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Inter Partes Review Proceedings
October 9, 2012
John Murnane
Christina Schwarz
Initiating Inter Partes Review (IPR)
Who can seek IPR?
•Non-owner of patent (petitioner) may file a petition to institute IPR (§ 311(a)) unless
the petitioner/real party in interest (RPI):
• Previously filed a civil action challenging validity of a claim of the patent
(§ 315(a)(1)), or
• Was sued for infringement of a claim of the patent and more than 1 year has
elapsed since receipt of complaint (§ 315(b))
Filing deadlines?
•A petition shall be filed after the later of either:
• 9 months after the grant or reissue of a patent (§ 311(c)(1)) or
• Termination of any post-grant review (PGR) (§ 311(c)(2))
Grounds for cancellation?
•Grounds under 35 U.S.C. §§ 102, 103 (limited to prior art patents and printed
publications) (§ 311(b))
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Initiating Inter Partes Review (IPR) –
Petition
Petition requirements (§ 312(a); 37 CFR § 42.104)
•Payment of fee: $27,200 for 20 or fewer claims ($600 for each additional claim) (37
CFR § 42.15)
•Certification that patent is subject to IPR and petitioner is not estopped from
requesting IPR
•Identification of all “real parties in interest” (RPIs) (see 77 FR at 48759-60)
•Identification of each claim challenged, grounds on which challenge is based, how
challenged claim is to be construed, and supporting evidence
•Copies of all patents or printed publications and any affidavits with supporting
evidence or expert opinion
•Petition and all supporting evidence must be supplied to the patent owner
Public proceeding
•Petition will be made available to the public (§ 312(b))
• Petitioner may file motion to seal confidential information (37 CFR § 42.55)
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Initiating Inter Partes Review (IPR) –
Patent Owner’s Response
Patent owner may file a preliminary response to the petition (§ 313)
•Response must be filed within 3 months; patent owner can expedite proceedings
electing to waive preliminary response (37 CFR § 42.107(b))
•Response limited to providing reasons why the petition fails to meet the
requirements for grant, such as: (see 77 FR at 48764)
• Petitioner is statutorily barred from pursuing review (e.g., petition is untimely;
petitioner previously filed declaratory judgment action)
• Asserted references are not prior art; prior art lacks a material claim limitation;
prior art teaches away
• Petitioner’s claim interpretation is unreasonable
•Patent owner not permitted to present any testimonial evidence, unless “necessary in
the interests of justice” (37 CFR § 42.107(c); 77 FR at 48764)
•No adverse inferences will be drawn where patent owner elects not to file a response
or elects to waive the response (77 FR at 48689)
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Mandatory Initial Disclosures
• Trial Practice Guide sets forth two options for “Mandatory Initial Disclosures” (77 FR
48761-62)
• Parties may agree to provide the mandatory initial disclosures set forth in the Trial
Practice Guide (37 CFR § 42.51(a)(1))
• Parties’ agreement must be submitted by filing date of the patent owner
preliminary response or due date for that response if no response is filed
• If parties fail to agree on mandatory initial disclosures, a party may file a motion
seeking such disclosures (37 CFR § 42.51(a)(2))
• Protective Order may be entered to protect exchange and submission of confidential
information (37 CFR § 42.54)
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Mandatory Initial Disclosures
Patent Trial Practice Guide’s options for initial disclosures: (77 FR at 48761-62)
• Option 1: identification of (a) persons likely to have discoverable information and (b)
documents/things that may be used to support a claim or defense (similar to FRCP
Rule 26)
• Option 2: Where petition seeks cancellation of claims based on a non-published
public disclosure or obviousness (secondary considerations), identification of:
• All persons reasonably likely to know of the disclosure/have information
relevant to secondary considerations, and whether they are within the
petitioner’s control and represented by counsel (excludes persons offering
affidavits)
• All documents and things relating to the disclosure/secondary considerations
within petitioner’s possession, custody, or control
• All things relating to the disclosure/secondary considerations, their locations,
and whether petitioner will produce them for inspection/testing
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The Director’s Decision to Grant IPR
• Director must render a decision within 3 months of receiving patentee's response,
