PROMETHEUS LABORATORIES INC. v. ROXANE LABORATORIES, INC.

Filing 255

OPINION fld. Signed by Judge Faith S. Hochberg on 12/16/13. (sr, )

IN THE UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
____________________________________
:
PROMETHEUS LABORATORIES INC., :
Civil No. 11-230 (FSH)
:
Civil No. 11-1241 (FSH)
Plaintiff,
:
:
v.
:
OPINION
:
ROXANE LABORATORIES, INC., et al., :
:
Defendants.
:
December 16, 2013
:
:

HOCHBERG, District Judge:
I.

INTRODUCTION
Defendants Roxane Laboratories, Inc. and Cipla Ltd. (“Roxane” and “Cipla,” collectively

referred to as “Defendants”) bring a motion for summary judgment of non-infringement of the
’014 patent, and Cipla brings a motion for summary judgment seeking to invalidate the ’770
patent under 35 U.S.C. § 305.

Plaintiff Prometheus Laboratories, Inc. (“Prometheus” or

“Plaintiff”) opposes both motions and brings a motion for summary judgment of no invalidity
under § 305 for the ’770 patent. The Court held a hearing on November 21, 2013 to address the
parties’ outstanding motions. During the November 21, 2013 hearing, the parties resolved their
dispute with respect to the ’014 patent. That patent is no longer at issue in this matter.
The parties have also filed the following motions:
•

Defendants’ Motion in Limine No. 1 Regarding Magnet and Rubicon

•

Plaintiff’s Motions in Limine Regarding Dr. Howden’s “Single Actor” Testimony,
Clinical Studies Evidence, Label Preparation Evidence, and Reexamination
Evidence

•
II.

Both parties’ motions to seal the courtroom during trial

BACKGROUND 1
Prometheus filed the current actions against Defendants alleging that Defendants have or

will infringe U.S. Patent No. 6,284,770 (“the ’770 patent”) under 35 U.S.C. §§ 271(a), 271(b),
271(c), and 271(e)(2)(A) and that Defendants have or will infringe U.S. Patent No. 6,175,014
(“the ’014 patent”) under 35 U.S.C. §§ 271(b) and 271(g). (Am. Compl., ¶¶ 38, 42-44, 49, 50
[Dkt. No. 67].) 2 Prometheus holds an approved New Drug Application (“NDA”) under § 505(a)
of the FFDCA, 21 U.S.C. § 355(a), for alosetron hydrochloride tablets (NDA No. 21-107),
selling under the brand name LOTRONEX®. 3

(DS ¶ 45; PR ¶ 45.)

Prometheus acquired

LOTRONEX® and the ’770 patent in 2007. (DS ¶ 43; PR ¶ 43.)
Prometheus’ claims arise from Roxane’s filing of an Abbreviated New Drug Application
(“ANDA”) with the FDA seeking approval to commercially market a generic version of
Prometheus’ LOTRONEX® drug product prior to the expiration of the ’770 patent. (Am. Compl., ¶
1.)

Cipla manufactures the active pharmaceutical ingredient (“API”), i.e., alosetron

hydrochloride, used in Roxane’s ANDA products. (PCS ¶¶ 2, 3; DRC ¶¶ 2, 3.) Cipla admits

1

The facts below are taken from the parties’ statements of undisputed facts. “DS” refers to the
Defendants’ Statement of Facts, “PR” refers to the Plaintiff’s Response to Defendants’ Statement
of Facts, “PS” refers to the Plaintiff’s Statement of Facts, “DR” refers to Defendants’ Response
to Plaintiff’s Statement of Facts, “PCS” refers to Plaintiff’s Counter Statement of Facts, and
“DRC” refers to Defendants’ response to Plaintiff’s Counter Statement of Facts.
2

All docket numbers refer to docket entries in Civ. No. 11-1241 unless otherwise noted.

