In re: Fenofibrate Patent Litigation

January 07, 2013

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: In re: Fenofibrate Patent Litigation, Case No. 11 MDL 2241 (JSR), 2012 U.S. Dist. LEXIS 182648 (S.D.N.Y. Dec. 27, 2012) (Rakoff, J.)

Drug Product and Patent(s)-in-Suit: Antara® (fenofibrate); U.S. Pat. Nos. 7,101,574 (“the ’574 patent”) and 7,863,331 (“the ’331 patent”)

Nature of the Case and Issue(s) Presented: The ’574 patentdiscloses specific fenofibrate capsule formulations containing granules. Each granule consists of a neutral microgranule surrounded by an active layer that contains micronized fenofibrate, binding cellulose derivative, and a surfactant. The single asserted claim states that the ratio of fenofibrate to binding cellulose derivative must be “between 5/1 and 15/1.” The ’331 patent claims a method of decreasing “food effect” when treating patients, enabling the composition to be effective even if the patient has not eaten food before administration of the drug. Claim 1 of the ’331 patent is the only asserted claim, and like the asserted claim of the ’574 patent, it states that the ratio of fenofibrate to binding cellulose derivative must be “between 5/1 and 15/1.” Mylan’s ANDAproducts contain a mass ratio of fenofibrate to binding cellulose derivative of no more than 4.7/1. Therefore, the Court must determine whether 4.7/1 is between 5/1 and 15/1.

The defendants brought four summary-judgment motions. Mylan and Apotex separately move for summary judgment of non-infringement 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. The court granted defendants’ motions for summary judgment of non-infringement. Having granted those motions, the court dismissed as moot defendants’ counterclaims for invalidity, and therefore it did not reach the defendants’ related motions for summary judgment of invalidity.

Why Mylan and Apotex Prevailed: Mylan asserts that summary judgment of non-infringement of both patentsshould be granted because its ANDAproducts do not contain a ratio of fenofibrate to binding cellulose derivative that falls between 5/1 and 15/1. Lupin argues that “4.7/1 does, indeed, fall between 5/1 and 15/1” because 4.7 rounds to 5. The Court disagreed. Relying on Federal Circuit precedent, the court found that “the overall phrase—a quantity between ___ and ____—is a construction that implies a specific range . . . . It does not imply a range between two values which are themselves ranges.” This was especially true here where Lupin was asserting only literal infringement. The key word, the court noted, was “between.” During claim construction, Lupin did not argue that the phrase “between 5/1 and 15/1” should be construed to embody anything other than its ordinary meaning. The space or interval that separates 5 and 15 includes numbers greater than or equal to 5, and lesser than or equal to 15. Moreover, Lupin did not show that the standard industry practice in this circumstance was to round the numerical values. Finally, it was undisputed that the inventors wrote the claims narrowly in order to distinguish them from the prior art. When the patentee added claim 19 to the ’574 patent, it distinguished the prior art by explaining that “the ratio fenofibrate/binding cellulose derivative of the claimed comosition is between 5/1 and 15/1; while the ratio fenofibrate/hydrophilic polymer of the [prior art] is between 1/10 and 4/1.” The patentee used similar language during the prosecution of the ’331 patent. The court held that because the patentee construed the claim narrowly to distinguish the prior art, Lupin cannot now seek to broaden the claim through rounding, not least because such rounding would not comport with standard industry practice.

The court next turned to Apotex’s motion for summary judgment of non-infringement. Apotex argued that its ANDAproduct did not infringe the patents because it did not include, among other things, the binding cellulose derivative required by the ’574 patent or the HPMC required by the ’331 patent. Lupin does not deny that Apotex’s ANDA products are without those ingredients. Instead, Lupin asserts that Apotex’s motion is “simply premature.” Given that 35 U.S.C. § 271(e) creates an artificial act of infringement so that the court must determine whether the manufacture of the product proposed in the ANDAwould infringe on the patent, even though the ANDAproduct has not yet been sold, and the Federal Circuit’s directive not to look beyond the four corners of the ANDA, the court proceeded with its analysis.

Lupin argued that Apotex’s 130 mg ANDAproduct has more sodium lauryl sulfate than the FDA will allow, and therefore, “it seems quite likely that the FDA will request, or perhaps already has requested, that Apotex adjust the formulation of its ANDAProducts.” Lupin, however, lacks standing to challenge whether Apotex’s ANDA products meet the FDA’s regulatory guidelines, because there is no private right of action under the Federal Food, Drug, and Cosmetics Act. The sole basis for opposing Apotex’s motion was because it was “premature.” But the court held that Apotex’s motion was not “premature” because: (i) it was timely made according to the court’s previously-set schedule; (ii) Lupin did not move to compel discovery; and (iii) Lupin did not file a Rule 56(d) affidavit seeking a delay in the discovery or summary judgment schedules. Summary judgment of non-infringement was proper.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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