United States District Court, D. Delaware
pending before the Court is Plaintiffs Motion for Estoppel
under 35 U.S.C. § 315(e)(2). (C.A. No. 14-1289, D.I.
193; C.A. No. 14-1494, D.I. 120; C.A. No. 15-0078, D.I.
120). Defendant Par Pharmaceutical has indicated
that it "takes no position" on the estoppel issue.
(D.I. 195). Thus, Plaintiffs motion for estoppel is
unopposed. However, as Plaintiff bears the burden of
demonstrating that estoppel applies under 35 U.S.C. §
315(e)(2), I have reviewed Plaintiffs brief and the record to
ensure that Plaintiff has met its burden.
Novartis Pharmaceuticals filed three suits against Defendant
Par Pharmaceutical on October 10, 2014 (C.A. No. 14-1289,
D.I. 1), December 18, 2014 (C.A. No. 14-1494, D.I. 1), and
January 23, 2015, (C.A. No. 15-78, D.I. 1), respectively.
Plaintiff also filed related suits against Defendants
Breckenridge and West-Ward. (D.I. 193 at 5 n.4). The parties
agreed that the validity of U.S. Patent No. 5, 665, 772
("the '772 patent") would be tried only once.
(D.I. 139 at 3-4). Before trial, Defendants conceded that
their proposed products meet all limitations of the '772
patent. (D.I. 152 at 34). At trial, Defendants challenged the
validity of claims 1-3, 7, and 10 of the '772 patent on
obviousness grounds, citing twenty-seven pieces of prior art.
(D.I. 139 at 6).
litigation was pending, Defendant Par challenged claims 1-3
and 8-10 of the '772 patent in an inter partes review
("IPR") proceeding. (IPR2016-00084, "the Par
IIPR"). The Patent Trial and Appeal Board
("PTAB") instituted the Par I IPR on April 29,
2016. After institution of the Par I IPR, Defendants filed
four additional IPR petitions challenging the '772 patent
along with motions to join the Par I IPR. (IPR2016-01059,
IPR2016-01023, IPR 2016-01103, IPR2016-01102). On October 27,
2016, the PTAB instituted the two IPRs which challenged
claims 1-3 and 8-10 and joined them with the Par I IPR. (D.I.
139 at 6-7). The PTAB declined to institute and join IPRs
challenging claim 7 of the '772 patent because Defendant
Par, failed to explain why claim 7 was omitted from the Par I
March 28, 2017, I issued a trial opinion, determining that
the asserted claims of the '772 patent were invalid for
obviousness-type double patenting. (D.I. 169 at 32). I did
not address Defendants' obviousness defenses or
counterclaims. (Id.). Defendants appealed. On
January 11, 2018, while the appeal was pending on the
obviousness-type double patenting decision, the PTAB issued a
final written decision in the Par IIPR upholding the
patentability of claims 1-3 and 8-10 of the '772 patent.
Par Pharm. Inc. v. Novartis AG, 2018 WL 389192, at
*l (P.T.A.B. Jan. 11, 2018). The Federal Circuit later
reversed the obviousness-type double patenting decision.
Novartis Pharms. Corp. v. Breckenridge Pharm. Inc.,
909 F.3d 1355, 1367 (Fed. Cir. 2018). After the Federal
Circuit issued its mandate in the appeal, I asked the parties
in these cases to file a status report summarizing the issues
that still needed to be addressed in the suits relating to
the '772 patent. (D.I. 187).
time, Plaintiff raised the possibility that 35 U.S.C. §
315(e)(2) would estop Defendants' obviousness defenses
and counterclaims based upon the final written decision of
the Par I IPR. (D.I. 191 at 2-3). Defendant Breckenridge
raised several objections to the application of IPR estoppel
and asserted that the Court should resolve the obviousness
defenses/counterclaims at the same time as estoppel.
(Id. at 3-4). On March 1, 2019, 1 issued an order
requesting briefing by Plaintiff on estoppel and joint
briefing from Defendants on obviousness. (D.I. 192). After
that order, the suits including Defendants Breckenridge and
West-Ward were dismissed by joint stipulation. (C.A. No.
14-1196, D.I. 221; C.A. No. 16-0431, D.I. 99; C.A. No.
14-1043, D.I. 212). Plaintiff has filed an opening brief
moving for estoppel of Defendant Par's obviousness
counterclaims. (D.I. 193). Defendant Par has indicated that
it "takes no position" on the estoppel issue. (D.I.
