FRESENIUS KABI USA, LLC v. FERA PHARMACEUTICALS, LLC

Filing 333

CORRECTED OPINION, filed herewith, relates to ECF no. 328. It corrects typographical errors and also incorporates minor stylistic edits for clarity. There is no change in substance. Signed by Judge Kevin McNulty on 9/23/16. (nic, )

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UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY

FRESENIUS KABI USA, LLC,

No. 15-cv--3654 (KM)(MAH)

Plaintiff,

FERA PHARMACEUTICALS, LLC, et al.,

CORRECTED OPINION
(Preliminary Injunction and
Motion to Dismiss)

Defendants.

KEVIN MCNULTY, U.S.D.J.:
The plaintiff, Fresenius Kabi USA, LLC, brings two motions against two
of the defendants in this suit, Fera Pharmaceuticals, LLC, and Oakwood
Laboratories, LLC (collectively, “Fera”)’: 1) a motion to dismiss Fera’s
inequitable conduct counterclaims (ECF No. 89), and 2) a motion for
preliminary injunction (ECF NO. 187). Fresenius’s underlying suit against Fera
is for patent infringement. The patents-in-suit are Patent Nos. 9,006,289 (“the
‘289 patent”), 9,168,238 (“the ‘238 patent”), and 9,168,239 (“the ‘239 patent”).
All three describe formulations of levothyroxine, a hormone produced by the
thyroid. These patents claim a form of lyophilized (i.e., freeze—dried)
levothyroxine that can be reconstituted and injected into patients who lack a
properly functioning thyroid. (P1. Opening 1) Claims 1, 2, 4, 14, 15, and 16 of
the ‘289 patent are the subject of this preliminary injunction motion. (Prel. Inj.

At the parties’ request, this patent infringement suit was consolidated for
pretrial purposes with one against InnoPharma, Inc. and InnoPharma Licensing, LLC
(collectively, “InnoPharma”), originally filed under the docket number 15—3655. (See
ECF No. 79) Fresenius has not asked for a preliminary injunction against
InnoPharma. A third suit, docket number 15—3853, was originally consolidated with
these two, but those defendants settled with Fresenius after the opening briefs were
filed. (See ECF No. 120)
I

1

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Br.

9)2

Simultaneously herewith, I am filing a Markman opinion construing the

terms of the patent, which is incorporated herein.
The Food and Drug Administration (“FDA”) approved Fresenius’s New
Drug Application (“NDA”) on June 24, 2011. (3AC Fera

2

¶

15) The ‘289 patent

Citations to the record will be abbreviated as follows:

“3AC Fera”
No. 83).

—

“Fera Answer”

Third Amended Complaint of Fresenius against Fera (ECF
—

Fera’s Answer to 3AC Fera (ECF No. 84).

“084 Application”
U.S. Provisional Patent Application No. 6 1/529,084,
Appendix B to the Fera Answer (ECF No. 84-2).
—

“884 application”
non-provisional Patent Application No. 13/5g7,884,
Appendix C to the Fera Answer (ECF No. 84-3).
—

“Usayapant Deci.”
December 23, 2014 Declaration of Dr. Arunya Usayapant,
Appendix I to the Fera Answer (ECF No. 84-9).
—

“Notice of Allowance”
Notice of Allowance of the ‘884 application by the
USPTO, Appendix J to the Fera Answer (ECF No. 84-10)
—

“Prel. Inj. Br.”
Fresenius’s Brief in Support of their Motion for Preliminary
Injunction (ECF No. 188).
—

“P1. Ex.”
Fresenius’s Exhibits (ECF Nos. 187—2 to 187—9), attached to the
Declaration of Keith J. Miller (ECF No. 187—1).
—

“Meachum Deci.”

—

Declaration of Scott Meachum (ECF No. 188—2).

“Prel. Inj. Opp.”
Fera’s Brief in Opposition to Fresenius’s Motion for
Preliminary Injunction (ECF No. 253).
—

“Def. Ex.”— Fera’s Exhibits (ECF Nos. 253—2 to 253—16), attached to the
Declaration of Adam D. Sussman (ECF No 253—1).
“Prel. Inj. Reply”
Fresenius’s Reply Brief in Support of their Motion for
Preliminary Injunction (ECF No. 265).
—

“Bedford”— Description of Bedford Laboratories grandfathered levothyroxine
formulation (Ex. D to Def. Ex. 2 (ECF No. 253-4)).
“Nentwich”— Description of grandfathered levothyroxine formulation in
Intravenous Therapies textbook by Phyllis Nentwich (Ex. G to Def. Ex. 2 (ECF No, 2534)).
“289 Patent”
“238 Patent”
“239 Patent”

—

United States Patent No. 9,006,289, P1. Ex. 1 (ECF No. 187—2).

—

United States Patent No. 9,168,238, P1. Ex. 2 (ECF No. 187—3).

—

United States Patent No. 9,168,239, P1. Ex. 3 (ECF No. 187—4).
2

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was issued on April 14, 2015, and is due to expire on October 3, 2032. (3AC
Fera J 10, 16) The ‘238 and ‘239 patents were issued on October 27, 2015,
and are due to expire on August 29, 2032. (3AC Fera

¶f

11—12, 16) Fera filed

an Abbreviated New Drug Application (“ANDA”) that sought approval to
commercially market a generic version of Fresenius’s patented levothyroxine
formulations. (Fera Answer

¶

17) This lawsuit followed.
3

On July 25, 2016, I convened a hearing on the motion of Fresenius for a
preliminary injunction. To shorten the hearing, I directed the parties that I
would accept affidavits in lieu of direct testimony, and offered both sides the
opportunity to cross-examine the affiants. Both sides declined the opportunity,
and opted to rely on their papers. As a result, any facts related herein rest on
the persuasiveness, or not, of written representations; there was no
opportunity to assess credibility. This opinion is structured primarily as a
discussion of the motion for a preliminary injunction. The arguments on the
motion to dismiss the inequitable conduct claims are discussed in the context
of the likelihood of success on the merits.
I.

BACKGROUND

A grandfathered version of a levothyroxine injectable, not approved by
the FDA, has been available in the United States since 1969. (Prel. Inj. Opp. 4
(citing Def. Ex. 253-6 at 6280)) In the early 2000s, APP Pharmaceuticals
marketed that grandfathered version. On December 18, 2006, APP received a
warning letter from the United States Food and Drug Administration notifying
it that an NDA would be required. (Meachum Deci.

¶

14) In 2008, Fresenius

acquired APP. In 2010, Fresenius filed an NDA on a “more stable formulation of
its Levothyroxine product.” That NDA was approved on June 24, 2011.

