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Judge Burke issues claim construction in ANDA litigation; recommends claims not indefinite


In a recent Report and Recommendation, Magistrate Judge Christopher J. Burke construed the terms “multi-phase product,” “multiphase oral contraception product” and “phase” (collectively, the “phase terms”), in addition to the terms “daily dosage units” and “daily oral dosage units” (collectively, the “daily terms”) with respect to the only patent-in-suit, U.S. Patent No. 8,071,577 (the “’577 Patent”). Bayer Pharma AG v. Watson Laboratories, Inc., C.A. No. 12-1726-LPS-CJB (D. Del. Sept. 30, 2014). The patent-in-suit contains only three claims, each of which are independent. Defendant argued that claims 1 and 2 “are hybrid claims that recite both a product and a method of using that product at the same time” and should therefore be found indefinite as a matter of law. Id. at 8.

Addressing defendant’s indefiniteness argument, Judge Burke acknowledged that “a single patent may include claims directed to one or more of the classes of patentable subject matter, but no single claim may cover more than one subject matter class.” Id. at 9. In particular, such a “hybrid claim,” is indefinite because it is “not sufficiently precise to provide competitors with an accurate determination of the metes and bounds of protection involved and is ambiguous.” Id. at 10. Judge Burke explained, for example, that such indefinite hybrid claims may arise when the “claims describ[e] a system that also require[s] the user of the recited system to take specific action.” Id. at 12. On the other hand, an indefinite hybrid would not arise if the “claims contain[] language simply describing a system as well as the capabilities of the claimed system.” Id. Addressing the “phase terms” of claims 1 and 2, Judge Burke determined that the use of the term “phase” referred to “physical components of a claimed composition” rather than use of the composition. Id. at 25. Further, following a thorough analysis, Judge Burke concluded that “[t]he other intrinsic evidence . . . does not give the Court enough cause to alter that view.” Id. Judge Burke thus provided constructions for the “phase terms” consistent with these conclusions. Id. Turning to the “daily terms” Judge Burke concluded that “[f]or the same reasons as described above in reference to the ‘phase’ terms, the Court declines to construe these ‘daily’ terms so that they inject method steps into claims 1 and 2,” and adopted constructions for these terms consistent with that conclusion. Id. at 26. In support of that conclusion, Judge Burke explained that “none of the claim language in composition claims 1 or 2 explicitly requires that the drug be actually administered to a patient in a certain manner.” Id.

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