Cephalon Inc. v. Hetero Labs Ltd. et al

Filing 325

MEMORANDUM. Signed by Judge Gregory M. Sleet on 4/29/2015. (mdb)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

IN RE BENDAMUSTINE CONSOLIDATED
CASES

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Civil Action No. 13-2046-GMS
CONSOLIDATED

MEMORANDUM
I.

INTRODUCTION
The plaintiff Cephalon, Inc. ("Cephalon"), pursuant to the Hatch-Waxman Act, filed patent

infringement actions against Sagent Pharmaceuticals, Inc.; Dr. Reddy's Laboratories, Ltd., and Dr.
Reddy's Laboratories, Inc.; Uman Pharma, Inc.; and InnoPharma, Inc. (collectively, "the Moving
Defendants"), alleging, among other things, that the Moving Defendants have infringed at least
one or more claims of U.S. Patent Nos. 8,436,190 and/or 8,609,863 ("the '190 and '863 patents")
by the filing of their respective Abbreviated New Drug Applications ("ANDA") with the FDA.
Presently before the court is the Moving Defendants' Motion for Judgment on the Pleadings with
respect to Cephalon's claims for infringement of the '190 and '863 patents. (D.I. 58.) For the
reasons that follow, the court will grant the Moving Defendants' motion.
II.

BACKGROUND
The Moving Defendants (among others) triggered these lawsuits under the Hatch-Waxman

Act by filing their respective ANDAs, seeking FDA approval to market a generic version of
Cephalon' s TREANDA®product. The '190 and '863 patents are among a number of patents listed
for TREANDA® in the FDA's Orange Book. The '190 and '863 patents claim compositions/
preparations that include tertiary-butyl alcohol ("TBA").
products do not contain TBA. (D.I. 59.)

The Moving Defendants' ANDA

III.

STANDARD OF REVIEW
When deciding a Rule 12(c) motion for judgment on the pleadings based on an allegation

that the plaintiff has failed to state a claim, the motion "is analyzed under the same standards that
apply to a Rule 12(b)(6) motion." Revell v. Port Auth., 598 F.3d 128, 134 (3d Cir. 2010). That is,
the court must view all facts and inferences drawn from the pleadings in the light most favorable
to the non-moving party. Green v. Fund Asset Mgmt., L.P., 245 F.3d 213, 220 (3d Cir. 2001). But
the court is "not compelled to accept unsupported conclusions and unwarranted inferences, or a
legal conclusion couched as a factual allegation." Baraka v. McGreevey, 481 F.3d 187 (3d Cir.
2007) (internal citations and quotation marks omitted). The issue for the court is "not whether the
plaintiff will ultimately prevail, but whether the claimant is entitled to offer evidence to support
the claims." Scheuer v. Rhodes, 416 U.S. 232, 236 (1974).

IV.

DISCUSSION
The instant motion raises a narrow question for the court's consideration. The parties

appear to agree that Cephalon's theory of infringement for '190 and '863 patents is premised on
the doctrine of equivalents, rather than literal infringement. (D.I. 108 at 1, 7-8.) Moreover, the
Moving Defendants concede that Cephalon has satisfied the basic pleading requirements to
provide adequate notice. (D.I. 184 at 2-3.) Therefore, the only issue is whether Cephalon's
doctrine-of-equivalents arguments are barred by the "disclosure-dedication rule."
As an initial matter, Cephalon attacks the Moving Defendants' process in filing this motion.