waiver or expiration of the time period to file a response (§ 314(b))
• Standard for granting IPR: “there is a reasonable likelihood that the petitioner
would prevail with respect to at least 1 of the claims challenged” (§ 314(a))
• Claim terms are to be given their broadest reasonable construction in light of
the specification (37 CFR § 42.100(b))
• PTO must provide written notice of the decision to the parties and public (§ 314(c))
• Board will identify, on a claim-by-claim basis, the grounds on which the trial
will proceed (see 77 FR at 48757)
• Director's decision is final and cannot be appealed (§ 314(d))
• Party may request rehearing as to points believed to have been overlooked or
misapprehended (37 CFR §§ 42.71(c), (d))
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Relationship to Other Proceedings
Multiple Proceedings
• Director can consolidate petitions in the case of multiple filings (§ 315(c))
• During pendency of IPR, Director can stay, transfer, consolidate or terminate other
proceedings or matters involving the same patent(s) (§ 315(d))
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Conduct During IPR –
The Scheduling Order
• If review is instituted, proceedings are conducted by the Patent Trial and Appeal
Board (§ 316(c))
• Scheduling Order will be entered concurrent with decision to institute IPR (77 FR at
48636)
• Approximately one month after institution of IPR, Board will hold a conference call
to discuss Scheduling Order and anticipated motions (77 FR at 48758)
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Representative Timeline for IPR
Pre-Review
Petition
Filed
PO
Preliminary
Response
3 months
Discovery & Briefing
PO Response
& Motion to
Amend Claims
Decision
on Petition
No more than
3 months
3 months
PO
Discovery
Period
Petitioner
Reply to PO
Response &
Opposition to
Amendment
3 months
Motions
PO Reply to
Opposition to
Amendment
1 month
Petitioner
Discovery
Period
PO
Discovery
Period
Oral
Hearing
Final
Written
Decision
Hearing Set
on Request
Period for
Observations &
Motions to
Exclude Evidence
No more than 12 months
(77 Fed. Reg. at 48757)
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Discovery & Briefing
Due date 1: Patent owner’s response to petition and/or motion to amend patent to
cancel or amend challenged claims
•Evidence cited in reply/response may include compelled testimony (e.g. crossexamination transcripts) and uncompelled testimony (affidavits) (37 CFR § 42.53)
•Prior to due date 1, patent owner may engage in limited discovery: (37 CFR §§ 42.51,
42.53)
• Initial Disclosures: discovery of information identified in mandatory initial
disclosures
• Routine discovery: evidence directly related to factual assertions advanced by
parties: (a) exhibits cited, (b) cross-examination of affiants, (c) relevant
information inconsistent with a position advanced by the party
• Additional discovery: a party may move for additional discovery where it is “in
the interests of justice”
•Sanctions may be imposed for: abuse of discovery (e.g., failure to disclose prior
inconsistent statement), improper purpose, abuse of process (37 CFR § 42.12; 77 FR at
48618)
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Discovery & Briefing – e-Discovery
• Practice Guide contains a Model Order Regarding E-Discovery (Appendix C), which
is expected to supplement the Scheduling Order
• Model Order: (77 FR at 48771-72)
• Cost-shifting for disproportionate ESI production requests and dilatory
discovery tactics
• Production of ESI shall not include metadata other than the document date,
time, and distribution list, if available
• Production of ESI shall not include email, absent agreement or Board Order
• Where authorized by agreement or Board Order, email searches limited to
five custodians using five search terms per party, with five additional
terms permitted if need shown
• Party seeking to modify Model Order must show “good cause”
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Discovery & Briefing –
Motion to Amend
Motion to amend patent to cancel or amend challenged claims
• Requirements (§ 316(d); 37 CFR § 42.121):
• Only one motion to amend may be filed absent Board authorization
• Additional motions may be permitted for “good cause” or upon joint
request “to materially advance settlement”
• Patent owner must confer with Board prior to filing motion
• Motion must be filed no later than the filing of the patent owner’s response
unless other date specified by Board
• Must set forth support in original patent disclosure for each claim
• Amendments must respond to an asserted ground of unpatentability
