Title: ACI
1ACIs 9th Annual Paragraph IV Disputes
PTO Proceedings Retrospect Exploring the Growing
Use of IPR, PGR and CBM review in Hatch-Waxman
Litigation April 27, 2015
Tweeting about this conference?
2Speakers
- Laura A. Lydigsen
- Shareholder and Co-Chair,
- Appellate Practice Group
- Brinks Gilson Lione
- Gregory A. Morris Irena Royzman
- Of Counsel Partner
- Paul Hastings LLP Patterson Belknap Webb
Tyler - Martin B. Pavane Paul Ragusa
- Member and Vice-Chair, IP Department \
Partner - Co-Chair, ANDA and Biologics Baker
Botts, LLP - Cozen O'Connor
3PTAB Petitions for Orange Book Patents -
Statistics
Year IPR (Listed/Total) CBM (Listed/Total) PGR (Listed/Total)
2012 3/94 (3.2) 0/15 0
2013 9/695 (1.3) 0/89 0
2014 42/1495 (1.7) 6/173 1/3
2015 (4/15) 25/446 (5.6) 0/38 0/2
4PTAB Petitions for Orange Book Patents -
Statistics (Continued).
- Grounds for challenge
- Obviousness (90)
- Anticipation (35)
- Types of claims challenged
- Formulation (80)
- Method of Treatment (gt50)
- Compound (15)
- IPRs as Tool for Hedge Funds
5Agenda
- Initial IPR Considerations
- Laura A. Lydigsen
- Claim Construction and Instituting Trial
- Irena Royzman
- Lessons Learned After The First IPR Final Written
Decisions - Gregory A. Morris
- PTAB Trial Practice
- Martin B. Pavane
- IPR Appeals
- Laura A. Lydigsen
- PGRs CBMs
- Paul Ragusa
6Initial IPR Considerations
- Laura Lydigsen
- Shareholder, Brinks, Gilson Lione
7Initial Considerations Advantages of PTAB Patent
Challenges
- Lower burden of proof for invalidity
- PTAB preponderance of the evidence, 35 U.S.C.
316(e) (IPR), 326(e) (PGR/CBMPR) - District Court clear and convincing evidence
- Claim construction standard
- PTAB Broadest reasonable interpretation (BRI),
37 C.F.R. 4.2100(b), 200(b), 300(b) In re
Cuozzo Speed Techs., LLC., _ F.3d _, 2015 WL
448667 (Fed. Cir. Feb. 4, 2015) - District Court ordinary meaning at the time of
invention. Phillips v. AWH Corp., 415 F.3d 1303
(Fed. Cir. 2005) (en banc)
8Initial Considerations Advantages of PTAB Patent
Challenges Contd
- Time to decision
- PTAB 18 months, extendable to 24 months after
filing of petition. 35 U.S.C. 3.14(b) 37
C.F.R. 42.100(c) - District court 2.5 years (source
http//www.pwc.com/en_US/us/forensic-services/publ
ications/assets/2014-patent-litigation-study.pdf) - Grounds
- PTAB
- IPR anticipation and obviousness based on
printed publications. 35 U.S.C. 311(b). - CBM/PGR
- Any grounds that is a condition for
patentability. 35 U.S.C. 321(b) 37 C.F.R.
304(b)(2) - PGR Important new or unsettled legal questions.
37 C.F.R. 42.208(d). - District Court Any grounds that is a condition
for patentability. 35 U.S.C. 282.
