United States Court of Appeals
for the Federal Circuit
__________________________
SUN PHARMACEUTICAL INDUSTRIES, LTD.,
Plaintiff-Appellee,
v.
ELI LILLY AND COMPANY,
Defendant-Appellant.
__________________________
2010-1105
__________________________
Appeal from the United States District Court for the
Eastern District of Michigan in case no. 07-CV-15087,
Judge George Caram Steeh.
__________________________
ON PETITION FOR PANEL REHEARING AND
REHEARING EN BANC
__________________________
CHARLES E. LIPSEY, Finnegan, Henderson, Farabow,
Garrett & Dunner LLP, of Reston, Virginia, filed a com-
bined petition for panel rehearing and rehearing en banc
for defendant-appellant. He also filed a reply to the brief
amici curiae of Teva Parenteral Medicines, Inc., et al.
With him on the petition and reply were ROBERT D.
BAJEFSKY, HOWARD W. LEVINE, ROBERT F. SHAFFER, and
JESSICA R. UNDERWOOD, of Washington, DC. Of counsel
on the petition and reply was JAMES P. LEEDS, Eli Lilly
and Company, of Indianapolis, Indiana.
SUN PHARMACEUTICAL v. ELI LILLY 2
JAMES F. HURST, Winston & Strawn LLP, of Chicago,
Illinois, filed a response to the combined petition for
plaintiff-appellee. With him on the response were GAIL J.
STANDISH and PETER E. PERKOWSKI, of Los Angeles,
California.
MATTHEW D. MCGILL, Gibson, Dunn & Crutcher LLP,
of Washington, DC, for amicus curiae Washington Legal
Foundation. With him on the brief was WILLIAM G.
JENKS. Of counsel on the brief were DANIEL J. POPEO and
RICHARD A. SAMP, Washington Legal Foundation, of
Washington, DC.
LESLIE MORIOKA, White & Case LLP, of New York,
New York, for amicus curiae Biotechnology Industry
Organization. Of counsel on the brief were HANS SAUER,
Biotechnology Industry Organization, of Washington, DC;
CHRISTOPHER M. HOLMAN, UMKC School of Law, of Kan-
sas City, Missouri.
DAVID W. OGDEN, Wilmer Cutler Pickering Hale and
Dorr LLP, of Washington, DC, for amicus curiae Pharma-
ceutical Research and Manufacturers of America. With
him on the brief were DAVID A. MANSPEIZER, of New York,
New York and FELICIA H. ELLSWORTH, of Boston, Massa-
chusetts.
ELIZABETH J. HOLLAND, Kenyon & Kenyon LLP, of
New York, New York, for amici curiae Teva Parenteral
Medicines, Inc. and Teva Pharmaceuticals USA, Inc.
With her on the brief was SHEILA MORTAZAVI.
__________________________
3 SUN PHARMACEUTICAL v. ELI LILLY
Before RADER, Chief Judge, NEWMAN, LOURIE, BRYSON,
GAJARSA, LINN, DYK, PROST, and MOORE, Circuit Judges.
PER CURIAM.
NEWMAN, Circuit Judge, with whom RADER, Chief Judge,
and LOURIE and LINN, Circuit Judges, join, dissents from
the denial of the petition for rehearing en banc.
__________________________
ORDER
A combined petition for panel rehearing and rehear-
ing en banc was filed by Defendant-Appellant, and a
response thereto was invited by the court and filed by
Plaintiff-Appellee. The court granted leave to Defendant-
Appellant to file a reply.
The court also granted leave to file briefs amici curiae
to Pharmaceutical Research and Manufacturers of Amer-
ica, Biotechnology Industry Organization, Washington
Legal Foundation, and Teva Parenteral Medicines, Inc.
(f/k/a SICOR Pharmaceuticals, Inc.), et al. Appellant filed
a motion for leave to file a reply to the brief amici curiae
filed by Teva Parenteral Medicines, Inc., et al.
The petition for panel rehearing was considered by
the panel that heard the appeal, and thereafter the peti-
tion for rehearing en banc, response, reply, and briefs
amici curiae (and Appellant’s reply thereto) were referred
to the circuit judges who are authorized to request a poll
on whether to rehear the appeal en banc. A poll was
requested, taken, and failed.
Upon consideration thereof,
IT IS ORDERED THAT:
SUN PHARMACEUTICAL v. ELI LILLY 4
(1) Appellant’s motion for leave to file a reply to the
brief amici curiae submitted by Teva Parenteral Medi-
cines, Inc., et al. is granted.
(2) The petition of Defendant-Appellant for panel re-
hearing is denied.
(3) The petition of Defendant-Appellant for rehearing
en banc is denied.
(4) The mandate of the court will issue on November
8, 2010.
FOR THE COURT
November 1, 2010 /s/ Jan Horbaly
—————————— ——————————
Date Jan Horbaly
Clerk
cc: James F. Hurst, Esq.
Charles E. Lipsey, Esq.