3

Alosetron hydrochloride is the active ingredient in LOTRONEX®.
2

that it has entered into supply contracts with generic pharmaceutical companies in the United
States, and a portion of Cipla’s export sales are derived from the United States. (Cipla Answer, ¶
7 [Dkt. No. 175].)
On September 4, 2001, the USPTO issued the ’770 patent titled “Medicaments for the
treatment of non-constipated female irritable bowel syndrome.” (DS ¶ 36; PR ¶ 36.) In 2007,
Prometheus purchased the LOTRONEX® franchise from GSK, which included the ’770 patent and
the right to market LOTRONEX®. (DS ¶ 43; PR ¶ 43.) Prometheus contends it currently owns the
’770 patent. (DS ¶ 44; PR ¶ 44.)
On August 3, 2009, Prometheus filed a request with the USPTO for ex parte
reexamination of the ’770 patent pursuant to 37 C.F.R. § 1.510. (DS ¶ 47; PR ¶ 47.) This
request attached and identified “Magnet” 4 and “Rubicon” 5 as non-patent literature documents.
(DS ¶ 48; PR ¶ 48.) In the request for reexamination Prometheus argued that “[b]ecause Magnet
and Rubicon were published more than one year before October 5, 1998, they raise a substantial
new question of patentability.” (DS ¶ 49; PR ¶ 49.) Prometheus’ request for reexamination did
not cite any prior art references other than Magnet and Rubicon. (DS ¶ 52; PR ¶ 52.) On
October 1, 2009, the USPTO mailed an order denying Prometheus’ request for reexamination of
the ’770 patent. (DS ¶ 54; PR ¶ 54.) In their petition for further review of the reexamination,
Prometheus stated that Magnet and Rubicon were prior art and should be given weight by a
reexaminer as such because they raised a substantial question of patentability. (DS ¶¶ 60, 61; PR

4

“Magnet” refers to M Magnet – The Magazine for Glaxo Wellcome plc staff. “GLAXO
WELLCOME; New Product Makes a Difference; M Magnet – The Magazine for Glaxo
Wellcome plc staff; July 1997; pg. 6.”
5

“Rubicon” refers to Rubicon – The International news magazine for Glaxo Wellcome R & D
staff. “GLAXO WELLCOME; For Women Only; Rubicon – The International news magazine
for Glaxo Wellcome R & D staff; August 1997; pg. 9.”
3

¶¶ 60, 61.) On December 30, 2009, the USPTO granted Prometheus’ petition seeking review of
the denial of its request for reexamination. (DS ¶ 62; PR ¶ 62.) On February 24, 2010, the
USPTO rejected claims 2, 3, 5, 6, and 8-18 under 35 U.S.C. § 103(a) as being unpatentable over
Rubicon in view of the Magnet, Bardhan, Hsyu, Drossman, and Saxena 6 references. (DS ¶ 63;
PR ¶ 63.) On April 23, 2010, Prometheus filed an amendment to the ’770 patent “[i]n response
to the Office Action mailed February 24, 2010. . . .” (PCS ¶ 46; DRC ¶ 46.) During the
subsequent reexamination, all of the original claims of the ’770 patent were either cancelled
(claims 1-4 and 7-9) or amended (claims 5-6) in response to the February 24, 2010 office action.
(DS ¶ 67; PR ¶ 67; PCS ¶¶ 50, 56; DRC ¶¶ 50, 56.) The reexamination certificate of the ’770
patent was issued on October 19, 2010 with amended claims 5-6 and new claims 10-16. (DS ¶
68; PR ¶ 68.) The ’770 patent was subsequently listed in the Orange Book with respect to
LOTRONEX®. (DS ¶ 70; PR ¶ 70.)
The parties now agree that Rubicon and Magnet are not prior art. (DS ¶¶ 74-76; PR ¶¶
74-76.)
III.