9Initial Considerations Orange Book Patents
- Prior decision upholding validity of OB patents
- Teva v. Viiv, IPR2015-00550 (filed Jan. 8, 2015)
(challenging OB patent for Trizavir/abacavir
sulfatedoutegravir sodiumvamivudine that is the
subject to Fed. Cir. Appeal Nos. 14-1303, -1304,
-1315) - Noven v. Novartis, IPR2014-00549, -550 (filed
Apr. 2, 2014) (IPR instituting on two OB patents
for Exelon patch/rivastigmine extended release
transdermal, one of which was instituted
notwithstanding brand argument that D.Del. has
upheld the validity of the 023 patent over many
of the same references raised) - Manageable number of OB patents
- But see Amneal v. Jazz (challenging some of 15
OB patents listed for Xyrem/sodium oxybate)
10Initial Considerations Orange Book Patents Contd
- Non-FTF status
- Consider pre-suit PTAB challenge
- Late second filer option
- Multi-defendant litigation
- Best known prior art already before the USPTO
- Complex technology/validity arguments
- Strong secondary considerations evidence
- Potentially weak validity defense
11Initial Considerations Timing
- Time restrictions on filing at the PTAB
- IPR 1 year or less after petitioner served with
infringement complaint. 35 U.S.C. 315(b).
Includes counterclaims. St. Jude Medical v.
Volcano Corp., 749 F.3d 1373 (Fed. Cir. 2014). - CBM Can file any time after 9 months from patent
issuance. 37 CFR 42.303. - PGR Must be filed 9 months or less after
issuance of patent or broadening reissue patent.
35 U.S.C. 321(c).
12Initial Considerations Timing (Contd)
- Joinder exception to the 1-year rule
- The 1-year time limitation set forth in the
preceding sentence shall not apply to a request
for joinder under subsection (c). - Joinder must be sought no later than one month
after the institution date of any inter partes
review for which joinder is requested. 37
C.F.R. 42.122(b) - Teva v. ViiV, IPR IPR2015-00550 (filed Jan. 8,
2015, pending) Teva seeks to join IPR filed by
Apotex that was instituted on Dec. 8, 2014
(Trizavir/abacavir sulfatedoutegravir
sodiumvamivudine) - Amneal v. Endo, IPR2014-1365 (filed Aug. 22,
2014, joinder granted Feb. 4, 2015) Amneal
permitted to join its own prior IPR (Opana
ER/oxymorphone)
13Claim Construction and Grounds for Instituting
IPR
Irena Royzman, J.D., Ph.D. Partner Patterson
Belknap Webb Tyler LLP
14BRI v. Phillips A Tale of Two Standards
Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir.
2005) (en banc)
37 C.F.R. 42.100(b)
15BRI v. Phillips An Academic Concern?
16BRI v. Phillips An Academic Concern?
BRI
Phillips
The broadest reasonable interpretation of a
claim term may be the same as or broader than the
construction of a term under the Phillips
standard. But it cannot be narrower.
Facebook, Inc. v. Pragmatus AV, LLC, 582 Fed.
Appx. 864, 869 (Fed. Cir. 2014)
17BRI v. Phillips Two Bites at the
The Federal Circuit also addressed the
corresponding method claim 4 of the 149 Patent,
but split in a 2-1 decision in which the majority
interpreted the claim more narrowly than the
dissent and found it not invalid. However, when
interpreted under the broadest reasonable
interpretation standard applicable in inter
partes review proceedings, claim 4 would have
been obvious for the same reasons as the
composition claims of the 463 Patent.
Ferrum Ferro Capital, LLC v. Allergan Sales, LLC,
IPR2015-00858, Petition at 3 (March 9, 2015)
18BRI v. Phillips In re Cuozzo
- Panel Majority (Dyk and Clevenger)
- BRI has been used in PTO proceedings for over 100
years. - Claims can be amended during IPR.
- AIA vests PTO with power to prescribe regulations.
- Dissent (Newman)
- Phillips should be the standard in IPRs same as
in district court. - IPRs are a surrogate for district court
litigation over validity. - No unfettered ability to amend claims in IPR.
In re Cuozzo Speed Techs., LLC., 778 F.3d 1271
(Fed. Cir. 2015)
19BRI v. Phillips In re Cuozzo
- Dissent (Newman)
- BRI serves not to state the correct meaning of
the claim, but to provide a framework for
clarification and amendment. - Adoption of a broadest interpretation renders
the PTAB rulings legally unreliable . - PTAB tribunals cannot serve as a surrogate for
district court litigation if the PTAB does not
apply the same law to the same evidence.
