NOTE: This disposition is nonprecedential.
United States Court of Appeals for the Federal Circuit
2009-1427, -1444
SANOFI-AVENTIS U.S. LLC,
SANOFI-AVENTIS, and DEBIOPHARM S.A.,
Plaintiffs-Appellants,
v.
SANDOZ, INC.,
Defendant-Appellee,
and
TEVA PARENTERAL MEDICINES, INC., TEVA PHARMACEUTICALS
USA, INC., and PHARMACHEMIE BV,
Defendants-Appellees,
and
MAYNE PHARMA LIMITED, MAYNE PHARMA (USA) INC., HOSPIRA
AUSTRALIA PTY LTD., and HOSPIRA, INC.,
Defendants-Appellees,
and
BARR LABORATORIES, INC. and PLIVA-LACHEMA A.S.,
Defendants-Appellees,
and
W.C. HERAEUS GMBH,
Defendant,
and
APP PHARMACEUTICALS, INC. and ABRAXIS BIOSCIENCE, INC.,
`` Defendants,
and
ACTAVIS TOTOWA LLC, ACTAVIS, INC., and ACTAVIS GROUP HF,
Defendants,
and
FRESENIUS KABI ONCOLOGY PLC (formerly known as Dabur
Oncology plc) and FRESENIUS KABI PHARMA LIMITED
(formerly known as Dabur Pharma Limited),
Defendants-Appellees,
and
SUN PHARMACEUTICAL INDUSTRIES LTD. and CARACO
PHARMACEUTICAL LABORATORIES, LTD.,
Defendants,
and
EBEWE PHARMA GES.M.B.H. NFG KG,
Defendant,
and
MUSTAFA NEVZAT ILAC SANAYII A.S. (also known as MN Pharmaceuticals),
PAR PHARMACEUTICAL COMPANIES, INC., and
PAR PHARMACEUTICAL, INC.,
Defendants.
Dominick A. Conde, Fitzpatrick, Cella, Harper & Scinto, of New York, New York,
argued for plaintiffs-appellants. With him on the brief were William E. Solander and
Nina Shreve. Of counsel was Brian L. Klock, of Washington, DC.
Patricia J. Thompson, Schiff Hardin LLP, of Chicago, Illinois, argued for
defendant-appellee Sandoz, Inc. With her on the brief were Douglass C. Hochstetler,
Jason G. Harp, and Amethyst C. Smith.
James F. Hurst, Winston & Strawn LLP, of Chicago, Illinois, argued for
defendants-appellees Mayne Pharma Limited, et al. With him on the brief were
James M. Hilmert, of Chicago, Illinois, Gail J. Standish and Peter E. Perkowski, of Los
Angeles, California, and Steffen N. Johnson and Andrew C. Nichols, of Washington,
DC.
David M. Hashmall, Goodwin Procter LLP, of New York, New York, for
defendants-appellees Teva Parenteral Medicines, Inc., et al. and Barr Laboratories,
Inc., et al. With him on the brief were Frederick H. Rein and Keith A. Zullow, of New
York, New York, and Henry C. Dinger, of Boston, Massachusetts.
Steven M. Lieberman, Rothwell, Figg, Ernst & Manbeck, of Washington, DC, for
defendants-appellees Fresenius Kabi Oncology PLC, et al. With him on the brief were
Minaksi Bhatt and Glenn E. Karta.
Appealed from: United States District Court for the District of New Jersey
Judge Joel A. Pisano
NOTE: This disposition is nonprecedential.
United States Court of Appeals for the Federal Circuit
2009-1427, -1444
SANOFI-AVENTIS U.S. LLC,
SANOFI-AVENTIS, and DEBIOPHARM S.A.,
Plaintiffs-Appellants,
v.
