Novartis Pharmaceuticals Corp v. Breckenridge Pharmaceutical ( 2018 )

United States Court of Appeals
for the Federal Circuit
______________________
NOVARTIS PHARMACEUTICALS CORPORATION,
NOVARTIS AG,
Plaintiffs-Appellants
v.
BRECKENRIDGE PHARMACEUTICAL INC., PAR
PHARMACEUTICAL, INC., WEST-WARD
PHARMACEUTICALS INTERNATIONAL LIMITED,
Defendants-Appellees
______________________
2017-2173, 2017-2175, 2017-2176, 2017-2178, 2017-2179,
2017-2180, 2017-2182, 2017-2183, 2017-2184
______________________
Appeals from the United States District Court for the
District of Delaware in Nos. 1:14-cv-01043-RGA, 1:14-cv-
01196-RGA, 1:14-cv-01289-RGA, 1:14-cv-01494-RGA,
1:14-cv-01508-RGA, 1:15-cv-00078-RGA, 1:15-cv-00128-
RGA, 1:16-cv-00431-RGA, 1:17-cv-00389-RGA, 1:17-cv-
00420-RGA, Judge Richard G. Andrews.
______________________
Decided: December 7, 2018
______________________
CHRISTINA A. L. SCHWARZ, Venable LLP, New York,
NY, argued for plaintiffs-appellants. Also represented by
NICHOLAS NICK KALLAS, LAURA KATHERINE FISHWICK,
CHRISTOPHER EARL LOH.
2 NOVARTIS PHARMACEUTICALS CORP v. BRECKENRIDGE
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WILLIAM M. JAY, Goodwin Procter LLP, Washington,
DC, argued for all defendants-appellees. Defendant-
appellee West-Ward Pharmaceuticals International
Limited also represented by KEITH A. ZULLOW, STEVEN J.
BERNSTEIN, NAOMI BIRBACH, MICHAEL B. COTTLER, New
York, NY.
RACHEL C. HUGHEY, Merchant & Gould P.C., Minne-
apolis, MN, for defendant-appellee Breckenridge Pharma-
ceutical Inc. Also represented by CHRISTOPHER J.
SORENSON; B. JEFFERSON BOGGS, JR., Alexandria, VA;
DANIEL EVANS, Atlanta, GA.
DANIEL BROWN, Latham & Watkins LLP, New York,
NY, for defendant-appellee Par Pharmaceutical, Inc. Also
represented by BRENDA L. DANEK, MARC NATHAN ZUBICK,
Chicago, IL; GABRIEL BELL, ROBERT J. GAJARSA, Washing-
ton, DC.
______________________
Before PROST, Chief Judge, WALLACH and CHEN, Circuit
Judges.
CHEN, Circuit Judge.
This case involves the complicated, potential double-
patenting situation in which the later-filed of two related
patents, which share a common specification and effective
filing date, expires before the term of the earlier-filed
patent due to an intervening change in law by Congress
defining a patent’s term. When the patent owner filed for
the first patent, the governing law defined the patent
term as 17 years from the date the patent issued. When
the patent owner filed for its second, related patent, the
governing law was amended to define the patent term as
expiring 20 years from the patent’s earliest effective filing
date. Because of the two patents’ relatively early effective
filing date, the change in patent term law caused the
second patent to expire earlier than the first patent. The
NOVARTIS PHARMACEUTICALS CORP v. BRECKENRIDGE 3
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patent owner here concedes that the claimed inventions in
the two related patents are obvious variants of each other.
The legal question we confront in this appeal is whether
the law of obviousness-type double patenting requires a
patent owner to cut down the earlier-filed, but later
expiring, patent’s statutorily-granted 17-year term so that
it expires at the same time as the later-filed, but earlier-
expiring patent, whose patent term is governed under an
intervening statutory scheme of 20 years from that pa-
tent’s earliest effective filing date. See 35 U.S.C.
§ 154(a)(2) (2012).
Novartis Pharmaceuticals Corporation and Novartis
AG (collectively, Novartis) appeal the district court’s
decision to invalidate U.S. Patent No. 5,665,772 based on
obviousness-type double patenting. The invalidating
reference, Novartis’s U.S. Patent No. 6,440,990, was filed
after, and issued after, but expired before the ’772 patent.