In re Cuozzo Speed Techs., LLC., 778 F.3d 1271
(Fed. Cir. 2015)
20BRI v. Phillips In re Cuozzo
- Cuozzo filed a petition for rehearing en banc on
whether BRI is appropriate in IPR and whether
there is judicial review of PTABs decision to
institute IPR on appeal of a final decision. - Amici IPO, PhRMA, and 3M Company et al. urged en
banc review and adoption of Phillips standard. - NYIPLA urged en banc review of both issues raised
by Cuozzos petition. - Rehearing en banc?
- SCOTUS?
21Grounds for Instituting IPR
22Grounds for Instituting IPR In re Cuozzo
- Panel Majority (Dyk and Clevenger)
- PTABs institution of IPR of claims based on
references not identified in the petition for
those claims is not reviewable even after final
decision. - The fact that the petition was defective is
irrelevant because a proper petition could have
been drafted. - The failure to cite those references in the
petition provides no ground for setting aside the
final decision.
In re Cuozzo Speed Techs., LLC., 778 F.3d 1271
(Fed. Cir. 2015)
23Grounds for Instituting IPR In re Cuozzo
- Panel Majority (Dyk and Clevenger)
- It is not clear that IPR is strictly limited to
grounds asserted in the petition. - Mandamus may be available to challenge the
PTOs decision to grant a petition to institute
IPR after the Boards final decision . - We did not decide the question of whether the
decision to institute review is reviewable by
mandamus after the Board issues a final decision
.
In re Cuozzo Speed Techs., LLC., 778 F.3d 1271
(Fed. Cir. 2015)
24Grounds for Instituting IPR In re Cuozzo
- Dissent (Newman)
- The PTAB decision relies on arguments and
evidence that had not been raised in the petition
to institute, although the statute requires that
all arguments and evidence must be presented in
the petition. - The panel majority holds that the fact that
the petition was defective is irrelevant because
a proper petition could have been drafted. Such
broad and conflicting departure from the
statutory provisions cannot have been intended.
In re Cuozzo Speed Techs., LLC., 778 F.3d 1271
(Fed. Cir. 2015)
25Role of PTAB Examiners or Judges?
or
26Role of PTAB Examiners or Judges?
An inter partes review is neither a patent
examination nor a patent reexamination. Rather,
it is a trial, adjudicatory in nature and
constitutes litigation.
Google Inc. Apple Inc. v. Jongerius Panoramic
Technologies, LLC, IPR2013-00191, Decision at 4
(February 13, 2014)
27Role of PTAB Referee or Player?
or
28Lessons Learned
- Argue claim construction in Patent Owner
Preliminary Response. - Continue to argue claim construction. It may
change through final decision. - Argue claim construction under both BRI and
Phillips. - Stay flexible. Present evidence under
alternative claim constructions. - Make use of existing testimony, claim
construction and admissions from district court
proceedings. - Point out differences between grounds in petition
and decision to institute IPR. - Mandamus to challenge decision to institute IPR
after PTAB issues a final decision?
