IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`HELSINN HEALTHCARE S.A. and
`ROCHE PALO ALTO LLC,
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`Plaintiffs,
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`v.
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`CIPLA LTD., CIPLA USA, INC.,
`EUROHEALTH INTERNATIONAL SARL,
`WEST-WARD PHARMACEUTICAL CORP.
`and MYLAN INSTITUTIONAL LLC,
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`Defendants.
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`C.A. No. 13-688-GMS
`CONSOLIDATED
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`ORDER CONSTRUING THE TERMS OF U.S. PATENT NOS.
`7,947,724; 7,947,725; 7,960,424; 8,598,219 & 8,729,094
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`The court having considered the submissions of the parties and having heard oral
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`argument on the matter-IT IS HEREBY ORDERED, ADJUDGED, and DECREED that, as
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`used in the asserted claims of U.S. Patent Nos. 7,947,724 ("the '724 Patent"); 7,947,725 ("th~
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`'725 Patent"); 7,960,424 ("the '424 Patent"); 8,598,219 ("the '219 Patent"); and 8,729,094 ("the
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`'094 Patent"):
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`The '219 & '094 Patents
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`1. The term "said formulation is stable at 24 [ 18] months when stored at room
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`temperature" is construed to have its plain and ordinary meaning, requiring no
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`construction. 1
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`1 Only defendants Cipla Ltd. and Cipla USA, Inc. (collectively, "Cipla") seek construction of this claim
`term, which appears in several claims in both the '219 and '094 Patents. Specifically, Cipla argues that the claim
`term contains an implied pH limitation, in addition to the stability limitations, and proposes the following
`construction: "said formulation has a pH limitation that enables said formulation to be stable at 24 [18] months when
`stored at room temperature, wherein the pH is from 4 to 6." Cipla's primary support for its assertion comes from
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`Dr. Reddy’s Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Reddy Exhibit 1035
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`Exh. 1035, Page 1 of 4
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`statements in the prosecution history. The patent applications that Cipla highlights, however, ultimately issued as
`different patents-not the '219 and '094 Patents. Thus, the court must be careful not to import limitations based on
`a confused understanding of the prosecution history.
`The court fmds that the intrinsic record as a whole does not support Cipla's view. First, the claim language
`offers no indication that a pH limitation should be inferred. Rather, it does just the opposite. In particular, Claim 13
`of the
`'094 Patent has
`the disputed claim
`term, as well as an additional element: "wherein said
`solution ... optionally has a pH of from about 5.0±0.5." '094 Patent, claim 13. Were the court to adopt Cipla's
`proposal, Claim 13 would have two pH limitations-one that is optional and one that is mandatory. This result-
`even if the limitations are not altogether inconsistent-is counterintuitive and disfavored. See Phillips v. AWH
`Corp., 415 F.3d 1303 (Fed. Cir. 2005) ("[T]he context in which a term is used in the asserted claim can be highly
`instructive."); Hockerson-Halberstadt, Inc. v. Converse Inc., 183 F.3d 1369, 1374 (Fed. Cir. 1999) ("Proper claim
`construction ... demands interpretation of the entire claim in context, not a single element in isolation."). Although
`Claim 13 is the only one to include this optional pH limitation, terms are "presumed to have the same meaning
`throughout all of the claims in the absence of any reason to believe otherwise." See Digital-Vending Servs. Int 'I,
`LLC v. Univ. ofPhx., Inc., 612 F.3d 1270, 1275 (Fed. Cir. 2012)).
`The shared specification of the '219 and '094 Patents also does not support Cipla's view. The specification
`states that "[t]he inventors have further discovered that by adjusting the formulation's pH and/or excipient
`concentrations it is possible to increase the stability of palonosetron formulations." See, e.g., '219 Patent, col. 3 II.
`4-6 (emphasis added). Thus, the specification did not identify a specific pH range necessary to obtain the desired
`stability. The court can see no "clear disavowal of claim scope" from the specification language. See Golight, Inc.
`v. Wa/-Mart Stores, Inc., 355 F.3d 1327, 1331 (Fed. Cir. 2004) (quoting Telejlex, Inc. v. Ficosa N. Am. Corp.,
`299 F.3d 1313, 1327 (Fed. Cir. 2002).
`Finally, the court looks to the prosecution history, upon which Cipla relies most heavily. At the outset, the
`court notes that, in an Examiner-Initiated Interview conducted on September 30, 2013, the examiner for the '219
`Patent specifically identified the "lack of a pH limitation in claims." (D.I. 128, Ex. 29.) Although the Examiner's
`summary is not binding, the court fmds her conception of the claims noteworthy. The court rejects Cipla's
`suggestion that the Examiner interview during prosecution of the '219 Patent was a "litigation-driven attempt to
`claim more than what they actually invented." (D.I. 140 at 6.)
`As for its affirmative support, Cipla points to statements in ancestor patent applications suggesting that a
`pH between 4 and 6 was required to obtain the corresponding stability limitation. Cipla was unable to find any
`evidence in the patent applications for the '219 and '094 Patents. Statements made in the context of initial
`applications may be-but are not necessarily-probative on later-issued patents. See Masco Corp. v. United States,
`303 F.3d 1316, 1324 (Fed. Cir. 2002) ("The prosecution history of a parent application may be considered in
`construing claim tenns."). "When multiple patents derive from the same initial application, the prosecution history
`regarding a claim limitation in any patent that has issued applies with equal force to subsequently issued patents that
`contain the same claim limitation." Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 980 (Fed. Cir. 1999).
