preparing for pharma pgrs: lessons for patent owners from...
Post on 08-Jan-2019
224 Views
Preview:
TRANSCRIPT
Preparing for Pharma PGRs:
Lessons for Patent Owners From PGR Denials Leveraging Successful IPR Arguments, Strengthening Patent Applications to Survive PGR Petitions
Today’s faculty features:
1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific
The audio portion of the conference may be accessed via the telephone or by using your computer's
speakers. Please refer to the instructions emailed to registrants for additional information. If you
have any questions, please contact Customer Service at 1-800-926-7926 ext. 10.
THURSDAY, JANUARY 19, 2017
Presenting a live 90-minute webinar with interactive Q&A
Thomas L. Irving, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
Amanda K. Murphy, Ph.D., Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
Kerry Flynn, Vice President, Chief IP Counsel, Vertex Pharmaceuticals, Boston
Tips for Optimal Quality
Sound Quality
If you are listening via your computer speakers, please note that the quality
of your sound will vary depending on the speed and quality of your internet
connection.
If the sound quality is not satisfactory, you may listen via the phone: dial
1-866-819-0113 and enter your PIN when prompted. Otherwise, please
send us a chat or e-mail sound@straffordpub.com immediately so we can address
the problem.
If you dialed in and have any difficulties during the call, press *0 for assistance.
Viewing Quality
To maximize your screen, press the F11 key on your keyboard. To exit full screen,
press the F11 key again.
FOR LIVE EVENT ONLY
Continuing Education Credits
In order for us to process your continuing education credit, you must confirm your
participation in this webinar by completing and submitting the Attendance
Affirmation/Evaluation after the webinar.
A link to the Attendance Affirmation/Evaluation will be in the thank you email
that you will receive immediately following the program.
For additional information about continuing education, call us at 1-800-926-7926
ext. 35.
FOR LIVE EVENT ONLY
DISCLAIMER
These materials have been prepared solely for educational and informational
purposes to contribute to the understanding of U.S. intellectual property law.
These materials reflect only the personal views of the authors and are not
individualized legal advice. It is understood that each case is fact specific, and
that the appropriate solution in any case will vary. Therefore, these materials
may or may not be relevant to any particular situation. Thus, the authors and
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (including Finnegan Europe
LLP, and Fei Han Foreign Legal Affairs Law Firm), and Vertex Pharmaceuticals
cannot be bound either philosophically or as representatives of their various
present and future clients to the comments expressed in these materials. The
presentation of these materials does not establish any form of attorney-client
relationship with these authors. While every attempt was made to ensure that
these materials are accurate, errors or omissions may be contained therein, for
which any liability is disclaimed.
4
NUTS & BOLTS COMPARISON: IPRS AND PGRs
Post-Grant Review (PGR)
Inter Partes Review (IPR)
When Within nine months
of grant
More than nine months after grant (but one exception)
Threshold showing
More likely than not or novel legal question
Reasonable likelihood of success
Grounds 101, 102, 103, 112 102, 103 (Pats/pubs only)
Time at PTO 12-18 months 12-18 months
Anonymity No No
5
NUTS & BOLTS COMPARISON: IPRS AND PGRs (con’t)
Post-Grant Review (PGR)
Inter Partes Review (IPR)
Estoppel Issues raised or
reasonably could have been raised
Issues raised or reasonably could have been raised
Before whom PTAB PTAB
Discovery/ evidence
Declaration and discovery
Declaration and discovery
Appeal Both parties may appeal
to Federal Circuit* Both parties may appeal to
Federal Circuit*
6
Note: Phigenix, Inc. v. Immunogen, Inc., --F.3d__ (Fed. Cir. Jan. 9, 2017) that right to appeal does not
automatically confer standing.
Post-Grant Review (PGR)
Inter Partes Review (IPR)
Petition grant rate* 55% (16/29)*
(FY2014-FY2017 to date)
70% (2566/3690)* (2335 granted + 231 joinder)
(FY2014-FY2017 to date)
Final decisions**
83% all instituted claims unpatentable (5/6)
69.63% all instituted claims unpatentable
17% all instituted claims survived (1/6)
16.79% all instituted claims survived
13.59% mixed outcome
NUTS & BOLTS COMPARISON: IPRS AND PGRs (con’t)
*As of Jan. 9, 2017. Finnegan research
**“Mixed outcome”: at least one instituted claims survived and at least one
instituted claim was canceled.
**As of Dec. 1, 2016. (by case) Source: Finnegan research, http://www.aiablog.com/claim-and-case-disposition/
**As of Jan. 11, 2017 (by case).
*As of Nov. 30, 2016 https://www.uspto.gov/sites/default/files/documents/aia_statistics_november2016.pdf
7
As of Nov. 30, 2016 https://www.uspto.gov/sites/default/files/documents/aia_statistics_november2016.pdf
PGR PETITION FILING STILL LOW COMPARED TO IPR PETITION FILING
8
BUT GROWING
As of Nov. 30, 2016 https://www.uspto.gov/sites/default/files/documents/aia_statistics_november2016.pdf
9
PETITIONS BY TECHNOLOGY
Source of PGR data: Finnegan research; 36 PGR Petitions filed. As of Sept. 23, 2016;
Source of IPR data: https://www.uspto.gov/sites/default/files/documents/aia_statistics_november2016.pdf Average of FY 2015, 2016, and 2017 to date; As of Nov. 30, 2016
10
PGR PETITION ASSERTED GROUNDS
As of Jan. 9, 2017; Finnegan research; 38 PGR Petitions filed. Note, more than one ground may be asserted per petition.
11
PGR INSTITUTED GROUNDS
As of Jan. 9, 2017; Finnegan research; 16 instituted PGRs.
Note: 5 FWDs holding all instituted claims unpatentable so far; 3 based on § 101; 1 based on §102, §112(a); 1 based on §112(b). As of Jan. 9, 2017.
12
PGR INSTITUTION RATE LOWER THAN IPRs, BUT NUMBERS STILL VERY SMALL
(2335 granted + 231 joinder)
(FY2014-FY2017 to date)
USPTO stats
(16 granted/partially granted)
(FY2014-FY2017 to date)
Finnegan research
13
PGR INSTITUTION RATE
As of Jan. 9, 2017; Finnegan research; 29 institution decisions. An additional 3 petitions terminated prior to an institution decision (2 settled and 1 was dismissed as an improperly-filed PGR). “Partially granted” means instituted on fewer than all challenged claims.
Trial going ahead in 55% of
petitions filed
14
PGR CLAIM SURVIVAL RATE (BY CASE) SAME AS IPRs
As of Jan. 4, 2017; Finnegan research; 6 Final Written Decisions on the merits. In addition, 2 instituted PGRs settled prior to FWD.
As of Dec. 1, 2016. Source: Finnegan research, http://www.aiablog.com/claim-and-case-disposition/ “all instituted claims survived” Also, 13.59% (153/1126) cases had mixed outcome (some
instituted claims survived, some held unpatentable)
16.7% 1/6
15
PGR FWDs
• American Simmental Assoc. v. Leachman Cattle of Colorado, LLC,
2015-00003, Paper 56 (P.T.A.B. June 13, 2016)
• Claim 16. A computer-implemented method to determine relative
market value of a sale group, the sale group including cattle that
are fed and harvested for beef production, the method
comprising: . . .
