Sandoz Inc. v. Amgen Inc. et al

Filing 101

ORDER GRANTING DEFENDANTS' MOTION TO DISMISS; DISMISSING COMPLAINT WITHOUT LEAVE TO AMEND; VACATING HEARING. Signed by Judge Maxine M. Chesney on November 12, 2013. (mmclc1, COURT STAFF) (Filed on 11/12/2013)

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IN THE UNITED STATES DISTRICT COURT

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FOR THE NORTHERN DISTRICT OF CALIFORNIA

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For the Northern District of California

United States District Court

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SANDOZ INC.,
Plaintiff,

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No. C-13-2904 MMC
ORDER GRANTING DEFENDANTS’
MOTION TO DISMISS; DISMISSING
COMPLAINT WITHOUT LEAVE TO
AMEND; VACATING HEARING

v.
AMGEN INC., et al.,
Defendants.

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Before the Court is the “Motion by Defendants, Amgen Inc. [“Amgen”] and Hoffman-

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La Roche Inc. [“Roche”] to Dismiss for Lack of Subject-Matter Jurisdiction or, Alternatively,

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to Decline to Exercise Declaratory Judgment Jurisdiction,” filed August 16, 2013. Plaintiff

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Sandoz Inc. (“Sandoz”) has filed opposition, to which defendants have replied, and Sandoz,

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with leave of court, has filed a surreply. Having read and considered the papers filed in

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support of and in opposition to the motion, the Court deems the matter suitable for

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determination on the parties’ respective written submissions, VACATES the hearing

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scheduled for November 15, 2013, and rules as follows.

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BACKGROUND
The Food and Drug Administration (“FDA”) has approved the use of “Enbrel,” an

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Amgen product, to treat specified illnesses; Enbrel is a “human tumor necrosis factor (TNF)

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receptor” known as “etanercept.” (See Compl. ¶ 14; Winters Decl., filed August 16, 2013,

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Ex. 22.) Amgen takes the position that etanercept is covered by U.S. Patent No. 8,063,182

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(“the ’182 patent”) and U.S. Patent No. 8,163,522 (“the ’522 patent”). (See Compl. ¶ 2;

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Winters Decl. Exs. 22, 26.) Roche is the owner of, and Amgen is the exclusive licensee

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under, the two subject patents. (See Compl. ¶¶ 21-22, 29-30.)

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Sandoz alleges it is presently conducting clinical trials to test a “biologic drug

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containing etanercept” (see Compl. ¶ 3), and “intends to file an FDA application for

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licensure of its etanercept product as biosimilar to Enbrel” upon completion of the clinical

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trials (see Jankowsky Decl., filed September 19, 2013, ¶ 14).1

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In its complaint, Sandoz seeks declaratory relief, specifically, a declaration that its

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assertedly biosimilar product does not infringe any claim of either the ’182 patent or the

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’522 patent and that the subject patents are invalid and unenforceable.
DISCUSSION

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Defendants contend the instant action is premature for two separate but related

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reasons, and, consequently, is subject to dismissal. In particular, defendants argue,

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(1) a district court lacks statutory authority to consider a patent dispute involving a

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biosimilar product until after such time as an application for FDA approval of the biosimilar

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product has been filed, and (2) as a factual matter, a cognizable case or controversy does

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not presently exist. As set forth below, the Court agrees.

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Sandoz’s claims for declaratory relief are brought pursuant to 28 U.S.C. § 2201,

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under which a district court “may declare the rights and other legal relations of any

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interested party seeking such declaration” in a “case of actual controversy within its

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jurisdiction.” See 28 U.S.C. § 2201(a). The district court’s discretion to enter such

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declaratory judgment is, however, subject to certain limitations, and, as to “actions brought

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with respect to drug patents,” the limitations set forth in “section 351 of the Public Health

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Service Act.” See 28 U.S.C. § 2201(b).

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A “biosimilar is a drug product designed to be similar to a previously approved
biologic drug (a ‘reference product’) in its quality, safety, and efficacy.” (See Roth Decl.,
filed September 19, 2013, ¶ 4); see also 42 U.S.C. § 262(i)(2) (defining “biosimilar”
products).
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Section 351 of the Public Health Service Act, 42 U.S.C. § 262, provides the FDA

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with authority to license biological products that are “biosimilar to a reference product,” see

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42 U.S.C. § 262(k), and sets specific limitations on the timing of any litigation arising from

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the filing of an application for such license. See 42 U.S.C. § 262(l); see also 28 U.S.C.

