In re Fenofibrate Patent Litigation

910 F. Supp. 2d 708, 2012 WL 6709221, 2012 U.S. Dist. LEXIS 182648
District Court, S.D. New York·Decided December 27, 2012·No. No. 11 MDL 2241(JSR)·Published·Cited by 1 cases

Opinion

MEMORANDUM ORDER

JED S. RAKOFF, District Judge.

In this multi-district litigation, plaintiff Lupin Atlantis Holdings S.A. (“Lupin”), the owner of the approved New Drug Application for the prescription drug AN-TARA and the licensee of U.S. Patent No. 7,101,574 B1 (the “'574 patent”) and U.S. Patent No. 7,863,331 B2 (the “'331 patent”),1 alleges that defendants Mylan Inc. and Mylan Pharmaceuticals Inc. (collectively “Mylan”) and Apotex Inc. and Apotex Corp. (collectively “Apotex”) infringed both patents by seeking federal regulatory approval to manufacture generic versions of ANTARA.

The defendants bring four summary judgment motions, Mylan and Apotex separately move for summary judgment of noninfringement of both patents. Mylan and Apotex jointly move for summary judgment of invalidity of the '574 patent, and Mylan moves for summary judgment of invalidity of the ''331 patent. After careful consideration of the parties’ written and oral submissions, the Court concludes that the defendants’ motions for summary judgment of noninfringement should be granted. Having granted those motions, the Court dismisses as moot defendants’ counterclaims for invalidity, and therefore [710] the Court does not reach the defendants’ related motions for summary judgment of invalidity. Phonometrics, Inc. v. N. Telecom Inc., 133 F.3d 1459, 1468 (Fed.Cir. 1998) (“[A] district court has discretion to dismiss a counterclaim alleging that a patent is invalid as moot where it finds no infringement”).

Under Federal Rule of Civil Procedure 56(a), a party seeking summary judgment must demonstrate that there is “no genuine dispute as to any material fact” and that the party is “entitled to a judgment as a matter of law.” Fed.R.Civ.P. 56(a); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322-23, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). “[Sjummary judgment will not lie ... if the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).

The pertinent facts, viewed in the light most favorable to the non-moving party, are as follows. The two patents concern an active ingredient called fenofibrate, a chemical that treats high cholesterol and triglycerides. See Declaration of Natalie Clayton, Oct. 21, 2011 (“Clayton Deck”), Ex. 1 (“'574 Patent”) at 1:9-11; Clayton Deck Ex. 2 (“'331 Patent”) at 1:12-14. The '574 patent covers certain fenofibrate formulations, and the '331 patent covers a particular method for using those formulations. See '574 Patent; '331 Patent.

The '574 patent discloses specific fenofibrate formulations that are provided as capsules containing granules. '574 Patent at 2:16-18. Each granule consists of a neutral microgranule surrounded by an active layer that contains micronized fenofibrate, binding cellulose derivative,2 and a surfactant.

Although the '574 patent consists of thirty-four claims, claim 19 is the only claim from the '574 patent at issue in this case. Claim 19 states, in its entirety:

A pharmaceutical composition in the form of granules, wherein each granule comprises a neutral microgranule on which is a composition comprising: micronized fenofibrate, a surfactant, and a binding cellulose derivative as a solubilization agent, wherein the mass ratio of said fenofibrate to said binding cellulose derivative is between 5/1 and 15/1.

'574 Patent at 11:30-35. Therefore, Claim 19 makes clear that the '574 patent is directed toward particular mass ratios of fenofibrate and binding cellulose derivative. Specifically, the claim states that the ratio of fenofibrate to binding cellulose derivative must be “between 5/1 and 15/1.” Id.

The '331 patent was filed as a eontinuation-in-part of the '574 Patent. The '331 patent’s claims set forth a method of decreasing “food effect”3 when treating patients, enabling the composition to be effective even if the patient has not eaten food prior to the administration of the drug. '331 Patent at 2:58-67. The '331 patent consists of four claims, one of which, claim 1, is independent. Claim 1 is the only claim under the '331 patent at issue here. Like Claim 19 of the '574 patent, Claim 1 states that the ratio of fenofibrate to binding cellulose derivative must be “between 5/1 and 15/1.” In full, Claim 1 states:

[711] A method of reducing food effect when treating hypertriglyceridemias and/or hypercholesterolemias and/or hyperlipidemias in a patient in need thereof comprising administering to said patient a therapeutically effective amount of a pharmaceutical composition comprising micronized fenofibrate, a surfactant and hydroxypropylmethylcellulose [HPMC], wherein said composition is in the form of granules comprising:
(a) a neutral core; and
(b) an active layer, surrounding the neutral core;
wherein said neutral core comprises a sugar or a sugar mixed with starch; said active layer comprises the micronized fenofibrate, the surfactant, and the binding cellulose derivative; and wherein the mass ratio of said fenofibrate to said HPMC is between 5/1 and 15/1, and said HPMC represents between 5 and 12% by weight of the composition.

Id. at 16:48-67 (emphasis added).

Mylan and Apotex each filed an Abbreviated New Drug Application (“ANDA”) with the Food and Drug Administration seeking regulatory approval for generic versions of ANTARA. Mylan’s ANDA includes two generic dosages of ANTARA: a 43mg ANDA product and a 130 mg ANDA product (collectively “Mylan’s ANDA Products”). Mylan’s Statement of Undisputed Facts in Support of its Motion for Summary Judgment of Noninfringement (Mylan 56.1) ¶ 1; Lupin’s Response to Mylan’s Statement of Undisputed Facts (“Lu-pin Resp. to Mylan 56.1”) ¶ 1. Apotex’s ANDA also contains two generic dosages of ANTARA: a 43mg ANDA product and a 130mg ANDA product (collectively “Apotex’s ANDA Products”), Apotex Compl. ¶¶ 7, 24.

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In re Fenofibrate Patent Litigation, 910 F. Supp. 2d 708, 2012 WL 6709221, 2012 U.S. Dist. LEXIS 182648 (S.D.N.Y. 2012).

910 F. Supp. 2d 708 (In re Fenofibrate Patent Litigation) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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