Posts Tagged: "apotex"

In the recent case of Intellectual Ventures v. Toshiba, Judge Robinson noted that “the Federal Circuit has construed the language quite literally” in the use of the word “during.” The term is spelled out as “any ground that the petitioner raised or reasonable could have raised during that inter partes review” in § 315(e)(1). The judge noted that while extending the logic of non-instituted grounds as not being able to be raised “during” an IPR proceeding to prior art references that were never presented to the Patent Trial and Appeal Board at all “confounds the very nature of this parallel administrative proceeding, the court cannot divine a way around the Federal Circuit’s interpretation in Shaw.” Thus, she did not estop Toshiba from presenting the grounds never presented to the PTAB in a pair of orders in December and January, and heavily implied that the Federal Circuit should weigh in to clarify the issue.

The Federal Circuit held that there was no statutory language that made section (8)(A) non-mandatory. Further, Amgen v. Sandoz disposed of Apotex’s argument that (8)(A) would extend the 12-year exclusivity period given to a sponsor by 180 days (six additional months). Even when market entry is delayed under (8)(A) by 12 years plus 180 days, the result is the same, because the 12-year date is established as the earliest date, not the latest date, on which a biosimilar license can take effect. The Court affirmed that section (8)(A) covers applicants that filed (2)(A) notices as well as those that did not. This is to ensure that the necessary decision-making regarding further patent litigation starts from when the applicant’s product, uses, and processes are fixed by the FDA license. The 180-day period gives the sponsor essential time to assess its infringement position for the final FDA approved product and the as to yet-to-be-litigated patents. This is confirmed by the legislative history of the Biologics Act. Thus, an applicant must provide a reference product sponsor with the 180-day notice under 8(A), after approval and before commercial marketing begins, whether or not the applicant previously provided a (2)(A) notice of the FDA review.