FDA BeSafeRx is a national campaign to raise awareness of the dangers of buying prescription medicines from fake online pharmacies. On appeal, Hospira argued that any transaction that provides a commercial benefit to the inventor, in this case by stockpiling its product for future sale, was sufficient to trigger the on-sale bar. Next, the court found the allegations regarding third-party insurance providers “merely acknowledges potential infringement by others, not that Hikma has taken active steps to encourage direct infringement.” Finally, the court noted that the allegations in Takeda’s complaint stating Mitigare In this ongoing patent infringement case, Magistrate Judge Burke issued a report and recommendation to deny Teva’s Rule 12(b)(6) motion to dismiss GlaxoSmithKline’s (GSK) induced infringement allegations relating to generic product sales during a select time period (January 2008‒May 2011).
The specific activities and the nature of the invention matter.The US Court of Appeals for the Federal Circuit affirmed the finding of infringement from the US District Court for the District of Delaware under the doctrine of equivalents based on admissions from the defendant’s abbreviated new drug application (ANDA). Watson sent Bayer a Paragraph IV notice letter indicating it submitted an abbreviated new drug application (ANDA) seeking approval for 10 milligram vardenafil hydrochloride orally disintegrating tablets, prior to the expiration of the Orange Book-listed patents.Bayer brought suit against Watson alleging infringement under the Hatch-Waxman Act. Finally, the court determined that there was nothing in the prior art that would have given a POSA reason to use sorbitol and mannitol in an ODT, and that the tableting properties of mannitol and sorbitol mixtures are not obvious. Takeda appealed. The court found that Plaintiffs’ claim was inconsistent with the statutory text, which establishes that it “shall be an act of infringement to submit [an ANDA] for a drug Furthermore, in view of the facts pled, allowing a claim under §271(e)(2) would contradict the purpose of the statute. The court also rejected Hospira’s “stockpiling” argument finding that “mere stockpiling of a patented invention by the purchaser of manufacturing services does not constitute a ‘commercial sale’ under § 102(b). Otsuka also claimed that the FDA violated the notice and comment procedures.employing active moiety as a relevant criterion for determining whether a second-in-time application is barred promotes Hatch-Waxman’s goals by protecting ‘against approval of drugs with the same active moiety for the same exclusivity period use[,]’ while simultaneously encouraging competition by ensuring that exclusivity could ‘not block approval of drugs with different active moieties…that may have some advantages over previously approved active moieties.’The court acknowledged Otsuka’s claims that it may be unfair to allow a second-in-time drug applicant to rely on an innovator’s clinical investigations while avoiding the exclusivity awarded to that same innovator, but stated that Otsuka’s alternative reading would “extend the marketing exclusivity of the initial innovator drug in perpetuity” which the court explained would be “an even more absurd result.” Finally, the court rejected Otsuka’s contention that the FDA transgressed the Administrative Procedure Act by improperly amending or altering an unambiguous regulation in contravention of the requirements of notice and comment.In construing a claim involving a method for treating obesity, the US District Court for the District of Delaware determined that a phrase in the preamble stating that the method of treatment had “reduced adverse effects” was not a claim limitation. Zydus would have to pay Warner Chilcott a 25 percent royalty of its net sales, and Warner Chilcott would maintain the right to supply an authorized generic to another company. The court granted Defendants’ motion and dismissed the claim pursuant to Rule 12(b)(6).The court rejected Defendants’ argument for lack of subject matter jurisdiction, finding that Plaintiffs satisfied the low threshold necessary to meet the requirement. A district court found Apotex failed to show that Acorda’s citizen petition was objectively baseless and granted Acorda’s motion to dismiss.