In many cases, a 30-month stay operates to give the parties and the
court breathing space to decide issues of patent validity and infringement. The parties
agree that, for various reasons of timing, the 30-month stay does not apply here. See
21 U.S.C. § 355(j)(5)(B)(iii).
3

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(Meachum Deci.

¶f

15—17; see also Prel. lnj.

Opp.

4) Based on that new, FDA-

approved formulation, Fresenius applied for and eventually received the ‘289,
‘238, and ‘239 patents.
Fresenius’s newly patented formulations contain levothyroxine, a buffer,
and a specific amount of a bulking agent called mannitol. The innovation at the
heart of Fresenius’s patents is a claim that a lower amount of mannitol, as
compared with the grandfathered versions, unexpectedly increased the stability
of the formulation. (Prel. Inj. Br. 5)
F’era and InnoPharma filed ANDAs that sought approval to commercially
market generic versions of Fresenius’s patented levothyroxine injections.
Fresenius, claiming that these would infringe its patents, seeks to enjoin them
from doing so.
II.

ANALYSIS
Whether a preliminary injunction is warranted depends on four factors:

(1) whether the moving party is likely to succeed on the merits; (2) whether the
moving party is likely to suffer irreparable harm in the absence of preliminary
relief; (3) whether granting preliminary relief will result in even greater harm to
the nonmoving party; and (4) whether an injunction is in the public interest.
TrebroMfg., Inc. v. Firefly Equz., LLC, 748 F.3d 1159, 1165 (Fed. Cir. 2014)
(citing Winter v. Natural Res. Def Council, Inc., 555 U.S. 7, 20, 129 S. Ct. 365
(2008)); accord Columbia Gas Transmission, LLC v. .1.01 Acres, More or Less in
Penn Twp., York Cnty., Pa., Located on Tax ID # £440002800150000000 Owned
by Brown, 768 F.3d 300, 315 (3d Cir.2014). “These traditional four factors
‘apply with equal force to disputes arising under the Patent Act.”’ Apple Inc. v.
Samsung Elecs. Co., 695 F.3d 1370, 1374 (Fed. Cir. 2012) (quoting eBay Inc. v.
MercExchange, L.L.C., 547 U.S. 388, 391, 126 S. Ct. 1837 (2006)). No
individual factor is dispositive. Hybritech Inc. v. Abbott Labs., 849 F.2d 1446,
1451 (Fed. Cir. 1988) However, “a movant must establish the existence of both
of the first two factors to be entitled to a preliminary injunction.” Altana

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Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 1005 (Fed. Cir. 2009);
accord Otsuka Pharm. Co. v. Torrent Pharm. Ltd., Inc., 99 F. Supp. 3d 461, 475
(D.N.J. 2015).
A.

Likelihood of Success on the Merits
Fera’s challenge is directed primarily to the first factor: Fresenius’s

likelihood of success on the merits of its claim of patent infringement.
1.

Federal Circuit standard

The United States Court of Appeals for the Federal Circuit, which has
appellate jurisdiction over patent cases, applies the law of the regional circuits
when reviewing preliminary injunction decisions. Aevoe Corp. v. AE Tech Co.,
727 F.3d 1375, 1381 (Fed. Cir. 2013) (citing Abbott Labs. v. Sandoz, Inc., 544
F.3d 1341, 1367 (Fed. Cir. 2008)). However, it applies Federal Circuit law to
substantive matters of patent infringement, including the first of the four
preliminary injunction factors: the likelihood of success in establishing patent
infringement. Revision Military, Inc. v. Balboa Mfg. Co., 700 F.3d 524, 526 (Fed.
Cir. 2012). Fed. R. Civ. P. 65, of course, applies regardless.
In Amazon. corn, Inc. v. Bamesandnoble. corn, Inc., the Federal Circuit
announced, or reaffirmed, the standard by which district courts hearing patent
cases should review the preliminary injunction factor of likelihood of success
on the merits: If the alleged infringer “raises a substantial question concerning
either infringement or validity, i.e., asserts an infringement or invalidity defense
that the patentee cannot prove lacks substantial merit, the preliminary
injunction should not issue.” 239 F.3d 1343, 1350—5 1 (Fed. Cir. 2001) (internal
quotation marks omitted) (citing Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d
1361, 1364 (Fed. Cir. 1997)). The Amazon court further explained that, rather
than the “clear and convincing” standard for proving patent invalidity at trial,
“[vjulnerability is the issue at the preliminary injunction stage.” Id. at 1359.
Amazon’s standard may have been cast into doubt, however, by the
subsequent Supreme Court case of eBay Inc. v. MercExchange, L.L.C., 547 U.S.
388, 391, 126 S. Ct. 1837 (2006). In eBay, the Supreme Court reviewed a
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Federal Circuit post-trial decision to apply a “general rule that courts will issue
permanent injunctions against patent infringement absent exceptional
circumstances.”’ 547 U.S. at 391 (quoting MercExchange, LLC v. eBay, Inc., 401
F.3d 1323, 1339 (Fed. Cir. 2005)). The Court reemphasized that “the decision
whether to grant or deny injunctive relief rests within the equitable discretion
of the district courts, and that such discretion must be exercised consistent
with traditional principles of equity, in patent disputes no less than in other
cases governed by such standards.” Id. at 394. In short, the Supreme Court
seemed to reemphasize the primacy of the traditional four-factor analysis for
injunctive relief, albeit in the context of a permanent, not preliminary,
injunction. Id. at 391.
Doubts have thus arisen as to the continuing viability of the Federal
Circuit’s holding that, for preliminary injunctive relief, the “substantial
question” standard requires only a showing of patent “vulnerability.” Thus, in
the aftermath of eBay, Judge Newman dissented in two Federal Circuit
decisions that vacated preliminary injunctions in patent cases. Both times, she
objected to the majorities’ holdings that a “substantial question” of invalidity
suffices to defeat a motion for a preliminary injunction. Erico, 516 F.3d at
1359—60; Andrx Pharm., 452 F.3d at 1349—52. The fullest statement of Judge
Newman’s views is contained in her opinion in Sandoz, supra. There, although
she wrote for the majority, the relevant section of her opinion was not joined by
her companion in the majority or by the dissenting Judge Gajarsa. Judge
Newman thoroughly reviewed the preliminary injunction standards of all the
other circuits and argued that “all refer to the likelihood of the eventual
outcome, not whether a substantial question has been raised.” 544 F.3d at
1365. In Judge Newman’s view, certain panels of the Federal Circuit had
departed from the proper standard when they looked only to the alleged
infringer’s raising of a “substantial question” as to the patent’s validity. That
approach, in her view, undermined the proper application of the “likelihood of
success on the merits” standard. Id. at 1364.