Both patents claimed the same priority date. The ’990
patent expired before the ’772 patent because the ’990
patent was filed after the June 8, 1995 effective date of
the Uruguay Round Agreements Act of 1994 (URAA),
§ 532, Pub. L. No. 103-465, 108 Stat. 4809, 4983, and thus
expired on September 23, 2013, 20 years from its earliest
effective filing date. The ’772 patent, on the other hand,
was filed before the effective date of the URAA and—
pursuant to the URAA transition statute 35 U.S.C.
§ 154(c)(1)—expired 17 years from its issuance, on Sep-
tember 9, 2014. Due to a five-year patent term extension
(PTE) Novartis was subsequently granted under
35 U.S.C. § 156, the ’772 patent’s term expires on Sep-
tember 9, 2019. And due to the intervening change in law
through the implementation of the URAA, the lifespan of
the ’772 patent encompasses that of the ’990 patent (even
without considering the § 156 five-year term extension).
Applying our decision in Gilead Sciences, Inc. v. Natco
Pharma Ltd., 753 F.3d 1208, 1212 (Fed. Cir. 2014), which
held that a later-filed but earlier-expiring patent can
4 NOVARTIS PHARMACEUTICALS CORP v. BRECKENRIDGE
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serve as a double patenting reference for an earlier-filed
but later-expiring patent, the district court found the ’990
patent to be a proper double patenting reference for the
’772 patent. Because the parties stipulated to invalidity if
the court concluded that the ’990 patent is a double pa-
tenting reference to the ’772 patent, the district court
found claims 1–3, 7, and 10 of the ’772 patent invalid. We
disagree that the ’990 patent is an invalidating reference.
The patents at issue in Gilead were both filed after
the effective date of the URAA and claimed different
priority dates. 753 F.3d at 1210. Because Gilead’s earli-
er-filed patent claimed an earlier priority date, despite
issuing after the later-filed patent, that earlier-filed
patent expired before the later-filed patent. Id. As the
district court correctly summarized, we held in Gilead
that the expiration date is the benchmark of obviousness-
type double patenting. But our opinion was limited to the
context of when both patents in question are post-URAA
patents. Id. at 1216. Here we have one pre-URAA patent
(the ’772 patent) and one post-URAA patent (the ’990
patent), governed by different patent term statutory
regimes. Our decision in Gilead thus does not control the
present situation. Instead, the correct framework here is
to apply the traditional obviousness-type double patenting
practices extant in the pre-URAA era to the pre-URAA
’772 patent and look to the ’772 patent’s issuance date as
the reference point for obviousness-type double patenting.
Under this framework, and because a change in patent
term law should not truncate the term statutorily as-
signed to the pre-URAA ’772 patent, we hold that the ’990
patent is not a proper double patenting reference for the
’772 patent. Accordingly, we reverse.
BACKGROUND
Novartis owns the ’772 patent, which claims the com-
pound everolimus, and the ’990 patent, which is directed
to certain methods of treatment using everolimus and
NOVARTIS PHARMACEUTICALS CORP v. BRECKENRIDGE 5
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specific pharmaceutical compositions comprising everoli-
mus. Everolimus is the active ingredient in Zortress® and
Afinitor®, which can be used to treat certain cancers and
prevent rejection in kidney and liver transplantations.
Novartis sued Breckenridge Pharmaceutical Inc., Par
Pharmaceutical, Inc., and West-ward Pharmaceuticals
International Ltd. (collectively, Defendants/Appellees) for
infringing claims 1–3, 7, and 10 of the ’772 patent after
Defendants sought FDA approval to market generic
versions of Zortress® and Afinitor®.
In the district court, Defendants conceded that their
proposed products infringe the ’772 patent’s asserted
claims. The parties stipulated that the ’772 patent and
the ’990 patent are assigned to the same entity, and both
patents share the same named inventors. The parties
further stipulated that if the district court found the ’990
patent to be a proper double patenting reference to the
’772 patent, then the claims of the ’990 patent would
render the asserted claims of the ’772 patent invalid for
obviousness-type double patenting. J.A. 135. Thus, the
only question before the district court was whether the
’990 patent could serve as an obviousness-type double
patenting reference against the ’772 patent.