Leslie Morioka, Esq.
David W. Ogden, Esq.
Elizabeth J. Holland, Esq.
Matthew D. McGill, Esq.
United States Court of Appeals
for the Federal Circuit
__________________________
SUN PHARMACEUTICAL INDUSTRIES, LTD.,
Plaintiff-Appellee,
v.
ELI LILLY AND COMPANY,
Defendant-Appellant.
__________________________
2010-1105
__________________________
Appeal from the United States District Court for the
Eastern District of Michigan in Case No. 07-CV-15087,
Judge George Caram Steech.
__________________________
ON PETITION FOR REHEARING EN BANC
__________________________
NEWMAN, Circuit Judge, with whom RADER, Chief
Judge, and LOURIE and LINN, Circuit Judges, join, dis-
senting from denial of the Petition for Rehearing En Banc.
__________________________
I respectfully dissent from the court’s denial of the re-
quest to rehear this case en banc, for inconsistent precedent
warrants clarification. Until recently the law of double
patenting was clear, but it has become distorted by diver-
gent statements, leading to this flawed ruling.
SUN PHARMACEUTICAL v. ELI LILLY 2
Until recently it was beyond dispute that the law of
double patenting is concerned only with what is patented—
that is, what is claimed. To determine whether there is
double patenting it is the claims that are compared; thus,
obviousness-type double patenting occurs when the claims
of a later patent are an obvious variant of the claims of an
earlier patent. The specifications of the patents are irrele-
vant to the double patenting analysis, other than to guide in
construing the claims. A double patenting analysis occurs
only when the earlier patent is not prior art against the
later patent.
For the patents here at issue, the first application filed
on behalf of the Eli Lilly inventors described a new class of
chemical compounds having antiviral utility, including the
compound named gemcitabine. Thereafter, Lilly filed a
continuation-in-part application disclosing but not claiming
the anticancer utility of gemcitabine, and on the same day
Lilly filed a separate application having a different inven-
tive entity, describing and claiming the use of gemcitabine
to treat cancer. 1 The parent specification, but not the
continuation-in-part, is prior art against the application
claiming the anticancer use.
It has been held that the claims to gemcitabine and its
antiviral use do not render obvious the claims to use of
gemcitabine to treat cancer, and that the anticancer use
claims are patentable over all of the known prior art. 2 This
1 Lilly explains that the anticancer information was
concurrently added to the specification for the compound
claims in an abundance of caution concerning the “best
mode” of use of these compounds.
2 After the district court here entered final judgment,
a district court held that the earlier patent disclosing gem-
citabine and its antiviral use do not render the anticancer
method claims obvious under §103. See Eli Lilly & Co. v.
3 SUN PHARMACEUTICAL v. ELI LILLY
issue is not now before us. However, the panel held the
claims to the anticancer use to be invalid for double patent-
ing because the anticancer use was mentioned (but not
claimed) in the continuation-in-part specification that is not
prior art, stating that “[t]he asserted claims of the later ’826
patent simply claim the anticancer use disclosed in the
specification of the ’614 patent,” reported at 611 F.3d at
1389. This is the double patenting ruling for which Lilly
seeks review en banc.
The law of double patenting is contrary to the panel’s
holding. In General Foods Corp. v. Studiengesellschaft
Kohle mbH, 972 F.2d 1272, 1277 (Fed. Cir. 1992), the court
stated the established rule that “[d]ouble-patenting is
altogether a matter of what is claimed.” Precedent illus-
trates this rule in a variety of situations. See id. at 1281
(“Our precedent makes clear that the disclosure of a patent
cited in support of a double patenting rejection cannot be
used as though it were prior art, even where the disclosure is
found in the claims.”); In re Braat, 937 F.2d 589, 594 n.5
(Fed. Cir. 1991) (“The patent disclosure must not be used as
prior art.”); In re Kaplan, 789 F.2d 1574, 1579 (Fed. Cir.
1986) (“In considering the question [of obviousness-type
double patenting], the patent disclosure may not be used as
prior art.”).
This law was also fully established in our predecessor
court. E.g., In re Vogel, 422 F.2d 438, 441 (CCPA 1970) (“In
considering the question [of obviousness-type double patent-
ing], the patent disclosure may not be used as prior art.”); In
re Plank, 399 F.2d 241, 242 (CCPA 1968) (“Its claims are
used as the basis for a double patenting rejection. It is not a
prior art reference.”); In re Aldrich, 398 F.2d 855, 859
Sicor Pharms., Inc., 705 F. Supp. 2d 971, 1004–10 (S.D. Ind.
2010).