STANDARD OF REVIEW
Pursuant to Federal Rule of Civil Procedure 56(c), a motion for summary judgment will

be granted if the pleadings, depositions, answers to interrogatories, and admissions on file,
together with the affidavits, if any, show that there is no genuine issue as to any material fact and
that the moving party is entitled to judgment as a matter of law. See Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 247 (1986); Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). In other
words, “[s]ummary judgment may be granted only if there exists no genuine issue of material
fact that would permit a reasonable jury to find for the nonmoving party.” Miller v. Indiana
6

Bardhan, Hsyu, Drossman, and Saxena are prior art references cited by the USPTO during the
reexamination of the ’770 patent.
4

Hosp., 843 F.2d 139, 143 (3d Cir. 1988). All facts and inferences must be construed in the light
most favorable to the non-moving party. Peters v. Delaware River Port Auth., 16 F.3d 1346,
1349 (3d Cir. 1994). The judge’s function is not to weigh the evidence and determine the truth
of the matter, but to determine whether there is a genuine issue for trial. See Anderson, 477 U.S.
at 249. “Consequently, the court must ask whether, on the summary judgment record, reasonable
jurors could find facts that demonstrated, by a preponderance of the evidence, that the
nonmoving party is entitled to a verdict.” In re Paoli R.R. Yard PCB Litigation, 916 F.2d 829,
860 (3d Cir. 1990).
The party seeking summary judgment always bears the initial burden of production.
Celotex Corp., 477 U.S. at 323. This burden requires the moving party to establish either that
there is no genuine issue of material fact and that the moving party must prevail as a matter of
law, or to demonstrate that the nonmoving party has not shown the requisite facts relating to an
essential element of an issue on which it bears the burden. Id. at 322-23. Once the party seeking
summary judgment has carried this initial burden, the burden shifts to the nonmoving party.
To avoid summary judgment, the nonmoving party must then demonstrate facts
supporting each element for which it bears the burden, and it must establish the existence of a
“genuine issue of material fact” justifying trial. Miller, 843 F.2d at 143; accord Celotex Corp.,
477 U.S. at 324. The nonmoving party “must do more than simply show that there is some
metaphysical doubt as to material facts.” Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475
U.S. 574, 586 (1986). “Where the record taken as a whole could not lead a rational trier of fact
to find for the nonmoving party, there is no ‘genuine issue for trial.’” Id. at 587 (quoting First
National Bank of Arizona v. Cities Serv. Co., 391 U.S. 253, 289 (1968)). Further, summary

5

judgment may be granted if the nonmoving party’s “evidence is merely colorable or is not
significantly probative.” Anderson, 477 U.S. at 249-50.
IV.

DISCUSSION
Prometheus and Cipla have filed dueling motions for summary judgment related to

invalidity under § 305 of the Patent Act. Prometheus argues it is entitled to summary judgment
of no invalidity under § 305 with respect to the ’770 patent for two reasons. First, it argues that
whether or not claims were changed in light of prior art should be evaluated based on the record
at the time of reexamination using a subjective standard, which it argues is met here. Second, it
argues that the latter half of § 305 allows for amendments in response to an adverse action by the
USPTO, and there is no dispute that Prometheus amended the ’770 patent in response to an
adverse action by the USPTO. Cipla argues that it is entitled to summary judgment of invalidity
under § 305 regarding the ’770 patent because, as the parties now agree, Magnet and Rubicon are
not prior art.
a. Legal Background
A party challenging a patent in court “bears the added burden of overcoming the
deference that is due to a qualified government agency presumed to have done its job.”
PharmaStem Theraputics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1366 (Fed. Cir. 2007). Because
of this presumption, invalidity must be proven by clear and convincing evidence. Microsoft
Corp. v. i4i Ltd. P’ship, 131 S. Ct. 2238, 2246 (2011).
“Reexamination proceedings, governed by 35 U.S.C. §§ 301 et seq., are intended to
‘permit any party to petition the [PTO] to review the efficacy of a patent, following its issuance,
on the basis of new information about preexisting technology that may have escaped review at
the time of the initial examination.’” In re NTP, Inc., 654 F.3d 1268, 1275 (Fed. Cir. 2011)

6

(citing H.R. No. 66–1307, 96th Cong., 2d Sess. (1980), 3-4). “The scope of reexamination
proceedings is limited to ‘substantial new question[s] of patentability,’ 35 U.S.C. § 303(a), which
are questions that have not previously been considered by the PTO.”

