination, the pending claims must be given their broadest reasonable interpretation consistent with the specification. The Federal Circuit s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005) expressly recognized that the USPTO employs the broadest reasonable interpretation standard: The Patent and Trademark Office ( PTO ) determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction in light of the specification as it would be interpreted by one of ordinary skill in the art. (Citation omitted.) Because applicant has the opportunity to amend the claims during prosecution, giving a claim its broadest reasonable interpretation will reduce the possibility that the claim, once issued, will be interpreted more broadly than is justified. (Citations omitted.) 63

64 BuT USPTO Standard For Both IPR/PGR and Reissue Has Limits In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010): The PTO's construction here, though certainly broad, is unreasonably broad. The broadestconstruction rubric coupled with the term comprising does not give the PTO an unfettered license to interpret claims to embrace anything remotely related to the claimed invention. Rather, claims should always be read in light of the specification and teachings in the underlying patent. 64

65 How Does The Federal Circuit Review PTAB Claim Constructions? Deferential review: is the Board s decision reasonable in light of all of the evidence? See, e.g., In re Suitco Surface, Inc., 603 F.3d at 1259 (citing In re Morris, 127 F.3d 1048, 1055 (Fed. Cir. 1997) De novo review; see, In re Baker Hughes, 215 F.3d 1297 (Fed. Cir. 2000) ( [A]lthough the PTO gives claims the broadest reasonable interpretation consistent with the written description... claim construction by the PTO is a question of law that we review de novo,... just as we review claim construction by a district court ). 65

66 Remember: Different Results Are A Very Real Possibility Baxter In re Baxter Int l, 678 F.3d 1357 (Fed. Cir. 2012)(LOURIE, Moore)(Newman, dissenting) Board s decision of invalidity affirmed despite earlier opposite finding in district court and affirmance by Federal Circuit Considered Federal Circuit s earlier affirmance of validity, but nevertheless upheld rejections. PTO and courts take different approaches in determining validity and on the same evidence could quite correctly come to different conclusions Different claim construction standards; Different burdens of proof; and Different records. Because the two proceedings necessarily applied different burdens of proof and relied on different records, PTO did not err in reaching different conclusion than district court./fed. Cir. Congress has provided for reexamination system that permits challenges to patents by third parties, even those who have lost in prior judicial proceedings. 66

67 And End of Litigation May Not Be End of Case Fresenius II Fresenius USA, Inc. v. Baxter Int l., Inc., (Fresenius II), 721 F.3d 1330 (Fed. Cir. 2013)(DYK, Prost)(Newman, dissenting) Pending infringement suit must be dismissed as moot after PTO finding of invalidity during reexamination; wipes out $24 M damage award. USPTO s cancellation of the claims divested Baxter of a cause of action for infringement. Patentee argued that earlier final judgment by district court on damages operated as res judicata, precluding challenging district court s underlying holding of validity (upheld in Fresenius I) Majority disagreed, distinguishing between final judgments for the purposes of appeal and final judgments for the purposes of preclusion. Since scope of relief remained to be determined, there was no final judgment binding on the parties or the court. 67

68 Reissue and Supplemental Examination When is supplemental examination a better idea than reissue and does reissue basically get the owner to the same place a supplemental examination would in a shorter time? Would one use a combination of Reissue and Supplemental Examination to insulate reissued claims from allegation of inequitable conduct? 68

69 Supplemental Examination vs. Reissue? Reissue Cure May show prior art is not but-for material AIA eliminated the without deceptive intent requirement Examination Similar to ex parte prosecution RCE s and EOT s endless opportunity to amend Supplemental Examination (ex parte reexamination) Complete cure ex parte reexam if prior art raises a substantial new question of patentability but-for material? 2 Office actions before appeal No RCE s EOT s in limited situations only one opportunity to amend Examiner Regular examination corps Central Reexam Unit 3-examiner panel Timing with special dispatch Similar to ex parte prosecution Costs $3040 initial filing $1780 to issue Control Applicant PTO Error Must admit an error; dependent claim sufficient, see In re Tanaka Initial determination 3 mos Then ex parte reexam $4400 initial filing $12,200 if ex parte reexam No error needed 69

70 Supplemental Examination vs. Reissue 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? 70

71 Supplemental Examination vs. Reissue 3 months for PTO to indicate whether or not submitted information raises a SNQP. [ 257(a), 125 STAT. 325] If no SNQP, subject to exceptions on previous slide, patent cannot be held unenforceable on considered information ; isn t that but-for materiality? If yes, can trigger reexam But patentee cannot make submissions regarding the art or claims before first Office Action. Assuming the patentee establishes patentability of the claim (either in original or amended form) in the reexamination over the SNQ raised by the information reviewed, the patentee is insulated in subsequent litigation from a charge of inequitable conduct based on that information [ 257(c)(1), 125 STAT. 326], subject to exceptions noted previously. 71

72 Supplemental Examination vs. Reissue America Invents Act, SEC. 12 [125 STAT. 325] Allows submission of prior art in your own patents But SE effect does not apply against allegations already raised in district court or ANDA notice para. IV before date of filing request ( 257(c)(2)(A)), [125 STAT. 326] or SE effect shall not apply to any defenses raised in ITC litigation/district court litigation unless SE and any reexam ordered therefrom is finished before the date on which the action is brought ( 257(c)(2)(B)). [125 STAT. 326] 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[.] [125 STAT. 325] Prior art? Inconsistent positions? Errors? Therasense: Rule 56? 72

73 Supplemental Examination vs. Reissue 257(f), 125 STAT. 327: Nothing in this section shall be construed (1) to preclude the imposition of sanctions based upon criminal or antitrust laws (including section 1001(a) of title 18, the first section of the Clayton Act, and section 5 of the Federal Trade Commission Act to the extent that section relates to unfair methods of competition); (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. Do (1)-(3) compel full disclosure as discussed in Therasense majority and dissent? Are they adequate brakes on affirmative egregious misconduct? 73

74 Supplemental Examination vs. Reissue Fraud exception [ 257(e), 125 STAT ] (e) FRAUD. If the Director becomes aware, during the course of a supplemental examination or reexamination proceeding ordered under this section, that a material fraud on the Office may have been committed in connection with the patent that is the subject of the supplemental examination, then in addition to any other actions the Director is authorized to take, including the cancellation of any claims found to be invalid under section 307 as a result of a reexamination ordered under this section, the Director shall also refer the matter to the Attorney General for such further action as the Attorney General may deem appropriate. What is fraud and what investigation is needed? Is that an attempt to compel full disclosure? Does this make Supp Exam a non-starter? See the next slide: may be useful during litigation 74

75 Source: 75

76 If You Have A Pending Patent Application, How Good An Idea Is Reissue? 76

77 Donna M. Meuth Associate General Counsel Intellectual Property Eisai, Inc. 4 Corporate Drive Andover, MA Donna_Meuth@eisai.com Thank you. Erika Arner Finnegan, Henderson, Farabow, Garrett & Dunner, LLP Two Freedom Square Freedom Drive Reston, VA erika.arner@finnegan.com Deborah Herzfeld Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 901 New York Avenue, NW Washington, DC deborah.herzfeld@finnegan.com Tom Irving Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 901 New York Avenue, NW Washington, DC tom.irving@finnegan.com 77