TABLE OF CONTENTS
Page
I.
INTRODUCTION ..........................................................................................1
II.
B.
2.
III.
IV.
V.
VI.
B.
Background ..........................................................................................9
1.
2.
3.
C.
D.
Claim Construction.............................................................................19
1.
E.
2.
3.
4.
Caon .........................................................................................29
-i-
TABLE OF CONTENTS
(continued)
5.
F.
G.
H.
I.
J.
2.
2.
3.
4.
5.
2.
2.
TABLE OF CONTENTS
(continued)
K.
1.
2.
2.
3.
4.
VII. CONCLUSION.............................................................................................63
- iii -
TABLE OF AUTHORITIES
Page
CASES
Bayer Healthcare Pharms., Inc. v. Watson Pharms., Inc.,
713 F.3d 1369 (Fed. Cir. 2013) ..........................................................................62
Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.,
246 F.3d 1368 (Fed. Cir. 2001) ..........................................................................45
Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc.,
752 F.3d 967 (Fed. Cir. 2014) ......................................................................59, 60
Cuozzo Speed Techs., LLC v. Lee,
136 S. Ct. 2131 (2016) ........................................................................................19
Galderma Labs., L.P. v. Tolmar, Inc.,
737 F.3d 731 (Fed. Cir. 2013) ............................................................................62
Graham v. John Deere Co.,
383 U.S. 1 (1966) ................................................................................................31
Hoffmann-La Roche Inc. v. Apotex Inc.,
748 F.3d 1326 (Fed. Cir. 2014) ....................................................................31, 60
In re PepperBall Techs., Inc.,
469 F. Appx 878 (Fed. Cir. 2012) .....................................................................61
In re Skoll,
523 F.2d 1392 (C.C.P.A. 1975) ..........................................................................60
Iron Grip Barbell Co. v. USA Sports, Inc.,
392 F.3d 1317 (Fed. Cir. 2004) ..........................................................................61
KSR Intl Co. v. Teleflex Inc.,
550 U.S. 398 (2007) ............................................................................................31
New Hampshire v. Maine,
532 U.S. 742 (2001) ............................................................................................24
Pfizer, Inc. v. Apotex, Inc.,
480 F.3d 1348 (Fed. Cir. 2007) ....................................................................32, 59
- iv -
TABLE OF AUTHORITIES
(continued)
SanDisk Corp. v. Memorex Prods., Inc.,
415 F.3d 1278 (Fed. Cir. 2005) ..........................................................................24
SkinMedica, Inc. v. Histogen Inc.,
727 F.3d 1187 (Fed. Cir. 2013) ..........................................................................44
Warner Chilcott Co. v. Teva Pharms. USA, Inc.,
594 F. Appx. 630 (Fed. Cir. 2014) ....................................................................32
STATUTES
35 U.S.C. 102(b) ..............................................................................................27, 29
35 U.S.C. 103(a) ...................................................................................................31
REGULATIONS
37 C.F.R. 42.100(b) ..............................................................................................19
-v-
LIST OF EXHIBITS
EXHIBIT NO.
DESCRIPTION
1001
1002
Image File Wrapper For U.S. Patent No. 9,155,776 from Public
PAIR
1003
1004
1005
1006
1007
1008
1009
1010
1011
1012
LIST OF EXHIBITS
(continued)
EXHIBIT NO.
DESCRIPTION
1013
1014
1015
1016
1017
1018
1019
1020
1021
1022
1023
LIST OF EXHIBITS
(continued)
EXHIBIT NO.
DESCRIPTION
1024
1025
1026
1027
1028
1029
1030
1031
1032
1033
1034
- viii -
LIST OF EXHIBITS
(continued)
EXHIBIT NO.
DESCRIPTION
1035
1036
1037
1038
1039
1040
1041
1042
1043
1044
1045
1046
LIST OF EXHIBITS
(continued)
EXHIBIT NO.
DESCRIPTION
1047
1048
1049
1050
1051
1052
1053
1054
-x-
LIST OF EXHIBITS
(continued)
EXHIBIT NO.
DESCRIPTION
1055
Khan, et al., Glatiramer acetate 20mg subcutaneous twice weekly versus daily injections: results of a pilot, prospective,
randomised, and rater-blinded clinical and MRI 2-year study in
relapsing-remitting multiple sclerosis, MULTIPLE SCLEROSIS
2009; 15:S151-S269, S249-S250 (2009)
1056
1057
1058
1059
1060
1061
1062
- xi -
LIST OF EXHIBITS
(continued)
EXHIBIT NO.
DESCRIPTION
1063
1064
1065
1066
1067
- xii -
TABLE OF ABBREVIATIONS
Abbreviations
TABLE OF ABBREVIATIONS
(continued)
U.S. Patent No. 8,969,302....................................................................the 302 patent
U.S. Patent No. 9,155,776....................................................................the 776 patent
U.S. Patent No. 9,402,874....................................................................the 874 patent
U.S. Provisional Application No. 61/274,687 ............... the 687 priority application
- xiv -
I.
INTRODUCTION
U.S. Patent No. 9,155,776 (the 776 patent) claims a dosing regimen for
the drug glatiramer acetate (GA) to be used for the treatment of multiple
sclerosis (MS).
September 2016, the Board held all claims of the first three patents unpatentable as
obvious.1 The 776 patent fares no betterit adds nothing patentable to the 250,
413 and 302 patents. Patent Owner is expected to contend that the 776 patent is
somehow different because it claims reduced severity of certain adverse events
as a result of using the claimed dosing regimen as compared to daily GA dosing.
1
The first three patents are U.S. Patent Nos. 8,232,250 (the 250 patent),
8,399,413 (the 413 patent), and 8,969,302 (the 302 patent). The fifth patent
is U.S. Patent No. 9,402,874 (the 874 patent) and just issued on August 2, 2016.
-1-
But Patent Owner has already declared that the disclosure of improved
tolerability with the TIW dosing regimena characteristic expressly claimed in
the earlier 250 and 413 patents and deemed unpatentable by the Boardalso
discloses the reduced severity elements. The reduced severity elements recited
in the 776 patent thus cannot rescue the unpatentable matter claimed in the 413,
250, and 302 patents.
II.
-2-
Teva Pharms. USA, Inc. v. Dr. Reddys Labs., No. 14-cv-05672 (D.N.J.);
Teva Pharms. USA, Inc. v. Synthon Pharms. Inc., No. 14-cv-01419 (D.
Del.);
Teva Pharms. USA, Inc. v. Synthon Pharms. Inc., No. 14-cv-00975
(M.D.N.C.); and
Teva Pharms. USA, Inc. v. Amneal Pharms., LLC, No. 15-cv-00124 (D.