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§ 2201(b). Specifically, with limited exceptions not applicable here, neither a reference

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product sponsor, such as Amgen,2 nor an applicant, such as Sandoz, may file a lawsuit

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unless and until they have engaged in a series of statutorily-mandated exchanges of

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information. See 42 U.S.C. §§ 262(l)(2)-(6).

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Here, Sandoz does not contend, and cannot contend, it has complied with its

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obligations under §§ 262(l)(2)-(6), because, as it concedes in its complaint and opposition,

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it has not, to date, filed an application with the FDA. Rather, citing § 262(l)(8), Sandoz

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argues § 262 “provides [declaratory judgment] actions can be filed by either party upon the

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biosimilar manufacturer’s notice of commercial marketing, which Sandoz has given here.”

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(See Pl.’s Opp’n, filed September 19, 2013, at 24:9-10.) The Court, for several reasons, is

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not persuaded.

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First, as set forth in the section on which Sandoz relies, a “notice of commercial

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marketing” is required to be given by the applicant to the reference product sponsor “not

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later than 180 days before the date of the first commercial marketing of the biological

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product licensed under [§ 262] subsection (k).” See 42 U.S.C. § 262(l)(8)(A). Here,

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Sandoz cannot, as a matter of law, have provided a “notice of commercial marketing”

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because, as discussed above, its etanercept product is not “licensed under subsection (k).”

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See id. Second, even after an applicant provides a “notice of commercial marketing,” it

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cannot bring an action for declaratory relief until, at a minimum, it has complied with its

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obligations under § 262(l)(2)(A). See 42 U.S.C. §§ 262(l)(9); see also 28 U.S.C. § 2201(b).

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Moreover, Sandoz has not, at this time, established a “real and immediate injury or

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A “reference product sponsor” is a “sponsor of the application for the reference
product.” See 42 U.S.C. § 262(l)(1)(A). In this instance, the “reference product sponsor” is
Amgen, the entity that previously obtained a license for Enbrel.
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threat of future injury that is caused by the defendants.” See Prasco, LLC v. Medicis

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Pharmaceutical Corp., 537 F.3d 1329, 1338-39 (Fed. Cir. 2008) (setting forth requisite

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showing by declaratory relief plaintiff to establish “case or controversy”). Here, defendants

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state they have never advised Sandoz they intend to sue Sandoz, and are not in a position

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to consider the propriety of such action until after Sandoz has “prepared an [application] for

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approval to launch a product in the U.S.” (see Mot. at 5:9-11, 6:1-3; see also id. at 18:8-11);

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no evidence to the contrary has been offered. Nor has Sandoz submitted evidence

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demonstrating defendants, by some means other than an express threat to sue, have

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subjected Sandoz to an “immediate” threat of injury. See Prasco, 537 F.3d at 1339

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(holding patentee “can cause such an injury in a variety of ways”; providing examples).

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Although Sandoz points to public statements by Amgen that its patents cover etanercept,3

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and that it defends the patents it owns (see, e.g., Compl. ¶¶ 51-60), such statements do not

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suffice to show an “imminent threat,” see Prasco, 537 F.3d at 1339; see also id. at 1338

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(holding “mere existence of a potentially adverse patent does not cause an injury nor create

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an imminent risk of an injury”).
Finally, Sandoz’s allegation that it intends in the future to file an application with the

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FDA is insufficient to create a case or controversy. See Benitec Australia, Ltd. v.

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Nucleonics, Inc., 495 F.3d 1340, 1346 (Fed. Cir. 2007) (holding “fact that [declaratory

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judgment plaintiff] may file an [application for drug] in a few years does not provide the

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immediacy and reality required for a declaratory judgment”); Telectronics Pacing Systems,

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Inc. v. Ventritex, Inc., 982 F.2d 1520, 1527 (Fed. Cir. 1992) (affirming dismissal of

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declaratory judgment action brought by patentee where accused “device had only recently

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begun clinical trials, and was years away from potential FDA approval”).
Accordingly, the instant action is subject to dismissal.

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//

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//

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As noted, Amgen markets etanercept under the brand name “Enbrel.”
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CONCLUSION

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For the reasons stated, defendants’ motion to dismiss is hereby GRANTED, and the
complaint is hereby DISMISSED without prejudice and without leave to amend.
IT IS SO ORDERED.

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Dated: November 12, 2013
MAXINE M. CHESNEY
United States District Judge

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