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Judge Sleet Finds Conversion from Paragraph IV to Pharagraph III Certification does not Deprive Court of Jurisdiction

Judge Gregory Sleet recently denied a motion to dismiss a Hatch-Waxman case filed by Plaintiff AstraZeneca shortly before the case was to begin trial. Certain defendants in the consolidated cases had converted their Paragraph IV certifications to Paragraph III certifications and filed motions to dismiss arguing that “by converting to a Paragraph III certification, [they are] no longer engaged in the highly artificial act of infringement that confers subject matter jurisdiction under 35 U.S.C. § 27l(e)(2) . . . [because they do] not seek approval until the expiration of the [patent-in-suit].” AstraZeneca AB v. Aurobindo Pharma Ltd., et al., C.A. No. 14-664-GMS, Order at 2 n.3 (D. Del. Sept. 15, 2016) (internal citations omitted). Judge Sleet found, however, that “subject matter jurisdiction remains because the conduct at issue is capable of repetition, yet evading review . . . [because] a patent owner would be prevented from fully litigating its claims of infringement if every time a Paragraph IV filer amended its certification from IV to III, or some other designation, the court was determined to be deprived of subject matter jurisdiction.” Id.

Moreover, Judge Sleet found “circumstantial, if not direct, evidence that supports the conclusion that there is a reasonable expectation that the same controversy involving these parties will recur. . . . [including the] amended Paragraph III Certification transmitted to the FDA . . . [which stated that Defendant] ‘Wockhardt Bio AG maintains the already submitted Paragraph IV certification for said patent.’ When taken together, the reasonable inference to be drawn from the cited evidence supports the conclusion that there is a reasonable expectation that Astra Zeneca may well again at some future time be required to assert its interests in the [patent-in-suit].” Id.

AstraZeneca AB v. Aurobindo Pharma Ltd., et al., C.A. No. 14-664-GMS (D. Del. Sept. 15, 2016).

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