Recently, the Federal Circuit decided a case concerning the registration of a generic drug by Apotex, Inc. in light of AstraZeneca LP’s registration of their brand-name drug.[i] Both drugs contain an anti-inflammatory corticosteroid that treats respiratory diseases, namely asthma.[ii] Of particular interest in this case were the kit claims contained in the two patents owned by AstraZeneca. These claims stated:
29. A kit for treating respiratory diseases, the kit comprising (a) a budesonide composition in a sealed container, the composition containing 0.05 mg to 15 mg budesonide and a solvent, and (b) a label indicating administration by nebulization in a continuing regimen at a frequency of not more than once per day.[iii]
17. A kit for treating a respiratory disease, the kit comprising (a) a budesonide suspension in a sealed container, the suspension containing 0.05 mg to 15 mg budesonide and a solvent, and (b) a label indicating administration by nebulization in a continuing regimen at a frequency of not more than once per day.[iv]
At the District Court, Apotex argued that the kit claims contained in both of AstraZeneca’s patents were invalid due to the fact that the budesonide composition/suspension was known in the prior art and “the recited label could not render a known product patentable.”[v] The District Court agreed with Apotex’s argument that the “asserted kit claims were invalid.”[vi] An appealed followed.[vii]
On appeal, the Federal Circuit affirmed the lower court’s determination that the kit claims were invalid over the prior art.[viii] Federal Circuit precedent states that when “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.”[ix] In this particular case, the District Court had held that the instructions “simply explain how to use the known product” and this “type of relationship does not qualify as a functional one.”[x] Upon reviewing this determination, the Federal Circuit turned to 35 U.S.C. § 101, which states:
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.
The general rule has been that printed matter is outside the scope of § 101. One exception to this rule, as stated by the District Court above, has been, “[i]f 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.”[xi] The Court explained that, “[t]he 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.”[xii] The Federal Circuit held that the claimed instructions on the label were “not entitled to patentable weight” because they merely taught a new use of a known compound.[xiii] Furthermore, a holding to the contrary would permit “‘anyone [to] continue patenting a product indefinitely provided that they add a new instruction sheet to the product.'”[xiv]