SANDOZ, INC.,
Defendant-Appellee,
and
TEVA PARENTERAL MEDICINES, INC., TEVA PHARMACEUTICALS
USA, INC., and PHARMACHEMIE BV,
Defendants-Appellees,
and
MAYNE PHARMA LIMITED, MAYNE PHARMA (USA) INC., HOSPIRA
AUSTRALIA PTY LTD., and HOSPIRA, INC.,
Defendants-Appellees,
and
BARR LABORATORIES, INC. and PLIVA-LACHEMA A.S.,
Defendants-Appellees,
and
W.C. HERAEUS GMBH,
Defendant,
and
APP PHARMACEUTICALS, INC. and ABRAXIS BIOSCIENCE, INC.,
Defendants,
and
ACTAVIS TOTOWA LLC, ACTAVIS, INC., and ACTAVIS GROUP HF,
Defendants,
and
FRESENIUS KABI ONCOLOGY PLC (formerly known as Dabur
Oncology plc) and FRESENIUS KABI PHARMA LIMITED
(formerly known as Dabur Pharma Limited),
Defendants-Appellees,
and
SUN PHARMACEUTICAL INDUSTRIES LTD. and CARACO
PHARMACEUTICAL LABORATORIES, LTD.,
Defendants,
and
EBEWE PHARMA GES.M.B.H. NFG KG,
Defendant,
and
MUSTAFA NEVZAT ILAC SANAYII A.S. (also known as MN Pharmaceuticals),
PAR PHARMACEUTICAL COMPANIES, INC., and
PAR PHARMACEUTICAL, INC.,
Defendants.
On appeal from the United States District Court for the District of New Jersey in case
no. 3:07-cv-02762, Judge Joel A. Pisano.
___________________________
DECIDED: September 10, 2009
___________________________
Before LINN, PROST, and MOORE, Circuit Judges.
2009-1427, -1444 2
MOORE, Circuit Judge.
Sanofi-Aventis U.S. LLC, Sanofi-Aventis, and Debiopharm S.A. (collectively,
Sanofi) appeal from the district court’s grant of summary judgment of noninfringement of
U.S. Patent No. 5,338,874 (the ’874 patent). Because the district court erred in
construing composition claims as product-by-process claims, we vacate and remand.
BACKGROUND
This case is on appeal from a Hatch-Waxman infringement action concerning the
pharmaceutical oxaliplatin, the active ingredient in Sanofi’s Eloxatin®, approved for the
treatment of colorectal cancer. A number of drug manufacturers filed Abbreviated New
Drug Applications (ANDAs) seeking to market generic oxaliplatin products prior to the
expiration of the ’874 patent, which claims optically pure oxaliplatin. Sanofi sued the
generic drug manufacturers (collectively defendants) for infringement under
35 U.S.C.
§ 271(e)(2), triggering a thirty-month stay of approval by the United States Food & Drug
Administration (FDA) of the defendants’ ANDAs pursuant to
21 U.S.C. § 355(j)(5)(b)(iii).
On June 18, 2009, the district court construed claim 1 of the ’874 patent as a product-
by-process claim limited to “optically pure oxaliplatin that has been resolved by means
of the HPLC [high performance liquid chromatography] method described in the ’874
patent specification.” Sanofi-Aventis U.S. LLC v. Sandoz, Inc., No. 07-2762, slip op. at
16 (D.N.J. June 18, 2009) (Claim Construction Opinion). Holding that there was no
disputed issue that the defendants did not employ the HPLC method, the district court
granted summary judgment of noninfringement and entered final judgment on June 30,
2008. Sanofi filed its notice of appeal on that same day. On July 10, 2009, we granted
Sanofi’s request to stay the judgment. On August 7, 2009, despite the stay of judgment,
the FDA granted final approval of the ANDAs held by certain defendants. These
2009-1427, -1444 3
defendants then launched their generic oxaliplatin products. We granted Sanofi’s
motion for expedited review and heard arguments on September 2, 2009.
DISCUSSION
This court reviews a grant of summary judgment de novo. Immunocept, L.L.C. v.
Fulbright & Jaworski, L.L.P.,
504 F.3d 1281, 1286 (Fed. Cir. 2007). We also review
claim construction de novo. Cybor Corp. v. FAS Techs., Inc.,
138 F.3d 1448, 1455-56
(Fed. Cir. 1998) (en banc). The words of a claim are generally given their ordinary and
customary meaning as understood by a person of ordinary skill in the art in question at
the time of the invention. Phillips v. AWH Corp.,
415 F.3d 1303, 1312-13 (Fed. Cir.
2005) (en banc).
