Opinion ID: 178456
Heading Depth: 2
Heading Rank: 3

Heading: The Kit Claims

Text: The asserted kit claims recite two elements: (1) a budesonide composition or suspension in a sealed container containing 0.05 mg to 15 mg budesonide and a solvent, and (2) a label indicating administration by nebulization in a continuing regimen at a frequency of not more than once per day. See, e.g., '603 Patent col.12 ll.3-8; '099 Patent col.11 ll.9-14. The district court concluded that the kit claims are invalid, finding the claimed budesonide composition and suspension were known in the prior art and that the instructions in the claimed label are non-statutory subject matter and therefore not entitled to patentable weight. Opinion at 589-92. Regarding the instructions in the label, the district court explained that under Federal Circuit precedent [w]here . . . printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability. Id. at 590 (citation omitted). This court noted that here the parties disputed what constitutes the substrate, with Apotex contending that the label is the substrate and AstraZeneca asserting that the substrate is the drug. Id. at 592. After considering our precedent, the district court concluded that this dispute was immaterial because regardless of how the substrate was defined, the instructions simply explain how to use the known product. This type of relationship does not qualify as a functional one. . . . Id. at 591. AstraZeneca argues that a drug label and its associated drug are inextricably interrelated, as a drug cannot be approved unless and until the FDA approves its label. AstraZeneca notes that FDA regulations require the label for a drug to include information needed for proper use of the drug and argues that without the label a physician would be unable to safely and effectively treat patients. In light of this, AstraZeneca contends that a drug label is essential to physicians when prescribing a drug and, therefore, is functionally related to the drug. Apotex counters that, for the purposes of determining whether the claimed label is entitled to patentable weight, the relationship between the drug and the label is irrelevant. According to Apotex, the proper inquiry is whether there is a functional relationship between the printed matter and its substrate, i.e., the object the printed matter is printed on. Apotex contends that here the printed matter is the instruction for once-daily use and the substrate is the paper label. Citing In re Ngai, 367 F.3d 1336 (Fed.Cir.2004), Apotex argues that the instructions are not functionally related to the label on which they are printed because they do not function together in any way. There is no dispute that the budesonide suspension recited in the claims is known in the prior art. The question before us is whether the district court correctly determined that the recitation in the claims of a label instructing not more than once-a-day dosing is of no patentable consequence. This court reviews de novo the district court's determination that the asserted claims recite non-statutory subject matter. See In re Comiskey, 554 F.3d 967, 975 (Fed.Cir.2009) (explaining that whether the asserted claims . . . are invalid for failure to claim statutory subject matter under 35 U.S.C. § 101[] is a question of law which we review without deference. (quoting AT&T Corp. v. Excel Commc'ns, Inc., 172 F.3d 1352, 1355 (Fed.Cir.1999))). The categories of patentable subject matter are set forth in 35 U.S.C. § 101: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. This court has generally found printed matter to fall outside the scope of § 101. See In re Chatfield, 545 F.2d 152, 157 (CCPA 1976) (Some inventions, however meritorious, do not constitute patentable subject matter, e.g., printed matter. . . . (citation omitted)). However, as observed by the district court, this court has long recognized an exception to this general rule: If there is a functional relationship between the printed matter and its substrate, the printed matter may serve to distinguish the invention from the prior art. See In re Miller, 57 C.C.P.A. 809, 418 F.2d 1392, 1396 (CCPA 1969); In re Gulack, 703 F.2d 1381, 1385-87 (Fed.Cir. 1983). This court considered the printed matter exception in Ngai, a case similar to the one now before us. In Ngai, the Board affirmed the rejection of a claim reciting a kit comprising instructions to amplify ribonucleic acids. The Board found that the only difference between the claimed kit and the prior art was the content of the claimed instructions. Concluding that this content was not functionally related to the kit, the Board found that the claim was anticipated by the prior art. This court affirmed, rejecting the argument that the addition of new printed matter to a known product makes the product patentable. This court reasoned that the printed matter in no way depends on the kit, and the kit does not depend on the printed matter. All that the printed matter does is teach a new use for an existing product. Ngai, 367 F.3d at 1339. This court agrees with Apotex that as in Ngai the claimed instructions here are not entitled to patentable weight. The instructions in no way function with the drug to create a new, unobvious product. Removing the instructions from the claimed kit does not change the ability of the drug to treat respiratory diseases. Although AstraZeneca is correct that FDA regulations require a label containing information needed for the safe and effective use of any drug, this is a requirement for FDA approval, not patentability. This court also agrees with the district court that the dispute over whether the substrate is the label or the drug is immaterial, for in both cases the instructions do nothing more than explain how to use the known drug. Our decision in Ngai foreclosed the argument that simply adding new instructions to a known product creates the functional relationship necessary to distinguish the product from the prior art. As explained in Ngai, if this court concluded otherwise anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product. 367 F.3d at 1339. Neither the Patent Act nor our precedent countenances such an outcome. The district court's determination that the kit claims are invalid is affirmed.