AstraZeneca LP v. Breath Ltd.

The district court’s non-infringement holding was remanded in view of a different claim construction; its holding that the asserted claims were invalid as obvious was affirmed.

Winter 2013

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: AstraZeneca LP v. Breath Ltd., No. 2013-1312, -1352, 2013 U.S. App. LEXIS 22073, (Fed. Cir. Oct. 30, 2013) (Circuit Judges Rader, Bryson, and Linn presiding; Opinion by Linn, J.) (appeal from D.N.J., Bumb, J.) (The district court’s non-infringement holding was remanded in view of a different claim construction; its holding that the asserted claims were invalid as obvious was affirmed.)

Drug Product and Patent(s)-in-Suit: Pulmicort Respules® (budesonide); U.S. Patent Nos. 7,524,834 (“the ’834 patent”) and 6,598,603 (“the ’603 patent”)

Nature of the Case and Issue(s) Presented: Following the bench trial, the district court found, based on its construction of the term “micronized powder composition,” that claims 50 and 51 of the ’834 patent were not infringed by Apotex and Sandoz, and that claims 1, 2, 50, and 51 of the ’834 patent were not infringed by Breath and Watson. The district court also found that defendants’ labels induce infringement of asserted claims 1-3, 7, 8, 12-17, and 24-28 of the ’603 patent but that those claims were both anticipated and obvious based on a number of references and thus were invalid.

The district court treated as conceded and, thus, dismissed with prejudice AstraZeneca’s infringement contentions with respect to claims 6, 11, 18, and 21-23 (“dismissed claims”) of the ’603 patent because AstraZeneca presented no evidence at trial that those claims were infringed. The district court then declined to exercise jurisdiction over Apotex’s invalidity counterclaims directed to the dismissed claims and dismissed them without prejudice, concluding that the non-infringement judgment resolved the case and Apotex showed no additional benefit to be gained from an invalidity decision.

Plaintiffs appeal the district court’s judgment following a bench trial, holding that the asserted claims of the ’834 patent were not infringed and that the asserted claims of the ’603 patent were invalid as anticipated and obvious. The Federal Circuit reversed and remanded on the ’834 patent based on the district court’s incorrect claim construction, and affirmed the district court with respect to the finding of obviousness of the asserted claims of the ’603 patent.

Why AstraZeneca Partially Prevailed: The district court construed “micronized powder composition” to mean “heat sterilized finely divided dry particles” and explained that “heat sterilized” refers to “particles that have been sterilized through a process, consistent with heat sterilization, that allows them to essentially maintain the same pharmaco-logical activity, physico-chemical properties, chemical purity, and physical form as the starting material.” AstraZeneca argued that the district court erred by importing limitations into the claims because the plain meaning of “micronized powder composition” has nothing to do with heat sterilization. Defendants argued that the district court’s construction is correct, and that the plain language of the term and claim differentiation cannot control because the ’834 patent so limited the invention throughout the specification and prosecution history. The Federal Circuit agreed with AstraZeneca. First, it held that with respect to the ordinary, plain meaning of the term “micronized powder composition,” none of the three words imposes, or even implies, any form of sterilization. Second, while the patent refers only to dry heat sterilization as the preferred method of achieving the claimed limitation, and criticizes other forms of sterilization, “mere criticism of a particular embodiment encompassed in the plain meaning of a claim term is not sufficient to rise to the level of clear disavowal.” Concluding that the claim term’s plain meaning does not impart sterilization to the composition and that nothing contained in the specification or the prosecution history limits the term to a specific type of sterilization or disavows other types of sterilization, the Federal Circuit held that the term “micronized powder composition” should be construed more accurately as “finely divided dry particles.”

Concerning the ’603 patent, the district court found the asserted claims of the ’603 patent invalid as obvious as anticipated. As for obviousness, the district court concluded that a skilled artisan would be motivated to arrive at the ’603 patent’s purported invention, a once-daily dosing regimen for nebulized budesonide. The Federal Circuit found no clear error with the district court’s findings concerning: (i) prior art including numerous studies, which “taught the safety and efficacy of once-daily inhaled budesonide,” including once-daily treatment of children; (ii) that practitioners were taught to use a “stepwise” approach to dosing, wherein the practitioner would attempt to titrate the drug dose down to the lowest possible dose—a once-a-day dose; (iii) that it was a known problem that the dosing frequency of young children with asthma created “issues of compliance and convenience;” (iv) a publication by Brattsand & Selroos taught that budesonide can be delivered via several different mechanisms, including nebulization, and though mistaken as to the correct mechanism, teaches that budesonide delivered to the lungs exhibits a “depot effect” where the drug continues to have an effect for a significant period after it is administered; and (v) prior art did not teach away from the purported invention.

Furthermore, the district court found, and the parties agreed, that a known problem existed at the time of the invention: “significant difficulty in the treatment of young children, including infants, who suffer from respiratory disease.” Because children lack coordination and the ability to take strong breaths, nebulizers would have been an obvious way to overcome the problem of finding an effective delivery mechanism to treat young patients. The Federal Circuit affirmed the district court’s finding that the secondary considerations posited by AstraZeneca are “inconclusive and insufficient.” Given the Federal Circuit’s affirmance of the district court’s holding that the asserted claims are obvious, it did not reach the issue of anticipation.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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