Docket No. 2012-1062, -1103, -1104
RADER (D), DYK, MOORE
August 3, 2012
Brief summary: Post-marketing testing required by the FDA may be protected under 271(e)(1).
Summary: Amphastar appealed DC denial of its Emergency Motion to Dissolve or Stay the preliminary injunction regarding a generic version of the blood clot drug Lovenox (enoxaparin). The FC concluded that the DC applied an unduly narrow interpretation of the Hatch-Waxman safe harbor (35 U.S.C. 271(e)(1)). Lovenox is a low molecular weight version of heparin, the USP entry stating: “About 20 percent of the materials contain a 1,6-anhydro derivative on the reducing end of the chain, the range being between 15 and 25 percent.” The USP also includes a specific test for quantifying the 1,6-anhydro derivative, which is encompassed by claims 6, 16 and 53 of Momenta’s U.S. Pat. No. 7,575,866. The FC panel majority concluded that Amphastar was required by the FDA to use that test to confirm the generic product was not adulterated (“Amphastar, as a generic drug manufacturer under an ANDA, cannot sell a batch of enoxaparin unless it has established that its strength and quality is consistent with the standards set forth in the relevant official compendium.”) Accordingly, then, it concluded that the testing “falls squarely within the scope of the safe harbor” of 271(e)(1) which “does not stop at activities reasonably related to development of information submitted in an ANDA…[a]s long as the allegedly infringing use is ‘for uses reasonably related’ to the development and submission of that information” and that “the requirement to maintain records for FDA inspection satisfies the requirement….” The panel contrasted this case to Classen (FC 2011), in which the disputed studies were designed to determine “the timing of childhood vaccinations and the risk of developing certain immune-mediated disorders” but were not required by the FDA (although any adverse effects observed during the studies would need to be reported). It was concluded in that case that the scope of the safe harbor provision “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.” In this case, the panel concluded that the testing was required and therefore protected. Judge Rader’s dissent argued that 271(e)(1) was enacted “to permit a generic company to ‘use’ a patented product for the limited purpose of completing the testing necessary for FDA approval” (e.g., it should only apply to “experimentation” related to pre-market approval and “does not permit the commercial sale of a patented drug” (quoted from the legislative history)). Thus, the dissent argued, “[t]his new interpretation would allow almost all activity by pharmaceutical companies to constitute ‘submission’ and therefore justify a free license to trespass…the drug manufacturer need only make a record, which could potentially be inspected by the FDA”, thereby “essentially render[ing] manufacturing method patents worthless.”