Del.).
The litigations in the District of Delaware have been consolidated as In re
Copaxone 40 mg Consolidated Cases, No. 14-cv-01171 (D. Del.). Trial was held
on the 250, 413, 302 and 776 patents between September 26, 2016 and October
6, 2016 and the Courts decision is pending.
Inter partes reviews of the 250, 413, and 302 patents were instituted, and
all claims of the 250, 413, and 302 patents were found to be unpatentable for
obviousness on two independent grounds. Ex. 1008-1010 (IPR2015-00643, Paper
No. 85 (250 patent); IPR2015-00644, Paper No. 86 (413 patent); IPR201500830, Paper No. 80 (302 patent)). Patent Owner has requested reconsideration of
the Boards decisions in all three cases. The Board has not yet ruled on those
requests.
Petitioner previously petitioned for PGR of the 776 patent.
Ex. 1012
(PGR2016-00010, Paper No. 2). The Board did not institute review, determining
-3-
that the 776 patent is a pre-AIA patent based on Patent Owners representation
that improved tolerability of injection site reactions (ISRs) and post-injection
reactions discloses reduced severity. Ex. 1011 (PGR2016-00010, Paper No. 9)
at 9-10.
The 874 patent and Application No. 15/148, 215 are in the same family as
the 776 patent.
1.
Lead Counsel
Brandon M. White
(Reg. No. 52,354)
PERKINS COIE LLP
700 13th St., NW, Suite 600
Washington, DC 20005
BMWhite@PerkinsCoie.com
Tel: (202) 654-6200
Fax: (202) 654-9681
Back-Up Counsel
Jeffrey W. Guise
(Reg. No. 34,613)
Wilson Sonsini Goodrich & Rosati
650 Page Mill Road
Palo Alto, CA 94304
jguise@wsgr.com
Tel: (858) 350-2307
Fax: (858) 350-2399
2.
Back-Up Counsel
Emily Greb
(Reg. No. 68,244)
PERKINS COIE LLP
1 East Main Street, Suite 201
Madison, WI 53703-5118
EGreb@PerkinsCoie.com
Tel: (608) 663-7494
Fax: (608) 283-4494
Back-Up Counsel
Lorelei P. Westin
(Reg. No. 52,353)
Wilson Sonsini Goodrich & Rosati
12235 El Camino Real
Suite 200
San Diego, CA 92130
lwestin@wsgr.com
Tel: (858) 350-2225
Fax: (858) 350-2399
Please direct all correspondence to lead counsel and back-up counsel at the
contact information above. Petitioner consents to service by electronic mail at
-4-
bmwhite@perkinscoie.com,
egreb@perkinscoie.com,
jguise@wsgr.com, and
lwestin@wsgr.com.
III.
is available for inter partes review and that the Petitioner is not barred or estopped
from requesting inter partes review on the grounds identified herein.
Petitioner was first served with a complaint asserting the 776 patent on
November 10, 2015 (the Second Amended Complaint in Civil Action No. 14-cv1171 (D. Del.)). Ex. 1019. Accordingly, the one-year time period set forth in 35
U.S.C. 315(b) does not bar the present Petition.
IV.
776 patent under pre-AIA 35 U.S.C. 103, as set forth herein. Petitioners
detailed statement of the reasons for the relief requested is set forth below in the
section titled Statement of Reasons for Relief Requested. In accordance with 37
C.F.R. 42.6(c), copies of the exhibits are filed herewith. In addition, this petition
is accompanied by the Declaration of Ari Green, M.D., M.C.R. (Ex. 1003).
-5-
The challenged claims of the 776 patent are generally directed to methods
of treating relapsing-remitting multiple sclerosis (RRMS) by administering three
injections per week of GA in a 40 mg dose. Claims 1-30 of the 776 patent are
unpatentable based on the following grounds:
Ground 1: Claims 1-30 were obvious over Pinchasi in view of Flechter
2002A.
Ground 2: Claims 1-30 were obvious over Pinchasi in view of the SBOA.
Ground 3: Claims 1-30 were obvious over Pinchasi in view of Flechter
2002A and Caon.
Ground 4: Claims 1-30 were obvious over Pinchasi in view of the SBOA
and Caon.
V.
that the petitioner would prevail with respect to at least 1 of the claims challenged
in the petition. 35 U.S.C. 314(a). This Petition meets this threshold.
VI.
-7-
the 776 patent recite a method of administering 40 mg GA TIW to treat MS. Ex.
1001 at claims 1-30.
But before the earliest possible priority date (August 20, 2009), low
frequency GA dosage forms were well known in the art. As explained in detail
below, a 2007 Teva patent application to Pinchasi (Ex. 1004)the closest prior
art to the 250, 413, and 302 patentstaught the administration of a 40 mg
dosage of GA EOD. Ex. 1008 at 26; Ex. 1009 at 26; Ex. 1010 at 24; see also Ex.
1003 109-117. A number of other prior art references taught that administering
GA EOD is similarly efficacious to daily administration and improves patient
compliance and adherence by improving the tolerability of GA treatment. Ex.
1003 at 118, 127, 142-147 . The prior art also disclosed that the 40 mg dose
may improve efficacy over the 20 mg dose without increasing adverse effects. Ex.
1003 at 110-114.
The 776 patents claims recite only one element not expressly recited in the
250, 413, or 302 patents claims. Each of the 776 patents independent claims
requires that the treatment method induces reduced severity of injection site
reactions (ISRs) relative to administration of 20 mg GA daily (the reduced
severity element). Ex. 1001 at claims 1, 5, 12, and 16. Based on the Boards
prior decisions, the reduced severity element was obvious. In denying institution
of PGR on the 776 patent, the Board adopted Patent Owners argument that
-8-
BACKGROUND
1.
The 776 patent issued October 13, 2015 from an application filed five
months earlier, on May 22, 2015. That application was a continuation of earlier
applications, and claimed the benefit of related application numbers 13/770,677
(now the 302 patent) and 12/806,684 (now the 413 patent), which in turn claimed
the benefit of U.S. Provisional Application Nos. 61/337,612 and 61/274,687 (the
687 priority application). The 776 patents earliest possible priority date is
August 20, 2009.
The 776 patent issued with 30 claims directed to the 40 mg TIW dosing
regimen, with added limitations on reducing the severity and/or frequency of ISRs
-9-
- 10 -
- 11 -
The 776 patent was filed as a Track One application. Despite the pending
IPRs on its parent patents, the 776 patent issued less than five months after it was
filed. The Examiner issued only a single rejection based on nonstatutory double
patenting over claims 1-12 of the 302 patent, claims 1-20 of the 250 patent, and
claims 1-20 of the 413 patentall claims the Board has now found unpatentable.
