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Strategic Use of Patent Reissue:

Determining Whether and When

to Pursue a Reissue Application Correcting Errors, Responding to an IPR Challenge and Mastering the Recapture Rule

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Dr. Shing-Yi (Cindy) Cheng, Ph.D., Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Deborah M. Herzfeld, Of Counsel, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Thomas L. Irving, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

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Strategic Use of Patent Reissue: Determining Whether and When to Pursue a Reissue Application Correcting Errors, Responding to an IPR

Challenge, and Mastering the Recapture Rule

Donna Meuth

©Copyright Finnegan, 2016

Shing-Yi (Cindy) Cheng, Ph.D. Deborah Herzfeld Tom Irving

by

4

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.

5

Current Landscape: AIA Changes Impacting Patent Reissue

“without any deceptive intention” removed by AIA 35 U.S.C. § 251 – (a) IN GENERAL.—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 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.

6

How Have Patent Reissue Implications Changed Post-AIA?

Reissue applications can be merged with ex parte reexaminations. Reissue rules govern merged proceeding.

PGR/IPR PGR applicable for 9 months after reissue on new reissue claims (claims

with an EFD after March 15, 2013). Reissue “effective filing date” is original patent filing date.

Note §325(f): REISSUE PATENTS.—A post-grant review may not be instituted under this chapter if the petition requests cancellation of a claim in a reissue patent that is identical to or narrower than a claim in the original patent from which the reissue patent was issued, and the time limitations in section 321(c) would bar filing a petition for a post-grant review for such original patent.

IPR is available as normal.

We will now discuss what may the role of reissue be in these PGR/IPR proceedings.

7

How Have Patent Reissue Implications Changed Post-AIA?

Timing with concurrent PGR/IPR.

PGR/IPR filed or instituted before or after reissue

– reissue likely stayed.

PGR/IPR have 12-month statutory time limit; reissue has no

statutory time limit.

8

How Have Patent Reissue Implications Changed Post-AIA?

Timing with concurrent PGR/IPR (con’t)

No statute or rule dictating outcome; both are discretionary.

35 U.S.C. §315(d) and (325(d): (d) MULTIPLE PROCEEDINGS.—Notwithstanding sections 135(a), 251, and 252, and chapter 30, during

the pendency of an inter partes review [post grant review], if another proceeding or matter involving the patent is before the Office, the Director may determine the manner in which the inter partes review [post grant review] or other proceeding or matter may proceed, including providing for stay, transfer, consolidation, or termination of any such matter or proceeding.

37 C.F.R. 35 U.S.C. §42.122 and 42.222 (a) Multiple proceedings. Where another matter involving the patent is before the Office, the Board

may during the pendency of the inter partes review [post grant review] enter any appropriate order regarding the additional matter including providing for the stay, transfer, consolidation, or termination of any such matter.

Consistent with Response to Comment 90 in Changes to Implement Inter Partes

Review Proceedings, Post-Grant Review Proceedings, and Transitional Program for Covered Business Method Patents, 77 Fed. Reg. 48,680, 48707 (Aug. 14, 2012).

Effect of a reissue application filed after institution of a post-grant proceeding: “Under the rules, a stay, transfer, consolidation or termination would be an option in this situation. §§ 42.122 and 42.222. Both whether a stay, transfer, consolidation or termination would be ordered and the order of resolution would depend on particular facts and circumstances. The Board will take into consideration the impact on each proceeding on a case-by-case basis.”

9

Stays and Reissue

• Reissue likely stayed so IPR keeps to 1-year timeline. – Hewlett-Packard Co. v. MCM Portfolio, LLC, IPR2013-00217,

Paper 8 (May 10, 2013). – Two reissues were stayed pending PGRs (American Simmental

Assn. v. Leachman Cattle, PGR2015-0003, -0005).

• In terms of getting an IPR stayed in light of a pending

reissue. there has not been a lot of success so far of getting a stay in either direction. – See, e.g., Kaiser Aluminum v. Constellium Rolled Products

Ravenswood, LLC ,IPR2014-01002, a stay of the reissue/reexam in light of the IPR was requested and denied and a stay of the IPR in light of the reissue/reexam was requested and denied).

10

Stays and Reissue

• Requests to file motion to stay IPR: – Mercedes-Benz USA, LLC v. Velocity Patent, LLC, IPR2015-00290

(pending reexam; request filed prior to filing POPR): denied.

• Institution of IPR denied (pending reexamination): – Intromedic Co., Ltd. v. Given Imaging Ltd., IPR2015-00579: denied

• "Petitioner already had an opportunity to challenge the patentability of claim 1 in an inter partes [reexamination] proceeding, and currently is challenging the patentability of amended claim 1. Further, based on the current record, we are aware of no statutory bar or other impediment to Petitioner filing another petition seeking inter partes review of the ’634 patent, should a reexamination certificate issue in the future with amended claim 1 or any new claims. Based on the particular factual circumstances of this proceeding, including the fact that the only claim being challenged by Petitioner has been amended in the reexamination, the advanced stage of the reexamination involving the same parties, and the balance of potential prejudice to the parties, we exercise our discretion under 35 U.S.C. § 314(a) and 37 C.F.R. § 42.108(b) and decline to institute an inter partes review."

