As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding in the U.S. District Court for the Northern District of West Virginia, with a two-week trial scheduled to begin on June 12, 2023. On May 23, 2023, Amgen filed a motion to intervene in…
On May 1, 2023, Amgen filed a BPCIA complaint in the District of New Jersey against Sandoz related to Sandoz’s denosumab biosimilar of Amgen’s PROLIA® and XGEVA®. This is Amgen’s first BPCIA case filed with respect to a denosumab biosimilar. According to Amgen, PROLIA is “prescribed to treat patients with…
As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023. On April 19, the Court issued a claim construction order construing seven terms from the claims of the four…
FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. Pursuant to a law enacted in late 2020, a reference product sponsor must provide patent information to FDA for listing in the Purple Book once…
As we previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023, less than a year from Regeneron’s filing of its complaint in August 2022. The Court’s scheduling order, issued in October…
On January 6, 2023, Genentech and Tanvex reached a settlement in principle to resolve all claims with respect to Genentech’s BCPIA complaint. As we previously reported, Genentech filed a complaint against Tanvex in June 2022, alleging infringement of three patents under the BPCIA based on Tanvex’s submission of an aBLA…
On Friday, December 16, 2022, Regeneron moved to dismiss Mylan’s inequitable conduct defense and counterclaim against two of the six patents asserted in the parties’ BPCIA suit concerning Mylan’s proposed biosimilar to EYLEA. As previously reported, Regeneron narrowed the twenty-four patents originally asserted against Mylan to six following the Northern…
As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The BPCIA also introduced a new scheme to resolve…
As we previously reported, the Northern District of West Virginia ordered an expedited trial in Regeneron’s aflibercept BPCIA case against Mylan. Regeneron had asserted 24 patents in its complaint. As required by the court’s scheduling order, on October 28, Regeneron identified six patents for the first phase of the litigation. …
On November 9, 2022, the PTAB issued final written decisions in IPR2021-00880 and IPR2021-00881, filed by Mylan on two Regeneron patents related to aflibercept—U.S. Patent Nos. 9,254,338 and 9,669,069. The PTAB ruled in Mylan’s favor in both IPRs, holding all challenged claims of both patents invalid as anticipated by the same…