The ’990 patent issued later, but expired earlier, than
the ’772 patent due solely to a change in patent term law.
On June 8, 1995, the passage of the URAA changed the
term of a U.S. patent from 17 years from the issuance
date to 20 years from the filing date of the earliest U.S. or
Patent Cooperation Treaty (PCT) application to which
priority is claimed, excluding provisional applications.
Pub. L. No. 36-38, 12 Stat. 246, 246 (§ 16) (1861–1994);
Pub. L. No. 103-465, § 532(a), 108 Stat. 4809, 4983–85
(1994). The URAA transition statute expressly provides
that the term of a patent issuing from an application filed
before June 8, 1995 “shall be the greater of the 20-year
term as provided in subsection (a), or 17 years from grant,
6 NOVARTIS PHARMACEUTICALS CORP v. BRECKENRIDGE
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subject to any terminal disclaimers.” 35 U.S.C.
§ 154(c)(1).
The ’772 patent was filed on April 7, 1995, and issued
on September 9, 1997. Because it was filed before June 8,
1995, the expiration date of the ’772 patent is September
9, 2014 (17 years from the September 9, 1997 issuance
date). After the ’772 patent issued, Novartis obtained a
five-year patent term extension under 35 U.S.C. § 156. 1
The ’990 patent was filed on May 23, 1997 and issued on
August 27, 2002. Because it was filed after the URAA’s
effective date and claimed priority from a September 24,
1993 PCT filing date, the same effective filing date as the
’772 patent, the ’990 patent expired on September 24,
2013. The following diagram illustrates the relevant
dates for each patent, and how, because of the URAA, the
’990 patent has an earlier expiration date than the ’772
patent.
1 35 U.S.C. § 156 authorizes patent term exten-
sions, if certain requirements are met, and is one of the
statutes that codifies the Drug Price Competition and
Patent Term Restoration Act of 1984. Public Law 98-417,
98 Stat. 1585 (codified at 21 U.S.C. § 355(b), (j), (l); 35
U.S.C. §§ 156, 271, 282) (Hatch-Waxman Act). One
provision of this law seeks to restore the term of patents
covering certain products that must receive premarket
regulatory approval. See Eli Lilly & Co. v. Medtronic Inc.,
496 U.S. 661, 669 (1990). For these products, the patent
owner loses the value of the patent term during the early
years of the patent because the product cannot be com-
mercially marketed without approval from a regulatory
agency. Novartis was granted a five-year extension on
the ’772 patent (the maximum extension authorized by
§ 156) because the ’772 patent, among others, lost at least
five years of commercialization due to the lengthy FDA
regulatory review approval process.
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Relying on our decision in Gilead, which holds that a
later-filed but earlier-expiring patent can serve as a
double-patenting reference for an earlier-filed but later-
expiring patent in the post-URAA context, see 753 F.3d at
1212, the district court found here that the post-URAA
’990 patent is a proper double patenting reference against
the pre-URAA ’772 patent. Thus, the asserted claims of
the ’772 patent were invalid for obviousness-type double
patenting because they concededly were not patentably
distinct from the claims of the ’990 patent. The district
court acknowledged that there was no binding precedent
that addressed the precise issue of whether a post-URAA
patent may serve as a double patenting reference against
a pre-URAA patent; however, it concluded that this
court’s rationale regarding the public’s right to practice an
invention after a patent expires, underlined in Gilead,
applied. 753 F.3d at 1214 (“As discussed, it is a bedrock
principle of our patent system that when a patent expires,
the public is free to use not only the same invention
claimed in the expired patent but also obvious or patenta-
bly indistinct modifications of that invention.”) (citations
omitted). The district court was particularly persuaded
8 NOVARTIS PHARMACEUTICALS CORP v. BRECKENRIDGE
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by the fact that Gilead included a footnote that cited to Ex
parte Pfizer, Inc., 2010 WL 532133 (Bd. Pat. App. &
Interf. Feb. 12, 2010), a case with substantially similar
facts to the instant case. Gilead, 753 F.3d at 1211 n.2. In
Pfizer, the Board found that a later-filed, post-URAA
patent with an expiration date in 2015 could serve as a
double patenting reference for an earlier-filed, pre-URAA
patent with an expiration date in 2019. 2010 WL 532133
at *20–21. The Board in Pfizer reasoned that the later-
expiring, pre-URAA patent would otherwise impermissi-
bly extend the patent owner’s right to exclude the public
from practicing the invention. Id. at *21.