• Amendments cannot be used to enlarge scope of claims or add new subject
matter
• Rebuttable presumption that only one substitute claim would be needed to
replace each challenged claim
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Discovery & Briefing
Due date 2: Petitioner’s reply to patent owner’s response and/or motion to amend
• Evidence cited in reply/response may include compelled testimony (e.g. crossexamination deposition transcripts of patent owner’s deponents) and uncompelled
testimony (affidavits) (37 CFR § 42.53)
• Prior to due date 2, petitioner may engage in limited discovery to support reply to
response and/or motion to amend (77 FR at 48757-58)
Due date 3: Patent owner’s reply
• Prior to due date 3, patent owner may engage in further discovery to support reply
(77 FR at 48757-58)
• Reply limited to arguments raised by petitioner (37 CFR § 42.23(b))
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Post-Discovery Motions
Due date 4: Additional motions (e.g., observation on cross-examination of reply
witness, motion to exclude, request for oral argument)
• Either party may request a conference call to discuss additional motions as they
arise (77 FR at 48767)
• Motion for observation on cross-examination allows petitioner to draw Board’s
attention to relevant testimony (77 FR at 48767-68)
Due date 5: Responses to additional motions
Due date 6: Replies to additional motions
Due Date 7: Oral argument
• Parties have the right to an oral hearing before at least 3 Board members (77 FR at
48768)
• Board does not expect that live testimony will be necessary; however, parties can
file a motion for live testimony in appropriate circumstances (77 FR at 48768)
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Settlement
• IPR shall be terminated with respect to any petitioner upon joint request of the
petitioner and the patent owner, unless PTO has decided the merits of the
proceeding before the joint request is filed (§ 317(a))
• PTO may terminate IPR or proceed to final written decision if no petitioner remains
(§ 317(a))
• No estoppel shall attach to petitioner if IPR is terminated (§ 317(a))
• Any agreement or understanding between the patent owner and petitioner, made
in connection with, or in contemplation of, the termination of an IPR shall be in
writing and filed in the PTO (§ 317(b))
• Upon request, settlement can be treated as business confidential information
(§ 317(b))
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The Board’s Decision & Appeal
Final Decision
• Board must determine whether petitioner has proven unpatentability by a
preponderance of the evidence (§ 316(e))
• Board must issue final written decision within 1 year of institution of IPR, with up
to a 6-month extension permitted for “good cause” (§§ 316(a)(11), 318)
Appeal
• Either party may appeal the Board’s decision to the Federal Circuit (§ 319)
Certificate
• After the time for appeal has expired, or any appeal has terminated, the Director
shall issue and publish a certificate: (§ 318(b))
• Canceling any claim of the patent finally determined to be unpatentable
• Confirming any claim of the patent determined to be patentable
• Incorporating any new or amended claim determined to be patentable
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Intervening Rights
• Any amended or new claim determined to be patentable and incorporated into a
patent following an IPR shall have same effect as that for reissued patents with
respect to the right of any person who, before the issuance of the certificate:
• Made, purchased, or used within the United States anything patented by the
amended or new claim
• Imported into the United States anything patented by the amended or new
claim
• Made substantial preparation therefor
(§ 318(c))
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Relationship to Other
Proceedings - Estoppel
Petitioner Estoppel
• Where review results in final written decision:
• Petitioner/RPI/privy cannot “request or maintain a proceeding before the
Office with respect to [a claim involved in an IPR] on any ground that the
petitioner raised or reasonably could have raised during that inter partes
review” (§ 315(e)(1))
• Petitioner/RPI/privy cannot assert in an action under 28 U.S.C. § 1338 or an
action before the ITC, that “[a claim involved in an IPR] is invalid on any ground
that the petitioner raised or reasonably could have raised during that inter
partes review” (§ 315(e)(2))
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Relationship to Other
Proceedings - Estoppel
Patent Owner Estoppel
• Where adverse judgment is rendered against patent applicant or owner:
• “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.”