• PGR instituted on §101 and §103 grounds.
• PTAB: FWD all instituted claims unpatentable for failing to recite
statutory subject matter.
― Unpersuaded that Petitioner showed obviousness by a
preponderance of the evidence.
― Found that the claims were directed to a patent-ineligible
abstract idea and did not recite “something more.”
― Denied Patent Owner’s Motion to Amend.
16
PGR FWDs (con’t)
• American Simmental Assoc. v. Leachman Cattle of Colorado,
LLC, 2015-00005, Paper 52 (P.T.A.B. June 13, 2016) • Claim 8. A computer-implemented method to determine relative
market value of a sale group, the computer implemented method
comprising the steps of:: . . .
• PGR instituted on §101 and §103 grounds.
• PTAB: FWD all instituted claims unpatentable for failing to recite
statutory subject matter and obviousness. ― Petitioner showed obviousness of several claims by a preponderance of the
evidence.
― Rejected Patent Owner’s objective evidence of nonobviousness as
“cursory”
― Found that the claims were directed to a patent-ineligible abstract idea and did
not recite “something more.”
― Denied Patent Owner’s Motion to Amend.
17
• NetSirv v. BoxBee, Inc., 2015-00009, Paper 20 (P.T.A.B. Aug. 2, 2016)
• Claim 1. A method for stored item distribution to a user,
the user associated with a user identifier, the method comprising:…
• PGR instituted on §101 grounds.
• PTAB: FWD all instituted claims unpatentable for failing to recite statutory subject matter.
―“claim 1 is directed to the abstract idea of a bailment scheme using storage containers.”
―“we do not find claim language that recites significantly more than the abstract idea.”
18
PGR FWDs (con’t)
• Altaire Pharms., Inc. v. Paragon Bioteck, Inc.,
PGR2015-00011, Paper 48 (P.T.A.B. Nov. 14, 2016)
• Claim 1. A method of using an ophthalmic composition for
pupil dilation, the composition comprising R-phenylephrine
hydrochloride having an initial chiral purity of at least 95% and
an aqueous buffer, wherein the chiral purity of R-
phenylephrine hydrochloride is at least 95% of the initial chiral
purity after 6 months, the method comprising:
• administering the composition into an eye of an individual in
need thereof, wherein the composition is stored between –10
to 10 degree Celsius prior to administration, and wherein the
composition comprises R-phenylephrine hydrochloride having a
chiral purity of at least 95% when administered after storage.
19
PGR FWDs (con’t)
• Altaire (con’t)
• Asserted ground: obviousness over Altaire’s Product
(phenylephrine hydrochloride ophthalmic solution Lot # 11578
and Lot # 11581)
• PTAB: Preamble phrase, “wherein the chiral purity of R-
phenylephrine hydrochloride is at least 95% of the initial chiral
purity after 6 months” describes property of the composition to
be administered. It is not a claim limitation requiring an active
step of cold storage for six months.
• PTAB rejected Petitioner’s evidence showing the HPLC data of
Altaire’s Product meets the recited chiral-purity limitations –
“the tests and data submitted with the Petition do not meet the
requirements of 37 C.F.R. § 42.65.” ― For example, fails to explain how the test was performed and how
the data was generated. 20
PGR FWDs (con’t)
• Altaire (con’t)
• Similar objections to Petitioner’s optical-rotation data:
― “Petitioner does not point to any credible evidence to show
the lot number of the phenylephrine hydrochloride P6126 it
used as control, when the lot was manufactured, or how long
after the manufacturing date Petitioner used it as the
control. Indeed, for the optical-rotation data, as for the
HPLC data, Petitioner has not provided any affidavit in
compliance with 37 C.F.R. § 42.65(b).”
― “Patent Owner has presented sufficient evidence to
challenge the accuracy of estimating enantiomer purity
based on the specific rotation.”
21
PGR FWDs (con’t)
• US Endodontics, LLC v. Gold Standard Instruments, LLC,
PGR2015-00019, Paper 54 (P.T.A.B. Dec. 28, 2016)
• 12. A method for manufacturing or modifying an endodontic
instrument for use in performing root canal therapy on a tooth,
the method comprising:
― (a) providing an elongate shank having a cutting edge extending from
a distal end of the shank along an axial length of the shank, the shank
comprising a superelastic nickel titanium alloy, and
― (b) after step (a), heat-treating the entire shank at a temperature
above 25° C. up to but not equal to the melting point of the
superelastic nickel titanium alloy,
• wherein the heat treated shank has an angle greater than 10
degrees of permanent deformation after torque at 45 degrees of
flexion when tested in accordance with ISO Standard 3630-1.
22
PGR FWDs (con’t)
• US Endodontics (con’t)
• PGR instituted on 102, 103, and 112 grounds.
• Patent Owner disputed eligibility for PGR (see slide 29).
― Issued claims same as application filed Jan. 29, 2014.
― PTAB agreed with Petitioner that no priority to earlier applications for
lack of WD and enablement -> claims only entitled to actual filing
date.
• PTAB: All instituted claims unpatentable.
― Lack of enablement.
― “the guidance the Specification provides regarding how to achieve the
deformation characteristic recited in the “wherein” clause is quite limited
compared to the broad scope of claims 12–16.”
― Specification teaches deformation achieved using heat-treatment at
500°C for 75 minutes or “inherent heat-treatment” of undisclosed
parameters but Claims 12–16 encompass temperature ranges from
above 25°C or 300°C up to but not equal to about 1300°C, and are
not limited to any duration.
23
PGR FWDs (con’t)
• US Endodontics (con’t)
• PTAB: Lack of enablement (con’t)
― Claims include heat-treatment times and temperatures that do not
provide the deformation characteristic (inoperative species – relevant
though not determinative of lack of enablement).
― PTAB credited Petitioner’s testing evidence.
― Undue experimentation required for POSITA to practice full scope of
claims.
― Inventor testimony expressing doubt at specific temperatures.
• PTAB: Lack of written description
― “the Specification does not reasonably convey to those skilled in the
art that Dr. Luebke had possession of the subject matter of claims 12–
16.”
― Species disclosed in Ex. 4 does not support genus claimed.
24
PGR FWDs (con’t)
• US Endodontics (con’t)
• PTAB: Anticipated.
― Article qualified as prior art because claims not entitled to priority.
25
PGR FWDs (con’t)
• Telebrands Corp. v. Tinnus Enterprises, LLC, PGR2015-
00018, Paper 75 (P.T.A.B. Dec. 30, 2016)
• Claim 1. An apparatus comprising:
― a housing …; a plurality of flexible hollow tubes, …; a plurality of
containers, …; and a plurality of elastic fasteners, …each elastic
fastener configured to provide a connecting force that is not less
than a weight of one of the containers when substantially filled
with water, and to automatically seal its respective one of the
plurality of containers upon detaching the container from its
corresponding hollow tube, such that shaking the hollow tubes in a
state in which the containers are substantially filled with water
overcomes the connecting force and causes the containers to detach
from the hollow tubes thereby causing the elastic fasteners to
automatically seal the containers, wherein the apparatus is
configured to fill the containers substantially simultaneously with a
fluid.”