The district court also cited other post-Gilead district
court decisions reaching the same conclusion in cases with
similar fact patterns, including Janssen Biotech Inc. v.
Celltrion Healthcare Co., 210 F. Supp. 3d 278 (D. Mass.
2016), MLC Intellectual Property, LLC v. Micron Technol-
ogy, Inc., 2016 WL 4192009 (N.D. Cal. Aug. 9, 2016), and
DDB Technologies, LLC v. Fox Sports Interactive Media,
LLC, 2014 WL 12167628 (W.D. Tex. May 15, 2014). And
it rejected Novartis’s efforts to distinguish the present
case from Gilead.
First, the district court rejected Novartis’s argument
that there is no unjustified extension of patent rights or
public harm because the ’772 patent’s expiration date is
the same as it would have been had the ’990 patent never
issued. The district court emphasized that it was Novar-
tis’s choice to file the ’990 patent, and the harm to the
public lies in the inability to practice the invention
claimed in the ’990 patent once it expired.
Second, the district court dismissed Novartis’s argu-
ment that, unlike the patent owners in Gilead and
AbbVie, Inc. v. Mathilda & Terence Kennedy Institute of
Rheumatology Trust, 764 F.3d 1366 (Fed. Cir. 2014),
Novartis did not engage in any gamesmanship such as the
structuring of priority claims among related patents to
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obtain the benefit of one patent gaining a later expiration
date. The district court held that a patentee need not
engage in gamesmanship in order to violate the principles
of double patenting because neither Gilead nor AbbVie
held that gamesmanship is required.
Third, the district court was unpersuaded by Novar-
tis’s argument that allowing an earlier-expiring post-
URAA patent to serve as a double patenting reference for
a later-expiring, pre-URAA patent would effectively
shorten the statutorily mandated 17-year term of the pre-
URAA patent. The district court found that Novartis ran
this risk by seeking a second patent on an obvious variant
of its invention claimed in its first issued patent.
Finally, the district court addressed Novartis’s argu-
ment that the § 156 patent term extension it received for
its ’772 patent is not an unjustified extension of patent
rights and effectively immunized its patent from a double
patenting challenge. While the district court acknowl-
edged that this is true in the abstract, it noted that No-
vartis’s § 156 patent term extension grant is not at issue
here and that there is no case law supporting Novartis’s
proposition that a term extension immunizes a patent
from a double patenting challenge. 2 Thus, the district
2 This extension does not affect the obviousness-
type double patenting analysis here because the ’772
patent’s original expiration date of September 9, 2014
(without its patent term extension under § 156) is still
later than the ’990 patent’s expiration date of September
24, 2013. Thus, we need not address the interplay of
§ 156 PTEs and obviousness-type double patenting in this
opinion. We address that issue in a concurrently issued
opinion finding that obviousness-type double patenting
does not invalidate an otherwise validly obtained PTE
under § 156. See Novartis AG v. Ezra Ventures LLC, No.
2017-2284 (Fed. Cir. Dec. 7, 2018).
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court held that the ’990 patent is a proper double patent-
ing reference for the ’772 patent and that the ’990 patent
renders the ’772 patent invalid for obviousness-type
double patenting.
Novartis appeals. We have jurisdiction under 28
U.S.C. § 1295(a)(1).
DISCUSSION
“While the ultimate conclusion that a patent is invalid
under the doctrine of obviousness-type double patenting is
reviewed de novo, the underlying factual determina-
tions—including the existence of secondary factors such
as unexpected results—are reviewed for clear error.”
AbbVie, 764 F.3d at 1372 (citing Eli Lilly & Co. v. Teva
Parenteral Meds., Inc., 689 F.3d 1368, 1376 (Fed. Cir.