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The following year, both Judge Newman and Judge Gajarsa joined an
opinion by Judge Plager that attempted to reconcile the “substantial question”
standard with the traditional equitable factors. See Titan Tire Corp. v. Case New
Holland, Inc., 566 F.3d 1372 (Fed. Cir. 2009). Titan Tire started from the basic

principle that “tim assessing whether the patentee is entitled to the injunction,
the court views the matter in light of the burdens and presumptions that will
inhere at trial.” Id. at 1376 (citing Gonzales v. 0 Centro Espirita Beneficente
Uriiao do Vegetal, 546 U.S. 418, 429, 126 S. Ct. 1211(2006)). Issued patents
maintain a statutory presumption of validity at trial, and the defense of
invalidity must be proven by clear and convincing evidence. Id.; see 35 U.S.C.

§

282. On a motion for preliminary injunction, Titan Tire held, the patent likewise
enjoys a presumption of validity. Should its validity be challenged, however, the
patentee has the burden to respond and show a likelihood of success on the
merits. Id. at 1377.
The Titan Tire court then analyzed New England Braiding Co. v. A. W.
Chesterton Co., 970 F.2d 878 (Fed. Cir. 1992), which was cited in the
Genentech case from which the Amazon panel drew the “substantial question”
standard. In New England Braiding, the court wrote:
The district court cannot be held to have erred in deciding that the
patentee failed to make a sufficient showing of likelihood of
success required to support a preliminary injunction where the
evidence presented in support of invalidity raises a substantial
question, although the defense may not be entirely fleshed out....
While it is not the patentee’s burden to prove validity, the patentee
must show that the alleged infringer’s defense lacks substantial
merit.
970 F.2d at 883 (emphasis added). Viewing this paragraph as a whole, Titan
Tire concluded that a trial court should consider both the evidence of invalidity
and the patentee’s rebuttal evidence. 566 F.3d at 1377—78 (citing Genentech,
108 F.3d at 1364 (“In other words, if Novo raises a ‘substantial question’
concerning validity

...

(i.e., asserts a defense that Genentech cannot show

‘lacks substantial merit’) the preliminary injunction should not issue”).

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Attempting to synthesize the case law, Titan Tire stated that denial of a
preliminary injunction entails a conclusion “that the patentee is unlikely to
succeed on the merits of the validity issue because the patentee is unable to
establish that the alleged infringer’s invalidity defense lacks substantial merit.”
Id. at 1378. That is a substantial bar, said Titan Tire, but it does not
prematurely require that the opponent of relief meet its ultimate burden of
proving invalidity by clear and convincing evidence. Rather, at the preliminary
injunction stage, the court must “assess the potential of a ‘clear and
convincing’ showing [of invalidity] in the future, but in terms of what is ‘more
likely than not’ presently.” Id. at 1380.
Judges of the Federal Circuit—albeit in rionprecedential or nonmajority
decisions—have questioned whether the Titan synthesis has truly reconciled
the Federal Circuit preliminary injunction standard with the traditional
equitable factors, in keeping with eBay, supra. For example, Kimberly-Clark
Worldwide, Inc. v. First Quality Baby Products, LLC, 431 F. App’x 884, 887 (Fed.
Cir. 2011), an unpublished decision, continued to cite the “vulnerability”
language from Amazon, to the evident consternation of Judge Newman: “[T]he
attempted reconciliation in Titan Tire appears to have failed, for this panel
provides no qualification for its position that if validity is reasonably
questioned, the injunction will be denied.” Kimberly-Clark Worldwide, Inc. v.
First Quality Baby Products, LLC, 660 F.3d 1293, 1299 (Fed. Cir. 2011)
(Newman, J., dissenting from denial of rehearing, joined by Judges O’Malley
and Reyna). Judge O’Malley added that “[d]istrict courts across the country
4
have struggled with our precedent in this area, concluding in large measure
that, whatever their views of the merits of a particular preliminary injunction

As a district judge, Judge O’Mafley had subscribed to a position similar to that
of Judge Newman. See Avery Dennison Corp. v. Alien Tech. Corp., 626 F. Supp. 2d 693,
699 (N.D. Ohio 2009); Erico Int’l Corp. v. Doc’s Mktg., Inc., Civ. No. 05—2924, 2007 WL
108450, at 9 (N.D. Ohio Jan. 9, 2007). His championing of the perplexed district
judge is thus rooted in personal experience.
4

8

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request, this court’s precedent virtually mandates denial of all such motions.”
Id. at 1301 (O’Malley, J., dissenting).
Unpublished Federal Circuit opinions dating from after the KimberlyClark rehearing denial have cited Titan Tire. See Hoffmann-La Roche Inc. v.
Apotex Inc., 496 F. App’x 46, 50—51 (Fed. Cir. 2012) (“Regarding the likelihood
of success on the merits, it was Roche’s burden to show, in light of the burdens
and presumptions that will inure at trial, that it will likely prove infringement
and that it will likely withstand any invalidity challenge to the patent.”); Warner
Chilcott Labs. Ireland Ltd. v. Mylan Pharm. Inc., 451 F. App’x 935, 938—39 (Fed.
Cir. 2011) (“the trial court first must weigh the evidence both for and against
validity that is available at this preliminary stage in the proceedings”)

.

Other post-Titan Federal Circuit panel decisions, however, both reported
and unreported, seem to apply the legacy Amazon standard in reviewing
preliminary injunction decisions. See, e.g., LifeScan Scotland, Ltd. v. Shasta
Techs., LLC, 734 F.3d 1361, 1366 (Fed. Cir. 2013); Sciele Pharma Inc. v. Lupin
Ltd., 684 F.3d 1253, 1261 (Fed. Cir. 2012); Kimberly-Clark Worldwide, Inc. v.
First Quality Baby Products, LLC, 431 F. App’x 884, 886—87 (Fed. Cir. 2011);
Altana Pharma, 566 F.3d at 1005—06; Erico Int’l Corp. v. Vutec Corp., 516 F.3d
1350, 1356 (Fed. Cir. 2008); Abbott Labs. v. AndrxPharm., Inc., 452 F.3d 1331,
1335 (Fed. Cir. 2006). It is not clear, however, that the standard made any
difference in those cases. In LfeScan, for example, the Court held that the
defendant had “established a patent exhaustion defense as a matter of law.”
The other reported case applying the “substantial question” standard, Sciele,
does not cite or discuss the relevance of Titan.
In this district, some recent decisions have followed the guidance of Titan
Tire. See, e.g., Roxane Labs., Inc. v. Camber Pharin. Inc., Civ No. 14—4042, 2014
WL 3854140, at *2 (D.N.J. Aug. 6, 2014), affd, 596 F. App’x 922 (Fed. Cir.