If "matters outside the pleadings are presented to and not excluded by the court, the motion must
be treated as one for summary judgment under Rule 56." Fed. R. Civ. P. 12(d); see also In re

Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1426 (3d Cir. 1997) ("[A] district court ruling
on a motion to dismiss may not consider matters extraneous to the pleadings."). Cephalon argues

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that the Moving Defendants reliance on the content of their respective ANDA filings converts this
Rule 12(c) motion into a premature motion for summary judgment. The court may, however,
accept additional documents "without converting the motion [to dismiss] into one for summary
judgment" if they are "integral to or explicitly relied upon in the complaint." In re Burlington
Coat Factory, 114 F.3d at 1426 (alteration in original). "[W]hat is critical is whether the claims

in the complaint are 'based' on an extrinsic document and not merely whether the extrinsic
document was explicitly cited." Id. The court is satisfied that the '190 and '863 patents, their file
histories, as well as the Moving Defendants' ANDA filings are all properly before the court, even
at this preliminary stage. See AstraZeneca Pharms. LP v. Apotex Corp., 669 F.3d 1370, 1378 n.5
(Fed. Cir. 2012). Cephalon does not raise a challenge to the documents' authenticity. Indeed, the
patents and the ANDA filings comprise the entire basis for Cephalon's complaints against the
Moving Defendants-Cephalon's argument that they are not "integral" is puzzling.
Finding no procedural flaw in the Moving Defendants' motion, the court turns to the merits
of the disclosure-dedication rule:
[W]hen a patent drafter discloses but declines to claim subject
matter, ... this action dedicates that unclaimed subject matter to the
public. Application of the doctrine of equivalents to recapture
subject matter deliberately left unclaimed would conflict with the
primacy of the claims in defining the scope of the patentee's
exclusive right.
See Johnson & Johnston Assocs. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1054 (Fed. Cir. 2002)

(internal quotation marks omitted). But the rule "is not without restriction" and "does not mean
that any generic reference in a written specification necessarily dedicates all members of that
particular genus to the public. Rather, the disclosure must be of such specificity that one of ordinary
skill in the art could identify the subject matter that had been disclosed and not claimed." SanDisk
Corp. v. Kingston Tech. Co., 695 F.3d 1348, 1363 (Fed. Cir. 2012) (internal quotation marks

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omitted) (quoting PSC Computer Prods., Inc. v. Foxconn Int'l, Inc., 355 F.3d 1353, 1360 (Fed.
Cir. 2004)). "Whether the disclosure-dedication rule prevents a patentee from pursuing a doctrine
of equivalents infringement theory is a question of law .... " Id. at 1364.
The common specification for the '190 and '863 patents includes a list of possible organic
solvents:
[T]he organic solvent is selected from one or more of tertiary
butanol, n-propanol, n-butanol, isopropanol, ethanol, methanol,
acetone, ethyl acetate, dimethyl carbonate, acetonitrile,
dichloromethane, methyl ethyl ketone, methyl isobutyl ketone, 1pentanol, methyl acetate, carbon tetrachloride, dimethyl sulfoxide,
hexafluoroacetone, chlorobutanol, dimethyl sulfone, acetic acid,
and cyclohexane.
'190 Patent, col. 5, 11. 6-14; see also id., col. 16, 11. 39-50. 1 The specification identifies TBA as
the "more preferred organic solvent" of the list. '190 Patent, col. 5, 1. 16; see also id. col. 16, 11.
41-49 ("The most typical example of the solvent used to prepare this formulation is tertiary butanol
(TBA). Other organic solvents can be used including [list].") But the '190 and '863 patents only
claim compositions or preparations containing TBA-the other enumerated solvents are not
specifically claimed.
This is not a situation where the specification makes a "generic reference" to a broad genus,
such as all "organic solvents." See SanDisk, 695 F.3d at 1363. Rather, as illustrated in the above
quote, the specification identifies precise alternatives to TBA. Thus, it is unnecessary to inquire
into whether "one of ordinary skill in the art could identify the subject matter that had been
disclosed [but] not claimed"-the list is self-explanatory. As a result, the court is confident that
this issue is capable of being resolved at the motion to dismiss stage.

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For convenience, the court only cites the '190 patent for references to the common specification.