29Lessons Learned After the First IPR Final Written
Decisions
Gregory Morris, J.D., Ph.D. Of Counsel Paul
Hastings
30IPRs on OB Patents by the Numbers
106 Petitions filed
4 FWDs
7 Settled
81 Pending at some stage
14 Not instituted
13 Filed by hedge funds
31The First Four Data Points
1 Amneal v. Supernus IPR2013-00368 Dec. 9, 2014 Oracea
2 Amneal v. Supernus IPR2013-00371 Dec. 9, 2014 Oracea
3 Amneal v. Supernus IPR2013-00372 Dec. 9, 2014 Oracea
4 Apotex v. Wyeth IPR2014-00115 Apr. 20, 2015 Tygacil
32Amneal v. Supernus
- Three OB patents challenged
- 8,206,740 (Chang II)
- 8,394,405 (Chang III)
- 8,394,406 (Chang IV)
IPR2013-00368 IPR2013-00371 IPR2013-00372
33Amneal v. Supernus
F
D
E
P
F
F
D
E
P
A
AmnealFilesReply toPO Response
AmnealFilesPetition
AmnealsPetition Granted
POPreliminaryResponse
FinalWrittenDecision
Oral Hearing
PO Response
May2014
Aug.2014
Dec.2014
June2013
Dec.2013
Sept.2013
March2014
AmnealsDiscovery Period
PODiscovery Period
PODiscovery Period
34Amneal v. Supernus
- Challenged claims of all three patents found not
invalid after FWD
F
D
E
P
F
F
D
E
P
A
AmnealFilesReply toPO Response
AmnealFilesPetition
AmnealsPetition Granted
POPreliminaryResponse
FinalWrittenDecision
Oral Hearing
PO Response
May2014
Aug.2014
Dec.2014
June2013
Dec.2013
Sept.2013
March2014
AmnealsDiscovery Period
PODiscovery Period
PODiscovery Period
35Amneal v. Supernus
No appeal
F
D
E
P
F
F
D
E
P
A
AmnealFilesReply toPO Response
AmnealFilesPetition
AmnealsPetition Granted
POPreliminaryResponse
FinalWrittenDecision
Oral Hearing
PO Response
May2014
Aug.2014
Dec.2014
June2013
Dec.2013
Sept.2013
March2014
AmnealsDiscovery Period
PODiscovery Period
PODiscovery Period
36Apotex v. Wyeth
- OB patent challenged
- 7,879,828
IPR2014-00115
37Apotex v. Wyeth
C
C
F
E
A
ApotexFilesReply toPO Response
ApotexFilesPetition
ApotexsPetition Granted
FinalWrittenDecision
Oral Hearing
PO Response
Nov.2014
Jan.2015
Apr. 2015
Nov.2013
Apr.2013
July2014
ApotexsDiscovery Period
PODiscovery Period
38Apotex v. Wyeth
- Challenged claims found not invalid after FWD
C
C
F
E
A
ApotexFilesReply toPO Response
ApotexFilesPetition
ApotexsPetition Granted
FinalWrittenDecision
Oral Hearing
PO Response
Nov.2014
Jan.2015
Apr. 2015
Nov.2013
Apr.2013
July2014
ApotexsDiscovery Period
PODiscovery Period
39Apotex v. Wyeth
- PTAB Dr. Nelsons unsupported and unexplained
opinions are not persuasive.
C
C
F
E
A
ApotexFilesReply toPO Response
ApotexFilesPetition
ApotexsPetition Granted
FinalWrittenDecision
Oral Hearing
PO Response
Nov.2014
Jan.2015
Apr. 2015
Nov.2013
Apr.2013
July2014
ApotexsDiscovery Period
PODiscovery Period
40Lessons Learned
- Branded pharmaceutical patents, even formulation
patents, can be successfully defended before the
PTAB
41Lessons Learned
- Interpretation of the facts by experts is
critical - Carefully select experts whom PTAB will credit
and prepare declarations addressing in detail how
a POSA would view the cited art - Cross-examine opposing experts in depositions in
same manner as at a trial because they wont
testify live
42Lessons Learned
- Use clear and persuasive demonstratives that cite
to the record to drive your points home before
the PTAB at oral argument
43Lessons Learned
- Use clear and persuasive demonstratives that cite
to the record to drive your points home before
the PTAB at oral argument - KNOW YOUR RECORD COLD!
