The case involved a patent dispute between AstraZeneca, which held patents on methods and kits for administering the asthma drug budesonide, and Apotex, which sought to market a generic version through an FDA abbreviated new drug application. AstraZeneca obtained a preliminary injunction preventing Apotex from launching its product, while the district court invalidated the kit claims in the patents. On appeal, the Federal Circuit affirmed the injunction grant, finding no abuse of discretion, and upheld the invalidity ruling on the kit claims as not clearly erroneous. The decision centered on the proper construction of patent terms, prior art anticipation, and compliance with FDA labeling and certification requirements for generics.
Teva Pharmaceuticals, a generic drug manufacturer, filed a declaratory judgment action against Eisai seeking a ruling that its proposed generic version of donepezil did not infringe four of Eisai's Orange Book patents for the brand-name Alzheimer's drug Aricept. As a subsequent Paragraph IV filer under the Hatch-Waxman Act, Teva's FDA approval was blocked by the 180-day exclusivity period of the first filer, Ranbaxy, which had not yet been triggered. The district court dismissed the case for lack of Article III jurisdiction, concluding there was no justiciable controversy. The Federal Circuit reversed, holding that Teva alleged a concrete injury-in-fact from the delayed approval that was traceable to Eisai's patents and redressable by a declaratory judgment of noninfringement, which would trigger the exclusivity period, and found no basis to decline jurisdiction under the Declaratory Judgment Act.
The case involved Princo's challenge to U.S. Philips Corporation's enforcement of patents covering CD-R and CD-RW technology standards set forth in the Orange Book, which Philips and Sony jointly developed. Princo argued that Philips committed patent misuse by agreeing with Sony not to license an alternative Lagadec patent that could have competed with the Orange Book standards. The Federal Circuit upheld the International Trade Commission's ruling that no patent misuse occurred and that Philips could enforce its patents. The court reasoned that the patent misuse doctrine is narrow and judge-made, applies only when a patentee imposes conditions exceeding the scope of the patent right, and should not be expanded to cover agreements that do not demonstrably suppress viable competing technologies.
This case involved a patent infringement dispute over U.S. Patent No. 6,655,566, which claims an improved 'bundle breaker' machine for separating stacks of corrugated board using 'compliance structures' to handle logs of varying heights. After a trial ended in a hung jury, the district court granted judgment as a matter of law that the patent claims would have been obvious. The Federal Circuit affirmed, holding that the invention was obvious in light of prior art machines such as the Pallmac and Visy systems, which addressed similar compliance issues, combined with the ordinary skill of a mechanical engineer. The court also noted that near-simultaneous invention of a comparable Tecasa machine further supported the obviousness determination by showing the level of skill in the art.
This case concerned the scope of the counterclaim provision in 21 U.S.C. § 355(j)(5)(C)(ii) of the Hatch-Waxman Act, which allows generic drug manufacturers to challenge brand-name companies' patent listings in the FDA's Orange Book. The underlying dispute involved Novo Nordisk's listing of a patent covering combination therapy for the diabetes drug repaglinide and whether Caraco could force correction of that listing to enable a carve-out for its generic product. A Federal Circuit panel ruled that the counterclaim was unavailable because the listed patent information was not inaccurate on its face. The full court denied Caraco's petition for panel rehearing and rehearing en banc after a poll of the active judges failed.
This case involved Avid Identification Systems' petition for panel rehearing and rehearing en banc after a prior Federal Circuit decision held its patent unenforceable for inequitable conduct during prosecution, despite a jury finding the patent valid and willfully infringed. Avid also moved to join or stay the mandate pending the en banc decision in Therasense v. Becton Dickinson, which addresses standards for materiality and intent in inequitable conduct claims. The court denied the motion to stay or join, denied both the panel rehearing and en banc rehearing petitions after a failed poll of active judges, and directed that the mandate issue on July 23, 2010. The core reasoning was that the en banc poll did not succeed and no basis existed to delay finality in light of the separate Therasense proceeding. Judge Newman dissented, arguing that a stay was warranted due to potential changes in inequitable conduct law that could affect the outcome.
