MERCK SHARP & DOHME CORP. v. SANDOZ INC.

Filing 62

MEMORANDUM DECISION filed. Signed by Judge Peter G. Sheridan on 2/14/2013. (eaj)

NOT FOR PU13LICATION
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY

MERCK SHARP & DOFIME CORP..
Civil Action No. 12-3289 (PGS)
Plaintiff,

MEMORANDUM DECISION
SANDOZ INC.
Defendant.

SHERIDAN, U.S.D,J,
Presently before the Court are two motions to dismiss, asserted by two separate sets of
defendants in two separate patent litigations initiated by plaintiff Merck Sharp & Dohme
Corporation (Merek” or Plaintiff’). In both lawsuits. Merck is asserting that the defendant
generic drug companies infringed two of its patents: U.S. Patent No. 5,591,336 (the ‘336
patent”) and U.S. Patent No. 5,716,942 (“the ‘942 patent”). Defendants are Accord Healthcare.
Inc.. Accord Healthcare. Inc. USA, and Intas Pharmaceuticals Ftc!. (collectively Accord”) in the
matter captioned Merck Shaiy & Do lime Loip. r. Accord J-Jea!ihcare. Inc. USA, ci aL, No. 1 2_

cv-3 324, and Sandoz Inc. (“Sandoz”) in the above captioned matter (Accord and Sandoz
collectively, “Defendants”). In both matters, Defendants have moved to dismiss only with
respect to the ‘942 patents. For the reasons set forth below, both motions are denied.

I

A pharmaceutical company is required to submit a New Drug Application (“NDA”) to
the Federal Food and Drug Administration (“FDA”) before introducing a new drug into interstate
commerce. See 21 U.S.C.

§

355(a), The NDA must, inter a/ia, identify any patents for “which a

claim of patent infringement could reasonably be asserted if a person not licensed by the owner
engaged in the manufacture. use, or sale of the drug.” 21 U.S.C.

§

355(b)(l). When an NDA is

approved by the FDA. this patent information is published in an official FDA publication entitled
the

1pproved

Drug Products with Therapeutic Equivalence Evaluations, known as the “Orange

Book.” Merck & Co., Jnc. v. Hi-Tech Pharmacal, Inc., 482 F.3d 1317, 1319 (Fed. Cir. 2007).
Generic drug manufacturers may subsequently file an Abbreviated New Drug
Application (“ANDA”) lbr FDA approval of a generic version of a drug approved under an
NDA. 21 U.S.C.

§

355(j). An ANDA filer must submit, inter a/ia, one of four certifications

with respect to each patent listed in the Orange Book by the NDA holder. 21 U.S.C.

§

3S5(j)(2)(A)(ai) The. tpe of certification at issue here is a patagraph IV ccrtifiLatlon

heie

the ANDA filer, for each of the patents listed in the Orange Book by the NDA holder, certifies
‘that such patent is invalid or will not be infringed by the manufacture. use, or sale of the new
drug for which the ANDA is submitted,” 21 U.S.C.

§

355(j)(2)(A)(vii)(IV). A paragraph IV

certification requires a generic applicant to make an early disclosure to the patentee of its
detailed legal and factual basis for a patent challenge to a listed patent. 21 U.S.C.

§

355(j2)(’\)(ii)(I\/) 355(j)(2)(B(i) (‘s) A paiagraph Pv certifiLalion also can result in an
automatic stay of FDA approval pending litigation, referred to as a “30—month stay.” See 21
F SC

‘

‘55(j)(5hB(1ii) I he centvil quLt1on before the Court is nhethLr

i

paragiaph l\

certification is necessary in order for a District Court to assert jurisdiction over a claim pursuant
to

35 U.SC.

§ 271(a).
II

Merck is the owner of the two patents at issuc in this litigation: the ‘336 patent and ‘942
patent. The 336 patent claims, among other things, the composition of matter fosaprepitant
dimeglumine, the active ingredient in the drug products at issue in the litigation. The 942 patent
is directed to a method of use of fosaprepitant. Merck holds a NDA for an injectable form of
fosaprepitant dimeglumine used for the prevention of retching and vomiting associated with
cancer chemotherapy. The drug is sold by Merck as EMEND for Injection.
s
t
Merck NDA includes two dosage strengths of EMEND, 115 mg and 150 mg. For the
115 mg strength, Merck submitted information to the FDA concerning related patents, which
included the ‘336 and ‘942 patents. Thereafter, upon approval of the 115 mg NDA in 2008, the
‘336 and ‘942 patents were listed in the Orange Book in the entry for that NDA. Later Merck
filed a supplement to its NDA adding the 150 mg dosage strength and submitted similar patent
information to the FDA, again listing both the ‘336 and ‘942 patents. However, upon approval
of the NDA for the 150 mg dose, only the ‘336 patent was listed in the Orange Book,’ Any
reference to the ‘942 patent was excluded. The omission was corrected in April 2012, shortly
before the filing of this lawsuit, but