26
PGR FWDs (con’t)
• Telebrands (con’t)
• PTAB instituted PGR on §112(b) and §103 grounds.
• PTAB FWD: all instituted claims unpatentable for indefiniteness.
― “apply the test for indefiniteness approved by the Federal Circuit in
Packard [751 F.3d 1307, 1313 (Fed. Cir. 2014)], i.e., ‘a claim is indefinite
when it contains words or phrases whose meaning is unclear.’”
― “We do not understand Nautilus, however, to mandate the Board’s
approach to indefiniteness in patent examination or reexamination
matters9 or in AIA proceedings, in which the claims are interpreted under
the broadest reasonable interpretation standard, and an opportunity to
amend the claims is afforded.10”
― FN 10 “We need not, and do not, decide in this case the approach to
indefiniteness to be applied in Board proceedings where the BRI standard is
inapplicable and an opportunity to amend is unavailable, such as when the
patent being challenged has expired. See In re CSB-System Int’l, Inc., 832
F.3d 1335, 1342 (Fed. Cir. 2016).”
27
PGR FWDs (con’t)
• Telebrands (con’t)
• PTAB FWD: Claim 1 is indefinite.
― “Specification consistently teaches that whether a container is ‘filled’
depends, subjectively, on whether a desired size or volume has been
reached.”
― “the level of water in a ‘substantially filled’ container is not ascertainable
or measurable by reference to any objective standard.”
― Note: Patent Owner warned of need for objective standard in
Institution Decision: “In our Institution Decision, we informed Patent
Owner of the significance of the absence of an objective standard, but
Patent Owner did not identify persuasively any such standard in the
Patent Owner Response.”
― “Neither claim 1 nor the Specification provides an objective standard for
measuring the scope of ‘a connecting force that is not less than a weight of
one of the containers when substantially filled with water’ as applied to an
expandable container[.]”
― Found Patent Owner’s expert’s testimony conclusory and unpersuasive as to
understanding of a POSITA.
28
PGR FWDs (con’t)
PGR PETITION DENIED BECAUSE CLAIMS NOT ELIGIBLE FOR PGR
• Front Row Tech., LLC v. MLB Advanced Media, L.P., 2015-00023,
Paper 8 (P.T.A.B. Feb. 22, 2016)
• Filing date Jan. 29, 2010; no claim for priority or benefit.
• Petitioner said PGR-eligible because of amendments submitted Sept.
23, 2013.
• PTAB: Claims not eligible for PGR.
― “Nowhere does the statute contemplate that the effective filing date
might depend on the date of a later-filed amendment to a claim.”
― “as a matter of law, if a claim in the application is not entitled to an
earlier filing date, then the effective filing date is the actual filing
date of the application (per subparagraph (A)), regardless of whether
a later-filed amendment to a claim finds sufficient support in the
application.”
29
PGR PETITION DENIED BECAUSE CLAIMS NOT ELIGIBLE FOR PGR
• Mylan Pharms. Inc. v. Yeda Research & Development
Co. Ltd., 2016-00010, Paper 9 (P.T.A.B. Aug. 16, 2016)
• Petitioner: claims PGR-eligible because not entitled to benefit of
priority claim to August 20, 2009 (priority applications do not provide
written description support for all claim limitations); effective filing
date is actual filing date of May 22, 2015.
• PTAB: Claims not eligible for PGR.
― Examiner specifically addressed that pre-AIA applied to claims.
― Examiner found claims supported by priority document.
― Petitioner did not show break in priority chain; “Petitioner has not
demonstrated that it is more likely than not that the ’776 patent
has at least one claim having an effective filing date on or after
March 16, 2013.”
30
PGR PETITION DENIED BECAUSE CLAIMS NOT ELIGIBLE FOR PGR
• David O.B.A. Adepbimpe v. Johns Hopkins Univ., 2016-
00020, Paper 14 (P.T.A.B. July 25, 2016)
• Parties filed briefs on PGR eligibility prior to Patent Owner filing
POPR.
• Priority claim to Oct. 4, 2012 and Feb. 25, 2013.
• Amended claims filed March 17, 2015.
• PTAB: Claims not eligible for PGR.
― “Section 100(i)(1) does not make any provision for the effective
filing date to be later than the actual filing date of the application
in question, even when the application is amended later, and even
when thelater amendment introduces claims that lack written-
description support in the original specification.
31
PATENT OWNER UNSUCCESSFUL WITH INELIGIBILITY ARGUMENT
• US Endodontics, LLC v. Gold Standard Instruments, LLC, PGR2015-00019
• PTAB: Instituted PGR over Patent Owner’s argument that claims not eligible
for PGR because of priority date benefit.
• Accepted Petitioner’s arguments that claims not supported by priority document
and therefore only entitled to actual filing date.
• Claims eligible for PGR
• “a patent that issues from an application filed after March 16 [15 sic], 2013,
that claims priority to an application filed before March 16, 2013,3 is
available for post-grant review ‘if the patent contains . . . at least one claim
that was not disclosed in compliance with the written description and
enablement requirements of § 112(a) in the earlier application for which the
benefit of an earlier filing date prior to March 16, Inguran, LLC v. Premium
Genetics (UK) Ltd., Case PGR2015-00017, slip op. 11 (PTAB Dec. 22, 2015)
(Paper 8).”
• Initial burden on petitioner: • “a petitioner seeking post-grant review carries the burden to show that the
patent is subject to the first-inventor-to-file provisions of the AIA and, therefore, eligible for post-grant review[.]”
32
PTAB GUIDANCE:
Precedential
• http://www.uspto.gov/patents-application-process/appealing-
patent-decisions/decisions-and-opinions/precedential
Representative
• http://www.uspto.gov/patents-application-process/appealing-
patent-decisions/decisions-and-opinions/representative-orders
Informative
• http://www.uspto.gov/patents-application-process/appealing-
patent-decisions/decisions-and-opinions/informative-opinions-0
33
CAFC/USSC AFFIRMED PTAB’S APPROACH
• In re Cuozzo Speed Technologies, LLC, 793 F.3d 1268 (Fed. Cir. 2015)
• No jurisdiction to review PTAB’s IPR institution decision (See 35 U.S.C. § 314(d)).
• Affirm PTAB’s Final Written Decision in full (all instituted claims unpatentable as obvious)
― No error in PTAB’s application of BRI claim construction standard;
― No error in obviousness determination; and
― No error in denial of Cuozzo’s motion to amend.
― Lack of written description support;
― Improper broadening
• Cuozzo Speed Techs., LLC v. Lee, 136 S.Ct. 2131 (U.S., June 20, 2016)
― Affirmed Federal Circuit decision not allowing attack of the decision to institute. ― In this case, §314(d) bars judicial review of whether PTAB wrongly instituted an IPR on grounds not
specifically mentioned in a third party’s review request.