Id.

“These new

considerations must be based only on ‘prior art consisting of patents or printed publications.’”
Id. (citing 35 U.S.C. §§ 301, 302). “The function of reexamination is to increase the reliability
of patents thought to be of doubtful validity.” In re Freeman, 30 F.3d 1459, 1468 (Fed. Cir.
1994).
Under 35 U.S.C. § 301(a)(1) any person at any time may cite to the USPTO “prior art
consisting of patents or printed publications which that person believes to have a bearing on the
patentability of any claim of a particular patent.” 35 U.S.C. § 302 states that “[a]ny person at
any time may file a request for reexamination by the Office of any claim of a patent on the basis
of any prior art cited under the provisions of section 301.”
Section 305 states:
. . . In any reexamination proceeding under this chapter, the patent owner will be
permitted to propose any amendment to his patent and a new claim or claims
thereto, in order to distinguish the invention as claimed from the prior art cited
under the provisions of section 301, or in response to a decision adverse to the
patentability of a claim of a patent. No proposed amended or new claim
enlarging the scope of a claim of the patent will be permitted in a reexamination
proceeding under this chapter. . . .
35 U.S.C. § 305 (emphases added). 7
“Under 35 U.S.C. § 305, a patent owner may propose an amendment to its patent to
distinguish the claimed invention from the prior art or to respond to an adverse decision as to the
patentability of one of the claims. Claim amendments during reexamination are limited to

7

Defendants do not assert that Prometheus broadened the scope of the ’770 patent during
reexamination.
7

‘amendment in light of prior art raising a substantial new question of patentability.’” Sw. Bell
Tel. Co. v. Arthur A. Collins, Inc., 279 F. App’x 989, 992 (Fed. Cir. 2008) (affirming summary
judgment of invalidity based on an improper purpose for reexamination); 8 see also Cordis Corp.
v. Medtronic Ave, Inc., 511 F.3d 1157, 1185 (Fed. Cir. 2008), supplemented sub nom. Cordis
Corp. v. Boston Scientific Corp., 275 F. App’x 966 (Fed. Cir. 2008). A violation of § 305 results
in the invalidity of the amended or added claims. Quantum Corp. v. Rodime, PLC, 65 F.3d 1577,
1584 (Fed. Cir. 1995).
b. The Parties’ Dispute
Cipla 9 argues that the claims of the ’770 patent are invalid under 35 U.S.C § 305 because
Prometheus amended the claims of the ’770 patent during reexamination for an improper
purpose—specifically, that Prometheus used non-prior art to initiate a reexamination. Cipla
argues that claims amended or added to overcome references that are not prior art violates the
restrictions § 305 places on amendments made during reexamination and therefore invalidates
the patent.
Both parties agree that Magnet and Rubicon are not prior art. But Cipla notes that when
initiating ex parte reexamination, Prometheus’ prosecution attorney stated that both Magnet and

8

In Southwest Bell, the district court found that the patent applicant’s own reexamination filings
with the USPTO showed that it filed the reexamination “to preclude any interpretation of the
claims in accordance with [a prior district court’s claim construction] opinions.” Sw. Bell Tel.,
L.P. v. Arthur Collins, Inc., 464 F. Supp. 2d 588, 596 (N.D. Tex. 2006).
9