Claim 1 of the ’874 patent recites:
1. Optically pure cis-oxalato (trans-l-1,2-cyclohexanediamine) Pt(II)
having a general formula of Formula (1).
Claim 2, the only other claim at issue on appeal, depends from claim 1 and adds a
melting point limitation. The district court construed the term “optically pure oxaliplatin”
as “optically pure oxaliplatin that has been resolved by means of the HPLC method
described in the ’874 patent specification.” 1 Claim Construction Opinion at 16.
1
Mayne views this construction as an interpretation of the level of purity
required by term “optically pure.” Tr. of Oral Argument at 23:51-23:59, Sanofi-Aventis
U.S. LLC v. Sandoz, Inc., No. 2009-1427 (Fed. Cir. Sept. 2, 2009), available at
http://oralarguments.cafc.uscourts.gov/. However, the district court stated that it did not
determine the level of purity required by the term “optically pure.” See Claim
Construction Opinion at 3 n.6. On remand, the district court may, if necessary,
determine the level of purity required by the term “optically pure,” by looking to “‘those
2009-1427, -1444 4
On appeal, Sanofi argues that the district court erred when it construed claim 1
as limited to optically pure oxaliplatin purified by the HPLC process. Sanofi argues that
this claim is a composition claim and does not contain a process limitation. Defendants
argue that in light of the specification and prosecution history, the district court properly
limited claim 1 to optically pure oxaliplatin purified by the HPLC process.
As the district court noted, “[t]here is no dispute that nothing on the face of the
claims of the ’874 patent limits the claims to ‘optically pure’ oxaliplatin that is produced
through the use of HPLC.” Claim Construction Opinion at 16. Claim 1 is a straight
forward composition claim. The district court held that the claims were nonetheless
limited to oxaliplatin purified by the HPLC method in view of the specification and
prosecution history. We do not agree.
We have repeatedly warned of “the danger of reading limitations from the
specification into the claim.” See, e.g., Phillips, 415 F.3d at 1323. “Absent a clear
disavowal or contrary definition in the specification or the prosecution history, the
patentee is entitled to the full scope of its claim language.” Home Diagnostics, Inc. v.
Lifescan, Inc.,
381 F.3d 1352, 1358 (Fed. Cir. 2004). To narrow the plain language of a
claim, a disclaimer must be clear and unmistakable. Cordis Corp. v. Boston Scientific
Corp.,
516 F.3d 1319, 1329 (Fed. Cir. 2009). We see no such disclaimer in the
specification or prosecution history of the ’874 patent.
sources available to the public that show what a person of skill in the art would have
understood disputed claim language to mean,’” including “‘the words of the claims
themselves, the remainder of the specification, the prosecution history, and extrinsic
evidence concerning relevant scientific principles, the meaning of technical terms, and
the state of the art.’” Phillips, 415 F.3d at 1314 (quoting Innova/Pure Water, Inc. v.
Safari Water Filtration Systems, Inc.,
381 F.3d 1111, 1116 (Fed. Cir. 2004)).
2009-1427, -1444 5
The defendants point to examples in the specification that compare the purity of
oxaliplatin produced using the process discussed in a prior art reference, the Kidani
process, with the purity of oxaliplatin after the HPLC process. In the “Comparative
Example,” the results indicate that following the Kidani process yields oxaliplatin having
an optical purity of 90%.
Id. col.7 ll.25-50, col.8 ll.13-15. Table 1 compares the purity of
the samples obtained in all of the examples before and after resolution by HPLC. ’874
patent col.8 ll.3-15. The results indicate that using HPLC optical purity was obtained.
Id. col.8 ll.3-15. Thus, the examples illustrate how to obtain optically pure oxaliplatin.
They do not clearly and unmistakably disclaim any process, and they do not justify
reading a process limitation into a composition claim.