11

Stays and Reissue (con’t)

• In Greene’s Energy Group, LLC v. Oil States Energy Services, LLC, IPR2014-00216, PTAB noted that if the Patent Owner filed a reissue application, it had to inform PTAB: – “Patent Owner indicated that it was considering filing an application to reissue at least

one of the patents involved in these inter partes reviews. We reminded Patent Owner that, because the Board exercises jurisdiction over the patents, see 37 C.F.R. § 42.3(a), Patent Owner must contact the Board before filing any reissue application concerning the ’053 or ’993 patents.”

• 37 C.F.R. § 42.3(a) The Board may exercise exclusive jurisdiction within the Office over every involved application and patent during the proceeding, as the Board may order.

• In Focal Therapeutics, Inc. v. Senorx, Inc., IPR2014-00116, during a conference call,

the Patent Owner indicated it wanted to file a reissue application. PTAB stated: – “The Board explained that authorization or permission by the panel is not required in

this regard. If it so wishes, Patent Owner may go through usual channels to request such action before the Office. We explained, however, that given our one year statutory deadline for completing an inter partes review, we would not grant a stay of this proceeding pending the outcome of a request for certificate of correction and/or reissue application. We also indicated that if Patent Owner takes such action, it shall keep the panel and Petitioner apprised of relevant events by filing a copy of relevant papers with the Board promptly.”

12

The AIA Post-Grant Options Contrast with Reissue (Other Than Supplemental Examination)

Ex Parte Reexam

Post-Grant Review

Covered Business Methods PGR

Inter Partes Review

When After grant Within nine months of grant (only AIA patents)

After grant, for covered business method patents

After 9 months of grant (AIA patents) or

terminated PGR

Threshold showing

SNQ More likely than not claim is unpatentable or novel legal

question

More likely than not PLUS sued or

charged with infringement

Reasonable likelihood of

success

Grounds Patents/printed publications

102, 103

101, 102, 103, 112

101, 102, 103, 112 Patents/printed publications

102, 103

Time at PTO Years 12-18 months 12-18 months

12-18 months

Anonymity Yes No No No

13

The AIA Post-Grant Options Contrast with Reissue (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

PTO: raised or could have raised

Dist Ct: raised

Issues raised or reasonably could have been raised

Before whom

CRU PTAB PTAB PTAB

Discovery/ evidence

Declaration Declaration and “discovery”

Declaration and “discovery”

Declaration and

“discovery”

Appeal Only patent owner may appeal to PTAB then

Federal Circuit

Both parties may appeal to Federal Circuit

Both parties may appeal to Federal Circuit

Both parties may appeal to Federal Circuit

14

ISSUE PGR/CBM PGR/IPR DISTRICT COURT

Burden of proof 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

IPR/PGR Weighted Against the Patent Owner: Reissue Has Same Standards but one CRU Examiner

no deference

15

Rocket Docket Procedure/Timeline for Post-Grant Options: An Opening for Reissue but what about Stays?

Petition Final

Written Decision

Oral Hearing

PO Reply Petitioner

Reply/ Opposition

PO Response/ Motion to

Amend

Decision/ Institution

PO Prelim. Response

PO Discovery on Real Parties in

Interest (3 months)

PO Discovery (3 months)

Petitioner Discovery

(3 months)

PO Discovery

(1 month)

3 3 3 ≤ 3 1 ≤ 3 months 2

Period for

Observation & Motions

(2 months)

Sample timeline from USPTO.

16

Reissue Applications Now Go to Central Reexam Unit – Historically, Not the Fast

Lane…

17

Source: USPTO CRU statistics, http://www.uspto.gov/sites/default/files/documents/Website%20Op%20stats%20FY15%20070815.pdf No specific statistics for reissue applications.

17

SNAPSHOT OF REISSUE APPLICATIONS: 63% GRANT RATE (6860/10957)(2006-2015)

1103 1057 1080

1035

1144 1158 1212

1074

1207

887

500 548

662

398

861

969 921

809

661

531

0

200

400

600

800

1000

1200

1400

2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Reissue applications filed Reissue patents issued

Source: USPTO Annual Reports. 2015, reissue patents = <1% of total patent applications filed (617,216 in 2015) Volume is similar to that of plant patents. 63% of reissue applications filed issued (6860/10957). Reissue application filing fee: $280 (!) (37 C.F.R. § 1.16) 18

Thus far in IPRs… Hundreds of claims, entire patents cancelled*

*As of Dec. 1, 2015. Source: Finnegan research., http://www.aiablog.com/claim-and-case-disposition/

19

What Patent Strengthening Benefits Can Reissue Provide In

AIA Post-Grant Proceedings Before PTAB, As Well As In District Court Litigation?