Ex. 1002 at 259-67. In the rejection, the Examiner stated that [a]lthough the
claims at issue are not identical, they are not patentably distinct from each other
because the patent claims fully encompass the subject matter of the pending
claims. Id. at 265 2. Rather than dispute the rejection or the Examiners
characterization of claim scope, the applicant responded by filing a terminal
disclaimer. Id. at 188-90. The examiner then allowed all claims. Id. at 30-36.
- 12 -
2.
The 776 patentand several of its family members, including the 250,
413, and 302 patentsclaim priority to the 687 priority application, filed on
August 20, 2009. Like the 776 patent, the 250, 413, and 302 patents all relate
to [a] method of alleviating a symptom of relapsing-remitting multiple sclerosis
using low frequency glatiramer acetate therapy, i.e., administering 40 mg GA
TIW to treat MS. Ex. 1024-1026 at Abstract, Title. The 250 patent additionally
claims, e.g., methods of reducing the frequency of ISRs or IPIRs relative to 20 mg
GA daily, Ex. 1024, claims 14, 16, 17; treating GA-nave patients, id. at claim 13;
increasing the tolerability of GA treatment, id. at claim 15; and reducing relapse
rate, brain atrophy, enhancing lesions, and EDSS-scored disability, id. at claims 1,
4, 5-7, 10-11, 19. The 413 patent additionally claims a specific formulation (i.e., a
prefilled syringe for self-administration with a mannitol excipient, where the pH is
between 5.5 and 7.0), Ex. 1025 at claims 12-13, 19-20; certain clinical benefits of
administering 40 mg GA TIW including reducing the frequency of relapses, id. at
claims 19, 20; and reducing the frequency of IPIRs or ISRs relative to
administration of 20 mg daily, id. at claim 7. The 302 patent additionally claims
administration on specific days of the week. Ex. 1026 at claims 4, 5, 11.
The Board granted inter partes review and held unpatentable all claims of
the 250, 413, and 302 patents on two grounds: obviousness over Pinchasi (Ex.
- 13 -
1004) and Flechter 2002A (Ex. 1005) and obviousness over Pinchasi and the
SBOA (Ex. 1006). Ex. 1008-1010. Throughout its decisions, the Board credited
the testimony of Petitioners expert, Dr. Ari Green. See, e.g., Ex. 1008 at 10-13,
15-23, 26, 32, 34. The Board found that Pinchasi taught a method for alleviating a
symptom in an RRMS patient wherein the symptom is frequency of relapses, and
the patient is administered one subcutaneous injection of 40 mg GA EOD (i.e.,
seven administrations in a two-week period, as compared to the patents claims to
six administrations within the same two-week period). Ex. 1008 at 9-10; Ex. 1009
at 11-14; Ex. 1010 at 11-13. The Board further found that a POSA would have
been motivated to modify the method of treatment from EOD to TIW to increase
patient compliance, without fearing an increase in side effects or decrease in
efficacy. Ex. 1008 at 10-21, 31-33; Ex. 1009 at 11-23, 31-33; Ex. 1010 at 13-21,
28-30. The Board agreed that a POSA would have had a reasonable expectation of
success because the claimed regimen administered 120 mg GA per week, which
was within the dosing range known to be therapeutically effective, and nearly
identical to the FDA-approved 20 mg daily dosing regimen of 140 mg per week.
Ex. 1008 at 20-21; see also Ex. 1009 at 20-22; Ex. 1010 at 17-20.
The Board likewise found obvious the patents claimed treatment parameters
and effects. Claimed treatment effectssuch as reducing relapses, brain atrophy,
enhancing lesions, and EDSS-scored disabilitywere well-known beneficial
- 14 -
effects resulting from, and are the natural results of, the administration of a firstline therapy, such as GA. Ex. 1008 at 22 (internal quotations omitted). Likewise,
the 413 patents nave patient claimthe claimed method of treatment wherein
the patient has not received glatiramer acetate therapy prior to initiation of the
subcutaneous injections, (Ex. 1025) claim 6was obvious over Pinchasi and the
prior art, Ex. 1009 at 23-24, as were claims to specific excipients and pH, id. at 1113, 23-24. And ultimately, the Board found obvious purported improvements to
tolerability, because a POSA would have had a reason to switch patients treated
with GA from dosing 20 mg daily to 40 mg three times over a period of seven
days, and would have known that doing so would increase the tolerability of GA
treatment. Ex. 1008 at 24; see also Ex. 1010 at 27-28.
Patent Owner has requested rehearing of the Boards decisions in all three
inter partes review proceedings. The Board has not yet ruled on those requests.
3.
Petitioner previously requested PGR of the 776 patent, arguing inter alia
that the 776 patents claims were not entitled to an August 20, 2009 priority date
and that all claims lacked written description. Based on the later priority date it
advocated, Petitioner also argued that the claims were anticipated or obvious over a
2015 McKeage reference. Ex. 1012 at 52-65.
- 15 -
The 687 priority application and 776 patent employ the same definition of
tolerability. Compare Ex. 1033 at 18, l. 28 - 19, l. 2 with Ex. 1001 at col. 7, ll.
38-42.
- 16 -
Indeed, Patent Owner made not just one, but several such statements
explicitly equating increased tolerability of treatment with a corresponding
reduction in severity of ISRs and IPIRs. See, e.g., Ex. 1013 at 41 (A POSA
would have understood from the inclusion of these measures of tolerability in
Example 1 that the example was directed to a method for reducing the severity of
injection site reactions and immediate post injection reactions.); id. at 30 ([T]he
disclosure in the claims of the 687 Application and other ancestor Applications of
the 776 patent of methods of increasing tolerability . . . includes a reduction in the
severity of injection site reactions and thus provides additional written description
support for the claims of the 776 patent.); id. at 37-38 (These disclosures
describe a method of increasing the tolerability of GA treatment, i.e., improving
the frequency and severity of injection site reactions.). Patent Owner also made
clear that the improve[ment in] tolerability of 40 mg TIW was as compared to 20
mg daily. See, e.g., id. at 38 (A POSA reviewing the specification, therefore,
would understand that the described increase in tolerability is necessarily relative
to administration of 20 mg of GA daily.); id. at 28 (increasing tolerability
relative to a 20 mg/day subcutaneous dose of GA).
