AstraZeneca Pharms. et al. v. Apotex et al., No. 10-338 (D. Del. 2010)
Crestor (rosuvastatin) is FDA-approved for the treatment of various cholesterol-related conditions, including hyperlipidemia, hypertriglyceridemia, homozygous familial hypercholesterolemia (HoFH) and heterozygous familial hypercholesterolemia (HeFH), and for the prevention of cardiovascular disease in patients with elevated levels of C-reactive protein. The uses of rosuvastatin for the last two indications are claimed in U.S. Patent Nos. 6,858,618 and 7,030,152, respectively, both of which are listed in the Orange Book. The first three indications are not covered by Orange Book-listed patents.
Nine generic drugmakers filed rosuvastatin ANDAs with section viii statements for the '618 and '152 patents, asserting that they do not seek approval for the indications claimed in those two patents. (A tenth company, Sandoz, filed an ANDA with Paragraph IV certifications to the patents.)
AstraZeneca then filed suit against the ANDA applicants under 35 USC 271(e)(2), alleging infringement of the '618 and '152 patents. Section 271(e)(2) states (in part):
It shall be an act of infringement to submit an [ANDA] . . . if the purpose of such submission is to obtain approval to engage in the commercial manufacture, use, or sale of a drug claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.
In response, the ANDA applicants who filed section viii statements on the '618 and '152 patents moved to dismiss for lack of subject matter jurisdiction under Fed. R. Civ. P. 12(b)(1). They argued in their motions that Section 271(e)(2) creates a justiciable patent infringement dispute only if an ANDA includes a Paragraph IV certification. AstraZeneca, on the other hand, argued that the plain language of Section 271(e)(2) does not require a Paragraph IV certification to have been filed. AstraZeneca also pointed to several cases in which courts have recognized infringement under Section 271(e)(2) when there was no Paragraph IV certification. The Federal Circuit, however, has never squarely addressed this issue.
In an opinion filed yesterday, the district court granted the ANDA applicants' motions to dismiss. The court described the specific issue in the case as "whether Plaintiffs may bring an infringement claim under Section 271(e)(2) based on two FDA-approved method-of-use patents even though Defendants seek approval to manufacture and market rosuvastatin calcium for FDA-approved indications not claimed by Plaintiffs' patents." In deciding this question in the negative, the court relied on the Federal Circuit's decision in Warner-Lambert v. Apotex, 316 F.3d 1348, which found that there was no 271(e)(2) claim when a generic drugmaker sought approval for only non-patented indications. AstraZeneca attempted to distinguish that case, but was unsuccessful.
The court went on to address AstraZeneca's argument that Section 271(e)(2) would be rendered meaningless if generic manufacturers can evade suit simply by filing conclusory section viii statements. According to the court, the argument is "misguided," because "the formality of submitting a section viii statement does not immunize a generic manufacturer from suit under Section 271(e)(2)." Further, the court stated, "nor does filing a Paragraph IV Certification automatically trigger Section 271(e)(2)." The court concluded:
Thus, the district court has jurisdiction under Section 271(e)(2) when, regardless of whether the ANDA contains a Paragraph IV Certification or a section viii statement, the ANDA actually seeks approval for a patented indication. In that event, the filing of an ANDA constitutes an "act of infringement" which confers jurisdiction under Section 271(e)(2)(A). In order to determine whether an ANDA actually seeks approval for a patented indication, a court need only compare the ANDA's proposed labeling, which provides the basis for FDA approval and defines the indications for which the generic manufacturer can market the drug, to the indications claimed in the patents. If there is no overlap, then there is no claim under Section 271(e)(2) and no justiciable controversy.
In a separate opinion earlier this year, the validity of AstraZeneca's patent on rosuvastatin calcium was upheld. But because the method-of-use patents will not expire until two to four years after the compound patent expires, the effect of losing the method-of-use patents could be significant to AstraZeneca. Accordingly, it seems likely that the Federal Circuit will finally address the issues in this case directly.