Judge O’Mailey wrote Warner, and Judges Newman and O’Malley sat on the
unanimous panel in Hoffman.
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2015) (“To obtain a preliminary injunction, Roxane must show that it will likely
prove infringement, and that it will likely withstand challenges, if any, to the
validity of the patent.”). See also e.g., Otsuka Pharm. Co. v. Torrent Pharm. Ltd.,
Inc., 99 F. Supp. 3d 461, 475, 497, 499 (D.N.J. 2015) (citing vulnerability
standard, but also seemingly adopting the Titan Tire burden shifting analysis,
concluding that “these Defendants
of invalidity

...

...

have established a substantial question

and [the plaintiff] has not shown that this question of invalidity

lacks substantial merit.”). Others, however, have cited the “vulnerability”
language from Amazon without qualification. See, e.g., Yowie N. Am., Inc. u.
Candy Treasure, LLC, Civ No. 14-1409, 2014 WL 1871910, at *4 (D.N.J. May 8,
2014).
So what to do? Even if Titan Tire has, as a doctrinal matter, laid the issue
to rest, there remains the problem of conflicting panel decisions. The Federal
Circuit, like many, “has the rule that in the event of conflict between panels the
earlier holding prevails until overturned en banc.” Sandoz, 544 F.3d at 1371
(citing Newell Companies v. Kenney Mfg. Corp., 864 F.2d 757, 765 (Fed. Cir.
1988)); accord Texas Am. Oil Corp. v. U.S. Dep’t of Energy, 44 F.3d 1557, 1561
(Fed. Cir. 1995) (“This court applies the rule that earlier decisions prevail
unless overruled by the court en banc, or by other controlling authority such
as intervening statutory change or Supreme Court decision.”) Thus Titan Tire, a
panel decision, could not of its own authority overturn the standard
announced in the earlier panel decision of Amazon. That rule, of course, is
subject to the still more basic principles that intervening precedent of the U.S.
Supreme Court must in all events control, and that Fed. R. Civ. p. 65 binds
every district court, whether in a patent or non-patent case.
eBay is not so clearly on point as to simply overrule earlier Federal
Circuit preliminary injunction cases, such as Amazon. If that were so, the issue
would be an easy one. The eBay decision involved a remedial question:
whether, after a trial in which infringement was found, the court should apply
a general presumption that a permanent injunction should issue. The

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preliminary injunction context poses problems of its own, involving the

probability that infringement will be found, the allocation of risk in the interim,
and the desirability of maintaining the status quo.
By the same token, however, Titan Tire does not merely overturn prior
panel decisions, which, under the Court’s operating procedures, it was not
empowered to do. Titan Tire does not purport to overthrow, but rather to
reconcile, the strands of the case law. I believe it succeeds in doing so----placing
the burden on the defendant to raise a substantial issue, in which case the
patentee must demonstrate the likelihood that it will succeed in meeting its
ultimate burden of persuasion by clear and convincing evidence.
As a district judge, I am ill-equipped to enforce the internal operating
procedures of the Federal Circuit,

6

or to decide which of its precedents to give

priority. I tend to agree that the traditional preliminary injunction factors
should be paramount, and that the Supreme Court has so signaled in eBay.
Under that approach, where a substantial issue has been raised, the likelihood
of success factor would require a court to weigh both sides’ evidence and
contentions, and to assess the plaintiff’s likelihood of prevailing at trial. And
that factor, of course, will be informed by the substance and procedures of
patent law. I will therefore attempt to remain faithful to Federal Circuit case
law and apply the Titan synthesis. As noted herein, I do not believe the
standard would influence the result as to most issues, but I have noted where I
believe it might, to facilitate review.
2.

Infringement

Fresenius argues that Fera’s product, if marketed, will infringe
independent claims 1 and 14 and dependent claims 2, 4, 15, and 16 of the ‘289
patent. (Prel. Inj. Br.

§ III.A. 1) Fresenius’s expert submits that Fera’s proposed

1 will not venture into the meta-question of how to reconcile a
disagreement between panels as to whether there is a conflict between panel
decisions.
6

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generic formulations fall within the limitations of each of those claims. Fera’s
only challenge to those infringement allegation per se is that the patent
requires a buffer. A buffer, argues Fera, should be defined as a liquid, whereas
Fera’s formulation is a lyophilized solid with no liquid components. (Prel. Inj.
Opp.

§ II.A) In the accompanying Markman claim construction opinion, I have

construed the term “buffer” in a manner that is fatal to this argument.
Consequently, I find that Fera has not raised a substantial issue, and that
Fresenius is likely to succeed on this issue.
3.

Patent validity

Fera next argues that Fresenius is unlikely to succeed on the merits
because its patents are invalid. In support, Fera asserts the doctrines of double
patenting; anticipation and the on-sale bar; obviousness; and inequitable
conduct/unclean hands. I consider them in order.
i.

Double patenting

The chief vice of double patenting is the potential for an unwarranted
extension of the patent term. An inventor cannot, by re-patenting the same
invention, extend the monopoly beyond the original term. Fera argues that the
‘289 patent is invalid because it is “virtually the same” as, or an obvious
variant on, the earlier-expiring ‘239 patent. (Prel. Inj. Opp.

§ 2 .B)

The ‘289 patent was issued on April 14, 2015; the ‘238 and ‘239 patents
were issued a few weeks later, on October 27, 2015. As it happens, however,
the ‘289 patent received a patent term adjustment from the PTO under 35
U.S.C.

§ 154(b) that extended its anticipated expiration date to October 3,

2O32. Thus the ‘238 and ‘239 patents, though issued later, expire five weeks
earlier, on August 29, 2032. These facts appear to be undisputed.

A section 154(b) extension is granted based on the USPTO’s own delays
in processing. 35 U.S.C. § 154(b).
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In Gilead Scis., Inc. v. Natco Pharma Ltd., the Federal Circuit held that an
earlier expiring patent, even if issued later, would “qualify as an obviousnesstype double patenting reference for a later-expiring patent.” 753 F.3d 1208,
1217 (Fed. Cir. 2014), cert. denied, 135 S. Ct. 1530 (2015). Albeit under
circumstances different from this case, Gilead proclaimed categorically that the
“patent expiration dates

[]

should control” because that approach best

comports with the “bedrock principle of our patent system that when a patent
expires, the public is free to use not only the same invention claimed in the
expired patent but also obvious or patentably indistinct modifications of that
invention.” Id. at 1214-45. That holding receives further support from Abbvie
Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust, which
specifically mentioned patents that are “filed at the same time

...

[yet] have

different patent terms due to examination delays at the PTO.” 764 F.3d 1366,
1373 (Fed. Cir. 2014) (citing 35 U.S.C.

§

8
154(b)).