In other words, Patent Owner consistently argued in the PGR that disclosure
of any improvement in the tolerability of GA treatment describes a reduction in
ISR severity. Ex. 1003 43-51. Thus, under Patent Owners own interpretation
- 17 -
of the 776 patents reduced severity claims, a prior art teaching of improved
tolerability teaches a reduction in severity of ISRs and IPIRs.
The Board denied institution of the PGR. See Ex. 1011. In its denial, the
Board largely adopted Patent Owners interpretation of reduced ISR and IPIRs
severity as encompassing an improvement in the tolerability of GA treatment. The
Board agreed with Patent Owner that claim 10 of the 687 priority application
which discloses increasing the tolerability of GA treatmentdiscloses the claimed
reduced severity of ISRs and IPIRs. Id. at 9-10. The Board also noted that, in
prosecution, the Examiner had issued a statutory double patenting rejection over
the 302 patents claims to improved tolerability. Id. at 7-8 (Furthermore, as
noted by Patent Owner, the Examiner found in rejecting the claims for
obviousness-type double patenting over the 302 patent that the claims of the
application that matured into the 776 patent were fully disclosed in the 302
patent and is covered by that patent.). Rather than attempt to overcome the
rejections substance, Patent Owner filed a terminal disclaimer. The Examiner also
applied a pre-AIA effective filing date to the 776 patent during prosecution. Id. at
10. The Board therefore determined that the Petition had not set forth sufficient
evidence to deny Patent Owner the August 20, 2009 priority date. Id. at 9-10.
Accordingly, the Board did not address Petitioners written description,
anticipation, or obviousness arguments.
- 18 -
C.
CLAIM CONSTRUCTION
The claims of the 776 patent are presumed to take on the broadest
reasonable construction in light of the specification of the patent in which it
appears. 37 C.F.R. 42.100(b); see also Cuozzo Speed Techs., LLC v. Lee, 136 S.
Ct. 2131, 2142-46 (2016).
1.
All claims include a recitation that the claimed method reduces the severity
of injection site reactions and/or immediate post injection reactions compared to
the 20 mg daily regimen (the reduced severity terms).
- 19 -
One basis for Petitioners PGR petition was that the 776 patents claims
lack written description for the claim term reduced severity of injection site
reactions relative to administration of 20 mg glatiramer acetate s.c. daily.
In response to the petition and to avoid institution of the PGR, Patent Owner
argued that the reduced severity terms were adequately supported in the
specification and ancestor applications. Specifically, Patent Owner asserted that a
parent patent application to which the 776 patent claimed priority, the 687
application, included a claim that reads:
10. A method of increasing the tolerability of GA treatment in a
human patient suffering from relapsing-remitting multiple sclerosis or
a patient who has experienced a first clinical episode and is
- 20 -
of
pharmaceutical
composition
comprising
- 21 -
Petitioner has taken that position in parallel district court litigation, and also
argued that the reduced severity terms were indefinite because a POSA would not
know how to measure severity.
determinations affecting these issues. In claim construction, the Court accepted the
- 22 -
Petitioners proposed construction in the PGR when it found that reduced severity
is encompassed in increased tolerability. Petitioner therefore submits that the
Board should simply adhere to its prior holding that disclosure of increasing the
tolerability of GA treatment also discloses the reduced ISR and IPIR severity
claimed in the 776 patent.
In sum, to construe the reduced severity terms, the Board need look no
further than its decision denying institution of PGR on the 776 patent. According
to that decision, disclosure of a regimen that increases the tolerability of GA
treatment must include the reduced ISR severity claimed in the 776 patent.
b.
Even if the Board does not find its PGR decision binding or persuasive, the
statements Patent Owner made to the Board during the PGR proceedings judicially
parties agreement that the reduced severity terms limit the claims and that
severity means the intensity of a patients ISRs and/or IPIRs (a construction that
did not resolve the dispute over whether disclosure of improved tolerability
discloses the reduced severity terms). See Ex. 1021. Moreover, the District Court
does not follow the broadest reasonable construction rule in construing patent
claims.
- 23 -
estop Patent Owner from seeking a construction of the reduced severity terms that
does not encompass increased tolerability.
Judicial estoppel is an equitable doctrine that prevents a litigant from
perverting the judicial process by, after urging and prevailing on a particular
position in one litigation, urging a contrary position in a subsequent proceeding
or at a later phase of the same proceedingagainst one who relied on the earlier
position. SanDisk Corp. v. Memorex Prods., Inc., 415 F.3d 1278, 1290 (Fed. Cir.
2005). Three factors have firmly tip[ped] the balance of equities in favor of
applying judicial estoppel: (1) the partys later position is clearly inconsistent
with its earlier position; (2) the party succeeded in persuading a court to adopt the
earlier position in the earlier proceeding (particularly where there is a risk of
inconsistent determinations or a possible perception of one of the courts being
misled); and (3) the party seeking to assert an inconsistent position would
derive an unfair advantage or impose an unfair detriment on the opposing party if
not estopped. New Hampshire v. Maine, 532 U.S. 742, 750-51 (2001).
All three factors are clearly met here. Patent Owners 776 PGR preliminary
response took firm positions on claim construction and the prosecution history.
The Board relied on those statements in interpreting tolerability and severity
and ultimately in denying institution of PGR on the 776 patent. Should Patent
Owner deviate from the positions taken in its PGR preliminary response on the
- 24 -
same patent, Patent Owner would derive an unfair benefit, prejudice Petitioner, and
risk the Board issuing inconsistent opinions. Therefore, Patent Owner is bound by
its previous statements in the 776 PGR preliminary response (Ex. 1013) that an
increase in the tolerability of GA treatment necessarily includes a reduction in the
severity of ISRs and IPIRs.
E.
- 25 -
89-91, 111.
Pinchasi discloses that treating patients with its daily and EOD
In 1996, the FDA reviewed Tevas new drug application (NDA) for 20 mg
daily Copaxone. That reviewthe SBOAwas disclosed to Mylan (and so
publicly available) more than one year prior to the earliest possible priority date of
the 776 patent. In the SBOA, the FDA reviewer questioned:
In light of the fact that Copolymer-1 is most likely acting as a peptide
vaccine, it is unclear to me why it is necessary to inject the drug on a
daily basis. This dosing regimen seems like it would subject the
patient to an excessive amount of discomfort if it is not necessary to
- 26 -
The relapse rate and Expanded Disability Status Scale (EDSS) score were
measured. Id. Using those endpoints, Flechter 2002A found similar efficacy rates
with 20 mg daily and 20 mg EOD treatment. 4 Id. at 5. Moreover, Flechter
2002As results indicated increased tolerability and compliance for patients treated
with less frequent dosing60.3% of patients treated with EOD dosing completed
two years of treatment while only 39.7% of patients receiving daily treatment
completed two years of treatment. Id. at 5.