`Importantly, however, the applications identified by Cipla all had express pH limitations in the claims. Thus, the
`value to be drawn from prosecution statements in those prior applications is greatly reduced, if not eliminated
`entirely.
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`Cipla's reliance on Microsoft Corp v. Multi-Tech Systems, Inc. is misplaced. 357 F.3d 1340 (Fed. Cir.
`2004). Cipla argues that the drafters of the '219 and '094 Patents understood the "invention as a whole" to require a
`pH limitation, and this understanding is evidenced by the prosecution statements in the prior applications. (D.I. 128,
`Ex. 22 at A-241); see Microsoft at 1349 ("We cannot construe the claims to cover subject matter broader than that
`which the patentee itself regarded as comprising its inventions and represented to the PTO. "). But the evidence of
`the patentees' "understanding" of the invention was much more explicit in Microsoft-both the specification and
`prosecution history statements were in agreement and "unambiguous[]." See Microsoft at 1348-49. Here, Cipla is
`only able to point to the drafter's quotation of the Manual of Patent Examining Procedure ("MPEP") in a traversal of
`an obviousness rejection for the '424 Patent. (D.I. 128, Ex. 22 at A-241 (quoting MPEP § 2141.02).) The court
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`Exh. 1035, Page 2 of 4
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`The '219 Patent
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`2. The term "for intravenous administration to a human to reduce the likelihood of
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`cancer chemotherapy-induced nausea and vomiting" is construed to be limiting in its
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`entirety.2
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`The '724. '725 & '424 Patents
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`3. The court declines to construe "phannaceutically stable" at this time.3
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`cannot agree that a pH limitation of 4 to 6 was ''unambiguously" part of the patentees' understanding of the entire
`invention. See Microsoft at 1349. Thus, there was no clear disavowal of claim scope, and the disputed claim term is
`entitled to its plain and ordinary meaning. See Go light, 355 F .3d at 1331.
`To the extent the parties disagree as to the meaning of "stable" within this term, the court will hear expert
`testimony at trial. See infra note 3.
`2 The Plaintiffs assert that the preamble language of Claims 1 and 8 of the '219 Patent is limiting. Of the
`defendants, only Cipla disagrees. The preamble provides in its entirety: "A pharmaceutical single-use, unit-dose
`formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapy-induced
`nausea and vomiting." The parties agreed that the first portion-"A pharmaceutical single-use, unit-dose
`formulation"-was limiting. Moreover, following the February 18, 2015, Markman hearing, the parties entered a
`stipulation whereby they also agreed that "for intravenous administration to a human" was also limiting. (D.I. 159.)
`Therefor~, the only remaining dispute is whether the final portion-"to reduce the likelihood of cancer
`chemotherapy-induced nausea and vomiting"-is similarly limiting.
`"No litmus test defines when a preamble limits claim scope." Catalina Mktg. Int'l, Inc. v.
`Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed: Cir. 2002). This maxim is especially appropriate here where the
`parties have dissected the preamble into diffe~ent pieces. Nevertheless, there is no requirement that the entire
`preamble be treated as an "undifferentiated whole." JobDiva, Inc. v. Monster Worldwide, Inc., No. 13-CV-8229
`KBF, 2014 WL 5034674, at *13 (S.D.N.Y. Oct. 3, 2014). Thus, the court undertakes to determine whether the
`disputed portion "recites essential structure or steps, or if it is 'necessary to give life, meaning, and vitality' to the
`claim." See Catalina, 289 F.3d at 808 (quoting Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305
`(Fed. Cir. 1999)).
`Unfortunately, the parties devote the vast majority of their briefmg to the issue of "intravenous
`administration," which has since been resolved. There is almost no discussion of chemotherapy-induced nausea and
`vomiting ("CINV"). The oral argument was likewise confmed. But based on the evidence before it, the court is
`convinced that the remaining preamble language-"to reduce the likelihood of cancer [CINV]"-is limiting. For
`example, Claims 1 and 8 include elements that reference the "said formulation" of the preamble. "[D]ependence on
`a particular disputed preamble phrase for antecedent basis may limit claim scope .... " !d. The court is persuaded
`that the entirety of the preamble language-rather than bits and pieces-is "necessary to give life" to the subsequent
`reference in the body. In the court's view, a formulation that meets all other limitations but is not used to reduce
`CINV would not truly be "said formulation," as described in the preamble. Moreover, the summary of the
`Examiner-Initiated Interview stated: "Mr. Sullivan [the prosecutor] highlighted the limitations that were in the
`claims, including ... [CINV]." (D.I. 128, Ex. 29.) Thus, the drafter and the Examiner understood the preamble to
`be limiting. The court agrees.
`3 The parties (which, this time, includes each of the Defendants) both assert that "pharmaceutically stable"
`should be given its plain and ordinary meaning, but they dispute what this meaning should be. "A determination
`that a claim term 'needs no construction' or has the 'plain and ordinary meaning' may be inadequate when a term
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`Exh. 1035, Page 3 of 4
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`Dated: March _g_, 2015
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`has more than one 'ordinary' meaning or when reliance on a term's 'ordinary' meaning does not resolve the parties'
`dispute." 02 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1361 (Fed. Cir. 2008). After
`reviewing the briefing, the court is convinced that additional extrinsic evidence from those skilled in the art is
`required to construe the term. The court will hear testimony on this issue at trial. Because this will be a bench trial,
`there are no jury concerns to manage.
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`Exh. 1035, Page 4 of 4