Gilead reasoned that its holding would “preserve[] the ability of inventors
to use a terminal disclaimer of later-expiring patents to create one expiration
date.” 753 F.3d at 1216. By a “terminal disclaimer,” Gilead meant a patentee’s
voluntary relinquishment of the portion of the second-expiring patent’s term
that extends beyond that of the first-expiring patent. Such disclaimers, said
Gilead, “effectively overcome any objection to improper term extension.” Id.
Here, Fresenius notified the Court that it has filed for a terminal
disclaimer that, if accepted by the PTO, would shorten the extended expiration
of the’289 patent and bring it into conformity with those of the ‘238 and ‘239

8 Gilead confined the inquiry to the expiration date because the Uruguay Round
Agreements Act (“URAA”) “changed the term for a U.S. patent from seventeen years
from the patent issue date to twenty years from the earliest effective filing date.”
Gilead, 753 F.3d at 1211 (citing Pub.L. No. 103—465, § 532(a), 108 Stat. 4809, 4983—
85 (1994)). Should there be a circumstance where a terminal disclaimer is unavailable,
the holding that expiration dates control seems potentially draconian if it could
invalidate a patent whose expiration date is later because of a patent term adjustment
where the delay is solely the fault of the PTO.

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patents. (See ECF. No. 291) In essence, Fresenius has agreed to give up the
last five weeks of patent protection in August—October 2032. That concession, I
find, removes any substantial basis for the double patenting objection. And
because the term extension resulted, not from any action of Fresenius but from
delay in the PTO’s examination process, there is no implication of sharp
practice.
While the PTO has not yet accepted the terminal disclaimer, it seems
likely that it will do so, and Fera has not suggested otherwise. (See ECF No.
292) Thus, Fera is unable to raise a substantial question of invalidity on this
issue, and Fresenius has demonstrated a likelihood of success on the merits as
to double patenting.
ii.

Anticipation and the on-sale bar

Fera argues that claims 1 and 2 of the ‘289 patent are anticipated by the
grandfathered products and thus unpatentable under the on-sale bar. “To
establish an on-sale bar, it must be shown that the device sold fully anticipated
the claimed invention or would have rendered the claimed invention obvious by
its addition to the prior art.” Allen Engg Corp. v. Bartell Indus., Inc., 299 F.3d
1336, 1352 (Fed. Cir. 2002) (internal quotation marks and citations omitted).
A prior art reference can only anticipate a claim if it discloses all
the claimed limitations arranged or combined in the same way as
in the claim. However, a reference can anticipate a claim even if it
d[oes] not expressly spell out all the limitations arranged or
combined as in the claim, if a person of skill in the art, reading the
reference, would at once envisage the claimed arrangement or
combination.
Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir.
2015) (internal quotation marks and citations omitted). In short, the
grandfathered drug must literally duplicate the current formulation, or be so
close as to be an obvious variant.
Specifically, Fera argues that the grandfathered levothyroxine
formulations, which contain 500 pg of levothyroxine sodium per vial and either
10 or 15 mg of mannitol (Bedford; Nentwich 357), anticipate claims 1 and 2 of

14

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the ‘289 patent, which describe 100 or 200 pg doses of levothyroxine and 2-4
or 3 mg of mannitol. (‘289 Patent claims 1—2) Fera’s argument is that a simple
segregation of, say, 1 / 5 or 1 / 2 of the grandfathered product would produce a
product indistinguishable from that described by the ‘289 patent. (Prel. Inj.
Opp.

§

II.C.2)

The preparations of both Bedford’s and Nentwich’s grandfathered
products belie this argument. Each describes a vial containing either 200 or
500 pg but with the amount of mannitol remaining at 10 or 15 mg, irrespective
of the total amount of the lyophilized product. (Bedford; Nentwich 357) Thus,
these formulations are consistent with Fresenius’s claim that, prior to its
discovery, the conventional wisdom was that more mannitol was better. (Prel.
Inj. Br. 5)
[U]nless a reference discloses within the four corners of the
document not only all of the limitations claimed but also all of the
limitations arranged or combined in the same way as recited in the
claim, it cannot be said to prove prior invention of the thing
claimed and, thus, cannot anticipate under 35 U.S.C. § 102.
Net MoneyI Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).

Nor is it apparent from these grandfathered formulations that a person of
ordinary skill in the art would realize that stability would be enhanced by a
reduction in the amount of mannitol. The grandfathered formulations may
contain the same or similar ingredients, but they keep the mannitol amount
consistent for different sized formulations. They therefore do not arrange the
proportions of the ingredients in a way that is identical to, or an obvious
variant on, the formulation in the ‘289 patent. Under the “substantial issue”
standard, this is a closer question. Nevertheless, in light of the considerations
discussed here and in the following subsection, Fresenius has demonstrated a
likelihood of success.
iii.

Obviousness/on sale bar

Relatedly, Fera argues that portioning the grandfathered formulations
can demonstrate the obviousness of the ‘289 patent. They claim that
Fresenius’s formulation with less mannitol would be an obvious variant of the
15

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grandfathered Bedford or Nentwich formulation when creating a 100 pg
composition (Prel. Inj. Opp.

§ II.C.3) To simplify, Fresenius’s patent teaches

that the amount of mannitol, contrary to expectation, should remain at
between 2 and 4 pg for that size dose. But look, says Fera. Take Nentwich’s
500 pg formulation, which contains 15 pg of mannitol, and divide it by five.
The result is a 100 pg formulation, which contains 3 pg of mannitol, a
formulation that falls within the scope of the ‘289 patent. This, however, misses
9
the point of the claimed innovation. The innovation, says Fresenius, is that a
composition can be stabilized by keeping the level of mannitol low—i.e., by not
multiplying or dividing the amount of mannitol to keep it in a fixed proportion
to the amount of the formulation as a whole. Fera presents no substantial
argument as to why a person of ordinary skill in the art would act otherwise
and challenge what Fresenius presents as the conventional wisdom: that the
larger dose required a large amount of mannitol for optimal stability.
“If a person of ordinary skill in the art can implement a predictable
variation, and would see the benefit of doing so,

§ 103 likely bars its

patentability.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 401, 127 S. Ct. 1727
(2007). Fera does not successfully suggest that the ‘289 patent is a predictable
variation, nor has Fera argued why, prior to the discovery upon which the
patent rests, a person of ordinary skill in the art would see the benefit of
reducing the amount of mannitol.
Further, even if the obviousness showing had been stronger, Fera does
not bring evidence to dispute the unexpected properties allegedly discovered by
Fresenius. “Objective evidence of nonobviousness can include

...

unexpected

properties of the claimed invention. These objective considerations can protect
against the prejudice of hindsight bias, which often overlooks that the genius of

Fresenius points out that the Nentwich formulations were not shown to
contain a phosphate buffer or phosphate salt, either. That circumstance renders their
status as prior art even more problematic.
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invention is often a combination of known elements which in hindsight seems
preordained.” Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc., 711
F.3d 1348, 1368 (Fed. Cir. 2013).
I observe in passing that the grandfathered formulation remains
unpatented. At oral argument counsel pointed out, without contradiction, that
anyone (subject to regulatory approvals, of course) is free to market that
unpatented, grandfathered formulation. The Fresenius formulation, now
patented and being marketed, is an incremental improvement on that
formulation, which has a longer shelf life. Clearly this is not a scientific
breakthrough, but the record is uncontradicted that it is a previouslyunanticipated improvement. Fera’s “slice and dice” argument does not raise a
substantial question as to the legitimacy of the innovation. Fresenius is likely
to prevail on this issue.
iv.