20

PGR/IPR/Reissue—Timing Requirements Related to Litigation

• Cannot file AIA post grant challenge if challenger also filed civil action challenging validity of patent (35 U.S.C. §315(a)(1) and §325(a)(1)). – Petitioner, real party, or privy of petitioner. – Does not include counterclaim. – No such limitation against Patent Owner’s Reissue.

• Cannot file IPR more than 12 months after the petitioner is served with

a complaint alleging infringement of patent. – No such limitation on Reissue.

• No such timing requirements on Reissue other than the normal ones,

and particularly the two year bar against broadening reissue.

21

Petitioner Estoppel: PGR and IPR 35 U.S.C. §315(e) and §325(e)

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

No petitioner estoppel if no PTAB decision on the merits. •§317(a) and §327(a): 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.

Also remember §325(f): REISSUE PATENTS.—A post-grant review may not be instituted under this chapter if the petition requests cancellation of a claim in a reissue patent that is identical to or narrower than a claim in the original patent from which the reissue patent was issued, and the time limitations in section 321(c) would bar filing a petition for a post-grant review for such original patent.

22

But: Patent Owner Estoppel Could Make Reissue An Interesting Alternative If

No Pending Continuation Application

• AIA post grant 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.

• Reissue has no formal patent owner estoppel, but subject

to patentably distinct requirement?

23

In IPR/PGR, Patent Owner Can Theoretically Make Limited Amendments Once

35 U.S.C. §316(d)(1) and §326(d)(1) • Reissue: multiple amendments subject to recapture, broadening,

§112 requirements.

• In AIA post grant, Patent Owner must confer with the Board before filing a motion to amend the claims. – Office Patent Trial Practice Guide, 77 Fed. Reg. 47,864 (Aug. 14, 2012):

“Patent owners in IPR, PGR, and CBM proceedings will be permitted to file a first motion to amend the patent, after conferring with the Board. §§ 42.121(a) and 42.221(a).”

• Use PTAB decisions designated as “Representative” to guide Motion

to Amend practice. – Although statute contemplates multiple motions to amend (35 U.S.C.

§316(d)(2) and §326(d)(2)), no additional motions to amend granted yet; assume only get one motion to amend.

24

PTAB’s Representative Decisions on

Motions to Amend

• Nichia Corp. v. Emcore Corp., IPR2012-00005, Order regarding Written Description Support for Substituted Claims, Paper 27, June 3, 2013

– Conference call clarifying that Emcore complied with the requirement to

confer with the Board before filing of its motion to amend.

– PTAB comments: • “a motion to amend claims must clearly identify the written description support for the

proposed substitute claims. In particular, 37 C.F.R. § 42.121(b)(1) requires the patent owner to set forth the support in the original disclosure of the patent for each proposed substitute claim.”

• “merely indicating where each claim limitation individually described in the original

disclosure may be insufficient to demonstrate support for the claimed subject matter as a whole.”

• “should the claim language does not appear in ipsis verbis in theoriginal disclosure, a

mere citation to the original disclosure without any explanation as to why a person of ordinary skill in the art would have recognized that the inventor possessed the claimed subject matter as a whole may be similarly inadequate”

25

PTAB’s Representative Decisions on

Motions to Amend (con’t)

• Idle Free Systems, Inc. v. Bergstrom, Inc., IPR2012-00027, Paper 26 (Providing guidance on motions to amend), June 11, 2013

– Motion to Amend dismissed because motion was deficient and Patent Owner filed without

having conferred with the Board first. Patent Owner provided opportunity to re-file. • Renewed motion to amend denied in Final Written Decision holding challenged claims unpatentable.

– PTAB comments:

• “in the absence of special circumstance, a challenged claim can be replaced by only one claim, and a

motion to amend should, for each proposed substitute claim, specifically identify the challenged claim which it is intended to replace. Without such indication, the Board does not have adequate basis to determine the reasonableness of the number of substitute claims for each original claim. The determination is made on a claim-by-claim basis, consistent with statutory language that refers to a reasonable number of substitute claims for “each” challenged claim. 35 U.S.C. § 16(d)(1)(B); 37 C.F.R. § 42.121(a)(3). All proposed claims should be traceable to an original challenged claim as a proposed substitute claim for that challenged claim.”

• “A proper substitute claim under 37 C.F.R. § 42.121(a)(2)(i) must only narrow the scope of the

challenged claim it replaces.”

• “For each proposed substitute claim, we expect a patent owner: (1) in all circumstances, to make a

showing of patentable distinction over the prior art; (2) in certain circumstances, to make a showing of patentable distinction over all other proposed substitute claims for the same challenged claim; and (3) in certain circumstances, to make a showing of patentable distinction over a substitute claim for another challenged claim.”