2012)). This appeal presents a narrow legal question: can
a post-URAA patent that issues after and expires before a
pre-URAA patent qualify as a double patenting reference
against the pre-URAA patent? We conclude under the
circumstances of this case that it cannot. Therefore, the
district court erred in using the ’990 patent as a double
patenting reference for the ’772 patent.
A.
“Non-statutory, or obviousness-type, double patenting
is a judicially created doctrine designed to foreclose
‘claims in separate applications or patents that do not
recite the ‘same’ invention, but nonetheless claim inven-
tions so alike that granting both exclusive rights would
effectively extend the life of patent protection.’” Takeda
Pharm. Co. v. Doll, 561 F.3d 1372, 1375 (Fed. Cir. 2009)
(quoting Perricone v. Medicis Pharm. Corp., 432 F.3d
1368, 1373 (Fed. Cir. 2005)). In Gilead, we laid out the
principles underlying the prohibition against double
patenting. See 753 F.3d 1212–14. The core principle is
that, in exchange for a patent, “an inventor must fully
disclose his invention and promise to permit free use of it
NOVARTIS PHARMACEUTICALS CORP v. BRECKENRIDGE 11
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at the end of his patent term.” Id. at 1212. Prohibiting
double patenting prevents a patentee from obtaining
sequential patents on the same invention and obvious
variants, to thereby effectively manufacture a timewise
extension of its patent exclusivity through a later-expiring
patent. Id. The key purpose of obviousness-type double
patenting is thus to prevent a patent owner from control-
ling the public’s right to use the patented invention
beyond the statutorily allowed patent term of that inven-
tion.
Federal courts have applied the principles of obvious-
ness-type double patenting for over a century to restrict a
patent owner’s patents on an invention and obvious
variants to one 17-year patent term. See, e.g., Eli Lilly &
Co. v. Barr Labs., Inc., 251 F.3d 955, 967 (Fed. Cir. 2001).
Traditionally, courts looked at the issuance dates of the
respective patents, because, under the law pre-URAA, the
expiration date of the patent was inextricably intertwined
with the issuance date, and used the earlier-issued patent
to limit the patent term(s) of the later issued patent(s).
See Miller v. Eagle Mfg. Co., 151 U.S. 186, 196–97 (1894)
(citing Suffolk in finding that a first issued patent claim-
ing the same invention invalidates a second issued pa-
tent); Suffolk Co. v. Hayden, 70 U.S. 315, 319 (1865)
(finding that where two patents covering the same inven-
tion or device were issued to the same party, the later one
issued was void, even though the application for it was
filed first, and holding that it is the issuance date, not the
filing date, which determines which patent issued to the
same inventor on the same invention is void); In re Longi,
759 F.2d 887, 895–897 (Fed. Cir. 1985); Perricone v.
Medicis Pharm. Corp., 432 F.3d 1368, 1372 (Fed. Cir.
2005); Eli Lilly, 251 F.3d at 967.
For example, for the traditional scenario of two pre-
URAA patents, if a first patent issued in, say, 1990, then
that first patent would expire 17 years later in 2007. If
the patent owner secured a second, patentably indistinct
12 NOVARTIS PHARMACEUTICALS CORP v. BRECKENRIDGE
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patent in 1992, then the patent owner would be required
to file a terminal disclaimer with the second patent so
that it would expire at the same time as the first patent in
2007, rather than two years later in 2009. Without the
terminal disclaimer, the second patent would be invalid
for obviousness-type double patenting because otherwise
the first and second patents collectively would give the
patent owner a 19-year period of exclusivity.
In Gilead, we recognized that the change in patent
term law under the URAA altered the analytical inquiry
for double patenting; issuance dates of post-URAA pa-
tents did not serve as reliable stand-ins for the expiration
date of the patent as is true for pre-URAA patents, and
the proper reference point for an obviousness-type double
patenting inquiry is the expiration date of the patent in
question. 753 F.3d at 1215. On appeal, Appellees argue
that Gilead controls here and urge us to apply the same
expiration date-based analysis applied in Gilead, which
would find the earlier-expiring ’990 patent a proper
obviousness-type double patenting reference against the
’772 patent. We disagree. Gilead addressed a question
that is not applicable here. In Gilead, we concluded that,
under the circumstance where both patents were post-
URAA, a patent that issues after but expires before
another patent can qualify as a double patenting refer-
ence against the earlier-issuing, but later-expiring patent.