Inequitable conduct

Fera also asserts the doctrine of inequitable conduct. “Inequitable
conduct is an equitable defense to patent infringement that, if proved, bars
enforcement of a patent. This judge-made doctrine evolved from a trio of
Supreme Court cases that applied the doctrine of unclean hands to dismiss
patent cases involving egregious misconduct.” Therasense, Inc. v. Becton,
Dickinson & Co., 649 F.3d 1276, 1285 (Fed. Cir. 2011). The inequitable
conduct claim here is that Fresenius “concealed but-for material information
showing that the prior art lyophilized compositions were as stable as the
purported invention.” Prel. Inj. Opp at 1.
Many of Fera’s inequitable conduct claims, asserted as counterclaims,
are the subject of a motion to dismiss.’° In their preliminary injunction briefs,
the parties incorporate by reference their briefs from that motion to dismiss.

Some of the arguments are new and have not been pleaded. (Prel. Inj.
24—25; Prel. Inj. Reply 10)
10

17

Opp

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(Prel. lnj.

Opp.

22; Prel. Inj. Reply 10 n.4) The discussion here is therefore

relevant to both the motion to dismiss and the preliminary injunction motion.
In Therasense, Inc. v. Becton, Dickinson & Co., the Federal Circuit, sitting
en banc, set out the contours of the inequitable conduct doctrine:
To prevail on a claim of inequitable conduct, the accused infringer
must prove that the patentee acted with the specific intent to
deceive the PTO. A finding that the misrepresentation or omission
amounts to gross negligence or negligence under a “should have
known” standard does not satisfy this intent requirement. In a
case involving nondisclosure of information, clear and convincing
evidence must show that the applicant made a deliberate decision
to withhold a known material reference. In other words, the
accused infringer must prove by clear and convincing evidence that
the applicant knew of the reference, knew that it was material, and
made a deliberate decision to withhold it.
649 F.3d 1276, 1290 (Fed. Cir. 2011) (internal quotation marks and citations
omitted). Intent and materiality are the elements of an inequitable conduct
claim and independent evidence of each is required to prove the defense. Id. (“A
court must weigh the evidence of intent to deceive independent of its analysis
of materiality. Proving that the applicant knew of a reference, should have
known of its materiality, and decided not to submit it to the PTO does not prove
specific intent to deceive.”).
Therasense also set forth the test for proving the intent element:
Because direct evidence of deceptive intent is rare, a district court
may infer intent from indirect and circumstantial evidence.
However, to meet the clear and convincing evidence standard, the
specific intent to deceive must be the single most reasonable
inference able to be drawn from the evidence. Indeed, the evidence
must be sufficient to require a finding of deceitful intent in the light
of all the circumstances. Hence, when there are multiple
reasonable inferences that may be drawn, intent to deceive cannot
be found.
Id. at 1290—9 1.
Therasense also refined the Federal Circuit’s standard for materiality:
This court holds that, as a general matter, the materiality required
to establish inequitable conduct is but-for materiality. When an
applicant fails to disclose prior art to the PTO, that prior art is but
for material if the PTO would not have allowed a claim had it been
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aware of the undisclosed prior art. Hence, in assessing the
materiality of a withheld reference, the court must determine
whether the PTO would have allowed the claim if it had been aware
of the undisclosed reference. In making this patentability
determination, the court should apply the preponderance of the
evidence standard and give claims their broadest reasonable
construction.
Id. 1291—92.
I briefly address and deny the motion to dismiss, which is analyzed on a
lower standard than, and is logically prior to, the preliminary injunction.
The parties dispute whether the “single most reasonable inference” test of
intent applies on a motion to dismiss. Prior to Therasense, the Federal Circuit
set out in Exergen Corp. v. Wal-Mart Stores, Inc. the requisites for pleading
inequitable conduct:
[Tb plead the “circumstances” of inequitable conduct with the
requisite “particularity” under Rule 9(b), the pleading must identify
the specific who, what, when, where, and how of the material
misrepresentation or omission committed before the PTO.
Moreover, although “knowledge” and “intent” may be averred
generally, a pleading of inequitable conduct under Rule 9(b) must
include sufficient allegations of underlying facts from which a
court may reasonably infer that a specific individual (1) knew of
the withheld material information or of the falsity of the material
misrepresentation, and (2) withheld or misrepresented this
information with a specific intent to deceive the PTO.
575 F.3d 1312, 1328—29 (Fed. Cir. 2009). “Exergen involved a motion to amend
after a full trial on the merits.” Jersey Asparagus Farms, Inc. v. Rutgers Univ.,
803 F. Supp. 2d 295, 308 (D.N.J. 2011). But “courts in this District have held
that .Exergen applies to the pleading stage.” Mycone Dental Supply Co. v.
Creative Nail Design, Inc., No. CIV.A. 11-4380 JBS, 2013 WL 3216145, at *5
(D.N.J. June 24, 2013) (collecting cases). Further, the Federal Circuit itself
continued to cite Exergen in a motion to dismiss case decided after Therasense:
A charge of inequitable conduct based on a failure to disclose will
survive a motion to dismiss only if the plaintiffs complaint recites
facts from which the court may reasonably infer that a specific
individual both knew of invalidating information that was withheld
from the PTO and withheld that information with a specific intent
to deceive the PTO. Exergen v. Wal—Mart Stores, Inc., 575 F.3d
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1312, 1318, 1330 (Fed. Cir. 2009); see generally Therasense, Inc. v.
Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc).
Delano Farms Co. v. California Table Grape Comm’n, 655 F.3d 1337, 1350 (Fed.
Cir. 2011).
In essence, Fera pleads that various persons associated with Fresenius’s
patent prosecution knew that the grandfathered formulations performed well in
stability testing. The very heart of the patent, however, was its claim of
improved stability. These actors therefore allegedly compared the stability of
their formulation, not to the grandfathered product, but to the poor stability
tests of formulations other than the one Fresenius had previously marketed.
They referred to these different formulations as “prior art” or “conventional,”
allegedly with the intent to mislead the patent examiner.
That, in my view, meets the relatively low threshold of being a sufficient
allegation. The motion to dismiss is therefore denied. I move on to the
preliminary injunction aspect.
The Therasense standard applies to the likelihood of success inquiry on a
preliminary injunction. At the preliminary injunction phase, however, the
Court is predicting the future; it is required “to assess the potential of a ‘clear
and convincing’ showing in the future, but in terms of what is ‘more likely than
not’ presently.” Titan Tire, 566 F.3d at 1380. And of course, unlike a motion to
dismiss, a preliminary injunction application requires examination of the
affidavits and proofs put forward by the parties.
The ‘289 patent claims priority over a provisional application, U.S.
’
1
Provisional Patent Application No. 6 1/529,084 (“‘084 application”). (Fera
Answer