195). Defendant Par also has not filed any briefing on the
obviousness issue in response to my March 1 order, stating
instead that it believes that a decision can be rendered
based upon the briefing and testimony submitted to
Standard for IPR Estoppel Under 35 U.S.C. §
U.S.C. § 315(e)(2) provides,
The petitioner in an inter partes review of a claim in a
patent under this chapter that results in a final written
decision under section 318(a). . . may not assert in either a
civil action arising in whole or in part under section 1338
of title 28 . . . that the claim is invalid on any ground
that the petitioner raised or reasonably could have raised
during that inter parties review.
Federal Circuit has not directly addressed the issue of
whether estoppel applies to prior art references that were
not raised in the IPR proceeding. However, the majority of
District Courts have determined that IPR estoppel applies to
any prior art that reasonably could have been raised, even if
not actually raised in the IPR proceeding. See, e.g.,
Bio- Rad Labs., Inc. v. 10XGenomics, Inc., 322
F.Supp.3d 537, 541 (D. Del. 2018) (citing Bio-Rad Labs.,
Inc. v. 10XGenomics, Inc., C.A. No. 15-152, D.I. 228 at
28:17-29:14 (D. Del. Sept. 26, 2017)); Parallel Networks
Licensing, LLC v. IBM Corp., 2017 WL 1045912,
at * 11-12, (D. Del. Feb. 22, 2017); Am Tech.
Ceramics Corp. v. Presidio Components, Inc.,
2019 WL 365709, at *2, 4-5 (E.D.N.Y. Jan. 30, 2019);
Milwaukee Electric Tool Corp. v. Snap-On Inc., 271
F.Supp.3d 990, 1029-30 (E.D. Wise. 2017); Network-I
Techs., Inc. v. Alcatel-Lucent USA, Inc., No.
6:ll-cv-00492-RWS, 2017 U.S. Dist. LEXIS 178857, at *6-7
(E.D. Tex. Oct. 27, 2017).
have stated previously, the general purpose of the statute as
well as the statutory language indicate that the most
plausible interpretation is that any prior art that the IPR
petitioner could have raised in the proceeding is estopped if
there is a final written decision from the PTAB that the
challenged claims are valid. See Bio-Rad, C.A. No.
15-152, D.I. 228 at 28:17-29:14. Prior art "reasonably
could have been raised" when "a skilled searcher
conducting a diligent search reasonably could have been
expected to discover" the prior art. See, e.g.,
Cong. Rec. SI375 (daily ed. Mar. 8, 2011) (statement of Sen.
Kyl). Moreover, one of the policy objectives behind the
introduction of IPR proceedings was an intention to conserve
judicial resources. Am Tech., 2019 WL 365709, at *2.
Allowing an IPR petitioner to have two bites at the apple by
holding back certain obviousness combinations runs counter to
both the clear language and purpose behind § 315.
Parallel Networks, 2017 WL 1045912, at *12.
Breckenridge also raised an objection to the application of
IPR estoppel after the district court has held trial. (D.I.
191 at 3-4). I do not think the application of IPR estoppel
is dependent on the order in which certain events occur. This
is a matter of first impression. While previously raised in
Senju Pharmaceutical Co. v. Lupin Ltd., C.A. No.
14-667 (D.N.J.), the parties settled before the Court could
determine the issue. Senju Pharm., C.A. No. 14-667,
D.I. 301 (D.N.J. Aug. 1, 2016), D.I. 302 (D.N.J. Aug. 2,
2016), D.I. 314 (D.N.J. Aug. 29, 2016).
plain language of the statute does not indicate that Congress
intended for there to be a time limitation upon the estoppel
effect of a final written decision of an IPR. The parties in
Senju focused upon the use of the terms
"request" and "maintain" in §
315(e)(1) and the term "assert" in §
315(e)(2). Senju Pharm., C.A. No. 14-667, D.I. 302
at 1-3. It appears to me that the differences in statutory
language is a result of the forum in which the estoppel
occurs, rather than evidence that Congress intended IPR
estoppel to be limited to time before trial is completed.
Section (e)(1) describes the estoppel effect of a final
written decision on other PTAB proceedings. As this section
deals with administrative proceedings, the language is
appropriately directed to that context. Thus, §
315(e)(1) states that after a final written decision is
issued, the petitioner may not "request or maintain
a proceedings (emphasis added). In contrast, §
315(e)(2) is directed at claims or defenses that
could be raised in a judicial proceeding and not the
proceeding itself. Therefore, § 315(e)(2) uses the term
"assert," which does not indicate a time
limitation. Moreover, in the context of judicial proceedings,
the term "assert" is often used in a manner
consistent with "maintaining." For example, while a
party may assert a multitude of patent claims at the
beginning of suit, by summary judgment, there may be only a
few "Asserted Claims" left. Thus, the plain
language of the statute, along with the previously discussed
policy objectives of judicial economy, indicates that IPR
estoppel will still apply post-trial where the Court has not
entered a final judgment on the relevant ground.