Id. at 1211–12, 1217. Here, however, Novartis owns one
pre-URAA patent (the ’772 patent) and one post-URAA
patent (the ’990 patent), and the 17-year term granted to
the ’772 patent does not pose the unjustified time exten-
sion problem that was the case for the invalidated patent
in Gilead.
Gilead involved U.S. Patent Nos. 5,763,483 and
5,952,375. Id. at 1209. When Gilead Sciences, Inc. (Gile-
ad) sued Natco Pharma Limited (Natco) for infringement
of its ’483 patent, Natco asserted that the ’483 patent was
invalid for obviousness-type double patenting over Gile-
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ad’s ’375 patent. Id. The ’375 and ’483 patents were
issued to the same inventors, commonly owned by Gilead,
and contained very similar specification disclosures. Id.
at 1210. The post-URAA ’375 patent was filed on Febru-
ary 26, 1996, claimed priority from a patent application
filed on February 27, 1995, and expired on February 27,
2015. Id. The post-URAA ’483 patent was filed on De-
cember 27, 1996, claimed priority from a provisional
application filed on December 29, 1995, and expired on
December 27, 2016. Id. The following diagram illustrates
the relevant dates for the two patents at issue in Gilead:
While we found that the ’375 patent could serve as a
double patenting reference against the ’483 patent, even
though the ’483 patent issued first and expired 22 months
after the ’375 patent, our holding was limited to the post-
URAA context.
Throughout Gilead, we repeatedly noted that our
analysis was rooted in the consequences that flow from
the implementation of the URAA’s new patent term rule
14 NOVARTIS PHARMACEUTICALS CORP v. BRECKENRIDGE
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under which a patent expires 20 years from the effective
filing date:
[F]or double patenting inquiries, looking to patent
issue dates had previously served as a reliable
stand-in for the date that really mattered—patent
expiration. But as this case illustrates, that tool
does not necessarily work properly for patents to
which the URAA applies, because there are now
instances, like here, in which a patent that issues
first does not expire first.
Id. at 1215.
And we discussed several shortcomings of relying on
issuance dates for patents in the post-URAA context
where the patent term is 20 years from the earliest effec-
tive filing date, but none are applicable to this case. One
such shortcoming is that patent terms could be subject to
significant gamesmanship during prosecution. Id. If the
double patenting inquiry post-URAA was limited to
focusing on patent issuance dates, inventors could orches-
trate patent term extensions by filing serial applications
on obvious variants of the same invention, claiming
priority from different applications in each, and arranging
for the application with the latest filing date to issue first.
Id. We noted in our opinion that Gilead had “crafted a
separate ‘chain’ of applications, having a later priority
date than the ’375 patent family” such that the later-filed
but earlier-issued ’483 patent expired second. Id. at 1210.
Another shortcoming of using the issuance date for
post-URAA patents is that a mere day’s difference in the
issuance of multiple patents could result in a significant
difference in an inventor’s period of exclusivity. Id. at
1215. To illustrate this, in Gilead we noted that if the
’375 patent had issued the day before the ’483 patent, the
last 22 months of the term of the ’483 patent would have
been an improper extension of patent term. Id. at 1215–
16.
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Here, the present facts do not give rise to similar pa-
tent prosecution gamesmanship because the ’772 patent
expires after the ’990 patent only due to happenstance of
an intervening change in patent term law. Both the ’772
and the ’990 patents share the same effective filing date of
September 24, 1993. If they had been both pre-URAA
patents, the ’990 patent would have expired on the same
day as the ’772 patent by operation of the terminal dis-
claimer Novartis filed on the ’990 patent, tying its expira-
tion date to that of the ’772 patent. And if they had been
both post-URAA patents, then they would have also both
expired on the same day. Thus, the current situation does
not raise any of the problems identified in our prior
obviousness-type double patenting cases. At the time the
’772 patent issued, it cannot be said that Novartis im-
properly captured unjustified patent term. The ’990
patent had not yet issued, and the ’772 patent, as a pre-
URAA patent, was confined to a 17-year patent term.
