UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`Plaintiffs,
`
`v.
`
`FRESENIUS KABI USA, LLC,
`
`Defendant.
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`Plaintiffs,
`
`v.
`
`ACCORD HEALTHCARE, INC.,
`
`Defendant.
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`Plaintiffs,
`
`v.
`
`BPI LABS, LLC AND BELCHER
`PHARMACEUTICALS, LLC,
`
`Defendants.
`
`CONFIDENTIAL: FILED UNDER SEAL
`PURSUANT TO OMNIBUS SEALING
`ORDER ENTERED ON 12/3/2015
`
`Civil Action No. 3:14-cv-07869(MAS)(LHG)
`Civil Action No. 3:14-cv-08082(MAS)(LHG)
`Civil Action No. 3:15-cv-02631(MAS)(LHG)
`
`Civil Action No. 3:14-cv-08079(MAS)(LHG)
`Civil Action No. 3:15-cv-02520(MAS)(LGH)
`
`Civil Action No. 3:14-cv-08081(MAS)(LHG)
`Civil Action No. 3:15-cv-02521(MAS)(LHG)
`
`AVENTIS EXHIBIT 2086
`Mylan v. Aventis, IPR2016-00712
`
`

`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`Plaintiffs,
`
`v.
`
`APOTEX CORP. AND APOTEX, INC.,
`
`Defendants.
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`Civil Action No. 3:15-cv-00287(MAS)(LHG)
`Civil Action No. 3:15-cv-01835(MAS)(LHG)
`
`Plaintiffs,
`
`v.
`
`Civil Action No. 3:15-cv-00289(MAS)(LHG)
`Civil Action No. 3:15-cv-01836(MAS)(LHG)
`
`BRECKENRIDGE PHARMACEUTICAL,
`INC.,
`
`Defendant.
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`Plaintiffs,
`
`v.
`
`MYLAN LABORATORIES LTD.,
`
`Defendant.
`
`Civil Action No. 3:15-cv-00290(MAS)(LHG)
`Civil Action No. 3:15-cv-03392(MAS)(LHG)
`
`- 2 -
`
`

`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`Plaintiffs,
`
`v.
`
`ACTAVIS LLC,
`
`Defendant.
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
`Plaintiffs,
`
`v.
`
`DR. REDDY’S LABORATORIES, INC. AND
`DR. REDDY’S LABORATORIES, LTD.,
`
`Defendants.
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and SANOFI
`
`Plaintiffs,
`
`v.
`
`GLENMARK PHARMACEUTICALS, INC.,
`USA and GLENMARK
`PHARMACEUTICALS LTD.,
`
`Defendants.
`
`Civil Action No. 3:15-cv-00776(MAS)(LHG)
`Civil Action No. 3:15-cv-03107(MAS)(LHG)
`
`Civil Action No. 3:15-cv-02522(MAS)(LHG)
`
`Civil Action No. 15-cv-02523(MAS)(LHG)
`
`DEFENDANTS’ JOINT RESPONSIVE CLAIM CONSTRUCTION BRIEF
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`- 3 -
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`

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`portion of the preamble that was added to overcome a rejection was the portion requiring “a
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`patient with prostate cancer that has progressed during or after treatment with docetaxel,” which
`
`Defendants agree is limiting. In contrast, in Helsinn, relied on by Sanofi, the preamble language
`
`found to be limiting was added to overcome an enablement rejection. See 2015 WL 1817109, at
`
`*8-*9.
`
`Moreover,
`
`the statements from the prosecution history relied upon by Sanofi are
`
`referring to “unexpected results”8 that applicants alleged were produced when the claimed
`
`method was carried out (i.e., when cabazitaxel and a corticoid were administered to a prostate
`
`cancer patient), rather than to what the claims actually require. For example, the statement from
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`the Examiner’s Reasons for Allowance relied on by Sanofi (ECF No. 59 at 14 (citing ECF No.
`
`59-2 at SA_JEV_0004765-66))
`
`that “it
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`is surprising and unexpected that
`
`the claimed
`
`combination of cabazitaxel and a corticoid are clinically effective in the treatment of prostate
`
`cancer that has progressed during or after treatment with docetaxel” does not indicate that
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`“clinical effectiveness” or “treatment of prostate cancer” is a claim limitation. Rather, the
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`Examiner was accepting applicants’ proffered evidence that the claimed method (i.e., carrying
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`out the steps required by the body of the claim) was patentable because, in the Examiner’s view,
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`it allegedly showed “unexpected results”—namely, clinical effectiveness in the treatment of
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`prostate cancer that has progressed during or after treatment with docetaxel.9 However, that does
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`8 One way that an applicant can establish that a patent claim is not obvious is by showing that the
`claimed subject matter may produce unexpected results in comparison to the closest prior art.
`See Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014).
`9 Applicants did not compare the claimed subject matter to the closest prior art (the numerous
`prior art references describing the TROPIC study) or even disclose that prior art to the Examiner,
`and thus the Examiner’s acceptance of applicants’ proffered evidence of unexpected results is
`not probative of non-obviousness of the claims.
`13
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`