26

PTAB’s Representative Decisions on Motions to Amend (con’t)

• Int'l Flavors & Fragrances Inc. v. The United States of America, IPR2013-00124, Paper 12 (Granting-in-part Motion to Amend), May 20, 2014

– Most but not all proposed substitute claims granted.

– Unopposed.

– PTAB comments:

• No broadening of scope.

• Showed written description support.

• Showed most proposed substitute claims patentable over the prior art.

27

PTAB’s Representative Decisions on Motions to Amend (con’t)

• Corning Optical Communications RF, LLC v. PPC Broadband, Inc., IPR2014-00441, Order on Motion to Amend Claims, Paper 19, October 30, 2014 – Eventually motion to dismiss for failure to name all real-parties-in-interest granted. – Conference call providing guidance on motions to amend. – PTAB comments:

• A proposed substitute claim should be responsive to the ground of unpatentability applicable to the original patent claim for which it is a substitute.”

• “The presumption is that only one substitute claim is needed for each original patent claim.. . . The proposed substitute claim must be traceable back to the original patent claim that it is intended to replace.”

• “The Patent Owner bears the burden of proof to establish that it is entitled to the relief requested in the motion to amend. See 37 C.F.R. §42.20(c). If the motion is granted, the proposed substitute claims will be added to the involved patent, without examination.”

• “In the motion to amend, the Patent Owner also must show written description support in the specification for each proposed substitute claim. Importantly, citation should be made to the original disclosure of the application, as filed, rather than to the patent as issued. Also, it is inadequate to show written description support for just the feature added by the proposed substitute claim. Instead, the Patent Owner must show written description support for the entire claim.”

• “If a new term is used in a proposed substitute claim, the meaning of which reasonably can be anticipated as subject to dispute, the Patent Owner should provide a proposed claim construction in the motion to amend. ”

• “the motion to amend should include a discussion of the ordinary skill in the art, with particular focus on the feature added to provide the basis of patentable distinction.”

28

PTAB’s Representative Decisions on Motions to Amend (con’t)

• MasterImage 3D, Inc. v. RealD Inc., IPR2015-00040, Paper 42 (PTAB July 15, 2015)

– Expanded panel of 6 judges.

– Conference call indicating Patent Owner should follow Idle Free, with following clarification:

• “prior art of record” means: – any material art in the prosecution history of the patent; – any material art of record in the current proceeding, including art asserted in grounds on

which the Board did not institute review; and – any material art of record in any other proceeding before the Office involving the patent.

• “prior art known to the patent owner” means “no more than the material prior art that Patent

Owner makes of record in the current proceeding pursuant to its duty of candor and good faith to the Office under 37 C.F.R. § 42.11, in light of a Motion to Amend.

• “once Patent Owner has set forth a prima facie case of patentability of narrower substitute claims over the prior art of record, the burden of production shifts to Petitioner…[but] the ultimate burden of persuasion remains with Patent Owner, the movant, to demonstrate the patentability of the amended claims.”

29

Cannot Rely on Being Able to Amend Claims in IPR

Finnegan research, http://www.aiablog.com/claim-and-case-disposition/ (as of Dec. 1, 2015).

26 substitute claims represent 4 cases.

There is an additional CBM case, Chicago Mercantile Exchange Inc., v. 5th Market Inc., CBM2013-00027, Paper 38 (PTAB March 23, 2015), granting-in-part Patent Owner’s Request for Rehearing and modifying the Final Written Decision to grant 5th Market’s motion to amend proposed substitute claim 54. 30

Winds of Change for Amending Claims? Not Really

• Director's Forum: A Blog from USPTO's Leadership, Friday Mar 27, 2015

– Announced new rules will raise the page limits for motions to amend

and petitioner’s reply from 15 pages to 25 pages, effective immediately.

– Second rule package may include further modifications to the motion to amend process:

• "a patent owner will not be required to make a prior art representation as to the patentability of the narrowed amended claims beyond the art of record before the office.“

– Although “the duty of candor and good faith [still] requires the patent owner to make of record any additional prior art material to patentability known by the patent owner.”

Did not happen in 2nd rules package released Aug. 20,

2015

31

Motions-to-Amend Practice Discussed in Proposed Rules

• 10 additional pages for patent owner’s motion to amend, claims appendix allowed, and 10 additional pages for a petitioner’s reply brief.

• “At this time, the Office does not contemplate seeking assistance from the Examining Corps for review of motions to amend.” (Response to Comment 3).

• Using opinions to shape motions-to-amend practice. – “The Office is committed to improving its rules and practices for

motions to amend and AIA trial practice in general. Accordingly, the Office will continue to make improvements and clarifications via the rule-making process, by updating the Office Patent Trial Practice Guide, and by designating opinions as precedential or informative, as warranted.” (Response to Comment 1).