44Practice Before the Patent Trial and Appeal Board
- Martin B. Pavane
- Cozen O'Connor
- Vice Chair, Intellectual Property Department
- Co-Chair, ANDA and Biologics Practice Group
- 277 Park Avenue New York, NY 10172
- P 212.883.4994 F 646-588-1478
- mpavane_at_cozen.com
45Overview - Post Grant Review
- Process begins with a third party filing a
petition within 9 months after the grant of the
patent or reissue patent - Other than for business method patents,
post-grant review is available only for
patents that have a priority date later than
March 15, 2013 - Any ground of invalidity may be asserted. Not
limited to 35 U.S.C. 102 or 103 or prior
art patents and printed publications - Petitioner cannot file if it has initiated a
litigation - Requester showing that it is more likely than not
that at least one challenged claim is
unpatentable - Entitled to routine discovery additional
discovery if agreed to, or requested and granted
by the Board additional discovery must be for
good cause - If the proceeding is instituted, a final
determination by the Board will be issued within
1 year after institution (extendable for good
cause by 6 months)
46Overview Inter Partes Review
- Process begins with a third party filing a
petition - For patents having a priority date later than
March 15, 2013 - 9 months or more after the grant
of the patent or reissue patent (unless a
post-grant review was instituted, in which case,
a petition cannot be filed until after the
termination of such post-grant review) - For patents having a priority date of March 15,
2013 or earlier any time - Petitioner cannot file petition if it already
initiated a litigation or was served with a
Complaint in patent infringement action more than
one year prior to filing petition for inter
partes review - Inter partes review may only be based on 35
U.S.C. 102 or 103, and only on prior art
consisting of patents or printed publications - Inter partes review may be instituted upon a
showing that there is a reasonable likelihood
that at least one challenged claim is
unpatentable - Comparing the two standards, the reasonable
likelihood standard is lower than the more
likely than not standard. The reasonable
likelihood standard allows for the exercise of
discretion but encompasses a 50/50 chance whereas
the more likely than not standard requires
greater than a 50 chance of prevailing.
Message from Chief Judge James Donald Smith,
Board of Patent Appeals and Interferences USPTO
Discusses Key Aspects of New Administrative
Patent Trials (http//www.uspto.gov/aia_implementa
tion/smith-blog-extravaganza.jspheading-1) - Entitled to routine discovery additional
discovery if agreed to, or requested and granted
by the Board additional discovery must be in
the interests of justice - If the proceeding is instituted, a final
determination by the Board will be issued within
1 year after institution (extendable for good
cause by 6 months)
47Overview - Estoppel
- For both post grant review and inter partes
review - Pre-AIA the estoppel provision of 315 is
triggered not when examination is completed but
only after all appeal rights have been
exhausted. Bettcher Indus. v. Bunzl USA, Inc.,
661 F.3d 629, 642-643 (Fed. Cir. 2011) - AIA Estoppel attaches upon PTABs final written
decision, after which the petitioner may not
assert either in a civil action or in a
proceeding before the International Trade
Commission that the claim is invalid on any
ground that the petitioner raised or reasonably
could have raised during post-grant or inter
partes review. See 35 U.S.C 315, 325 - Since invalidity grounds that petitioner can
raise in post grant review are broader than inter
partes review, scope of estoppel will likely be
broader - Parties can settle post grant review or inter
partes review no estoppel without final written
decision
48Overview - Differences Between Litigation and
Post Grant Review/Inter Partes Review
- No need for case or controversy for PTAB
proceedings. Note that there is a need for case
or controversy to appeal a PTAB decision to CAFC.
See Consumer Watchdog v. Wisconsin Alumni
Research Found., 753 F.3d 1258 (Fed. Cir. 2014). - Claim Construction Broadest reasonable
construction vs. court interpretation - Standard of Proof preponderance of evidence vs.
clear and convincing evidence - Discovery limited in PTAB proceedings vs. full
discovery in litigation - Patentee can amend claims (once) during post
grant review or inter partes review (but PTAB has
not granted many requests to amend claims) - Cost
49Overview - Ex Parte Reexamination
- Still available after AIA
- May only be based upon patents or printed
publications - Requires a showing that the prior art establishes
a substantial and new question of patentability - Requester can be anonymous
- Other than petition for ex parte reexamination,
requester is not involved (unless patent owner
files response to petition) - No estoppel
- Patentee can amend claims more freely than in
post grant review or inter partes review
50PTAB Proceedings - Discovery
- Three categories of discovery
- Mandatory initial disclosures
- Routine discovery and
- Additional discovery.