after

submission of Defendants’ ANDAs. Therefore, at the

time Defendants submitted their ANDAs, the adjacent entries in the Orange Book appeared as
follows:

‘The parties dispute the reasons for the ‘942 patent’s absence from the 150 mg listing in the Orange Book, but this
dispute is not material to this motion,

The top entry. for the 1 1.5 mg dosage strength. lists both the ‘942 patent and the ‘336 patent.
among others. But appearing directly below that, the entry for the 11 5 mg dosage strength listed
only the ‘336 patent.
Defendants tiled ANDAs only for the 1 50 mg dosage strength but not for the 11 5 mg
dosage strength. Because the ‘336 patent was listed in the Orange Book entry for the 150 mg
dosage strength at the time Defendants submitted their ANDAs, Defendants were required to,

and did, make paragraph IV certifications that the ‘336 patent is invalid or will not be infringed
by the manufacture. use, or sale of the new drug for which the ANDAs were submitted.
Accordingly, the present case involves an automatic stay of FDA approval based on the ‘336
patent infringement claim

Sce 21 U S C

355(j)(5)(B)(na) I3ecause the 942 patent xas not

listed in the Orange Book at the time Defendants submitted their ANDAs, Defendants did not
make paragraph IV certifications that the ‘942 patent is invalid or will not be infringed by the
manufacture, use, or sale of the new drug for which the ANDAs were submitted.
Nevertheless, despite the absence of paragraph IV certifications with respect to the ‘942
patent. Mercks complaint alleges that Defendants seek approval to engage in the use and sale of
a drug product claimed in both the ‘336 and 942 patents. and the use or sale of a drug product
the use ol which is claimed in the ‘336 and ‘942 patents. before the expiration of those patents,

md h’uc. thcrefore mtrlngLd both patents undLr 3 L S C
4

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2
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27 \)

Defendants claim, however that a generic drug applicant must file a paragraph IV
certification with respect to a patent in order for a NDA holder to state a claim for infringement
of that patent under 35 U.S.C.

§ 271(e)(2)(A) and to give rise to a District Court’s subject matter

jurisdiction over that claim. Relying on two unpublished decisions from this Court, Defendants
contend that Merck failed to list the ‘942 patent in the Orange Book, as such no paragraph W
certification was involved, and therefore no subject matter jurisdiction over the ‘942 patent
claims arose. See Elsa! Co. v. Mutual Pharmaceutical Co., Civ. Action No. 06-36 13, 2007 WL
4556958 (D.N.J. Dec. 20,2007); Novo Nordisk Inc. v. Mylan Pharmaceuticals Inc., Civ. Action
No. 09-2445, 2010 WL 1372437 (D.N.J. Mar. 31, 2010).
Plaintiffdoes not dispute the District ofNew Jersey cases upon which Defendants rely;
but Plaintiff argues that more recent precedent of the Federal Circuit controls. According to
Plaintiff, the Federal Circuit has ruled that a paragraph W certification is not a requirement as a
mailer of law for subject matter jurisdiction or for the court to reach the merits of a claim under
35 U.S.C.

§ 271(e)(2)(A). See AstraZeneca Pharm. LP v. Apotex Corp., 669 F.3d 1370 (Fed.

Cir. 2012).
III

On a motion to dismiss for failure to state a claim pursuant to Fed. R. Civ. P. l2(b)(6),
the Court is required to accept as true all allegations in the complaint and all reasonable
inferences that can be drawn therefrom, and to view them in the light most favorable to the nonmoving party. See, e.g., Ashcroft v. Iqbal, 556 U.S. 662, 129 5. Ct. 1937, 1949-50, 173 L. Ed. 2d
868 (2009); Bell Atlantic Corp. v. Twombly, 550 U.S. 544,555, 1275. Ct 1955, 167 L. Ed. 2d

929(2007); Oshiver v. Levin, Fishbein, Sedran & Berman, 38 F.3d 1380, 1384 (3d Cir. 1994).
A complaint should be dismissed only if the alleged facts, taken as true, fail to state a claim.
5