― Affirmed Federal Circuit decision (unanimous), as to the BRI standard. ― USPTO has authority under §316(a)(4) to enact 37 CFR §42.100(b) (BRI is the claim construction standard
in IPRs).
34
PGR PETITIONS DENIED
• Dr. Reddy’s Laboratories, Ltd. v. Helsinn Healthcare
S.A., PGR2016-00008, Paper 11 (P.T.A.B. Aug. 17, 2016)
• PTAB: Petition denied.
• Patent Owner laid the groundwork for defending against the
§102 and §112 attacks during prosecution.
• PTAB: ― “Here, it is undisputed that the specification describes
formulations comprising the same ingredients, in the same
amounts, concentrations, and combinations required by the
challenged claims. Given this disclosure, one of ordinary skill in the
art could hardly fail to recognize a description of the claimed
formulations in the specification, whether or not the claims recite
that the formulations are stable.”
35
PGR PETITIONS DENIED
• DRL v. Helsinn, PGR2016-00008 (con’t)
• PTAB:
― “The AIA enlarged the scope of prior art under § 102 with
respect to territory, and also added the clause ‘otherwise
available to the public.’ …As an AIA first-inventor-to-file
patent, the ’942 patent is subject to AIA § 102(a)(1).”
― “The court in Helsinn Healthcare…concluded ‘that §102(a)(1)
requires a public sale or offer for sale of the claimed invention’
and ‘[t]he new requirement that the on-sale bar apply to public
sales comports with the plain language meaning of the
amended section, the USPTO’s interpretation of the
amendment, and the legislative history of the AIA.” Id. at *45.”
(issue in Teva v. Helsinn appeal, argued October 4, 2016).
36
• DRL v. Helsinn, PGR2016-00008 (con’t)
• PTAB (con’t):
― “Moreover, the court emphasized that ‘the post-AIA on-sale bar inquiry is not focused on
the public disclosure of the sale or offer for sale; rather, the ‘sale’ prong of the on-sale
bar requires that the sale make the claimed invention available to the public one year
prior to its critical date.’ Id. at *52.”
― “Petitioner has established that MGI’s Form 8-K SEC filings and Helsinn’s press releases
made public the existence of the Supply and Licensing Agreements, but Petitioner has
not shown that the heavily redacted SEC filings or the press releases, devoid of detail,
made the claimed invention available to the public. Thus, we determine that the Supply
and Licensing Agreements did not make the claimed invention available to the public
one year prior to the critical date at issue here. Accordingly, we determine that
Petitioner has failed to show that it is more likely than not that claims 1–19 are in
violation of the on-sale bar under 35 U.S.C. § 102(a)(1).”
PGR PETITIONS DENIED
37
PGR PETITIONS DENIED
• DRL v. Helsinn, PGR2016-00007, Paper 12 (P.T.A.B. Aug.
17, 2016)
• PTAB: Petition denied.
• Patent Owner laid the groundwork for defending against the
§103 attacks during prosecution.
― At least one of the asserted references was before the
examiner during prosecution.
38
PGR PETITIONS DENIED • DRL v. Helsinn, PGR2016-00007 (con’t)
• PTAB:
― “We agree with Patent Owner that a person of ordinary skill
in the art would have considered Tang to be relevant to a
“palonosetron development project.” …We need not
determine whether Tang actually teaches away from the
claimed formulations—it is enough that we agree with Patent
Owner that Tang would not have led a person of ordinary
skill in the art to expect that a solution of palonosetron at a
concentration of 0.05 mg/mL would be effective in treating
emesis. Id. at 39 (citing Ex. 1008, 466). If anything, Tang
would have suggested amounts and concentrations still
higher than the highest dose and concentration evaluated by
Tang.”
39
PGR PETITIONS DENIED
• DRL v. Helsinn, PGR2016-00007 (con’t)
• PTAB:
―“We agree with Patent Owner that Petitioner has
not established that one of ordinary skill in the art
would have had a reason to formulate a
pharmaceutical sterile intravenous solution
comprising “palonosetron hydrochloride . . . at a
concentration of 0.05 mg/mL,” as required by all
the challenged claims..”
40
LOAD UP ON YOUR EVIDENCE DURING PROSECUTION!
The “objective evidence of nonobviousness” (also known as “secondary
considerations,” as the term was coined in Graham v. John Deere) can, for
example, include:
• Long-felt but unsolved need,
• Failure of others,
• Commercial success,
• Unexpected results created by the claimed invention, and
• Skepticism of skilled artisans before the invention.
See In re Rouffet, 149 F.3d 1q350, 1355 (Fed. Cir. 1998).
These objective considerations, when present, are important evidence, as
they protect against the prejudice of hindsight bias, which frequently
overlooks the fact that “[t]he genius of invention is often a combination of
known elements which in hindsight seems preordained.”
McGinley v. Franklin Sports, Inc., 262 F.3d 1339, 1351 (Fed. Cir. 2001).
42
LOAD UP ON YOUR EVIDENCE DURING PROSECUTION!
Indeed, secondary consideration evidence “may be the
most probative and cogent evidence in the record.”
Apple Inc. v. ITC, 725 F.3d 1356, 1366 (Fed. Cir. 2013)
(internal quotation marks and citations omitted).
Objective evidence of these secondary considerations
can establish that “an invention appearing to have been
obvious in light of the prior art was not.” Stratoflex,
Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir.
1983).
43
OBJECTIVE EVIDENCE OF NONOBVIOUSNESS:
USE EVIDENCE FROM PROSECUTION
• Strong patentability positions during drafting and
prosecution.
Analyze carefully considered strong arguments and/or
declarations supporting §112 positions (written
description and enablement) and §103 positions
(nonobviousness)
• Consider Therasense
Careful thought and planning.
44
DECLARATIONS
• Declarations need to be as solid as possible. PTAB has found that
defective declarations relied on for patentability during
prosecution can form an independent basis for instituting an IPR.
• K-40 Electronics, LLC v. Escort, Inc., IPR2013-00203, Paper 6 (PTAB
Aug. 29, 2013)
― PTAB reviewed a § 1.131 declaration from the prosecution,
found it deficient, and reapplied the prior art the declaration
had antedated, instituting the IPR.
― Case also had live testimony from inventor at oral hearing.
― One might want declarations from the inventor during prosecution
that can then by referred to by the Patent Owner in the optional
Preliminary Response to try to ward off institution.
45
SAMPLE EXPERT DECLARATION DEALING WITH OBJECTIVE EVIDENCE
These declarations establish that there would have been no reasonable
expectation of success of the claimed subject matter by showing:
1) significant unexpected results in the teeth of strong skepticism by
FDA experts and fulfillment of a long-felt need;
2) the claimed subject matter is reasonably commensurate in scope
with commercial success, coupled with a nexus between that
commercial success and the merits of the claimed invention;
3) the claimed subject matter relating to NMR chemical shifts and
solvent used is neither necessarily present or inherently anticipated,
nor in any way suggested …patent relied on for the ODP rejection.