¶

41) The ‘289 patent actually issued from non-provisional Patent

Application No. 13/597,884 (“the ‘884 application”). (Fera Answer 42) The three

The inequitable conduct allegations are essentially the same for the other two
I will focus on the ‘289 patent because it is the subject of the preliminary
patents.
injunction but the motion to dismiss ruling applies with equal force to all three
patents.
11

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inventors listed on the ‘084 application are the same as those on the ‘289
Patent: Zhi—Qiang Jiang, Arunya Usayapant, and George Monen. (See ‘084
application cover sheet; ‘289 Patent)
Page 6 of the ‘084 application contains two tables. The first table
contains the ingredients of five levothyroxine formulations, labeled A—E, that
underwent stability testing. All have 10mg of mannitol and between 100 and
500 pg of levothyroxine. Formulations A and B, labeled as “conventional,”
contain tribasic sodium phosphate. Formulations C, D, and E, labeled as
“modified,” contain dibasic sodium phosphate. The A/B “conventional
formulations,” according to Fera, contain essentially the same formulation as
the grandfathered Bedford formulation. (Fera Answer

¶{

47—50, 74—76)

Formulations C, D, and E contain dibasic sodium phosphate, and are similar
to the formulation that is the subject of the ‘289 patent.
Table 2 lists amounts of liothyronine (or “T3”), a degradation product of
levothyroxine, in formulations C-E tested at different times over 18 months.
(‘084 application at 6) “Each of formulations C, D and E included 0.17

-

0.18%

T3 at the beginning of the testing. The amount of T3 increased over time in
formulations C and D, whereas the amount of T3 in formulation E remained
relatively stable.” (‘084 application at 7

¶

0026) The results as to “conventional”

formulations A and B are not presented in a table, but the ‘084 application
explains in text:
The instability of levothyroxine in the modified formulations C and
D was unexpected in view of the behavior of the conventional
formulations A and B. During storage at 25° C for a period of from
4 to 19 months, the amount of T3 in formulation A varied from
0.16 0.34%, but did not exhibit an increase over time. Likewise,
the amount of T3 in formulation B varied from 0.22 0.27% during
storage at 25 °C for a period of from 8 to 28 months, but did not
exhibit an increase over time.
-

-

(‘084 application at 7

¶

0028) It further explained that “[s]urprisingly, the

stability of levothyroxine in lyophilized formulations containing dibasic sodium
phosphate instead of tn basic sodium phosphate was found to decrease with an
increase in the ratio of mannitol to levothyroxine in the formulation.” (‘084
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application at 7

¶

0031 (emphasis added; see also Fera Answer

¶

59) In other

words, the stabilizing effect that is the foundation of the claimed invention is
observed in relation to the dibasic, but not the tribasic, formulation.
Here is the problem, says Fera: The non-provisional ‘884 application does
not compare formulations with dibasic sodium phosphate to those with
tribasic. (Fera Answer

¶

65) That ‘884 application was the subject of four

separate office actions. In the fourth rejection the examiner notes that the data
presented by the applicant is not a direct comparison with the relevant prior
art, and that art teaches a formulation containing tribasic sodium phosphate.
(Fera Answer

¶

120)12 Fera faults the applicants for allegedly never submitting

to the patent examiner the original stability test results on formulations A and
B, which are tribasic sodium formulations. (See, e.g., Fera Answer

¶

124)

A declaration by Dr. Usayapant was submitted on December 23, 2014,
as part of a response to the fourth rejection. (Usapayant Deci.) In that
declaration Dr. Usapayant refers to the stability benefits of the new formulation
as compared to conventional formulations. She cites to a table comparing
formulations, all containing dibasic sodium phosphate, but containing varying
amounts of mannitol. (Usayapant Deci.

¶

9; see Fera Answer

¶

128)

Usayapant’s declaration elsewhere refers to “prior art,” but Fera complains that
these references do not explicitly distinguish between prior art formulation as
containing dibasic or tribasic sodium phosphate. (Usayapant Decl.
see Fera Answer

¶

¶

14—17;

132—33) Usayapant’s data, however, and her stability

comparisons, clearly relate to dibasic.
The examiner, who was aware of the dibasic/ tribasic issue, found the
arguments filed on December 23, 2014, persuasive and issued a notice of
allowance. (Fera Answer

¶

149; Notice of Allowance 2). She highlighted that

Fera stresses the number of times that Fresenius’s applicants represented
that their formulation was an improvement over conventional formulations. If this was
an attempt to fool the patent examiner, as Fera claims, she clearly was not falling for
it, as witnessed by the four rejections. (Fera Answer ¶J 73—118)
12

22

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“since Applicants have discovered that the previous formulations are unstable,
and that decreasing the amount of mannitol to between 2 and 4 mg increases
stability, leading to a more stable product having an increased shelf-life, the
claims of the instant application are novel and nonobvious over the closest
related prior art.” (Notice of Allowance 6)
I see no substantial evidence of misrepresentation, or intentional
withholding of material information from the patent examiner. The analysis is
hampered somewhat by Fera’s failure to depose the persons involved in the
patent prosecution. Proof of the necessary intent to deceive, see Delano Farms
Co., supra, for example, will often depend on such evidence. There is enough
here, however, to demonstrate the point. The patent examiner knew very well
that some of the prior art taught a tribasic formulation. The provisional
application, containing the allegedly omitted information, was before the patent
examiner, who should be presumed to have been familiar with it. More
fundamentally, throughout the process, the relevant apples-to-apples
comparison, as presented to and understood by the examiner, was between
dibasic formulations containing different proportions of mannitol. That was the
thrust and point of the application.
This is one area where the preliminary injunction standard could make a
difference. My finding that Fera has not raised a substantial question is based
primarily on the state of the paper record, but the question is a close one.
Under the traditional Rule 65 standard, I find with more ease that Fresenius
has shown a likelihood of success on patent validity in relation to the
inequitable conduct issue.
v.