32

Recent Federal Circuit Opinion Relating To Motions To Amend

• Prolitec, Inc. v. Scentair Technologies, Inc., 807 F.3d 1353 (Fed. Cir. 2015)

– PTAB: Challenged claims unpatentable and denied Prolitec's motion to amend for failure to show patentability of proposed substitute claim over prior art.

– FC: Affirmed. • Prolitec argued that it did not have the burden to establish patentability over prior

art references cited in the patent's original prosecution history because they are not prior art of record in the IPR.

• PTAB: “The Board's position—that the patentee's burden on a motion to amend includes the burden to show patentability over prior art from the patent's original prosecution history—is not in conflict with any statute or regulation. Moreover, it is not unreasonable to require the patentee to meet this burden.”

– MasterImage 3D, Inc. v. RealD Inc., IPR2015–00040, 2015 WL 4383224 (PTAB July 15, 2015): “prior art of record” includes “any material art in the prosecution history of the patent.”

33

So, Consider Having Patent Owner in IPR/PGR Go to Reissue

• As seen, Motions to Amend have not been very successful.

• 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 PTO-imposed patent owner estoppel.

34

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, considering likely stay.

• Reissue likely stayed pending disposal of IPR/PGR within the one year period from institution.

• If claims of patent canceled in IPR/PGR, Patent Owner wants to look for patentably distinct claims in reissue that are enforceable and still infringed.

35

Particularly in Pharma

• 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 Orange book listed claims.

• Institute new Hatch-Waxman litigation with narrower reissue claims, but probably will not get a 30 month stay on the reissue claims if in fact, there was a 30 month stay based on other Orange Book listed patents in an earlier H-W litigation.

• But how realistic will this be, particularly if PGR/IPR patent owner estoppel sticks? – Owner would be looking for reissue claims that can be enforced but that

are separately patentable over claims lost in PGR/IPR?

36

Particularly in Pharma (con’t)

• Can the reissue beat IPR/PRG to the punch and be resolved BEFORE IPR/PGR?

• And perhaps the best is to have a pending continuing case where separately patentable claims can be pursued ex parte wihout stay. – AC Dispensing Equipment, Inc. v. Prince Castle, LLC, IPR2014-00511, Paper

(PTAB Oct. 17, 2014) • Petitioner requested permission to file a motion to stay the prosecution of the

continuation patent application. • PTAB: Denied.

– “Patent Owner will not be permitted to obtain in a patent any claims that are not patentably distinct from any claim that is canceled as a result of this proceeding. But whether any of the claims in the ’497 patent will be canceled is an issue that is not yet decided and will not necessarily be decided until a final written decision is entered in this case and appeals from it are exhausted. To bar Patent Owner from prosecuting claims now that may be patentably indistinct from the claims under review thus would be premature. It is sufficient, under the current circumstances, for Patent Owner to continue to take reasonable steps to apprise the Examiner of the status of this proceeding.”

37

AIA Makes No Difference on Doctrine of Intervening Rights

• No 3rd party intervening rights for reissue claims substantially identical to original patent.

• May be 3rd party intervening rights for changed reissue 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.

– But again, a pending continuing application could allow for patentably distinct claims without intervening rights.

38

AIA Does Not Affect Existing Doctrine Against Recapture Precluding Reissue

• Federal Circuit recapture test to be explained.

• Interplay of the recapture rule and the Orita doctrine. – Orita doctrine: when claims are restricted during original

prosecution of the underlying patent application, and those claims are not pursued in a divisional application, such claims cannot be obtained by patent reissue.

• MPEP will be most important to examiners on

reissue/recapture but Federal Circuit decisions could mean more to PTAB, a district court, and the Federal Circuit.

39

Traditional Recapture

• Subject matter surrendered to obtain the original patent cannot be recaptured by filing a reissue.

• Consider in context of broadest reasonable claim construction that will be applied by PTAB.

• “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.

40

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 (see also, MPEP §1412.02)

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 3rd step.

41

Prosecution Arguments May Trigger 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.

– 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.”

42

• 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; invalid under 35 U.S.C. § 251 for impermissibly recapturing subject matter surrendered during reissue examination.

– FC: Reversed and remanded. • 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.

Claim Construction May Impact Recapture

43

Further Considerations for Countering Future IPR/PGR Attacks:

Develop Validity/Patentability Positions in Reissue

44 44

If There Is No Co-pending Continuing Application, Reissue May be Best Way to Strengthen Patent

• 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.”

MPEP §1402 45

Use of Tanaka

• Reissue Declaration

46 46

Issues of Obviousness-type Double Patenting (ODP) Can Be Addressed In Reissue but Currently ODP

Cannot be raised in IPR or PGR

Given the present state of ODP law, that is not necessarily a good thing for the Patent Owner

Patent reform efforts to codify, e.g., Goodlatte “Innovation Act”

passed house in 2013 would codify ODP as section 106.

