- Azurity Pharma 23-1977.pdf

• (no holding tagged to this category)

- Janssen Pharma 25-1228.pdf

• (no holding tagged to this category)

- Jazz Pharma 24-2274.pdf

• Whether a permanent injunction may bar initiation of future clinical trials involving a patented drug product.: A court abuses its discretion by enjoining initiation of new clinical trials that are reasonably related to generating information for FDA submission, because such conduct is exempt from infringement under §271(e)(1) and §271(e)(3) bars injunctive relief prohibiting safe-harbor activity absent adjudication that the activity falls outside the safe harbor.
• Whether a permanent injunction may bar offering open-label extensions (OLEs) in ongoing clinical trials when the activity has not been accused or adjudicated as infringing or outside the safe harbor.: An injunction cannot preemptively prohibit OLE-related conduct where the activity has not been accused and adjudicated to fall outside §271(e)(1); §271(e)(3) requires the safe-harbor issue be decided before injunctive relief may restrict that activity.
• Whether submitting an application to the FDA (standing alone) constitutes infringement under §271(a) such that it can be enjoined as infringing conduct.: Submitting an FDA application is not a making, using, selling, offering to sell, or importing under §271(a), and thus is not itself an actual act of infringement; the safe harbor does not independently convert “submission of information” into the relevant infringing act.

- Merck Sharp & Dohme 23-2254.pdf [NEEDS_REVIEW]

• Whether, for a reissued patent, § 156©’s requirement that the regulatory review period “occur[] after the date the patent is issued” is measured from the original patent’s issue date or the reissue patent’s issue date.: In the context of reissued patents, § 156©’s reference to “the patent” is construed to refer to the original patent for purposes of calculating PTE when the original patent already contained (and the reissue retains) claims directed to the FDA-approved drug product.
• Role of statutory context and purpose in construing ambiguous language in Hatch-Waxman’s PTE provisions.: Where the isolated text of § 156© is ambiguous as applied to reissue, the statute should be read in context to effectuate the Hatch-Waxman purpose of restoring patent term lost to FDA review, and interpretations that would negate restoration solely due to seeking reissue are rejected absent a statutory basis.
• Whether § 156(a) and § 154(a)(2) inform the meaning of “the patent” for reissued-patent PTE calculations.: Related provisions referring to extension from the patent’s “original expiration date” and defining patent term by reference to the original filing support construing § 156©’s “the patent” as the original patent in the reissue setting where the reissue carries forward the original term.