This Court has found that Roxane failed to act with the proper diligence in moving to amend its
invalidity contentions to add failure to comply with 35 U.S.C. § 305 as a defense. (Dkt. No. 120;
Dkt. No. 158.) This defense is not available to Roxane under the law of the case.
8

Rubicon were prior art. Prometheus admits this fact. 10 Given the fact the parties agree Rubicon
and Magnet are not prior art, the resolution of the parties’ cross motions for summary judgment
relating to § 305 turns on what standard must be applied in evaluating “prior art” under § 305 at
the time of reexamination.
Prometheus argues that there are no genuine issues as to any material facts that the ’770
patent is not invalid under § 305. In support of this position, Prometheus makes two arguments.
First, Prometheus argues that its reexamination counsel initiated reexamination under §§ 301-302
and modified the claims of the ’770 patent under § 305 with the good-faith belief that Magnet
and Rubicon were prior art (whether or not they in fact were objectively prior art), thereby
meeting the “prior art” requirements of §§ 301, 302, and 305. Second, Prometheus argues that
because it amended and added claims to the ’770 patent “in response to a decision adverse to the
patentability” of the ’770 patent, Prometheus meets the alternative requirement of § 305.
In response to Prometheus’ first argument, Cipla asserts that it is the objective status of
the claimed prior art that governs whether or not a reexamination procedure was properly
initiated, not the subjective beliefs of the party initiating the reexamination. (Def. Reply Br. at
11, 16-17.) In other words, should a reexamination be initiated with the good-faith belief that a
document qualifies as prior art and later the document turns out to not qualify as prior art, the
reexamined claims are invalid under § 305 because the reexamination statute requires the cited
material to be “prior art.” Cipla argues that the statute requires “prior art,” and, therefore,
Prometheus’ initiation of the reexamination using what are in hindsight agreed to be non-prior art
documents violated the statute, resulting in the invalidity of the ’770 patent no matter what

10

Cipla and Roxane have moved in limine to prevent Prometheus from stating Rubicon and
Magnet are not prior art at trial. (Dkt. No. 306.) In light of the parties’ agreement that Rubicon
and Magnet are not prior art, the Court denies Defendants’ motion in limine on this issue.
9

occurred after the initiation of the reexamination proceedings. It is, in essence, a strict liability
standard as to what is prior art under the reexamination statute.
Cipla also asserts that because the reexamination procedure was initiated using Magnet
and Rubicon, any amendments Prometheus made in response to a rejection by the USPTO “are
the fruits of the poisonous tree that Prometheus first planted” by using Magnet and Rubicon as
prior art. (Def. Opp. Br. at 9.) Cipla also notes that the rejections Prometheus relies on to defend
the amendments made during reexamination all include the Magnet and Rubicon references.
(Def. Opp. Br. at 11.)
c. Invalidity Under Section 305
Cipla cites no case where a reexamined patent was invalidated for citing documents that
later turned out not to be prior art. Similarly, Prometheus cites no case holding that it is the
subjective belief of the party during reexamination that governs whether or not a § 305
reexamination is for a proper purpose. The majority of the case law addressing § 305 deals with
improper broadening of claims during reexamination. In the few cases addressing reexamination
for an improper purpose (other than the broadening of claims), there is usually a clear statement
by the patent applicant stating an improper purpose. See, e.g., Freeman, 30 F.3d at 1468 (noting,
in the context of issue preclusion, that the applicant’s disclosed purpose for reexamination was to
prevent readers from misconstruing his intent for the claims after an adverse claim construction
ruling in district court); 11 Sw. Bell Tel., 464 F. Supp. 2d at 596 (finding that filing a
reexamination “to preclude any interpretation of the claims in accordance with [a prior district
court’s claim construction] opinions” improper); Total Containment, Inc. v. Environ Products,

11

The claims in Freeman were rejected by the USPTO under § 305 because they were
broadening amendments not because the amendments were made for an improper purpose.
Freeman, 30 F.3d at 1463.
10

