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.
`
`
`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.
`__________________________
`
`O R D E R
`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.
`
`
`
` F
`
`OR THE COURT
`
`
`/s/ Jan Horbaly
`——————————
`Jan Horbaly
`Clerk
`
`
`
`
`November 1, 2010
`——————————
`Date
`
`
`
`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.
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