Moreover, unlike Gilead, Novartis here did not structure
the priority claim of its ’990 patent to capture additional
patent term beyond the term it was granted for its ’772
patent. In fact, the ’990 patent’s term expired before the
’772 patent’s original 17-year term. Given the different
circumstances in this case, our holding in Gilead does not
resolve the narrow question on appeal here.
B.
Following Gilead, we confirmed in AbbVie that obvi-
ousness-type double patenting continues to apply post-
URAA. 764 F.3d at 1368. While Appellees are correct on
appeal that the URAA does not abrogate the doctrine of
obviousness-type double patenting, we disagree with
Appellees that AbbVie controls here. Like Gilead, AbbVie
is inapposite because it also involved two post-URAA
patents. Id. at 1369–70. In AbbVie, appellant Kennedy
argued that the URAA and its implementation of a 20-
year period of protection running from a patent’s earliest
claimed priority date eliminated the need for the obvious-
16 NOVARTIS PHARMACEUTICALS CORP v. BRECKENRIDGE
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ness-type double patenting doctrine. Id. at 1373. We
disagreed. While we recognized “‘that the unjustified
patent term extension justification for obviousness-type
double patenting’ may have ‘limited force in . . . many
double patenting rejections today, in no small part be-
cause of the change in the Patent Act from a patent term
of seventeen years from issuance to a term of twenty
years from filing,’” we also reaffirmed its continued im-
portance. Id. at 1373–74 (citing In re Fallaux, 564 F.3d
1313, 1318 (Fed. Cir. 2009)).
AbbVie is a prime example of the post-URAA scenario
we contemplated in Gilead where an inventor, seeking to
prolong his exclusivity rights over his invention, applies
for a second patent on an obvious variant of his invention
protected by a first patent but chooses a different, later
priority date than the one relied on for the first patent so
that the second patent expires later than the first patent.
The following diagram illustrates the relevant dates for
the two patents at issue in AbbVie, U.S. Patent Nos.
7,846,442 and 6,270,766. Id. at 1369–70.
NOVARTIS PHARMACEUTICALS CORP v. BRECKENRIDGE 17
PHARMACEUTICAL
The first-issued ’766 patent was filed on August 1,
1996, claimed priority from October 8, 1992, and expired
October 12, 2012. Id. at 1369. The second-issued ’422
patent was filed on September 12, 2005, claimed priority
from August 1, 1996 (rather than October 8, 1992), and
expired on August 21, 2018. Id. at 1370. AbbVie sought a
declaratory judgment that claims of the ’422 patent
(second-issued, second-expiring) were invalid over the
’766 patent (first-issued, first-expiring) for obviousness-
type double patenting. Id. at 1370. We agreed with the
district court’s double patenting invalidity ruling, explain-
ing that the patent owner had impermissibly sought an
undue patent term extension for its later-expiring, pa-
tentably indistinct claims by choosing to claim different
priority dates for its patent applications, thereby ensuring
that the resulting patents would have different expiration
dates. AbbVie is distinguishable from the situation here
because it not only involved two post-URAA patents, but
also because the earlier-filed patent had an earlier issu-
ance date and earlier expiration date.
C.
In this particular situation where we have an earlier-
filed, earlier-issued, pre-URAA patent that expires after
the later-filed, later-issued, post-URAA patent due to a
change in statutory patent term law, we decline to invali-
date the challenged pre-URAA patent by finding the post-
URAA patent to be a proper obviousness-type double
patenting reference. 3 Instead, we apply our traditional,
pre-URAA obviousness-type double patenting practice, see
supra, to Novartis’s challenged pre-URAA patent. That
3 We recognize that there are other fact patterns
that could arise from hybrid situations in which one
patent is pre-URAA and the other is post-URAA. We
decline to address those other fact patterns in this opinion
and limit our opinion to the specific facts of this case.
18 NOVARTIS PHARMACEUTICALS CORP v. BRECKENRIDGE
PHARMACEUTICAL
is, we use the ’772 patent’s issuance date as the reference
point for our obviousness-type double patenting analysis.
