Issue of Statutory Symmetry Keeps Returning
The interpretation of the Hatch-Waxman statute was again at issue when the Federal Circuit took up Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. In this case, the scales tipped decisively in favor of infringers of research tool patents.
In Momenta, the patent covered methods for analyzing heterogeneous populations of various compounds, including heparin. This patent—a research tool patent—was not extendable under § 156(a). The defendant used the patented method to determine the molecular weight of its generic heparin. Even though the Abbreviated New Drug Application (ANDA) had been approved, the molecular weight of each commercial batch had to be tested before the batch could be marketed. Thus, the alleged infringing conduct occurred post-FDA approval.
The Momenta majority held that such conduct—since it was regulated and required by the FDA—was protected by § 271(e)(1). As pertinent here, the majority dismissed the plaintiff’s argument (noted by Chief Judge Rader in dissent) that § 271(e)(1) is not available unless the patent is extendable under § 156(a).
The court held that the Supreme Court in Eli Lilly recognized that this symmetry was not always achievable. In this regard, the Federal Circuit stated:
We too have rejected this strict interpretation of the safe harbor, explaining that “statutory symmetry is preferable but not required.” Abtox, 122 F.3d at 1029 (holding that Class II medical devices, which are not subject to a “rigorous premarket approval process” and thus cannot receive patent term extensions, are nonetheless covered by the safe harbor).
Accordingly, under Momenta, research tool patents could be subject to § 271(e)(1). In dissent, Chief Judge Rader stated that the majority ignored the binding precedent on post-approval testing and, as relevant here, the result rendered manufacturing test method patents “worthless.” To explain his reasoning, Chief Judge Rader stated:
This Court ... would apply the disadvantage of § [271(e)(1)] to a patentee who would not be able to obtain the benefits of § . The patentee of a manufacturing patent does not obtain the patent extension created in § [156(a)], yet this court’s new expansion of § [271(e)(1)] would allow its competitors to infringe during the life of its patent.
As noted above, the Supreme Court in Eli Lilly did not require symmetry between § 156(a) and § 271(e)(1), and, indeed, specifically recognized that instances of nonsymmetry could occur.
Two recent cases highlight the conflicting views of § 271(e)(1) as it applies to research tools. In these cases, Teva sued Sandoz and Mylan alleging that their use of Teva’s patented polypeptides as “molecular weight markers” in the development of their own generic versions of Copaxone infringed.
Significantly, the patents-in-suit covered the use of the peptides as therapeutics and markers. Both Sandoz and Mylan moved to dismiss and argued that § 271(e)(1) applied because the results of the tests were included in their respective ANDAs.
In opposing the motions, Teva argued that the patented polypeptides were not “drug products” as they had not been approved by the FDA. Indeed, even though such products had potential therapeutic uses, neither Sandoz nor Mylan were using the peptides in that way, but only as analytical tools in characterizing the products they intended to sell as pharmaceuticals.
The judge in these Teva cases made clear that regardless of the implications of the Act’s legislative history, § 271(e)(1) should not be limited to those patents extendable by § 156(a). This result is confirmed by the Supreme Court’s decision in Eli Lilly and the Federal Circuit’s decision in Momenta. Rather, as the Eli Lilly Court stated, § 271(e)(1) covers “all inventions.”