Inc., 921 F. Supp. 1355, 1383 (E.D. Pa. 1995) (finding a claim invalid under § 305 because the
patent applicant admitted it was added to cover prior art rather than distinguish the invention
from prior art raising a substantial new question of patentability), aff’d in part, vacated in part,
106 F.3d 427 (Fed. Cir. 1997). In the absence of case law, the Court is guided by the language
of the statute and its legislative history.
The first half of § 305 permits amendment during reexamination “in order to distinguish
the invention as claimed from the prior art cited under the provisions of section 301.” 35 U.S.C.
§ 305. Cipla does not dispute that Prometheus’ reexamination counsel subjectively believed
Magnet and Rubicon were prior art at the time of reexamination and that his belief was
objectively reasonable. Rather, Cipla asserts that it is the current litigation status of the alleged
prior art, viewed with the benefit of hindsight and new discovery, that controls whether a party
complied with §§ 301, 302, and 305 in the past, at the time of reexamination. While none of the
cases cited by the parties directly address whether Prometheus’ subjective belief that Magnet and
Rubicon were prior art is enough to meet the requirements of § 305, the plain language of § 301
supports finding that the statute requires only a good-faith subjective belief that is objectively
reasonable. Section 301 states that any person may cite to the USPTO “prior art consisting of
patents or printed publications which that person believes to have a bearing on the patentability
of any claim of a particular patent. . . .” 35 U.S.C. § 301(a)(1) (emphasis added). The focus of
§ 301 is on the belief of the person citing the prior art. 12

12

Former Magistrate Judge Shwartz also concluded that § 305 turns on
before the USPTO and not on the actual status of the alleged prior art.
(“The focus under § 305, therefore, is on the plaintiff’s actions before
whether a particular item is or is not, in fact, prior art, and the defendant
contrary.”).)
11

actions of the patentee
(Dkt. No. 131-4 at 15
the U.S. PTO and not
has cited no law to the

The legislative history of the statute also supports using a standard that requires a goodfaith belief that is objectively reasonable as to the status of prior art. According to that history,
only submissions that present a substantial question of patentability are allowed; this portion of
the statute was designed to reduce spurious applications for reexamination. (Dkt. No. 348-2,
Testimony of Hon. Sidney A. Diamond, Commissioner of Patents and Trademarks, from April
1980 (“Each request for reexamination will be carefully screened by a member of our
professional staff to assure that it at least raises a creditable case of invalidity or, in the bill’s
words, that there be a ‘substantial new question of patentability.’” (emphasis added)).) The fact
a third-party can initiate these proceedings makes the strict-liability flavor of Cipla’s position
harsh and inequitable.
Under Cipla’s view of the statute, a patent could be invalidated under § 305 if a thirdparty submitted alleged prior art to the USPTO, the USPTO issued a rejection leading the
patentee to amend the patent, and the “prior art” was later ruled to not qualify as prior art. 13 This
does not comport with the plain language of the statute or common sense. 14 Essentially this

13

Cipla also relies on Hewlett-Packard Co. v. Bausch & Lomb, Inc., 882 F.2d 1556 (Fed. Cir.
1989) for the proposition that § 305 requires strict liability with respect to “prior art.” But
Hewlett-Packard is inapposite. First, Hewlett-Packard is a case addressing the reissue statute
not the reexamination statute. Id. at 1558. Second, Hewlett-Packard addressed the statutory
requirement that a reissue must be based on an error. In Hewlett-Packard, the affidavits
submitted to the USPTO claiming error were “blatantly” wrong and “pure fiction.” Id. at 156162. In addition, the patentee failed to establish the second prong for reissue, inadvertent error in
conduct—a requirement that is explicitly in the statute. Id. at 1565. Given the difference in the
statutory language and the facts of the case, Hewlett-Packard does not assist Cipla.
14