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The question therefore becomes whether the Moving Defendants' ANDA products contain
one or more solvents that are disclosed but not claimed in the '190 and '863 patents. The ANDA
filings confirm that they do. (D.I. 59.) 2 As such, the court agrees with the Moving Defendants
that the disclosure-dedication rule bars Cephalon from arguing infringement of the '190 and '863
patents on a doctrine-of-equivalents theory. "[A] patentee cannot narrowly claim an invention to
avoid prosecution scrutiny by the PTO, and then, after patent issuance, use the doctrine of
equivalents to establish infringement because the specification discloses equivalents." Johnson &

Johnston, 285 F.3d at 1054. By claiming only TBA from among the listed organic solvents, the
patentee effectively disclaimed the remaining solvents in the list and cannot employ the doctrine
of equivalents to bring them back within the scope of the '190 and '863 patents.
Cephalon argues that the disclosure-dedication rule does not apply here because Cephalon
did not "decline to claim" or "deliberately [leave] unclaimed" the additional solvents. Cephalon
tried to claim the additional solvents previously during the prosecution of the '190 patent. (D.I.
108, Ex. A.). And Cephalon in fact succeeded in claiming them in a continuation application that
issued as U.S. Patent No. 8,461,350 ("the '350 patent").

But Cephalon's arguments inject

unnecessary layers of complexity into what is a relatively straightforward doctrine. Federal Circuit
law is well settled that intent is not relevant to the disclosure-dedication rule. See Johnson &

Johnston, 285 F.3d at 1053 n.1 ("The patentee's subjective intent is irrelevant to determining
whether unclaimed subject matter has been disclosed and therefore dedicated to the public."); see

also Toro Co. v. White Consol. Indus., Inc., 383 F.3d 1326, 1333 (Fed. Cir. 2004) ("[I]ntent is not
part of the Johnson & Johnston disclosure-dedication analysis."). The district court cases cited by

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Cephalon does not dispute that the solvents recited in the specification cover those present in the Moving
Defendants' ANDA products. (D.I. 108 at 9-10 ("[O]riginal claims 20 and 21 of the application that issued as the
'190 patent recited the solvents [which mirror the list found in the specification] used by Defendants in their ANDA
Products.").)

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Cephalon plainly misconstrue the holding of Johnson & Johnston, the leading Federal Circuit case
on the rule. See Janssen Prods., L.P. v. Lupin Ltd, No. 10-5954 (WHW), 2014 U.S. Dist. LEXIS
155248 (D.N.J. Mar. 12, 2014); Rosby Corp. v. Stoughton Trailers, Inc., No. 95 C 0511, 2003 WL
22232802 (N.D. Ill. Sept. 26, 2003). The fact that claims covering the disclosed subject matter
were ultimately allowed in another patent has no bearing on whether they were disclaimed in the
patent in question. The holding in Johnson & Johnston made this explicit: "A patentee who
inadvertently fails to claim disclosed subject matter ... is not left without remedy .... [A] patentee
can file a separate [continuation] application claiming the disclosed subject matter." Johnson &

Johnston, 285 F.3d at 1055. Like the plaintiff in Johnson & Johnston, Cephalon did just this with
the '350 patent. See id ("Johnston took advantage of [this] option[] by filing two continuation
applications that literally claim the relevant subject matter." (emphasis added)).
In the '190 and '863 patents, Cephalon disclosed but did not claim the additional organic
solvents. Therefore, as it relates to these patents, the subject matter was disclaimed and dedicated
to the public. See Mahn v. Harwood, 112 U.S. 354, 361 (1884) ("[W]hat is not claimed is public
property."). Of course, this does not rule out the possibility that another patent may still preclude
public use, such as the '350 patent. But Cephalon's allegations that the Moving Defendants
infringe the '190 and '863 patents under the doctrine of equivalents are barred as a matter of law
by the disclosure-dedication rule.

V.

CONCLUSION
For the foregoing reasons the court will grant the Moving Defendants' Motion for

Judgment on the Pleadings with respect to Cephalon's claims for infringement of the '190 and
'863 patents. (D.I. 58.)

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Dated: April

J.ft , 2015

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