46
OBJECTIVE EVIDENCE MUST BE SUPPORTED WITH MORE THAN
CONCLUSORY STATEMENTS
• In re Ethicon, --F.3d__ (Fed. Cir. Jan. 3, 2017)(LOURIE, Dyk,
Newman; Newman dissenting)
• PTAB upheld rejection for obviousness.
• FC: Affirmed.
― Substantial evidence supported factual findings and
conclusion of obviousness.
― Not outweighed by objective evidence of nonobviousness. ― “Ethicon relied solely on its expert’s conclusory testimony to
support its copying allegations.”
― “Ethicon’s expert never even opined that the results pointed to
would have been unexpected to a person of ordinary skill in the
art.”
• Note: Judge Newman considered that the Board erred in refusing to consider
the objective evidence.
47
PTAB REQUIRES NEXUS
• Gnosis S.p.A. v. Merck & Cie, IPR2013-00117, Paper 71 (P.T.A.B.
June 20, 2014)
― PTAB: Instituted claims held unpatentable (or canceled by Patent
Owner)
― “Merck argues, and Gnosis does not dispute, that administration of
each of the above Pamlab products to a patient falls within the scope
of the claims under review. ...It is not sufficient, however, that a
product or its use merely falls within the scope of a claim in order for
objective evidence of nonobviousness tied to that product to be given
substantial weight. There must also be a causal relationship, termed
a “nexus,” between the evidence and the claimed invention. . . . A
showing of sufficient nexus is required in order to establish that the
evidence relied upon traces its basis to a novel element in the claim,
not to something in the prior art. . . . Objective evidence that results
from something that is not ‘both claimed and novel in the claim’
lacks a nexus to the merits of the invention.” [citations omitted]
48
PTAB REQUIRES NEXUS (con’t)
• Gnosis (con’t)
― PTAB rejected objective evidence
― “Nexus must exist in relation to all types of objective
evidence of nonobviousness. GPAC, 57 F.3d at 1580
(generally); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996)
(commercial success); In re Antor Media Corp., 689 F.3d
1282, 1293 (Fed. Cir. 2012) (licensing); Wm. Wrigley Jr. Co.
v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir.
2012) (copying); Ormco Corp. v. Align Tech., Inc., 463 F.3d
1299, 1313 (Fed. Cir. 2006) (failure of others); Rambus Inc.
v. Rea, 731 F.3d 1248, 1256 (Fed. Cir. 2013) (long-felt need);
Kao, 639 F.3d at 1069 (unexpected results); Stamps.com
Inc. v. Endicia, Inc., 437 F. App’x 897, 905 (Fed. Cir. 2011)
(skepticism); Muniauction, Inc. v. Thomson Corp., 532 F.3d
1318, 1328 (Fed. Cir. 2008) (praise).”
49
PTAB REQUIRES NEXUS (con’t) • Gnosis (con’t)
― PTAB rejected objective evidence
― “Thus, for objective evidence to be accorded substantial
weight, the record ‘must establish a nexus between the
evidence and the merits of the claimed invention.’ . . . .
Moreover, establishing nexus involves a showing that novel
elements in the claim, not prior-art elements, account for the
objective evidence of nonobviousness. . . . As the Federal
Circuit explains, ‘[t]o the extent that the patentee
demonstrates the required nexus, his objective evidence of
nonobviousness will be accorded more or less weight.’ . . .
Thus, the stronger the showing of nexus, the greater the
weight accorded the objective evidence of nonobviousness.”
[citations omitted]
50
NEXUS REQUIRED FOR OBJECTIVE EVIDENCE OF NONOBVIOUSNESS IS
NOT A NEW CONCEPT
• CCPA, Federal Circuit, PTAB case law and
MPEP:
• All rely on Graham v. John Deere Co., 383 U.S. 1
(1966):
― (1) the scope and content of the prior art;
― (2) differences between the prior art and the claims at
issue;
― (3) the level of ordinary skill in the pertinent art; and
― (4) evaluation of any relevant secondary considerations.
51
RECENT FEDERAL CIRCUIT CASE REITERATING NEXUS REQUIREMENT
• In re Ethicon, --F.3d__ (Fed. Cir. Jan. 3,
2017)
• FC: “the evidence relied on by Ethicon to
support its claims of commercial success,
industry praise, and unexpected results did not
establish that any success, praise or unexpected
results were due to the 85:15 VDF:HFP coating,
rather than to an unclaimed feature such as the
drug or stent design, is supported by substantial
evidence.”
―
52
“NEXUS” BETWEEN EVIDENCE AND CLAIMED INVENTION
• Manual of Patent Examining Procedure
§716.01(b)
• “The term “nexus” designates a factually and
legally sufficient connection between the
objective evidence of nonobviousness and the
claimed invention so that the evidence is of
probative value in the determination of
nonobviousness. Demaco Corp. v. F. Von
Langsdorff Licensing Ltd., 851 F.2d 1387, 7
USPQ2d 1222 (Fed. Cir.), cert. denied, 488 U.S.
956 (1988).”
53
SO FAR, ONLY A FEW EXAMPLES OF SUCCESSFUL USE OF OBJECTIVE EVIDENCE OF NONOBVIOUSNESS
Objective evidence of nonobviousness must have
nexus.
Patent Owners not much success so far with
objective evidence of nonobviousness - not
showing nexus (linking the objective evidence of
obviousness to the merits of the claimed
invention).
54
OBJECTIVE EVIDENCE IN “RECORD” SUCCESSFULLY USED BY PATENT OWNER
TO GET IPR PETITION DENIED
Omron Oilfield & Marine, Inc. v. Md/Totco, A
Division Of Varco, L.P., IPR2013-00265, Paper 11
(PTAB Oct. 31, 2013)
― Patent Owner requested PTAB exercise its discretion
to deny the petition because of the same
art/arguments before the Office during
reexamination.
― Patent Owner was able to rely on evidence in the record
in a reexamination of the patent of commercial success.
55
OBJECTIVE EVIDENCE IN “RECORD” SUCCESSFULLY USED BY PATENT OWNER
TO GET IPR PETITION DENIED
Omron (con’t)
― PTAB: Petition denied.
― Found Petitioner established a prima facie case of
obviousness, and then reviewed the objective evidence of
nonobviousness provided to the examiner during a
reexamination, and agreed that it was persuasive.
― “we determine that Patent Owner has presented sufficient
evidence to establish a prima facie case of nexus.”
― No rebuttal by Petitioner.
― “We find that the ’142 Patent had significant commercial
success, which, here, overcomes the prima facie case of
obviousness.” 56
PETITIONER’S FAILURE TO ADDRESS OBJECTIVE EVIDENCE BASIS FOR DENIAL
• Praxair Distribution, Inc. v. Mallinckrodt Hospital Products,
IPR2016-00777, -00778, -00779, -00780, Paper 10 (P.T.A.B.
Sept. 22, 2016)
• PTAB: Denied petitions under 35 U.S.C. § 325(d). ― Patent Owner’s evidence of a clinical study showed unexpected
results.
― In prior proceedings, PTAB found the study “compelling
evidence” of nonobviousness.
