Biosimilar Applicants Cannot Avoid 180-Day Notice Requirement

Companies currently holding the exclusive rights to biologics should be celebrating the Federal Circuit’s decision released earlier this week.  In Amgen v. Apotex, the Court held that all biosimilar applicants must provide a 180-day notice to owners of the NDA for the referenced biologic before engaging in commercial marketing of their biosimilars.  Amgen Inc. v. […]

Federal Circuit Extends Biologic Exclusivity by 180 Days Gives Biosimilars A Choice Whether to Disclose Product Information Required by the BPCIA

The Federal Circuit handed down a decision interpreting the Biologics Price Competition and Innovation Act (BPCIA) in a way that effectively grants branded biologics an additional six months of exclusivity.  However, in a win for biosimilar applicants, the Federal Circuit also held that the statutory directive to disclose abbreviated application and manufacturing information to the […]

Patent Eligible Subject Matter After Mayo: Federal Circuit Invalidates Diagnostic Test Patent

Last week, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a district court finding that the asserted claims of a prenatal diagnostic testing method patent are not directed to patent eligible subject matter and are therefore invalid under § 101. The Patent. The patent at issue (the ‘540 patent) involves a technology […]

Another Court Denies Attempts of Biosimilar Manufacturer to Expedite Resolution of Patent Disputes

In the decision in Celltrion Healthcare v. Kennedy Trust for Rheumatology Research  issued earlier this week, Judge Cotty of the Southern District of New York declined to exercise declaratory judgment jurisdiction in a case that would have permitted Celltrion Healthcare to expedite the patent challenges that stand in the way of the launch of its […]