4
In Table 5 Flechter 2002A reports a mean relapse rate in the first 2 years of
treatment with EOD treatment of .56 (+/- 1.02). Ex. 1005 at 4. In that same table,
Flechter 2002A reports data from the underlying Meiner 1997 study for patients
that received daily treatment.
annualized rate from the Meiner 1997 paper over two years of 0.30 (+/- 0.5). Ex.
1005 at 4. The Meiner relapse rate is annualized (relapse rate per year), whereas
the Flechter 2002A relapse rate is not (relapse rate over two years). Ex. 1067 at 78; Ex. 1005 at 3. Accordingly, as the paper reports, Flechter 2002A and Meiner
1997 show similar relapse rates between the 20 mg daily and 20 mg EOD
regimens. Ex. 1003 n. 1. The Board previously agreed with Petitioner on this
issue in the prior IPRs, finding that Patent Owner misinterpreted the data in Table
5 of Flechter in arguing that less frequent dosing would decrease efficacy. Ex.
1008 at 26.
- 28 -
Flechter 2002A
Caon
Caon was published in March 2009, prior to the earliest possible priority
date of the 776 patent.
Caon is a meeting abstract describing the results of a 4-year, randomized,
rater-blinded study of 20 mg GA administered daily and EOD. Caon noted that
there were no difference[s] in relapse rate, disease progression, or any MRI
outcome between the EOD and daily treatment groups. Ex. 1007. Caon also
- 29 -
found that after 2 years of therapy all patients that had been administered daily
injections chose to switch to EOD injections. Id. Moreover, Caon stated that
[i]njection related lipoatrophy was significantly less in the [EOD] group. Id.
Caon also stated that [i]n vitro GA-proliferative responses and Th1/Th2 cytokine
expression did not differ between the two groups at any time point after
randomization. Id.
Caon concluded that GA 20 mg [subcutaneous] administered [daily] or
[EOD] may be equally effective in RRMS. Id.; Ex. 1003 79-81.
5.
In addition to the prior art discussed above, the declaration of Dr. Green
addresses additional prior art showing the POSAs general knowledge as of the
priority date. These additional publications confirm that a POSA would have
recognized that reducing the number of GA injections in a 7-day period would
increase patient adherence, compliance, and tolerability. See, e.g., Ex. 1003
117-130; Ex. 1007, 1053. The additional publications also confirm that as of the
priority date a POSA would have reasonably expected that EOD dosing would
have equivalent efficacy to daily dosing. See Ex. 1003 108-128; see also Ex.
1005 at 1; Ex. 1056 at 3-6; Ex. 1008 at 16-21; Ex. 1009 at 14-23; Ex. 1010 at 1421; Ex. 1053.
- 30 -
F.
- 31 -
Indeed, the expectation of success need only be reasonable, not absolute. Pfizer,
Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Similarly, in Warner
Chilcott Co. v. Teva Pharms. USA, Inc., 594 F. Appx. 630, 635 (Fed. Cir. 2014),
the Federal Circuit found in another dosing regimen case that [a]s longer dosing
intervals suit patient convenience and compliance, the prior art therefore provided
express motivation to pursue a monthly dosing regimen.
2.
claimed regimen is thus one dose every two weeks. Ex. 1003 131-132.
Modifying Pinchasi to remove this single dose every two weeks would have
been obvious to a POSA. It was well-known in the art that a TIW dosing schedule
was uniquely preferable, as it allowed patients to inject on the same three days
each week. Ex. 1003 131-132; Ex. 1008 at 15. Such a schedule was more
convenient and easier to remember than an EOD schedule, thus improving patient
compliance. Ex. 1003 129-130. In addition, as confirmed by the SBOA,
patients were known to prefer fewer injections, not only because patients dislike
painful injections, but also because GA induced injection-related adverse events,
- 32 -
such as ISRs and IPIRs. Ex. 1003 121-127, 142-147; Ex. 1008 at 13. POSAs
would have therefore been highly motivated to reduce injection frequency.
POSAs would also have held a reasonable expectation that a 40 mg TIW
regimen would be efficacious. POSAs would have considered Pinchasis 40 mg
EOD regimen to be therapeutically identical to the claimed regimenthe
difference between the two regimens is minor in light of standard interpatient
variability. Ex. 1003 131-134. Further, GA was known to be a forgiving drug,
as patients could take doses late or even miss doses entirely without compromising
efficacy. Id.; Ex. 1008 at 15-16. Indeed, Flechter 2002A confirmed in a study of a
20 mg EOD regimen that less frequent dosing is similarly efficacious. Ex. 1003
118; Ex. 1008 at 16-17, 20, 26, 32.
The Pinchasi, Flechter 2002A, and SBOA references, along with the prior
art which formed a POSAs background knowledge, demonstrates that, prior to
2009, POSAs had extensive interest in reducing the frequency of GA dosing to
improve patient convenience and reduce ISRs. Prior art studies established at least
the following foundational facts, which would have motivated POSAs to
administer 40 mg of GA TIW with a reasonable expectation of success:
Patients strongly preferred dosing schedules for GA treatment that required
less frequent injections; see Ex. 1003 127 (discussing Khan 2008 (Ex.
1053) and Caon (Ex. 1007)) (in study of daily vs. EOD 20 mg Copaxone
- 33 -
injections, [a]fter 2 years, all patients in the [daily] group opted to switch to
[EOD]);
Patient adherence and compliance for chronic therapies, a serious concern in
the art, is improved with less frequent and more convenient dosing
protocols; see, e.g., Ex. 1053 (noting that [t]here is considerable interest in
alternate dosing regimens of GA in RRMS. Daily SC injectable therapy can
be challenging for long-term patient compliance.); Ex. 1003 125;
EOD dosing is likely as effective as daily dosing. See, e.g., Exs. 1005, 1007,
1053; Ex. 1003 118, 122, 127;
Administering 40 mg GA daily was well-tolerated and effective. See, e.g.,
Ex. 1004 at 20, ll. 8-14; Ex. 1056 at Abstract (Glatiramer Acetate (GA) 40
mg was safe and well tolerated. The overall efficacy results suggested that a
40-mg dose of GA may be more effective than the currently approved 20-mg
daily dose in reducing MRI activity and clinical relapses.); Ex. 1003 111;
Administering 40 mg daily (by subcutaneous injection) created no safety or
tolerability concerns as compared to the daily administration of 20 mg GA.