― Petitioner did not address any of these arguments in its earlier
petitions or in its present petitions.
― Petitioner “does not explain why the many experts in the field
would have designed a study that did not exclude patients with
pre-existing LVD if it were obvious to do so.” ― “Petitioner’s argument is substantially the same as before[.]”
― Petitioner’s arguments that couldn’t find references earlier
contradicted by testimony of its own expert.
57
OBJECTIVE EVIDENCE SUCCESSFULLY USED BY PATENT OWNER AVOID
UNPATENTABILITY DETERMINATION IN FWD
Intri–Plex Technologies, Inc. v. Saint–Gobain Performance Plastics Rencol Ltd.,
IPR2014–00309, Paper 83 (PTAB March 23, 2014)
• Patent Owner submitted objective evidence of nonobviousness via a declaration
(prepared for the IPR) supporting the Patent Owner Response.
• PTAB: Final Written Decision that Intri-Plex did not meet its burden of showing
challenged claims unpatentable.
― “we determine that the first three Graham factors favor a determination that the
challenged claims are obvious. However, a proper obviousness determination requires a
consideration of all factors, and we determine that Saint-Gobain’s case for
nonobviousness based on secondary considerations is particularly strong, and outweighs
the other three factors. In particular, we are persuaded that our finding of commercial
success is particularly strong, …. Indeed, we determine that commercial success alone
sufficiently outweighs the other three factors, and that our finding of copying merely
strengthens further our finding that secondary considerations weigh in favor of Saint-
Gobain.”
58
PROSECUTION DECLARATIONS AND OBJECTIVE EVIDENCE
Phigenix, Inc. v. Immunogen, Inc., IPR2014-00676
• Petition challenged 8 claims; 8 asserted grounds. ― Submitted prosecution declarations as exhibits.
― Argued that the declarations submitted to overcome examiner’s rejection
did not in fact prove unexpected results and lack of reasonable
expectation of success.
• POPR: ― Petitioner failed to establish a reason to combine the prior art with a
reasonable expectation of success
― Petitioner failed to properly account for objective indicia of
nonobviousness as discussed in prosecution declarations. ― Unexpected results from clinical trials
― Praise in the industry
― long-felt need
― commercial success
― Cited Omron Oilfield & Marine, Inc. v. MD/Totco, to support denial because
petition fails to "challenge the merits of Patent Owner's secondary consideration
evidence" of record.
59
PROSECUTION DECLARATIONS AND OBJECTIVE EVIDENCE
Phigenix, Inc. v. Immunogen, Inc., IPR2014-00676 • PTAB instituted IPR on all challenged claims on one asserted
ground. ― “Petitioner has established a reasonable likelihood that it would prevail in
showing prima facie obviousness, i.e., that an ordinary artisan would have
had reason to make immunoconjugates as described in Chari 1992 using
huMAB4D5-8 disclosed in the HERCEPTIN® Label, with a reasonable
expectation of success in making them.”
― Considered objective evidence, but decided that Petitioner had made
sufficient showing for institution. ― The prosecution declarations addressed “a rejection during prosecution based on different
references than those cited in asserted grounds in the Petition.”
― “In addition, Patent Owner evidence of record at this time do not address adequately
considerations such as whether evidence of objective indicia are reasonably commensurate
with the scope of the challenged claims, whether a sufficient nexus exists between such
evidence and the merits of the claimed invention, or whether evidence of unexpected results
establishes a difference between the results obtained and those of the closest prior art.”
Maybe could have obtained denial
60
PROSECUTION DECLARATIONS AND OBJECTIVE EVIDENCE
Phigenix, Inc. v. Immunogen, Inc., IPR2014-00676, Paper
39 (PTAB Oct. 27, 2015)
• PTAB FWD: All claims survived (not shown to be unpatentable).
― “viewing the record as a whole, Petitioner does not persuade us that a
preponderance of the evidence establishes that a skilled artisan would
have had a reasonable expectation of success in 2000 that a Herceptin®-
maytansinoid immunoconjugate would be useful in the treatment of breast
tumors in humans[.]”
― “Petitioner has not established by a preponderance of the evidence that a
skilled artisan would have had reason to combine the teaching of the cited
references to make the immunoconjugates of claim 6 and 8.”
― “Although failure to establish a reason to combine the cited teachings is
sufficient, by itself, to conclude non-obviousness, Patent Owner cites
substantial evidence of objective indicia of non-obviousness in relation to
claim 8, which is directed to the T-DM1/Kadcyla® commercial product.”
61
PROSECUTION DECLARATIONS AND OBJECTIVE EVIDENCE
Phigenix, Inc. v. Immunogen, Inc., IPR2014-00676, Paper
39 (PTAB Oct. 27, 2015) • PTAB FWD: (con’t)
― Objective evidence ― unexpected superior results as compared to closest prior art compositions
― fulfilling a long-felt and unmet need for an immunoconjugate capable of targeting a solid
tumor in patients without excessive toxicity.
― praise in the field
― commercial success: sales and prescription data, marketing and promotional efforts.
― “we are persuaded that Patent Owner establishes a sufficient nexus in
relation to the cited objective evidence of nonobviousness.”
― “The specification of the 856 patent discloses, and claim 8 recites, the
very components that led to the unexpected results, praise and
commercial success. . . . Patent Owner sufficiently establishes that it is
the exact combination of those components recited in claim 8, rather than
different components previously combined in the prior art, that provided
the unexpected results at issue, and led to praise and commercial
success.”
62
REMEMBER: parallel and inconsistent outcomes VERY REAL POSSIBILITY
AND END OF LITIGATION MAY NOT BE
END OF CASE
Fresenius v. Baxter (Fed. Cir. 2013) – litigation decision was not final, PTAB decision wiped out award.
SAP v. Versata (Fed. Cir. 2014) – Litigation decision final (because
Versata waived injunction), but appeal dismissed after PTAB canceled claims.
63
Prosecution issues in view of the opportunities and pitfalls
afforded by the AIA,
including Jedi-Master-Mixer (JMM), particularly for avoiding
certain on-sale bars that could be raised in future PGRs
64
“section 3(n)(2) does indicate that the provisions of 35 U.S.C.
102(g), 135, and 291 as in effect on March 15, 2013, shall apply
to “each claim” of an application for patent, and not simply
the claim or claims having an EFD that occurs before March 16,
2013, if the condition specified in section 3(n)(2) occurs.
Therefore, “each claim” of an application presenting a claim to
a claimed invention that has an effective filing date before
March 16, 2013, but also presenting claims to a claimed
invention that has an effective filing date on or after March 16,
2013, is subject to AIA 35 U.S.C. 102 and 103 and is also subject
to the provisions of 35 U.S.C. 102(g), 135, and 291 as in effect
on March 15, 2013.”
FITF EXAMINATION GUIDELINES: SEC. 3(n)(2)
See pp. 11069, 11072 of Examination Guidelines (2/14/13)
66
Enactment: Sept. 16, 2011
PCT
Filing
First to Invent System Applies
STRADDLING THE EFFECTIVE DATE
“First To Invent” System or “FITF” System? (see SEC.