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`not mean that a purportedly “unexpected result” should be converted into an element required by
`
`the claims.10
`
`Indeed, Sanofi’s argument contradicts Federal Circuit law which mandates that while an
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`“unexpected result” is a benefit that may sometimes result from carrying out claimed subject
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`matter, that does not render the “unexpected result” a required element of the claims. Purdue
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`Pharma L.P. v. Endo Pharm. Inc., 438 F.3d 1123, 1136 (Fed. Cir. 2006) (en banc). In Purdue
`
`Pharma, the district court interpreted the asserted claims to require the result of “acceptable pain
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`control for 90% of patients over a four-fold dosage range” based on applicants’ argument during
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`prosecution that the claimed subject matter produced this unexpected result.
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`Id. at 1135. The
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`Federal Circuit reversed this claim interpretation, holding that the claims did not require this
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`unexpected result.
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`Id. at 1136 (finding that “property of, or a result of administering” did not
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`function as claim limitation).
`
`Likewise, in McNeil-PPC, Inc. v. Perrigo Co., 443 F. Supp.2d 492, 505 (S.D.N.Y. 2006),
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`the court refused to import into the claims an unexpected result that applicants relied upon during
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`prosecution, stating:
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`It is true that a patent applicant using unexpected results to show non-obviousness must
`provide data commensurate in scope with the claims which the evidence is offered to
`support. However, that does not mean that courts mechanically import limitations from
`the test results into the claims....Moreover, the Federal Circuit has held that claims
`allowed based on “surprising results” may be construed more broadly that the results
`themselves. ...
`The submission of extraordinary results that are narrower in scope than the claims does
`not, by itself, impose a limitation on the construction of the claims.
`
`Id. (internal citations omitted).
`
`10 The only subject matter that the Examiner explicitly indicated is required by the claims is a
`“combination of cabazitaxel and a corticoid,” which the Examiner did by referring to “the
`claimed combination of cabazitaxel and a corticoid.” The Examiner did not refer to being
`“clinically effective” or the “treatment of prostate cancer” as “claimed” elements.
`14
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`

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`Similarly, this Court rejected an argument that “unexpected results” relied upon during
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`prosecution mandated that a preamble reciting that result functions as a claim limitation because
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`the preamble was merely a statement of intended use. Bristol-Myers Squibb Co. v. Immunex
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`Corp., 86 F. Supp. 2d 447, 451 n. 4 (D.N.J. 2000) (“Bristol-Myers I”), aff’d-in-part, vacated-in-
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`part, and remanded, 246 F.3d 1368 (Fed. Cir. 2001).
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`Here, to convince the Examiner to allow the claims, Sanofi pointed to the alleged
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`unexpected result shown in the Sartor Declaration that the claimed subject matter (i.e., the
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`claimed combination of cabazitaxel and a corticoid) was clinically effective in the treatment of
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`prostate cancer that has progressed during or after treatment with cabazitaxel. ECF No. 59-2 at
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`SA_JEV_0004403 (“Dr. Sartor further demonstrates that the results of the claimed invention
`
`were truly unexpected to those skilled in the art.”). The Examiner accepted that argument in
`
`allowing the claims. Id. at SA_JEV_0004765. But, just as in Purdue, McNeil and Bristol-Myers
`
`I, that did not transform the alleged unexpected result (of being clinically effective in the
`
`treatment of prostate cancer that has progressed during or after treatment with cabazitaxel) into a
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`claim limitation.
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`At the very least, it is ambiguous whether Sanofi or the Examiner considered “clinical
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`effectiveness” to be a required element of the claims, or simply an unexpected (and unclaimed)
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`result that the claimed subject matter may produce. This does not constitute the sort of “clear
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`reliance” on the preamble to overcome a rejection that is required to convert preambles into
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`claim limitations. See Catalina, 289 F.3d at 808. Accordingly, Sanofi’s argument that the
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`prosecution history warrants converting the disputed portions of the preambles into claim
`
`limitations should be rejected.
`
`15