“As in all cases involving statutory construction, our starting point must be the language
employed by Congress, and we assume that the legislative purpose is expressed by the ordinary
meaning of the words used. Thus absent a clearly expressed legislative intention to the contrary,
that language must ordinarily be regarded as conclusive.” Am. Tobacco Co. v. Patterson, 456
U.S. 63, 68 (1982) (internal citations and quotation marks omitted). This “strong presumption
that the plain language of the statute expresses congressional intent is rebutted only in rare and
12

position is that, regardless of a good-faith subjective belief at the time that the references were
prior art, and despite the reasonableness of that belief at the time, Cipla argues that later
discovered evidence may constitute a basis for invalidating the patent and amendments submitted
during reexamination.
In accordance with the plain language of the statute, its legislative history, and case law
in the related areas of inequitable conduct and willful infringement, 15,16 the Court finds that §
305 requires that the patent applicant subjectively believes that he or she is submitting prior art to
the USPTO 17 and that such belief is objectively reasonable.

This same reasonable-belief

formulation appears in other areas of the law. Cf. Gomez v. Toledo, 446 U.S. 635, 639 (1980)
(“And in other contexts we have held, on the basis of [c]ommon-law tradition . . . and strong
public-policy reasons that certain categories of executive officers should be allowed qualified
exceptional circumstances.” United States v. Clintwood Elkhorn Min. Co., 553 U.S. 1, 11 (2008)
(internal quotation marks omitted).
15

“[T]o establish willful infringement, a patentee must show by clear and convincing evidence
that the infringer acted despite an objectively high likelihood that its actions constituted
infringement of a valid patent. Once the threshold objective standard is satisfied, the patentee
must also demonstrate that this objectively-defined risk . . . was either known or so obvious that
it should have been known to the accused infringer.” Bard Peripheral Vascular, Inc. v. W.L.
Gore & Associates, Inc., 682 F.3d 1003, 1005 (Fed. Cir. 2012), cert. denied, 133 S. Ct. 932
(2013).
16

Notably, inequitable conduct requires a much higher quantum of proof. See Therasense, Inc.
v. Becton, Dickinson & Co., 649 F.3d 1276, 1296 (Fed. Cir. 2011) (“the district court should
determine whether there is clear and convincing evidence demonstrating that Sanghera or Pope
knew of the [references], knew of their materiality, and made the conscious decision not to
disclose them in order to deceive the PTO.”) Here, Cipla argues for strict liability. Thus, even if
a patentee had a good-faith, objectively reasonable, belief that it was amending due to a piece of
prior art, its patent would be invalid if that belief was later proven to be wrong.
17

This is reinforced by an applicant’s duty of candor with the Patent Office. Avid Identification
Sys., Inc. v. Crystal Imp. Corp., 603 F.3d 967, 973 (Fed. Cir. 2010) (“PTO Rule 56, codified at
37 C.F.R. § 1.56, imposes on all individuals associated with the filing and prosecution of a patent
application a duty of candor and good faith in dealing with the PTO during the period of
examination of a patent application.”).
13

immunity from liability for acts done on the basis of an objectively reasonable belief that those
acts were lawful.” (internal citations and quotation marks omitted)); Nobelpharma AB v. Implant
Innovations, Inc., 141 F.3d 1059, 1071 (Fed. Cir. 1998) (Discussing Walker Process fraud and
noting that “in order to prove that a suit was within Noerr’s ‘sham’ exception to immunity, an
antitrust plaintiff must prove that the suit was both objectively baseless and subjectively
motivated by a desire to impose collateral, anti-competitive injury rather than to obtain a
justifiable legal remedy.”).
Because there was a subjective belief that was objectively reasonable at the time of the
reexamination request that Magnet and Rubicon were prior art, Prometheus’ reexamination
complied with § 305. The ’770 patent is not invalid under § 305.
d. Amendments Under Section 305
Under the second half of § 305, a party may make changes during reexamination “in
response to a decision adverse to the patentability of a claim of a patent.” 35 U.S.C. § 305. In
this case, there is no dispute that the USPTO issued a rejection citing Magnet, Rubicon, and four
other pieces of prior art. It is also undisputed that in response to that rejection Prometheus
amended, cancelled, and added claims to the ’770 patent. These types of amendments are
permitted under § 305. See Cordis, 511 F.3d at 1185 (reversing a finding of invalidity under
§ 305 because the amendments were “‘[r]esponsive to’ the office action that had rejected all but
two of the claims of the [patent-in-suit] in light of prior art references”); see also Total
Containment, 921 F. Supp. at 1383 (“Although TCI’s attorney did not state on the record that
these claims were submitted in response to the rejection of claim 9, this fact can be inferred from
the timing of their presentation and the fact that they contain all the limitations of claim 9.
Therefore, claims 13-18 of the ’408 patent do not violate 35 U.S.C. § 305.”).