As we recognized in Gilead, looking to the patent issuance
dates pre-URAA serves as a reliable guide for assessing
whether a patent may serve as a double patenting refer-
ence against another patent. See 753 F.3d at 1215.
Under this analysis, the ’990 patent is not a proper obvi-
ousness-type double patenting reference for the ’772
patent. When the ’772 patent issued, the ’990 patent had
not yet issued and thus did not exist as a double patent-
ing reference against the ’772 patent.
This approach is most consistent with the URAA
transition statute, which ensures that patent owners, like
Novartis with its pre-URAA ’772 patent, enjoy the greater
of a 20-year from earliest effective filing date or 17-year
from issuance patent term. The statute reads: “The term
of a patent that is in force on or that results from an
application filed before [June 8, 1995] shall be the
greater of the 20-year term as provided in subsection (a),
or 17 years from grant, subject to any terminal disclaim-
ers.” 35 U.S.C. § 154(c)(1) (emphasis added). While
Congress could have written the transition statute to
strictly give any patents filed before the transition date a
17-year-from-issuance term and any patents filed after
the transition date a 20-year-from-the-earliest-priority
date term, by using the language “shall be the greater of,”
Congress intended patent owners who filed patent appli-
cations before the transition date to the new patent term
law to enjoy the maximum possible term available for
their resulting patents under either patent term regime.
Thus, to require patent holders to truncate any portion of
the statutorily-assigned term of a pre-URAA patent that
NOVARTIS PHARMACEUTICALS CORP v. BRECKENRIDGE 19
PHARMACEUTICAL
extends beyond the term of a post-URAA patent would be
inconsistent with the URAA transition statute. 4
Moreover, this approach is consistent with the core
principle underlying the double patenting doctrine: giving
one invention and nonobvious variants of that invention
the same patent term. See infra. The key purpose of
obviousness-type double patenting is to prevent a patent
owner from extending the exclusivity rights over his
invention beyond a full patent term. We saw this imper-
missible practice in Gilead and in AbbVie, where the
patent owners claimed different effective filing dates for
different patents to extend the life of patent exclusivity.
Gilead, 753 F.3d at 1210–11; AbbVie, 764 F.3d at 1369–
71. Here, critically, Novartis did not seek to extend its
patent rights over its everolimus invention beyond one
patent term, in this case, 17 years from issuance of the
’772 patent. Had the law not changed, regardless of
whether Novartis obtained the ’990 patent, the ’772
patent would have expired on September 9, 2014 (Sep-
tember 9, 2019 with the patent term extension). The fact
that the law for the term of a patent changed, resulting in
4 Appellees point to the “subject to any terminal
disclaimers” language in the statute to argue that the ’772
patent was subject to a terminal disclaimer once the ’990
patent subsequently issued. But that argument lacks
merit because it assumes this statutory language com-
mands how to assess whether a given patent’s term
should be terminally disclaimed; we instead read “subject
to any terminal disclaimers” in its ordinary sense that a
patent’s term provided for in this transition provision may
be subject to a terminal disclaimer depending on the
relevant facts, as is true for the term of any patent. But as
explained supra, no terminal disclaimer was necessary for
the ’772 patent because the ’990 patent is not a proper
double patenting reference.
20 NOVARTIS PHARMACEUTICALS CORP v. BRECKENRIDGE
PHARMACEUTICAL
the later-issued ’990 patent having an earlier expiration
date than it would have pre-URAA should not affect the
’772 patent’s statutorily-granted 17-year patent term.
Rather than Novartis receiving a windfall with a 17-year
term for its ’772 patent, its ’990 patent’s term was trun-
cated by the intervening change in law. To find that
obviousness-type double patenting applies here because a
post-URAA patent expires earlier would abrogate Novar-
tis’s right to enjoy one full patent term on its invention.
CONCLUSION
The district court erred in finding that the post-URAA
’990 patent is a proper obviousness-type double patenting
reference for the pre-URAA ’772 patent. We have consid-
ered Appellees’ other arguments and find them unpersua-
sive. Therefore, we reverse the district court’s decision.
REVERSED
COSTS
No Costs.