Thus, under “Innovation Act,” ODP would be a grounds for review in Post-Grant Proceedings immediately after issue http://www.stlr.org/2014/03/a-not-so-obvious-threat-to-

pharmaceutical-patent-portfolios/

But as of right now, no patent reform bills have passed.

47 47

Obviousness-Type Double Patenting in IPR?

• No decision yet in IPR. – IPR2013-00269 (raised ODP, Patent Owner argued ODP not statutory basis

for IPR; terminated due to settlement)

– IPR2013-00607, IPR2013-00609, IPR2013-00612, IPR2013-00613,

IPR2013-00615, IPR2013-00616, IPR2013-00618 • Same Petitioner and Patent Owner

• Petitioner raised ODP but IPRs not instituted for failure to identify real-party-in-interest.

• But PTAB decision in CBM PGR said “no.” – “Obviousness-type double patenting is a judicially created, policy based

doctrine, not a statutory ‘ground specified in [the AIA statute]. Therefore,

obviousness-type double patenting is not a permissible ground for

challenging claims in Covered Business Method review.” Apple Inc. v.

SightSound Techs., CBM2013-00021, Paper 13, at 25 (Oct. 8, 2013).

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Later-Issued, First-Expiring is ODP Reference Against First-Issued, Later-Expiring

• Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014) – Gilead’s U.S. Pat. Nos. 5,763,483 and 5,952,375 commonly-owned, list same

inventors, similar written descriptions, BUT do not claim priority to a common patent application and have different expiration dates.

– Natco: ′483 patent was invalid for ODP over ′375 patent.

– Gilead: ′375 patent cannot serve as a ODP reference against the ′483 patent.

timeline from opinion 49

Federal Circuit Expands ODP? • Gilead (con’t)

– DC: Judgment of infringement. • “a later-issued but earlier-expiring patent” cannot “serve as a double-patenting reference

against an earlier-issued but later-expiring patent.”

– FC: Vacate and remand. • “Can a patent that issues after but expires before another patent

qualify as a double patenting reference for that other patent?...under the circumstances of this case that it can[.]”

• “it is a bedrock principle of our patent system that when a patent expires, the public is free to use not only the same invention claimed in the expired patent but also obvious or patentably indistinct modifications of that invention. …And that principle is violated when a patent expires and the public is nevertheless barred from practicing obvious modifications of the invention claimed in that patent because the inventor holds another later-expiring patent with claims for obvious modifications of the invention. Such is the case here.”

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Federal Circuit Expands ODP? Federal Circuit’s example “if the ’375 patent issued the day before the ’483 patent, in Gilead’s view, the last twenty-two months of the term of the ’483 patent would be an improper extension of patent term.”

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Federal Circuit Expands ODP? Federal Circuit’s example “if the ’375 patent issued the day after the ’483 patent, those last twenty-two months of the term of the ’483 patent would not be an improper extension of patent term.”

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Judge Rader Dissent • Gilead dissent (con’t)

– Court’s new rule expanding the judicially-created doctrine of obviousness-type

double patenting “unwarranted”

– No reason to apply double patenting • does not raise policy concern regarding subsequent extensions of patent term; • this case does not involve the potential for harassment by multiple assignees

asserting essentially the same patented invention.

– “Instead of claiming priority to the ′375 patent family, Gilead filed the

application that ultimately issued as the ′483 patent as a separate family. In the process, Gilead gave up roughly 10 months of priority. Consequently, the ′483 patent is subject to roughly 10 months of intervening prior art. Nevertheless, despite sacrificing almost a year of priority, the court contends that Gilead acted improperly by continuing to pursue claims in the application that issued as the ′375 patent.” (emphasis in red added)

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Gilead = Expansion or Limited to Facts?

• Specific circumstances: – both patents/applications are post-URAA (subject to

20-year from filing patent term); and – patents/applications have different earliest non-

provisional filing dates and therefore different expected expiration dates.

• What about impact on patents with PTA awards?

– particularly in patent families with continuations

• Status: Petition for certiorari denied, 135 S.Ct. 1530 (USSC March 9, 2015).

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Expanding Gilead?

• Abbvie, Inc. v. Kennedy, 764 F.3d 1366 (Fed. Cir. 2014) – Kennedy patents 7,846,442 (the ’442 patent) and 6,270,766

(the ’766 patent). • Both patents are directed towards methods of treating rheumatoid

arthritis by co-administering two drugs.

– AbbVie licensed the ’766 patent, but not the ’442 patent.

• FDA approval to sell Humira®

– AbbVie sued Kennedy for a DJ that the ’442 patent was invalid

under ODP.

– DC: ‘422 invalid for ODP. – FC: Affirmed.