See, e.g., Ex. 1004 at 20, ll. 8-14 (The increased efficacy observed with 40
mg/day GA . . . is not accompanied by a corresponding increase of adverse
reactions which would be expected upon a doubling of the administered
dose.); Ex. 1003 114;
- 34 -
The total weekly dose administered by the claimed regimen (120 mg) is
nearly identical to the FDA-approved 20 mg daily regimen (140 mg) and
falls within a range of total weekly doses known to be efficacious (70 mg to
280 mg), as shown in the below chart:
Figure 1. Copaxone prior art average total weekly dosing regimens. See Ex. 1003
134-135; Ex. 1008 at 15-16 (crediting Dr. Greens explanation of the range of
efficacious doses in the prior art and the forgiving nature of GA).
Further, the reduced severity limitations were obvious. Based on Patent
Owners prior statements and the Boards prior findings, disclosure of improved
tolerability discloses the reduced severity limitations. See supra Section VI.D.1;
Ex. 1003 43-51. And disclosure of improved tolerability was obviousindeed,
- 35 -
- 36 -
G.
- 37 -
- 38 -
regimen provides a more convenient and predictable dosing schedule than EOD
dosingallowing the patient to medicate on the same days of each week (e.g. M,
W, F)improving patient adherence, an important consideration in the treatment
of chronic conditions. Ex. 1003 129-130. Less frequent dosing would also have
been expected to reduce injection-related adverse events like ISRs and IPIRs,
further improving convenience and tolerability. Ex. 1003 145, 163-170.
Patent Owner may assert, as it did in the prior IPRs, that the FORTE trial
teaches away from a 40 mg dose because it found that a 40 mg daily dose does not
have superior efficacy to the 20 mg daily dose. But, as the Board previously
found, such an argument is not persuasive. Ex. 1008 at 12. [N]othing in FORTE
criticizes, discredits, or discourages the use of 40 mg of GA, so FORTE does not
teach away from the use of 40 mg of GA. Id. Indeed, FORTE demonstrated that
the 40 mg dose was equally effective and well-tolerated as the 20 mg dose, and
results suggested that the 40 mg dose may have a more rapid onset of action. Ex.
1057 at 1; Ex. 1003 92-94, 113, 167.
In addition to the clinical motivations, by 2009 there was an industryrecognized motivation to launch a new dosing regimen product to achieve further
marketplace exclusivity. By 2009, prior art 20 mg Copaxone had been on the
market for more than a decade and faced competition from less frequently injected
competitor products, oral therapies, and looming expiration of the 20 mg
- 39 -
Copaxone patents.
product was on the market and injected TIW. Ex. 1003 60, 129. The 776
patent did not contribute an inventive dosing regimen, but insteadin an attempt
to gain further market exclusivityadopted a predictably safe and effective
regimen that met the market pressures to offer a less frequent dosing regimen with
improved tolerability.
A POSA would also have had a reasonable expectation of success in
removing one dose every two weeks from the regimen disclosed in Pinchasi.
Flechter 2002A disclosed that a 20 mg EOD regimen was similarly efficacious to
20 mg daily. Ex. 1003 118; Ex. 1005 at Abstract, 4 (20 mg EOD slightly better
than 20 mg daily, with a slightly improved relapse rate and fewer adverse events),
5 (20 mg EOD is safe, well tolerated, and probably as effective as 20 mg daily
in reducing relapse rate and slowing neurologic deterioration). Flechter 2002A
disclosed that 20 mg daily and 20 mg EOD both demonstrated very few relapses,
and that disease severity was reduced by the same degree. Ex. 1005 at 5; Ex.
1003 118.
- 40 -
and other prior art references (supra Section VI.F.2.b at Figure 1); Ex. 1003 134.
Flechter 2002A disclosed that an average of 70 mg per week (20 mg EOD) is safe
and effective, and Pinchasi disclosed that the range of safe and effective doses
stretches at least to 280 mg per week (40 mg daily). The claimed regimen is 120
mg per week, not only within the range established by Pinchasi and Flechter
2002A, but also nearly identical to the FDA-approved 20 mg daily dose (140 mg
per week). A POSA also knew that GA was a forgiving drug, meaning it was
expected to have similar efficacy even with fluctuations in dosing schedule (e.g.,
taking a dose late, skipping a dose). Ex. 1003 132-134; see also Ex. 1008 at 1516 (crediting Dr. Greens testimony that an ordinary artisan would have
considered GA to be a forgiving drug.); supra Section VI.F.2 at Figure 1.
Based on these teachings, a POSA would have recognized that (1) reducing
the frequency of injections is desirable to improve patient adherence and
tolerability, (2) 40 mg dosing TIW would provide the same therapeutic profile with
the potential for a substantially improved safety and tolerability profile compared
to 20 mg daily dosing, and (3) 40 mg was a logical dosage choice for investigating
TIW administration because it kept the total weekly dose (120 mg) roughly
equivalent to Copaxones approved weekly dose (140 mg) and well within GAs
forgiving range. Ex. 1003 134; supra Section VI.F.2 at Figure 1. It would have
- 41 -
- 42 -
- 43 -
Claim 5 recites the same method as claim 1, but adds in the preamble that the
method induces one or more of the following treatment effects:
(1) reducing frequency of relapses by 30% or more as compared to placebo
in a human population,
(2) reducing the cumulative number of enhancing lesions on T1-weighted
images,
(3) reducing brain atrophy, or
(4) reducing the level of disability as measured by EDSS Score.
For the same reasons as stated in Section VI.G.1, supra, claim 5 was obvious
over Pinchasi and Flechter 2002A. As to the four treatment effects, to the extent
the Board finds them limiting, they are recited using the disjunctive or, meaning
a prior art teaching of any one of the four endpoints discloses the limitation.
SkinMedica, Inc. v. Histogen Inc., 727 F.3d 1187, 1199 (Fed. Cir. 2013) (The
disjunctive or plainly designates that a series describes alternatives.).
- 44 -
Regardless, as explained below, Pinchasi and the prior art render obvious each of
the four treatment effects. See Ex. 1003 149-159.
As an initial matter, these treatment effects should be construed as nonlimiting. The treatment effects do not alter the claimed methodthey merely
express the intended result of administering 40 mg GA TIW as claimed. See, e.g.,
Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir.
2001).
Should the terms be construed as limiting, all four treatment effects were
obvious over the prior art.