Jqbal, 129 S. Ct. at 1950. The question is whether the claimant can prove any set of facts
consistent with his or her allegations that will entitle him or her to relief, not whether that person
will ultimately prevail. Sernerenko v. Cendani Corp., 223 F.3d 165, 173 (3d Cir. 2000), cert
denied, Forbes v. Semerenko, 531 U.S. 1149, 121 5. Ct. 1091, 148 L. Ed. 2d 965 (2001).
Iv
The Court finds that it has subject matter jurisdiction over Merck’s claim of patent
infringement with respect to the ‘942 patent. 28 U.S.C.

§ 1338 grants federal courts “original

jurisdiction of any civil action arising under any Act of Congress relating to patents.” The
Complaint alleges jurisdiction under 28 U.S.C.
infringement arising under 35 U.S.C.

§ 1338 and causes of action for patent

§ 27l(e)(2), which is an Act of congress relating to patents.

Therefore, the Court has subject matter jurisdiction.
Defendants’ arguments that paragraph W certifications are needed with respect to the
‘942 patent are belied by the plain language of 35 U.S.C.

§ 271, and by Federal Circuit and

District of New Jersey case law. The existence of subject matter jurisdiction depends on whether
the cause of action alleged in the Complaint is one that arises under the patent laws. The Federal
Circuit recently rejected the argument by a generic drug company that

“

271(e)(2) creates a case

or controversy only if the accused ANDA contains a Paragraph IV certification.” See
AstraZeneca Pharm. LP v. Apotex Corp., 669 F.3d 1370, 1375 (Fed. Cir. 2012). “[S]ection
271(eX2) makes it possible for the district court to exercise its section 1338(a) jurisdiction in the
situation in which an ANDA has been filed.’ In other words, the requirements for jurisdiction in
the district courts are met once a patent owner alleges that another’s filing of an ANDA infringes
its patent under § 271(eX2), and the threshold jurisdictional determination does not depend on
the ultimate merits of the claims.” Ic! at 1377 (quoting Allergan, Inc. v. Alcon Laboratories,
6

Inc.. 324 R3d at 1330); see also Abraxis Bioscience Inc. v. avinta LLC, Civ, No, 07-1251, D.L
50 (D N J Oct 9 2007) (Pisano J ) (finding that juiisdiction under

‘

271(e)(2) is focused on the

hypothetical question of whether, “if the defendant s proposed generic drug was on the market.
would it infringe on the plaintiffs patent.”). Accordingly, Merck’s allegations of patent
infringement are sufficient for this Court to exercise its subject matter jurisdiction.

The court also finds that Merck has adequately stated claims of patent infringement with
respect to the ‘942 patent. “It shall be an act of infringement to submit an [ANDAj
claimed in a patent or the use of which is claimed in a patent.

.

.

.

.

.

for a drug

if the purpose of such

submission is to obtain approval under such Act to engage in the commercial manufacture, use,
or sale of a drug

.

.

.

claimed in a patent or the use of which is claimed in a patent before the

expiration of such patent.” Nothing in the plain language suggests that infringement actions
against ANDA filers must be based only on Orange Book listed patents. As Defendants cannot
dispute that their ANDAs are for drugs the use of which are claimed in Merck’s ‘942 patent,
Merck has properly alleged a claim of patent infringement within the statutory requirements.
This decision rests on the concept ofjudicial efficiency and common sense. Merck
alleges infringement of both the 336 and ‘942 patents based on AN1)As filed by Defendants.
While both patents are listed in the Orange Book for the 115 mg dosage strength. the entry fOr
the 150 mg dosage strength only listed the ‘336 patent at the time Defendants’ ANDAs were
flied. Because of their admission that they filed paragraph IV certifications against the ‘336
patent, I)efendants do not seek dismissal of the 336 patent infringement claim. Yet Defendants
have alleged the same defenses and will have to present the same case in order to prevail on both
claims The oerlap eighs in taor of tiing the txo infrrnement claims together In addition,

the purpose of 35 U.SC.
an ANDA

—

§

271(e) to promote the early resolution of patent disputes relating to

are implicated here with respect to both the 336 and the ‘942 patents.

For the reasons stated.

supra.

Defendants motions to dismiss the second count of the

Complaints are denied. The Court will issue appropriate orders.

(,

PETER G. SHERIDAN, USDJ.
February({. 2013

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