3(n)(1)(A) and (n)(2))
(Even if one claim not supported at priority date is
eventually canceled, still in FITF.)
PCT
Filing
Priority
Date
Enactment: Sept. 16, 2011 Effective Date:
March 16, 2013
Priority
Date
“FITF” System Applies
PCT
Filing
Enactment: Sept. 16, 2011
Scenario 1: no claims entitled to priority date: FITF
Scenario 2: all claims entitled to priority date: first-to-invent
Scenario:3: at least 1 claim not entitled to priority date: mixed
Assumes “priority date” is ex-US
67
Some may seek out SEC.3(n)(2), owing to advantages of AIA.
• Elimination of Metallizing Engineering forfeiture (according to
USPTO, see p. 11062 of Examination Guidelines (2/14/13);
• liberalization of the CREATE ACT and common ownership in
102(c);
• possible elimination of pre-AIA statutory bars that are not AIA
prior art!!!
Lab notebooks maybe even more important than before!
• Proving conception still important for antedating references,
including in IPRs/PGRs.
SEC. 3(n)(2): JEDI MASTER MIXER!
68
CONSIDER PURSUING SEVERAL PATENTS
FROM ONE APPLICATION Keeping a family member alive may help a patent owner facing
IPR or PGR. • If PTAB does not allow the patent owner to enter a particular proposed
substitute claim, if the subject matter of the proposed substitute claim is
patentably distinct from any canceled claims, such subject matter can still be
pursued in a pending family member.
• Perhaps avoid the need to amend claims in an IPR/PGR against potential
novelty and obviousness attacks based on patents and printed publications.
• Divisionals all protected from ODP attacks in litigation and could lead to
several patents each having numerous claims of varying scope that a petitioner
will have to challenge.
• Additionally, evidence and arguments submitted in the prosecution history of
other applications could be referenced in a POPR or Patent Owner Response
(POR) for the patent at issue in the IPR/PGR.
72
Caution on keeping a pending application: Study cases
discussing “unreasonable and unexplained delay.”
• Tafas v. Doll, 559 F.3d 1345 (Fed. Cir. 2009)
• In re Bogese, 303 F.3d 1362 (Fed. Cir. 2002)
• Symbol Tech., Inc. v. Lemelson Medical, Educ. & Research Foundation, 422
F.3d 1378 (Fed. Cir. 2005)
73
CONSIDER PURSUING SEVERAL PATENTS
FROM ONE APPLICATION (cont.)
CONSIDER KEEPING CONTINUATION APPLICATION PENDING (con’t)
Consider estoppel impact on a patent owner receiving an adverse
written decision and how it would likely preclude seeking
patentability of a claim in the continuation that is not
patentably distinct from the claim determined to be
unpatentable in the written decision.
• 37 C.F.R. §42.73(d)(3): “(3) 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.
74
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.”
KEEP CONTINUATION PENDING…
75
KEEP CONTINUATION PENDING… (con’t)
• PTAB indicated continuation application prosecution will not be
stayed.
• Telebrands Corp. v. Tinnus Enterprises, LLC, PGR2015-00018, Paper 62
(P.T.A.B. Aug. 29, 2016)
― PTAB denied Petitioner’s request to file a motion to suspend prosecution of 4 pending
continuation patent applications.
― “We deny Petitioner’s request for authorization to file a motion to suspend
prosecution of the co-pending applications. … Petitioner has not persuaded us that
any of the co-pending patent applications meets the ‘every involved application
and patent’ requirement, which triggers our authority under § 42.3(a).”
― “During the call, moreover, Petitioner was unable to cite any Board decision
granting a request to suspend prosecution of a related application (Ex. 1037, 11),
while Patent Owner cited several Board decisions denying such requests (id. at 13–
14 (citing EMC Corp. v. Personal Web Technologies, LLC., Case IPR2013-00083, slip
op. at 3 (PTAB March 19, 2013) (Paper 12); Apotex Inc. v. Wyeth LLC, Case IPR2014-
00115, slip op. at 5–6 (PTAB May 29, 2014) (Paper 19); Chums, Inc. v. Cablz, Inc.,
Case IPR2014-01240, slip op. at 2 (PTAB May 8, 2015) (Paper 22))).”
76
CONTINUATION APPLICATION MAY BE FILED ON DAY PARENT ISSUES
• Immersion Corp. v. HTC Corp., 826 F.3d 1357 (Fed. Cir. 2016)
• Immersion filed a continuation application on August 6, 2002,
the same day that the parent application issued.
• DC: Patent invalid.
― Priority for the continuation was unavailable because it was
not “filed before the patenting” of the parent application.
― See 35 U.S.C. §120.
• FC:
― “an application may be ‘filed before patenting’ of the
earlier application when both legal acts, filing and
patenting, occur on the same day.”
77
CONSIDER HAVING PATENT OWNER USE REISSUE
• Patent Owner Estoppel can be quite severe, reminiscent of
the body of law of interference estoppel.
• So maybe Patent Owner doesn’t amend claims in IPR/PGR
and rather provides a patentably distinct but useful claim
amendment in reissue, particularly if no continuation
pending.
• Reissue likely stayed pending disposal of IPR/PGR within the
one year period from institution.
• If claims of patent canceled in IPR/PGR, look for patentably
distinct claims in reissue that are enforceable and still
infringed.
78
REISSUE AND POST-GRANT PROCEDURES
Reissue applications can be merged with ex parte
reexaminations.
Reissue rules govern merged proceeding.
Timing with concurrent PGR/IPR: stays? PTAB discretion.
PGR/IPR
PGR applicable for 9 months after reissue on new reissue claims.
Reissue “effective filing date” is patent filing date.
IPR/PGR is available as normal.
What may the role of reissue be in these PGR/IPR proceedings?
79
PGR/IPR/REISSUE— TIMING REQUIREMENTS RELATED TO
LITIGATION
Cannot file if challenger also filed civil action challenging validity of patent (IPR
or PGR, §315(a)/§325(a)). • Petitioner, real party, or privy of petitioner.
• Does not include counterclaim.
Cannot file IPR more than 12 months after the petitioner is served with a
complaint alleging infringement of patent. (§315(b))
If a civil action alleging infringement of a patent is filed within 3 months patent
issues, the court may not stay its consideration of the patent owner’s motion for a
preliminary injunction on the basis that a petition for PGR filed or PGR instituted.
(§325(b))
No such timing requirements on reissue/pending applications other than the
normal ones.
80
PTAB DISCRETION
35 U.S.C. §315(d)/§325(d)
• (d) MULTIPLE PROCEEDINGS.—Notwithstanding sections 135(a), 251, and
252, and chapter 30, during the pendency of an inter partes 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
or other proceeding or matter may proceed, including providing for stay,
transfer, consolidation, or termination of any such matter or proceeding.
• §325(d) continues: “In determining whether to institute or order a
proceeding under this chapter, chapter 30, or chapter 31, the Director
may take into account whether, and reject the petition or request
because, the same or substantially the same prior art or arguments
previously were presented to the Office. (applies to both IPRs and PGRs).