(37 CFR § 42.73(d)(3))
• Potential implications for continuation applications?
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Relationship to Other
Proceedings – Parallel Litigation
• Recall that petitioner/RPI cannot file a petition if it has previously filed a declaratory
judgment action (§ 315(a)(1), (3))
• If the petitioner/RPI later files a civil action challenging validity, the civil action will
be “automatically” stayed until: (§ 315(a)(2))
• Patent owner moves to lift the stay
• Patent owner files a civil action or counterclaim alleging infringement by the
petitioner/RPI
• Petitioner/RPI moves to dismiss the civil action
• Courts will likely stay infringement litigation during pendency of IPR
• Final decisions in IPR may simplify litigation by limiting validity challenges, or
resolving dispute if patent claims are cancelled
• If court declines to grant stay, there is a possibility for different outcomes on
validity issues before the Board and District Court
• ITC may be more inclined to stay proceedings during pendency of IPR
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Key Differences Between IPR and PGR
Inter Partes Review
Post-Grant Review
Eligible
Patents
Any patent
Patents with an effective filing date on or
after March 16, 2013
Filing
Deadline
Can file anytime after 9 months after
patent issues/ re-issues
Must file within 9 months after patent
issues/ re-issues
Grounds for
request
Grounds that could be raised under §§
102 or 103 (must be based on prior art
patents / printed publications)
Any grounds under revised § 282(b)(2) or
(3) (§§ 101, 102, 103, 112, 251)
Threshold to
Initiate
Proceeding
Reasonable likelihood that the requester
would prevail with respect to at least 1 of
the claims challenged
Information that if not rebutted,
demonstrates that it is more likely than
not that a claim is unpatentable
OR a novel / unsettled legal question
Discovery
Evidence directly related to parties’
factual assertions (exhibits cited, crossexaminations of affiants)
Additional discovery available where it is
in the “interests of justice”
Evidence directly related to parties’
factual assertions (exhibits cited, crossexaminations of affiants)
Additional discovery available for “good
cause”
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Inter Partes Reexamination PTO Statistics (as of June 30, 2012)
• Requests filed 11/29/1999 – 6/30/2012: 1659
Chemical
(17%)
Electrical (52%)
Mechanical (30%)
Design
(1%)
• Annual Filings:
2010: 281
2011: 374
2012: 270 (up to June 30) (over 200 filings in the final week)
• Number of requests filed where patents known to be in litigation: 67%
• Inter partes reexamination requests granted: 94%
• Average time from filing date to certificate issue date: 36.1 months
• Certificates issued:
• All claims confirmed: 11%
• All claims canceled (or disclaimed): 42%
• Claims changed: 47%
• Percentage of examiner decisions appealed to BPAI: 33%
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77 FR at 48715;
PTO IP Quarterly Report
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Key Differences Between IPR and
Inter Partes Reexamination
Inter Partes Review
Inter Partes Reexamination
Patents
Any patent
Patents issued from applications filed
on/after November 29, 1999
Tribunal
Patent Trial and Appeal Board
(Administrative Law Judges)
Central Reexamination Unit
(primary patent examiners)
Grounds for
request
Grounds that could be raised under
§§ 102 or 103 (must be based on prior art
patents / printed publications)
Grounds based on prior art patents /
printed publications; double patenting
challenges have been permitted
Threshold to
Initiate
Proceeding
Reasonable likelihood that the requester
would prevail with respect to at least 1 of
the claims challenged
Substantial new question of
patentability
Average cost