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Two Patents on Combination Therapy

‘766 priority

date Oct. 8, 1992

‘766 patent

appln filed Aug.1, 1996

‘766 patent issued Aug. 7, 2001

‘766 patent expire Oct. 8, 2012

‘442 patent

appln filed Sept. 12,

2005

‘442 patent issued Dec. 7, 2010

‘442 patent expire

Aug. 21, 2018

claimed priority

claimed later priority

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Claims • ‘766 Claim 8: A method of treating rheumatoid arthritis in an

individual in need thereof comprising co-administering methotrexate and an [anti-TNFα] antibody or an antigen-binding fragment thereof to the individual, in therapeutically effective amounts.

• ‘442 Claim 1: A method of treating an individual suffering from rheumatoid arthritis whose active disease is incompletely controlled despite already receiving methotrexate comprising adjunctively administering with methotrexate therapy a different composition comprising an anti-human [TNFα] antibody or a human [TNFα] binding fragment thereof to the individual, wherein the anti-human [TNFα] or fragment thereof (a) binds to an epitope on human [TNFα], (b) inhibits binding of human [TNFα] to human [TNFα] cell surface receptors and (c) is administered at a dosage of 0.01-100 mg/kg, and wherein such administration reduces or eliminates signs and symptoms associated with rheumatoid arthritis.

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Specifications

• ‘766 Specification: a multiple dose regimen of . . . an [anti-TNF] antibody, when administered adjunctively with methotrexate to an individual suffering from a TNF-mediated disease[,] produces a highly beneficial or synergistic clinical response for a significantly longer duration compared to that obtained with a single or multiple dose regimen of the antagonist administered alone or that obtained with methotrexate administered alone.

• ‘442 Specification: identical

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District Court’s Claim Construction

• “coadministering”: encompass[es] three possibilities for the order of administration of the methotrexate and anti-TNFα antibody . . . : [“concomitantly”]; …methotrexate is begun first and treatment with antibody is then added (“adjunctively”); or …antibody is begun first and treatment with methotrexate is then added (“adjunctively”)[.]

• “adjunctively”: “method of administration of methotrexate and an anti-TNFα antibody in which therapy with an anti-TNFα antibody (or fragment thereof) is added to ongoing methotrexate treatment.”

• “the ’442 patent’s ‘adjunctive’ administration is one of the three forms of “co-administration” covered by the ’766 patent.”

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District Court Decision

• “[i]n light of the limited universe of treatment methods within the genus of co-administration defined by claims 8 through 14 of the ’766 patent, a person of ordinary skill in the art would have envisaged the species of adjunctive administration defined by claims 1 and 2 of the ’442 patent.”

• “a person of ordinary skill in the art would not consider there to be a substantial difference between the patient populations identified by claim 8 of the ’766 patent and claim 1 of the ’442 patent.”

• ’442 patent claims invalid for ODP over the ’766 patent.

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Federal Circuit Decision

• “We now make explicit what was implicit in Gilead: the doctrine of obviousness-type double patenting continues to apply where two patents that claim the same invention have different expiration dates. We hold that Kennedy is not entitled to an extra six years of monopoly solely because it filed a separate application unless the two inventions are patentably distinct.”

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Federal Circuit Decision Step 1: Construe Claims

• District court’s claim construction of “co-administration was correct.

– ’766 patent’s specification “makes clear that the invention described in the claims is limited to concomitant and adjunctive use.”

– “nowhere suggests that the invention includes administration of the antibody alone after discontinuing treatment with methotrexate.”

• “We assume, without deciding, that Kennedy's proposed construction of ‘active disease’ was correct.” – ‘442 directed to subset of patients with more severe rheumatoid arthritis;

– ‘766 directed to arthritis patients generally.

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Federal Circuit Decision Step 2: Analyze if Claims Are Directed to

“Patentably Distinct” Subject Matter • “Thus, species are unpatentable when prior art disclosures

describe the genus containing those species such that a person of ordinary skill in the art would be able to envision every member of the class. Here, we think it is clear that a reader of the ′766 patent could have easily envisioned a species limited to sicker patients.” (emphasis in red added)

• “the ′442 patent merely claims the known utility of the ′766 patent and does not claim a species with unexpected results.”

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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 § 1442.

A reissue can be useful in view of litigation, irrespective of any AIA

Post Grant proceeding considerations.

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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.)

USPTO Claim Construction Standard MPEP §2111: Applies to Both IPR/PGR and Reissue

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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 broadest-construction 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.”

But USPTO Standard For Both IPR/PGR and Reissue Has Limits

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• 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”).

How Does The Federal Circuit Review PTAB Claim Constructions?

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De Novo Review Because Only Intrinsic (First Departure From Complete Affirmance)

• Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292 (Fed. Cir. 2015)

– PTAB: all of the challenged claims except claim 24 unpatentable (IPR2012-00026 and IPR2013-00109)

– Microsoft appealed determination that claim 24 is patentable.

