Here are our picks for the top-five most significant legal developments in the world of biosimilars in 2016: 5) Congress passed and President Obama signed the 21st Century Cures Act. Among other things, the Act modifies the standards and review processes for FDA evaluation of applications to market new drugs,…
Today, the Supreme Court denied certiorari in Apotex v. Amgen, a closely-watched case involving the interpretation of key provisions of the BPCIA. Our most recent blog coverage can be found here. Even though the Court has declined to hear Apotex v. Amgen, the Supreme Court has before it another vehicle for addressing the hotly-contested…
Below is our Fall 2016 update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly update (Summer 2016).
On November 21, 2016, Apotex submitted a reply brief in support of its petition for certiorari in Apotex v. Amgen. Previous coverage of Amgen’s opposition is available here. A procedural note: the case was also distributed on November 21 for consideration at the Supreme Court’s private conference on December 9. Given…
Mylan filed an amicus brief in support of Apotex’s petition for certiorari in Amgen v. Apotex. Mylan’s arguments focus on the Federal Circuit’s interpretation of the BCPIA as requiring 180 days of pre-marketing notice after licensure of a biosimilar product by the FDA. It argues that the Federal Circuit’s decisions…
Earlier this week, we reported on the amicus curiae brief filed by the Biosimilars Council in support of Apotex’s petition in Amgen v. Apotex. Mylan Pharmaceuticals Inc. has also filed an amicus brief in support of Apotex. Mylan’s brief can be found here.
As we covered in a previous post, Apotex has filed a cert. petition asking the Supreme Court to review the Federal Circuit’s ruling on the BPCIA’s notice provision in Amgen v. Apotex. Last week, the Biosimilars Council filed an amicus brief in support of Apotex’s petition. The brief is available here….
In August, we reported that Coherus Biosciences, Inc. submitted an aBLA for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. Last week, Coherus announced that FDA has accepted its aBLA. Under the BPCIA, Coherus has 20 days from FDA acceptance to trigger the patent dance by providing the reference product sponsor (Amgen) with a…
Last week, Amgen filed a notice of appeal to the Federal Circuit from the district court’s judgment of non-infringement. The Federal Circuit has docketed the appeal as Case No. 17-1010. Amgen’s opening brief will be due in early December, absent any extensions of time or other delays in the appeal…
We have been closely following the Amgen v. Apotex case. On September 9, 2016, Apotex petitioned the Supreme Court for certiorari to review the Federal Circuit’s decision. In its petition, Apotex presents two questions for the Supreme Court: Whether the Federal Circuit erred in holding that biosimilar applicants that make…