for requester
Expected to cost more than inter partes
reexam given higher filing fees and ability
to conduct discovery
$128,000
(AIPLA 2011 Economic Survey)
Time to
completion
(pre-appeal)
1.5–2 years (decision by 1 year from
initiation date, with possible 6 month
extension)
About 3 years (no statutory time limits
for completion)
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Key Differences Between IPR and
Inter Partes Reexamination
Inter Partes Review
Inter Partes Reexamination
Discovery
Limited discovery permitted
Patent
owner’s
ability to
amend claims
1 motion to amend permitted; due with Broad right to amend and add claims
patent owner response (additional
throughout proceedings
motion for “good cause”/to promote
settlement); must respond to validity
challenges; “reasonable number” of
substitute claims
Requester’s
right to
participate
Petitioner submits briefs and
accompanying evidence; has right to
oral hearing
Requester can respond to patentee’s
arguments; no right to interview
Examiner
Parties’ right
to terminate
Parties can terminate proceedings by
settlement
No right to terminate (consent
judgment in parallel litigation may
terminate)
Appeal
Appeal to Federal Circuit
Appeal to BPAI (now PTAB), then to
Federal Circuit
Validity
If court action concludes first, failure to
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finding
in
prove invalidity will| not
impact IPR
No right to discovery
First to conclude after all appeals
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wins, i.e., if litigation concludes first,
Key Differences Between IPR and
Inter Partes Reexamination - Estoppel
Inter Partes Review
Inter Partes Reexamination
Estoppel triggering
event
Written decision by the Board
Exhaustion of all appeals
Estoppel triggering
outcome
Applies irrespective of outcome
Applies only where claim confirmed to
be valid or allowable
Later
proceedings
subject to
estoppel
Applies to PTO, District Court and ITC
proceedings
Applies to District Court and PTO
proceedings (second re-examination
while first is pending)
Scope of
estoppel
Issues the party “raised or reasonably
could have raised”
Issues the party “raised or could have
raised”
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Timing Considerations for ANDA Filers
where Drug has NCE Status
Patent
Issues
NDA
Approval
NCE Exclusivity (5 yrs)
ANDA
Filing
Typical Litigation
Yr 0
Yr 1
Yr 2
Yr 3
IPR
PGR
Yr 4
Appeal
Yr 5
Appeal
Appeal
If patent is invalidated in early-filed PGR/IPR, ANDA
filer loses opportunity to obtain 180 day exclusivity
IPR
Appeal
Litigation
Stay
Litigation
stay
Litigation
???
???
???
Late-filed IPR may result in stay of litigation, potentially
extending length of litigation
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Timing Considerations for ANDA Filers
Where Drug has NCE Status
Patent #1
Issues
NDA
Approval
NCE Exclusivity (5 yrs)
Yr 0
Yr 1
Patent #2
Issues
ANDA
Filing
Yr 2
Yr 3
IPR – Patent 1
PGR – Patent 1
Yr 4
Yr 5
Appeal
Appeal
IPR – Patent 1
Where additional patents are in play, ANDA
filers may challenge additional patents by
PGR/IPR without risking opportunity to
obtain 180 day exclusivity
Appeal
IPR – Patent 2
Appeal
Litigation
PGR – Patent 2
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IPR, PGR and District Court Litigation –
Key Considerations
• Patent challengers will need to carefully consider the best forum in which to raise
invalidity arguments (IPR, PGR, District Court) in view of the following
considerations, among others:
• Timing
• Grounds for review
• Cost
• Threshold to initiate review
• Need for discovery and extent of discovery required or desired
• Decision maker’s technical expertise
• Burden of proof
• Need or desire to have formal claim construction
• Time to decision
• Estoppel
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