Unclean hands

Fera asserts the equitable doctrine of unclean hands. In the present
context, however, this seems to be another name for its other contentions.
Thus, Fresenius is alleged to have unclean hands because it engaged in double
patenting or violated its duty of candor to the USPTO regarding prior art. I have
discussed those contentions more specifically above; they have no more
likelihood of success under the rubric of unclean hands.
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Fera adds that Fresenius has unclean hands because it did not report
Fera’s own inequitable conduct allegations to the PTO. I do not give significant
weight to this bootstrapping allegation.
B.

Irreparable Harm
Patent law recognizes the necessity of injunctive relief “to preserve the

legal interests of the parties against future infringement which may have
market effects never fully compensable in money.” Hybritech, Inc. v. Abbott
Labs., 849 F. 2d 1446, 1457 (Fed. Cir. 1988).
“[P]rice erosion, loss of goodwill, damage to reputation, and loss of
business opportunities are all valid grounds for finding irreparable harm.”
Celsis In Vitro, Inc. v. CellzDirect, Inc., 664 F.3d 922, 926 (Fed. Cir. 2012). Loss
of market share, for example, “constitutes irreparable injury because market
share is so difficult to recover.” Henkel Corp. v. Coral, Inc., 754 F. Supp. 1280,
1322 (N.D. Ill. 1991), aff’d, 945 F.2d 416 (Fed. Cir. 1991). Price erosion,
because of the difficulty of reversal, may constitute irreparable harm. Canon,
Inc. v. 0CC Intl Ltd., 263 F. App’x 57, 62 (Fed. Cir. 2008). The right to exclude
direct competition in a limited sphere, a right inherent in the grant of a patent,
is irreparably harmed by the loss of sales and the competitive foothold that the
infringer will gain. See Systemation, Inc. u. Engel Indus., Inc., 194 F.3d 1331,
1999 WL 129640 at *6 (Fed. Cir. 1999).
In addition to harm as such, the patentee must show that there is a
“sufficiently strong causal nexus” between the infringement and the harm.
Apple Inc. v. Samsung Electronics Co., 695 F.3d 1370, 1374 (Fed. Cir. 2012). In
particular, there must be a connection between the lost sales or market share
and the “infringing feature” of the competing product. Id. at 1374 (“Sales lost
to an infringing product cannot irreparably harm a patentee if consumers buy
that product for reasons other than the patented feature.”).
Fera indisputably seeks to be Fresenius’s direct competitor. Through its
ANDA, it seeks to market precisely the formulation as to which Fresenius
obtained FDA approval and patent protection. See Systemation, Inc.
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(emphasizing loss of sales to “direct competitor” as emblematic of irreparable
harm).
In Fera’s view, the presence of the grandfathered product places a
natural ceiling on the value of the patented product, which has a longer shelf
life but the same efficacy. Still, the evidence shows a dramatic increase in the
price of the patented product—in the five- to six- fold range—for which there is
no plausible explanation except for its patented status. The inference is
inescapable that customers are paying a premium for its stability. Fera itself
could presumably market the grandfathered product, but has not chosen to do
so, instead piggy-backing on the FDA-approved Fresenius product, which now
enjoys some $80 million in annual sales. That in itself is suggestive of the value
of the innovation, although I do not discount an element of irrationality, lag, or
less-than--perfect market information.
Because the product is one administered in hospitals, the customer base
comprises a relatively small class of Group Purchasing Organizations (GPOs).
(Meachum

¶

10) Relations with those customers, the reputation of Fresenius,

and the purchasers’ experience with the product are therefore of primary
importance. The market clout of such GPOs also implies that, should the price
erode as a result of infringement, a price rebound may meet stiff resistance.
Historical sales of the grandfathered product do give us an informational
backdrop. That market, however, has apparently dried up. The competitive
market for the patented product is not mature, or even well established. Thus
the effect of Fera’s projected price cutting on Fresenius’s (currently 100%)
market share is difficult to predict or quantify. And market share, once lost, is
difficult to regain in the event of a mistaken denial of injunctive relief. See
Henkel Corp., 754 F. Supp. at 1322.
Fera cites the presence of a new competitor in the market: Par Sterile
Products, LLC, and affiliates (“Par”). Par, the parties seem to agree, is not
precisely a third-party entrant. Rather, Par has entered into licensing and
distribution agreements with Fresenius on March 18, 2016, and July 1, 2016.
As a licensee, Par is within the patent estate, i.e., under the umbrella of
25

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Fresenius’s patent protection. “[T]hat a patentee has licensed others under its
patents does not mean that unlicensed infringement must also be permitted
while the patents are litigated.” See Acumed LLC v. Stryker Corp., 551 F.3d
1323, 1328 (Fed. Cir. 2008) (citing eBay, 547 at 393); Abbott Labs. V. Sandoz,
Inc., 544 F.3d 1341, 1362 (Fed. Cir. 2008)). A license, an ordinary means of
patent exploitation, does not imply that infringement by a non-licensee is
harmless. At best, it is a weak indicator that damages might be quantified as a
reasonable royalty, but even that is but one factor among many.
The irreparable harm factor tips in favor of Fresenius.
C.

Balance of Harms
On the balance of harms, Fera essentially argues that Fresenius has

made large profits and can well afford competition from Fera. Because some
version of the product has long been in existence, research and development
costs, as well as regulatory approval, allegedly set Fresenius back only $3
million. The product, which has accounted for some $310 million in sales over
the years, supposedly accounts for only 5% of Fresenius’s revenue.
Fera’s argument amounts to a contention that, even if it turns out to
have been infringing, Fresenius can absorb the competitive loss. Fresenius,
however, has made a showing of likelihood of success on the issues of
validity/infringement. The implication is that Fera has not made a strong
showing that it has a right to go to market; thus it is not likely to suffer a
legally cognizable “loss” by being enjoined. I therefore cannot find that the
balance of harms favors Fera.
D.

Public Interest
Cheaper generic drugs, as Fera points out, are in the public interest.

That argument, of course, proves too much; the patent laws reflect a balance
between that public policy and the policy of encouraging innovation through
the grant of a limited patent monopoly. Where the patent holder is acting
within the lawful scope of its patent, public policy favors an injunction. See

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generally PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1567 (Fed.
Cir. 1996).
III.

CONCLUSION
The motion to dismiss inequitable counterclaims is denied, but the

motion for a preliminary injunction is granted. An appropriate order
accompanies this Opinion.

J

Dated: September 23, 2016

Hon. Kevin McNulty
United States District Ju’

27

e