Reduction in relapses by 30% or more as compared to placebo: Pinchasi
expressly discloses that its method reduces the frequency of relapses in patients
suffering from RRMS. See, e.g., Ex. 1004 at 9, ll. 2-15. A POSA would have also
known that the prior art 20 mg daily regimen reduced relapses by 30% over
placebo. Ex. 1003 150-152. For example, Comi found that the mean relapse
rate was 33% lower in [20 mg daily] than in the placebo arm. Ex. 1031 at 5, see
also id. at Abstract. Because the prior art would have given a POSA a reasonable
expectation that the claimed regimen would be similarly efficacious to the 20 mg
daily regimen, see supra Section VI.G.1 and infra Section VI.G.3, the claimed
30% reduction in relapse rate would have been obvious.
- 45 -
- 46 -
Section VI.G.1, a POSA would have known that the 40 mg TIW regimen would
improve tolerability over the 20 mg daily regimena conclusion already reached
by the Board.
- 47 -
- 48 -
A POSA understood that the total weekly dose for 40 mg TIW (120 mg) was
similar to the total weekly dose for the FDA-approved 20 mg daily regimen (140
mg), and that both values were squarely within the therapeutically effective GA
dosing range of 70 mg per week (Flechter 2002A) to 280 mg per week (Pinchasi).
Ex. 1003 134, 174; see also Ex. 1008 at 20-21. A POSA would have expected a
similar weekly dose of GA to provide a similar safety, efficacy, and tolerability
profile. Ex. 1003 109-110, 134-135, 171-174. Thus, in view of Pinchasi and
Flechter 2002A, it would have been obvious to a POSA that 40 mg TIW would be
at least as effective as 20 mg daily. Ex. 1003 172-175. Patent Owners
recitation that 40 mg GA TIW is as effective as 20 mg GA daily does not render
claim 12 patentable.
4.
Independent claim 16 recites the same elements as claims 5 and 12, but only
claims that the frequency of relapses is reduced (without requiring the reduction to
be at least 30%).
Accordingly, for at least the reasons discussed previously in Sections
VI.G.2-3, Pinchasi in view of Flechter 200A renders claim 16 obvious. Ex. 1003
176-177.
- 49 -
5.
Dependent Claims 3-4, 10-11, 14-15, and 25-30: Dependent claims 3 and 4
ultimately depend from claim 1, claims 10-11 ultimately depend from claim 5,
claims 14-15 ultimately depend from claim 12, and claims 25-30 ultimately depend
from claim 16.
administered to a human patient that has not received glatiramer acetate therapy
prior to initiation of the treatment (the nave patient claims). Ex. 1001 at col.
16, l. 55-col. 19, l. 3.
Pinchasi in view of Flechter 2002A teaches this limitation. Ex. 1003 178179. A POSA would have understood that, as a first-line therapy for RRMS in
August 2009, GA would have been available and used to treat all MS patients,
including those who had not previously received GA (or any) therapy. Ex. 1003
179; see also Ex. 1008 at 21-23; Ex. 1007, 1053 (treatment-nave studies).
Dependent claims 6-8, and 17-20: Dependent claims 6-8 depend from
independent claim 5. Dependent claims 7-8 individually recite treatment effects
already recited in claim 5, and dependent claim 6 recites a combination of two:
reduction in brain atrophy and a 30% or more decrease in relapses as compared to
placebo. Dependent claims 17-20, which ultimately depend from claim 16, recite
a reduction in individual treatment effects as effectively as 20 mg daily
(collectively the treatment effect claims).
- 50 -
For the reasons stated supra in Section VI.G.2, the claimed treatment effects
(relapses, brain atrophy, enhanced lesions, and EDSS score) were taught by
Pinchasi in view of Flechter 2002A. Flechter 2002A also discloses that GA 20 mg
EOD is safe, well tolerated, and probably as effective as 20 mg daily in
reducing relapse rate and slowing neurologic deterioration. Ex. 1005 at 5; Ex.
1003 118, 149-159, 180-183.
Knowing that 40 mg TIW and 20 mg daily have similar weekly doses and
are expected to be effective, a POSA would thus reasonably expect 40 mg TIW to
exhibit reductions in relapse rate, brain atrophy, enhancing lesions, and EDSSscored disability at least as effectively as 20 mg daily. Ex. 1003 149-159,
180-183. Claims 6-8 and 17-20 were thus obvious over Pinchasi in view of
Flechter 2002A.
Claims 2, 9, 13, 21-24: Claim 2 depends from claim 1, claim 9 depends
from claim 5, claim 13 depends from claim 12, and claims 21-24 ultimately depend
from claim 16 (collectively the ISR and IPIR reduction claims). Whereas the
independent claims recite a reduction in the severity of ISRs relative to 20 mg
daily, and independent claims 12 and 16 recite a general improvement in
tolerability, these dependent claims also recite a reduction in frequency of ISRs
and IPIRs and the severity of IPIRs. This further limitation is likewise obvious in
view of Pinchasi. As explained above in Section VI.G.1, a POSA would know that
- 51 -
Ex. 1003
- 52 -
The SBOA thus notes that more frequent injections subject the patient to
discomfort, indicating that reducing the frequency of injections is generally
desirable. The FDA reviewer also recommended that Teva evaluate the necessity
of daily s.c. injections. See Ex. 1006 at 252; Ex. 1003 186-187; see also Ex.
1008 at 13. In view all of the reasons above and for these additional reasons,
claims 1, 5, 12, and 16 were obvious over Pinchasi in view of the SBOA.
2.
Dependent Claims 3-4, 10-11, 14-15, and 25-30: These nave patient
claims depend alternatively from independent claims 1, 5, 12, or 16. For the
reasons stated supra in Section VI.G.5, these claims were likewise obvious over
Pinchasi in view of the SBOA.
Claims 6-8 and 17-20: These treatment effect claims ultimately depend
from independent claims 5 and 16, respectively. For the reasons stated supra in
Section VI.G.2, improved treatment effects (relapses, brain atrophy, enhanced
lesions, and EDSS score) were taught by Pinchasi in view of the prior art. Claims
6-8 and 17-20 were thus obvious over Pinchasi in view of the SBOA.
Claims 2, 9, 13, 21-24: Claim 2 depends from claim 1, claim 9 depends
from claim 5, claim 13 depends from claim 12, and claims 20-24 ultimately depend
from claim 16. Whereas the independent claims recite a reduction in the severity
of ISRs relative to 20 mg daily, these dependent claims also recite a reduction in
- 53 -
frequency of ISRs and IPIRs and the severity of IPIRs. The SBOA explains that
less frequent injections reduce patient discomfort. Ex. 1006 at 252; Ex. 1003
198. Moreover, as detailed above in Section VI.G.5, these dependent claims
were also obvious over Pinchasi in view of Flechter 2002A. For these reasons, and
those given above in Sections VI.G.1-4 and VI.H.1, claims 2, 9, 13, and 21-24
were obvious over Pinchasi and the SBOA.