SUN PHARMACEUTICAL v. ELI LILLY 4
(CCPA 1968) (“[W]e reiterate that double patenting rejec-
tions cannot be based on section 103, or on the disclosures of
the patents whose claims are relied on to demonstrate
double patenting or on the ‘disclosures’ of their claims.”); In
re Boylan, 392 F.2d 1017, 1018 n.1 (CCPA 1968) (“[I]n
analyzing cases of these types, it must always be carefully
observed that the appellant’s patent is not ‘prior art’ under
either section 102 or section 103 of the 1952 Patent Act
. . . .”); In re Braithwaite, 379 F.2d 594, 600 n.4 (CCPA 1967)
(“While analogous to the non-obviousness requirement of 35
U.S.C. § 103, that section is not itself involved in double
patenting rejections because the patent principally underly-
ing the rejection is not prior art.”); In re Borah, 354 F.2d
1009, 1018 (CCPA 1966) (“We have no prior art here.”); In re
Sutherland, 347 F.2d 1009, 1015 (CCPA 1965) (stating that
claims relied on in double patenting rejections are not
treated as prior art); In re Sarett, 327 F.2d 1005, 1013
(CCPA 1964) (“We are not here concerned with what one
skilled in the art would be aware from reading the claims
but with what inventions the claims define.”).
Uniformly, unlike examination for obviousness based on
prior art, the issue of obviousness-type double patenting is
directed to whether the invention claimed in a later patent
is an obvious variant of the invention claimed in an earlier
patent. The panel opinion violates a vast body of precedent.
The panel apparently was misdirected by an overly-
broad statement in Geneva Pharmaceuticals, Inc. v.
GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003).
Geneva stated that “[o]ur predecessor court recognized that
a claim to a method of using a composition is not patentably
distinct from an earlier claim to the identical composition in
a patent disclosing the identical use.” Id. at 1385–86. The
court cites a 1931 decision, In re Byck, 48 F.2d 665, 666
(CCPA 1931), in which the court stated:
5 SUN PHARMACEUTICAL v. ELI LILLY
It would shock one’s sense of justice if an inventor
could receive a patent upon a composition of matter,
setting out at length in the specification the useful
purposes of such composition, manufacture and sell
it to the public, and then prevent the public from
making any beneficial use of such product by secur-
ing patents upon each of the uses to which it may be
adapted.
The Geneva decision does not mention Byck’s further state-
ment that the patentee “might have disclosed a use of the
invention which, together with other elements, might have
constituted a separate invention for which he would be
entitled to a patent. This, we hold, he did not do, in view of
the [prior art] Baekeland reference.” Id. at 667. However,
as in this case, there is no “shock” to “one’s sense of justice”
where the non-obvious, later-claimed use is the result of a
later discovery. Yet the statement in Geneva took on a life
of its own, as in Pfizer, Inc. v. Teva Pharmaceuticals USA,
Inc., 518 F.3d 1353 (Fed. Cir. 2008), where the court de-
clined to apply section 121 (negating double patenting
among divisionals) and found double patenting despite a
restriction requirement, citing Geneva for authority.
Extending Geneva to cover the facts of this case does not
further the policy of obviousness-type double patenting.
“Obviousness-type double patenting is a judicially created
doctrine intended to prevent improper timewise extension of
the patent right by prohibiting the issuance of claims in a
second patent which are not ‘patentably distinct’ from the
claims of a first patent.” Braat, 937 F.2d at 592. The panel
failed to explain how Lilly’s claims to the use of gemcitabine
to treat cancer, discovered after gemcitabine’s antiviral use
was disclosed in the original application, improperly extend
the patent right to gemcitabine as a compound, let alone
SUN PHARMACEUTICAL v. ELI LILLY 6
how these claims would “shock one’s sense of justice.” For
purposes of this case, there is no dispute that Lilly would be
entitled to a separate patent on the anticancer use if Lilly
had not included the disclosure of anticancer use in the
specification of the continuation-in-part filed the same day.
Such disclosure does not “improperly extend” any patent.
The amici curiae explained that particularly for biologi-
cal/pharmaceutical products, new uses may be discovered as
research continues after the initial filing. The Biotechnol-
ogy Industry Organization explains:
BIO’s members routinely engage in continuing re-
search on basic biotechnology inventions even after
initial patent applications have been filed. Often,
such research reveals something new about a basic
invention, including better and unexpected new
ways of using it that require patent protection for
their commercial development.
Br. of Amicus Curiae in Support of Def.-Appellant Eli Lilly
& Co.’s Combined Pet. for Panel Reh’g and Reh’g En Banc at
1.
A change of law “in ways that negatively impact the
patentability of important later-discovered uses” serves no
public purpose in areas in which commercial development
requires patent protection. Id. If the majority of the court
now believes, as a matter of policy, that the law should be
changed in this new direction, en banc treatment is particu-
larly appropriate, for the court’s rule is that the earlier
precedent prevails unless overruled en banc. A situation in
which the court ignores this rule, and applies whatever law
the panel prefers, is an indictment of the ability of this court
to provide stable law in the areas entrusted to us.
7 SUN PHARMACEUTICAL v. ELI LILLY
The denial of Eli Lilly’s petition for rehearing en banc
leaves the innovation community without guidance on
which the trial courts, and the users of the patent system,
can rely. I respectfully dissent.