81
PETITIONER ESTOPPEL: PGR AND IPR
PGR and IPR
Becomes effective once the Board issues a final written decision
Applies to any ground that petitioner raised or reasonably could have raised
Estoppel applies in subsequent proceedings before the PTO, in civil actions, and in ITC
proceedings
One-way: Only runs from PTAB to PTO/court
No estoppel if terminate by settlement
82
PATENT OWNER ESTOPPEL
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.
83
Ossia, Inc. v. Energous Corp., PGR2016-00023 and -00024, Paper 18 (P.T.A.B. Sept. 27, 2016)
• PGR petition filed May 31, 2016.
• PTAB and parties held conference call to discuss:
―Patent Owner request for Certificate of Correction to correct priority claim;
―Patent Owner request for Certificate of Correction to correct alleged errors in written description and claims;
―Patent Owner request for ex parte reexamination filed Aug 12, 2016.
PGR AND STAY OF EX PARTE REEXAM
84
Ossia (con’t)
• Requests for Certificates of Correction moot:
―PTO dismissed request to change priority claim
because that would mean a “change in the statutory
regime under which the application should have been
examined[.]”
―PTO denied request to correct errors finding that they
were not minor and “affect the scope of the
claims[.]”
PGR AND STAY OF EX PARTE REEXAM
85
Ossia (con’t)
• Appropriate to exercise discretion to stay reexam (35 U.S.C. §325(d) and 37 C.F.R.
§42.222(a)).
― PGR petition challenged claims as unpatentable under §112.
― Patent Owner amended all independent claims in the reexam.
― But PTO examines amended claims for compliance with §112 only with respect
to subject matter added in the reexam.
― So Petitioner’s PGR §112 arguments, directed to original claims, would
not/could not be evaluated in reexam.
― “[P]ermitting the reexamination to proceed could have the effect of
circumventing Petitioner’s §112 challenges, as well as the estoppel provisions
for post-grant review, if a reexamination certificate were to issue with all
amended claims.”
PGR AND STAY OF EX PARTE REEXAM
86
Ossia (con’t)
• PTAB explained further:
― “if the amended claims were found patentable in the
reexamination, and the instant proceedings terminated, Petitioner
would be time-barred from raising § 112 challenges to the
amended claims in another petition for post-grant review…. Also,
if a post-grant review were instituted and Petitioner were to
ultimately prevail in its § 112 challenges, Patent Owner would be
unable to obtain any claim that is not “patentably distinct” from a
claim cancelled as a result of the post-grant review. See 37 C.F.R.
§ 42.73(d)(3). Therefore, to the extent any of Patent Owner’s
amended claims in the reexamination are not patentably distinct
from an existing claim (an issue we need not, and do not, decide
at this time), Patent Owner potentially could obtain claims that
may not be permitted otherwise.”
PGR AND STAY OF EX PARTE REEXAM
87
Ossia (con’t)
• There is also overlap between the PGR and the reexamination - §103
arguments and prior art references.
• “Having two proceedings at the Office involving many of the same
claims and much of the same prior art taking place at the same time
is inconsistent with the Board’s rules designed to ‘secure the just,
speedy, and inexpensive resolution of every proceeding.’”
• The PGR may simply or obviate issues in the reexam.
PGR AND STAY OF EX PARTE REEXAM
88
SURVIVING CLAIMS: WHAT PATENT OWNERS DID
Strong foundation in prosecution history to draw on.
Consider requesting briefing/conference call on just the
PGR-eligibility issue prior to POPR.
89
SURVIVING CLAIMS: WHAT PATENT OWNERS DID
Put your best foot forward in the Preliminary Response
(POPR)
• Best case – institution denied
• Even if trial instituted, may narrow issues
• Have a clear and succinct section summarizing why AIA proceeding
should not be instituted.
• Get to see Board’s reaction to arguments and tailor future submissions
accordingly
Hold the Petitioner's feet to the fire • Focus on the weaknesses in the petitioner's case and aim to convince
the board that the burden of establishing likelihood of unpatentability
has not been met and thus there should be no institution.
90
SURVIVING CLAIMS: WHAT PATENT OWNERS DID
Expert testimony may be critical
• No page limits on declarations.
• Involve expert in development of every position the patent owner is
taking.
• Consider having declarations in the file history of the patent being
challenged in IPR/PGR for use with POPR/POR.
• Consider declarations that were prepared for other patent
applications but which have relevance in defeating institution of the
patent challenged.
91
SURVIVING CLAIMS: WHAT PATENT OWNERS DID
Get ready to get technical
• Patentable differences rooted in patent claims.
• Expertise of PTAB judges in science and law.
• Focus closely on the technology.
• But a key is to have a powerful summary, backed by
technical evidence, as to why PTAB either should not
institute, or if instituted, why the full record compels
PTAB to find patentability.
92
TAKE AWAYS
• Strategic use of prosecution or litigation
declarations.
• Best practices for establishing nexus
between the objective evidence and the
merits of the claimed invention.
93
TAKE AWAYS
• Provide detailed explanation linking the
objective evidence with the claimed
invention.
• If objective evidence of nonobviousness
arises late in the IPR/PGR proceeding, it may
still be possible for Patent Owner to get that
evidence before the PTAB.
94
TAKE AWAYS
• Best case scenario for a Patent Owner is to have the
petition denied and avoid an IPR/PGR, particularly
since denial cannot be judicially reviewed.
• Even if this is not achieved, the POPR may lead to the
trial being instituted on fewer grounds and/or fewer
claims than challenged in the petition -> still a
positive development for a Patent Owner now faced
with a trial narrower in scope.
• Patent Owner consider loading evidence into her
prosecution, along with crisp and compelling
arguments to show no prima facie case of obviousness,
at least in applications likely to end up in litigation or
an IPR/PGR. 95
TAKE AWAYS
• Solid evidentiary showings and/or possibly
declarations, in addition to on-point legal
arguments, may help to develop strong
patentability records.
• Prudently establishing such records during
prosecution could support Patent Owner's
efforts to persuade the PTAB that Petitioner
does not have a “reasonable likelihood” of
success and thus achieve denial of institution.
96
TAKE AWAYS
• The PTAB desires to have cases front-loaded to make the most
efficient use of the its resources by allowing it to make the
institution decision based on the most information possible.
• If Patent Owner has relevant and compelling information in the
prosecution history, or in related proceedings, such as
reexamination or litigation, that could well help Patent Owner
convince the PTAB to deny the petition. In particular, in the
POPR, Patent Owner can tell the PTAB in a concise, compelling
argument why the petition should be denied.
• Such concise and compelling arguments can help the PTAB
achieve both the policy objective that IPR proceedings be
“just, speedy, and inexpensive” and the statutory objective of
resolution 12-18 months from institution.
97
Thank You!
Contact Information:
Tom Irving
(202) 408 4082
tom.irving@finnegan.com
Amanda Murphy
(202) 408 4114
amanda.murphy@finnegan.com
Kerry Flynn
Kerry_Flynn@vrtx.com
98
top related