The Federal Circuit has issued its final decision in the biosimilar patent litigation between Amgen and Sandoz over the first product to be approved under the Biologics Price Competition and Innovation Act (BPCIA). Not surprisingly, the court determined that Amgen’s state law unfair competition claims were preempted by the “complex statutory scheme” of the BPCIA. Amgen’s … Continue reading this entry
Tags: Amgen, Biologics Price Competition Innovation Act (BPCIA), Patent Dance, Preemption, Sandoz
In Amgen Inc. v. Hospira, Inc., the Federal Circuit held that Amgen could not obtain discovery related to activities that might infringe a patent that it had not asserted in its biosimilar patent litigation against Hospira. In particular, the court held that it lacked jurisdiction—under the collateral order doctrine—over the district court’s denial of Amgen’s motion to … Continue reading this entry
Tags: Amgen, Biologics Price Competition Innovation Act (BPCIA), Epogen, Hospira
The Solicitor General of the United States has filed an amicus brief in Sandoz Inc. v. Amgen Inc., asking the Supreme Court to grant certiorari and reverse the Federal Circuit’s interpretation of one of the “patent dance” provisions of the biosimilar statute. In particular, the Solicitor General does not agree that the pre-marketing notice required … Continue reading this entry
Tags: Amgen, Biologics Price Competition Innovation Act (BPCIA), Neupogen, Sandoz, Zarxio
On August 4, 2016, Abbvie Inc. filed a complaint against Amgen, Inc. under the Biologics Price Competition and Innovation Act (BPCIA), asserting that Amgen’s application for approval of a biosimilar version of HUMIRA® infringes a number of AbbVie patents. The complaint specifically asserts infringement of ten HUMIRA® patents, but indicates that 51 others may be … Continue reading this entry
Tags: AbbVie, Amgen, Biologics Price Competition Innovation Act (BPCIA), Patent Dance
In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing begins.” The court dismissed concerns that its holding would extend the originator’s 12-year exclusivity period by 6 months, reasoning that the FDA could signal approval … Continue reading this entry
Tags: Biologics Price Competition Innovation Act (BPCIA)
Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to shorten that exclusivity period to expedite biosimilar market entry. Most recently, on June 23, 2016, Illinois Congresswoman Jan Schakowsky and Senators John McCain (R-AZ) and Sherrod … Continue reading this entry
Tags: Biologics Price Competition Innovation Act (BPCIA), Biosimilar, Biosimilars, PRICED Act
In Amgen v. Apotex, the Federal Circuit rejected Apotex’s arguments that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” process of the Biologics Price Competition and Innovation Act (“BPCIA”), expanding on its decision in Amgen v. Sandoz that 42 USC § 262(l)(8)(A) is a mandatory, stand-alone requirement. … Continue reading this entry
Tags: 180 Day, Amgen, Apotex, Biologics Price Competition Innovation Act (BPCIA)
Although Amgen originally did not petition the Supreme Court for certiorari to review the first Federal Circuit decision interpreting the BPCIA framework for resolving biosimilar patent disputes, Amgen now has filed a “Conditional Cross-Petition” for certiorari. Amgen urges the Court to deny Sandoz’s petition for certiorari, but asks the Court to grant its Conditional Cross-Petition if the Court decides to grant … Continue reading this entry
Tags: Amgen, Biologics Price Competition Innovation Act (BPCIA), Sandoz
Judge Cohn of the U.S. District Court for the Southern District of Florida has issued another decision interpreting the complicated provisions of the Biologics Price Competition and Innovation Action (BPCIA), ruling that the statute requires a biosimilar applicant to give 180 days’ pre-marketing notice after FDA approval even if it has engaged in the BPCIA’s patent … Continue reading this entry
Tags: Amgen, Apotex, Biologics Price Competition Innovation Act (BPCIA), Neulasta, Patent Dance
The Federal Circuit denied the petitions for rehearing en banc filed in Amgen Inc. v. Sandoz Inc., which was the court’s first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA). Perhaps the court thought that because both parties sought rehearing they must have gotten it right, but Amgen and Sandoz took issue with … Continue reading this entry
Tags: Amgen, Biologics Price Competition Innovation Act (BPCIA), Sandoz
In Amgen v. Sandoz, a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that appears to favor biosimilar applicants over owners of original biologic products (“reference product sponsors”). The court held that a biosimilar applicant does not have to share its biosimilar application with … Continue reading this entry
Tags: Amgen, Biologics Price Competition Innovation Act (BPCIA), Neupogen, Sandoz, Zarxio
Posted in Biosimilars
Posted in Biosimilars
Posted in Biosimilars