51PTAB Proceedings - Discovery
- Routine Discovery
- Information a party must provide to the other
side - No need for motion practice or discovery request.
Nichia Corp. v. Emcore Corp., IPR2012-00005,
Paper 19, page 2
52Routine Discovery
- Routine discovery
- any exhibit cited in a paper or in testimony
must be served with the citing paper or
testimony - Cross examination of affidavit testimony and
- relevant information that is inconsistent with a
position advanced by the party during the
proceeding.
53Exhibits Cited in a Paper or Testimony
- Party must provide such discovery at the same
time it serves a paper or testimony citing it - No requirement to create materials
- Does not require that all the underlying data
and lab notebooks be produced with a paper that
references an experiment. See Corning Inc. v.
DSM IP Assets B.V., IPR2013-00043, Paper 27, page
3.
54Cross Examination of Affidavit Testimony
- Party relying upon declarant must arrange to make
that witness available for cross-examination - Burden and expense falls upon party relying upon
declarant
55Information Inconsistent With a Partys Position
- Does not include material protected by
attorney-client privilege or attorney work
product immunity - Narrowly directed to specific information
known to the responding party to be inconsistent
with a position advanced . . . , and not broadly
directed to any subject area in general within
which the requesting party hopes to discover such
inconsistent information. Garmin Int'l Inc. et
al. v. Cuozzo Speed Techs. LLC, IPR2012-00001,
Paper 26, pages 3-4.
56Additional Discovery
- The parties may agree to additional discovery
- If the parties fail to agree, a party may move
for additional discovery - If parties do not agree, requests for additional
discovery are rarely granted
57Additional Discovery
- The moving party must show that additional
discovery - Is in the interests of justice in an IPR
proceeding - Meets the good cause standard in a post-grant
review proceeding - interests of justice standard is slightly
higher than the good cause standard, but PTAB
looks at same factors (Garmin factors) in both
cases. See Bloomberg Inc. v Markets-Alert, Pty
Ltd., CBM 2013-00005, Paper 32 (May 29, 2013).
58Additional Discovery - Factors
- PTAB in Garmin v. Cuozzo, IPR2012-00001, Paper 20
(Feb. 14, 2013) identified five factors to
consider when determining whether additional
discovery will be permitted - Request must be based upon more than a
possibility and mere allegation - Requests that seek discovery of litigation
positions and case theories are not appropriate - Requests for information a party can reasonably
figure out or assemble are not appropriate - The requests should be easily understandable
- The requests must not be overly burdensome to
answer.
59Additional Discovery First Factor
- To satisfy the first factor, the requesting party
must (1) possess evidence tending to show that
the requested discovery will lead to further
evidence and (2) establish that something useful
will be found. - PTAB decisions suggest that the first factor must
be met to have any possibility of getting
additional discovery. See Redline Detection, LLC
v. Star EnviroTech, Inc., IPR 2013-00106, Paper
31, page 5 (Aug. 27, 2013) (emphasis added).
60Joinder
- 35 U.S.C. 315(c)
- If the Director institutes an inter partes
review, the Director, in his or her discretion,
may join as a party to that inter partes review
any person who properly files a petition under
section 311 that the Director, after receiving a
preliminary response under section 313 or the
expiration of the time for filing such a
response, determines warrants the institution of
an inter partes review under section 314.
61Joinder
- Microsoft Corp. v. Proxyconn, Inc.,
IPR2013-00109, Paper 15, page 3 (February 25,
2013) - The Leahy-Smith America Invents Act (AIA)
permits joinder of like review proceedings. Thus,
an inter partes review (IPR) may be joined with
another inter partes review, and a post-grant
review (PGR) may be joined with another
post-grant review.