14

Because

Prometheus’ modifications during reexamination were in response to a rejection by the USPTO,
they were not improper under § 305.
Prometheus’ reexamination complied with § 305 as the changes to the ’770 patent were
made “in order to distinguish the invention as claimed from the prior art cited under the
provisions of section 301.” The Court grants Prometheus’ motion for summary judgment for this
separate and independent reason as well.
V.

OTHER OUTSTANDING ISSUES
During the hearing on November 21, 2013, the Court ruled on Plaintiff’s motions in

limine regarding Dr. Howden’s “single actor” testimony, clinical studies evidence, label
preparation evidence, and reexamination evidence [Dkt. No. 309 (Civ. No. 11-1241); Dkt. No.
196 (Civ. No. 11-230)]. The parties should consult the transcript of the hearing for the Court’s
ruling.
At the hearing, the Court also addressed the parties’ motions to seal the courtroom during
trial [Dkt. Nos. 323, 324 (Civ. No. 11-1241); Dkt. Nos. 210, 211 (Civ. No. 11-230)]. These
motions were denied without prejudice for the reasons stated in the hearing. The parties may reraise this issue, as appropriate, during trial.
During the hearing, Defendants represented that the FDA has not yet approved their drug
but that it may be approved during the first quarter of 2014. The Court requests that the parties
keep it apprised of any approval of Defendants’ drug by the FDA. The Court also reminds the
parties that motions for preliminary injunctions are not automatically granted and require that a
plaintiff meet a four-part test. “A plaintiff seeking a preliminary injunction must establish that
[it] is likely to succeed on the merits, that [it] is likely to suffer irreparable harm in the absence of
preliminary relief, that the balance of equities tips in [its] favor, and that an injunction is in the

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public interest.” AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1049 (Fed. Cir. 2010). “A
preliminary injunction should not issue if an alleged infringer raises a substantial question
regarding either infringement or validity, i.e., the alleged infringer asserts an infringement or
invalidity defense that the patentee has not shown lacks substantial merit.” Id. at 1050. Should a
time come when Plaintiff is considering applying for a preliminary injunction, it should carefully
consider these requirements.
Finally, the Court asks the parties to file a joint letter within 14 days of this Order
indicating whether they believe a settlement conference with the Honorable Michael A. Hammer,
U.S.M.J., or another mediator, would be fruitful.
VI.

CONCLUSION
For the reasons stated above, the Court denies Cipla’s motion for summary judgment of

invalidity of the ’770 patent under § 305 and grants Prometheus’ motion for summary judgment
of no invalidity of the ’770 patent under § 305. In light of the parties’ agreement that Magnet
and Rubicon are not prior art, the Court also denies Defendants’ motion in limine seeking a
pretrial ruling that Rubicon and Magnet are prior art. The remaining motions were addressed
and ruled on at the hearing, and the parties should consult the transcript for those rulings. An
appropriate Order will issue.

/s/ Faith S. Hochberg__________
Hon. Faith S. Hochberg, U.S.D.J.

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