– Proxyconn cross-appealed, challenging PTAB’s use of the BRI and unpatentability determinations.

– Fed. Cir.: • De novo review because “the intrinsic record fully determines the proper construction[.]” • Cuozzo controls.

– “Because we are bound by the decision in Cuozzo, we must therefore reject Proxyconn’s argument that the Board legally erred in using the broadest reasonable interpretation standard during IPRs.”

• Concluded that PTAB’s unpatentability determinations were based on an unreasonably broad construction - vacate and remand.

• On remand, PTAB again held claims unpatentable, Microsoft Corp. v. Proxyconn, Inc., IPR2012-00026, Paper 80 (P.T.A.B. Dec. 1, 2015).

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68

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 unpatentability affirmed despite earlier opposite finding in district court and affirmance by Federal Circuit

Considered Federal Circuit’s earlier affirmance of validity, but Federal Circuit in this case 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.

But if patent owner loses in litigation, cannot use reissue to resurrect the lost claims.

But can use reissue to secure claims separately patentable from the lost claims Patent Ownner needs to seek such cllaims that are nonetheless still infringed

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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.

But Fresenius is for the alleged infringer!

Paten t Owner would want to try to use reissue to secure separately patentable claims over claims lost at PTAB.

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71

Reissue and Supplemental Examination

When is supplemental examination a better idea than reissue and does reissue basically get the owner to the same place as supplemental examination would but in a shorter time?

Would one use a combination of Reissue and Supplemental Examination to insulate reissued claims from allegation of

inequitable conduct?

Supplemental Examination vs. Reissue? Reissue Supplemental Examination

(ex parte reexamination)

Cure May show prior art is not “but-for” material

AIA eliminated the “without deceptive intent” requirement

Complete cure ex parte reexam if prior art raises a

substantial new question of patentability – “but-for” material?

Examination Similar to ex parte prosecution RCE’s and EOT’s “endless” opportunity to amend

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

Initial determination – 3 mos Then ex parte reexam

Costs $3040 initial filing $1780 to issue

$4400 initial filing $12,200 if ex parte reexam

Control Applicant PTO

Error Must admit an error; dependent claim sufficient, see In re Tanaka

No error needed

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• 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?

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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.

• And some reexams historically have gone on for a long time

• 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.

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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?

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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”?

Supplemental Examination vs. Reissue

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• Fraud exception [§257(e), 125 STAT. 326-327]

– (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

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Supplemental Examination vs. Reissue

78 Source: http://www.uspto.gov/aia_implementation/statistics.jsp

Effect of Reissue

• Patent is deemed wholly or partly invalid or inoperable due to at least one error: the benefits of Tanaka.

• Reissue can cure that

• Unexpired term of the patent: no additional PTA or PTE, but also reissue doesn’t adversely affect either.

• Effective date of claims. – Can you foot fault into AIA with a PA on the day the

reissue is filed?

• Intervening rights.

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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.

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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 in IPR/PGR 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.

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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 two-

year anniversary of IPR: the signal is that PTAB cannot resolve cases within twelve month requirement if additional discovery is granted.

• If not stayed, a successful reissue can be good for litigation also perhaps provide a better case for defeating institution of IPR/PGR

82

What Are The Benefits 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 (subject to recapture and 2 year

window) New products (patent owner or third-party) Unclaimed embodiments or species

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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.

84

Portfolio Management: Consider Impact of Reissue On and

Before Ongoing PTAB IPRs and PGRs, Court Litigation, and Licensing Deals

85

• AC Dispensing Equipment, Inc. v. Prince Castle, LLC, IPR2014-00511, Paper (PTAB Oct. 17, 2014)

– Petitioner requested permission to file a motion to stay the prosecution of the continuation patent application.

– PTAB: Denied.

• “Patent Owner will not be permitted to obtain in a patent any claims that are not patentably distinct from any claim that is canceled as a result of this proceeding. But whether any of the claims in the ’497 patent will be canceled is an issue that is not yet decided and will not necessarily be decided until a final written decision is entered in this case and appeals from it are exhausted. To bar Patent Owner from prosecuting claims now that may be patentably indistinct from the claims under review thus would be premature. It is sufficient, under the current circumstances, for Patent Owner to continue to take reasonable steps to apprise the Examiner of the status of this proceeding.”

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Instead of Reissue, Keep Continuation Pending…

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

Shing-Yi (Cindy) Cheng, Ph.D. Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 901 New York Avenue, NW Washington, DC 20001-4413 202.408.4244 cindy.cheng@finnegan.com

Deborah Herzfeld Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 901 New York Avenue, NW Washington, DC 20001-4413 202.408.4368 deborah.herzfeld@finnegan.com

Donna M. Meuth Associate General Counsel Intellectual Property Eisai Inc. 4 Corporate Drive Andover, MA 01810 978.837.4862 Donna_Meuth@eisai.com

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