I.
- 54 -
- 55 -
Dependent Claims 3-4, 10-11, 14-15, and 25-30: These nave patient
claims depend alternatively from independent claims 1, 5, 12, or 16. For the
reasons stated supra in Section VI.G.5, these claims were likewise obvious over
Pinchasi in view of Flechter 2002A and Caon.
Claims 6-8 and 17-20: These treatment effect claims ultimately depend
from independent claims 5 and 16, respectively.
(relapses, brain atrophy, enhanced lesions, and EDSS score) were taught by
Pinchasi in view of the prior art, as well as by Flechter 2002A as detailed supra in
Section VI.G.2. Moreover, Caon taught that 20 mg EOD resulted in no difference
in the relapse rate, disease progression, or any MRI outcome, which would be
evident in endpoints such as brain atrophy measurements, T1-weighted images,
and EDSS score. Ex. 1007; Ex. 1003 209. Claims 6-8 and 17-20 were thus
obvious over Pinchasi in view of Flechter 2002A and Caon.
Claims 2, 9, 13, 21-24: These ISR and IPIR reduction claims ultimately
depend from independent claims 1, 5, 12, or 16, respectively.
- 56 -
Whereas the
- 57 -
2.
Dependent Claims 3-4, 10-11, 14-15, and 25-30: These nave patient
claims depend alternatively from independent claims 1, 5, 12, or 16. For the
reasons stated supra in Section VI.G.5, these claims were likewise obvious over
Pinchasi in view of the SBOA and Caon.
Claims 6-8 and 17-20: These treatment effect claims ultimately depend
from independent claims 5 and 16, respectively. For the reasons stated supra in
Section VI.G.2, improved treatment effects (relapses, brain atrophy, enhanced
lesions, and EDSS score) were taught by Pinchasi in view of the prior art and are
disclosed in Caon. Claims 6-8 and 17-20 were thus obvious over Pinchasi in view
of the SBOA and Caon.
Claims 2, 9, 13, 21-24: These ISR and IPIR reduction claims ultimately
depend from independent claims 1, 5, 12, or 16, respectively.
Whereas the
- 58 -
K.
TO
OVERCOME
THE
To counter the overwhelming evidence that all claims of the 776 patent
were obvious, Patent Owner may try to rely on secondary considerations of
nonobviousness, despite no showing of such secondary considerations in the
patent. Any such evidence would be insufficient to overcome the strong [case]
of obviousness here. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372 (Fed. Cir.
2007). Moreover, to establish the required nexus, any evidence of secondary
considerations must be unique to a 40 mg TIW regimen over the nearly identical
40 mg EOD regimen disclosed in Pinchasi. See Bristol-Myers Squibb Co. v. Teva
Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014) (explaining that evidence
must show that there is a difference between the results obtained and the closest
prior art). Ex. 1003 234-235. Nonetheless, Petitioner preliminarily addresses
some secondary considerations Patent Owner may raise, and reserves the right to
respond to any arguments by Patent Owner asserted in this proceeding.
1.
The 776 patent makes no claim that the methods recited in its claims
achieve any unexpected result. Quite to the contrary, the best the 776 patent could
claim is that its methods are at least as effective as the prior art. Ex. 1001 at col.
13, l. 46-col. 15, l. 50. And even these statements are unsupported by any data in
- 59 -
the 776 patent. Nonetheless, in view of the extensive disclosures in the prior art
as discussed in this Petition, the efficacy and tolerability of a 40 mg TIW regimen
as recited in the 776 patents claims is not surprising, and is certainly not
unexpected. Ex. 1003 216-221. In particular, a TIW dosing schedule possesses
no unexpected properties over an EOD dosing schedule, which is identical save for
one less dose every two weeks.
methods] superior efficacy does nothing to undercut the showing that there was a
reasonable expectation of success . . . , even if the level of success may have turned
out to be somewhat greater than would have been expected. Hoffmann-La Roche,
748 F.3d at 1334.
- 60 -
Patent Owner may also claim that there was a long-felt but unmet need for a
method of treating patients suffering from MS with less frequent injections and
that the 776 patent met that need. Yet, if there was any long-felt need, it was met
long ago by Pinchasi, among other references. Ex. 1003 222-225. Therefore,
others had previously solved any long-felt need alleged to be met by the
claims of the 776 patent. See In re PepperBall Techs., Inc., 469 F. Appx 878,
882-883 (Fed. Cir. 2012) (nonprec.). Moreover, it is irrelevant that, as of the
priority date, no one else had made and commercialized a method of treatment as
in the 776 patent. Because the 776 patent recites methods of using GA, a
compound that was covered by other U.S. patents at the priority date, no entity
other than the Patent Owner could have successfully brought [the claimed
- 61 -
methods] to market. Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 740
(Fed. Cir. 2013).
3.
Finally, to the extent Patent Owner argues that Petitioner and other generic
drug companies seek to copy the invention of the 776 patent by commercializing
generic versions of glatiramer acetate, this too fails to support non-obviousness.
As copying is required for FDA approval of generic drugs, any evidence of
copying in the [generic drug] context is not probative of nonobviousness. Bayer
Healthcare Pharms., Inc. v. Watson Pharms., Inc., 713 F.3d 1369, 1377 (Fed. Cir.
2013).
- 62 -
VII. CONCLUSION
For the foregoing reasons, Petitioner respectfully requests that the Board
institute trial and cancel all claims of the 776 Patent.
Respectfully submitted,
PERKINS COIE LLP
Dated: November 2, 2016
By:
- 63 -
- 64 -
Mylan
CERTIFICATE OF SERVICE
Pursuant to 37 C.F.R. 42.6(e) and 42.105, I certify that I caused to be
served a true and correct copy of the foregoing: Petition for Inter Partes Review of
U.S. Patent No. 9,155,776, including Exhibits 1001-1067 and Petitioners power of
attorney, by Federal Express Next Business Day Delivery on this day on the Patent
Owners correspondence address of record for the subject patent as follows:
COOPER & DUNHAM, LLP
30 Rockefeller Plaza
20th Floor
New York, NY 10112
and by Federal Express on this day on the Patent Owner of record for the subject
patent as follows:
Yeda Research & Development Co., Ltd.
Chief Intellectual Property Officer
Weizmann Institute of Science
Herzl Street, No. 2
Rehovot, 76100
Israel
Dated: November 2, 2016
- 65 -