The district court relied on Andersen Corp. v. Fiber Composites, L.L.C.,
474 F.3d
1361 (Fed. Cir. 2007), when construing claim 1 as a product-by-process claim. In
Andersen, this court held that claims to composite structures included a pelletizing
process limitation where the patentee relied on that process both to define the invention
and to distinguish the prior art. Andersen,
474 F.3d at 1372-74. We determined that
the specification attributed the claimed physical properties to the process and that the
specification indicated that the pelletizing step was a requirement, not a preference, of
the invention.
Id. at 1372. We further determined that the patentee had clearly
disavowed other processes during prosecution.
Id. at 1373-74; see also Chimie, 402
F.3d at 1385 (holding that “atomized precipitated silica particulates” was limited to a
those silica particulates formed by the patentee’s process because of an unequivocal
disclaimer of other processes to overcome prior art).
2009-1427, -1444 6
By contrast, here, the patent specification and prosecution history focus on the
property of the composition (optical purity) and not the process used to obtain that
property. The specification defines the invention as oxaliplatin of optically high purity,
not oxaliplatin prepared by the disclosed HPLC process. ’874 patent col.2 ll.3-5 (“The
present invention is cis-oxalato (trans-l-1,2-cyclohexanediamine) Pt(II) of optically high
purity having general formula of Formula (1).”). The specification never asserts that
HPLC is required to obtain optically pure oxaliplatin. It characterizes HPLC as an
“illustrative method” and a “representative process” by which the claimed compound
“may be prepared.” Id. col.2 l.16, col.2 l.52, col.3 l.65. Moreover, the specification does
not define the property (optical purity) by reference to the process of purification by
HPLC. Thus nothing in the specification limits the invention to optically pure oxaliplatin
purified using HPLC.
The prosecution history also illustrates that it is the optical purity of oxaliplatin
that distinguished it from the prior art, not the process used to obtain that purity. The
Examiner rejected the initially filed claims to oxaliplatin “of optically high purity” as
anticipated or rendered obvious by Kidani. 2 The Examiner stated that Kidani disclosed
“a single isomer [oxaliplatin] useful as an antitumor agent. Note that since the single
isomer complex was prepared, the optical purity of such material is very high or almost
pure isomer.” In response, the applicant (Tanaka Kikinzoku Kogyo K.K., referred to
herein as Sanofi) explained that it had repeated Kidani’s process “using identical
reactant materials and the subsequent testing thereof. . . . The resultant material was
2
The Examiner’s rejection was based on an article (Kidani et al., J. Med.
Chem. 21(12) 1315-18 (1978)), which does not substantively differ from the Kidani
patent.
2009-1427, -1444 7
tested and found to be 90% [oxaliplatin] not optically pure . . . .” Sanofi explained that
“[o]nly after HPLC resolution (in accordance with the teachings of the present
application) was optical purity obtained.” Sanofi further asserted that the products
prepared using Kidani’s method “do not have the presently claimed optical purity.”
Therefore, Sanofi argued that the claimed oxaliplatin “having high optical purity[] is not
found or taught in the prior art either by inherency or by being obvious thereover.”
Following a telephone interview, Sanofi agreed to amend the claims to “optically pure”
oxaliplatin, rather than oxaliplatin “of high optical purity.” The Examiner entered the
amendment and allowed the claims, stating that “[t]he Examiner agrees with applicants
that Kidani et al. does not teach[] the cis-oxalato(trans-l-1,2-cyclohexanediamine)Pt(II)
as an optically pure isomer. It is clear from Kidani et al. that also other isomers can be
in the final product.” Thus, Sanofi argued that the defining feature of the claimed
oxaliplatin was its optical purity, not the HPLC process. Nothing in the prosecution
history amounts to a clear and unmistakable disclaimer of optically pure oxaliplatin
prepared using other (non-HPLC) processes.
We conclude that the district court erred in its construction of claim 1. Claim 1 of
the ’874 patent is not limited to optically pure oxaliplatin produced by HPLC; this is a
composition claim, not a product-by-process claim.
CONCLUSION
Because we conclude that the district court erred when construing the claims, we
vacate the judgment of noninfringement and remand.
2009-1427, -1444 8