62Joinder
- Requests for joinder can be used by defendants in
related district court patent infringement
actions to ensure that an IPR will proceed even
if the patent owner settles with one IPR
petitioner/litigation defendant - The request should
- Explain why joinder is appropriate
- Identify grounds of unpatentability asserted in
the petition - Explain what impact, if any, joinder would have
on the trial schedule for the existing
proceeding and - Address how briefing and discovery may be
simplified. - See Kyocera Corporation v. Softview LLC,
IPR2013-00004, Paper 15, page 4 (April 24, 2013)
63Joinder Exception to the One-Year Ban
- 37 C.F.R. 42.101(b) (and 35 U.S.C. 315(b))
include a one-year bar, i.e., an inter partes
review may not be instituted if the petition
requesting the proceeding was filed more than one
year after the date on which the petitioner, real
party in interest or privy of the petitioner was
served with a patent infringement complaint - However, the one-year bar does not apply when the
petition for IPR is accompanied by a request for
joinder. See 37 C.F.R. 42.122(b) Microsoft
Corp. v. Proxyconn, Inc., IPR2013-00109, Paper
15, page 3 (February 25, 2013)
64Joinder Exception to the One-Year Ban
- Can petition for joinder be filed by same party
that filed original petition? - In Target Corp. v. Destination Maternity Corp.,
IPR2014-00508, expanded PTAB panel majority found
that joinder was permissible even though Target
was the petitioner in both proceedings.
65Settlement
- http//www.uspto.gov/sites/default/files/documents
/040915_aia_stat_graph.pdf
66Settlement
- Parties may file a joint motion to terminate a
proceeding on the basis of settlement - Preauthorization is required
- May be filed at any stage of the proceeding, even
before institution - Board has discretion to proceed to final written
decision more likely at an advanced stage when
all briefing is complete - Board is more likely to grant early motions to
terminate, i.e., without written decision
67PTAB Appeals
- Laura Lydigsen
- Shareholder, Brinks, Gilson Lione
68PTAB Appeals
- Notice of appeal
- Timing for notice 63 days v. 60 days (37 C.F.R.
90.3) - Content of the notice of appeal
- Involvement of USPTO solicitor
- The merits?
- How is the Federal Circuit handling multiple IPRs
on the same patent? - Briefing
- Argument
- Early outcomes
69Post Grant Review Covered Business Method Review
- Paul Ragusa
- Partner, Baker Botts, LLP
70Post-Grant Review
- Of 5 filed to date, 1 against an Orange Book
patent. - Accord Healthcare, Inc. v. Helsinn Healthcare
S.A., et al., IPR2014-00010 - Petition filed on September 2, 2014
- Asserted invalidity under Section 112.
- PGR Terminated November 24
- "Under these circumstances, and in view of the
preliminary stage of the current proceeding, we
determine that it is appropriate to enter
judgment and terminate the proceeding without
rendering a final decision."
71Covered Business Method Review
- Who can petition for CBM?
- Petitioner must have been sued for infringement
or have standing to bring DJ action against
patent. - 37 CFR 42.302(a).
- Covered business method patent
- "a patent that claims a method or corresponding
apparatus for performing data processing or other
operations used in the practice, administration,
or management of a financial product or service,
except that the term does not include patents for
technological inventions." 37 CFR 42.301(a).
72Covered Business Method Review (cont.)
- "Financial Product or Service"
- Term refers to products/services that concern
money, and not necessarily the financial services
industry - SAP Am., Inc. v. Versata Dev. Group, Inc.
CBM2012-000001 - Par Pharm., Inc., et al. v. Jazz Pharms., Inc.
- Patents listed in Orange Book as covering Risk
Evaluation and Mitigation System (REMS) for
Sodium Oxybate - Institution denied - not CBM patents
- Claims and spec did not apply to financial
services
73Covered Business Method Review (cont.)
- "Technological Inventions"
- A claim is not technological if
- its technical elements merely recite known
technologies, such as computer hardware,
communication or computer networks, software,
memory, computer readable storage media,
scanners, display devices, databases, etc. - it merely recites known prior-art technology to
accomplish a process or method, even if that
process or method is itself novel and nonobvious - it combines prior art structures to achieve the
normal, expected, or predictable result of that
combination. - A single non-technological claim of a patent is
sufficient to institute a CBM review.
74Questions?