Tag Archives: Amgen

Will The Avastin Biosimilar Patent Dance Go On?

Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but the Avastin biosimilar patent dance still may go on. Judge Sleet dismissed the complaint without prejudice and gave Genentech 45 days to amend its complaint. … Continue reading this entry

Will You, Won't You Join The Biosimilar Patent Dance?

In the latest dispute surrounding the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA), Genentech, Inc. has filed a complaint against Amgen, Inc., alleging that after opting into the BPCIA’s information exchange procedures, Amgen withheld relevant confidential information and unreasonably refused expert consultant review of Amgen’s Abbreviated Biologic License Application (aBLA). … Continue reading this entry

Supreme Court Will Judge Biosimilar Patent Dance

The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz, where the Federal Circuit decided that the biosimilar patent dance provisions are optional, but pre-marketing notice always is required.… Continue reading this entry

Solicitor General Sides With Sandoz On Interpretation Of Biosimilar Statute

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

AbbVie Sues Amgen On 10 Of 100 Humira Patents

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

Federal Circuit Requires 180 Day Notice For All Biosimilars, Even After Patent Dance

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

Amgen And Sandoz Do The Biosimilar Patent Dance Over Neulasta

Amgen Inc. has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Sandoz Inc. seeking approval of a biosimilar version of Neulasta® infringes two of its patents. According to the complaint, the parties followed the steps of the biosimilar patent dance and agreed which patents … Continue reading this entry

Amgen Hedges Its Bets With Cross-Petition For Certiorari Of Biosimilar Decision

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

Amgen Launches Enbrel Biosimilar Patent Litigation

Although Sandoz’ application for FDA approval to market a biosimilar version of ENBREL® (etanercept) has yet to be approved, Amgen has brought suit under the Patent Act and Biologics Price Competition and Innovation Act (BPCIA) to enforce five patents relating to that product and approved methods of use. Some of the BPCIA issues raised in … Continue reading this entry

Sandoz Asks Supreme Court To Reverse Biosimilar Decision

On February 16, 2016, Sandoz, Inc. filed a petition for writ of certiorari to the Supreme Court, asking the Court to overturn the Federal Circuit decision that interpreted the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA) as requiring the biosimilar applicant to give 180 days’ pre-marketing notice that cannot be given until … Continue reading this entry

PTAB Denies Challenge Of Abbvie Humira Patents

The USPTO Patent Trial and Appeal Board (PTAB) denied institution of two Inter Partes Review challenges brought by Amgen, Inc. against two Humira patents covering stable formulations of anti-human Tumor Necrosis Factor alpha antibodies. The PTAB decisions illustrate the potential importance of establishing unpredictability in the field when defending against obviousness challenges.… Continue reading this entry

Biosimilar Pre-Marketing Notice Always Required

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

No Rehearing Of Biosimilar Patent Dance Decision

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

Amgen And Apotex Do The Biosimilar Patent Dance

Amgen has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Apotex, Inc. infringes two of its patents. Although several complaints have invoked the BPCIA, this may be the first one in which the patent dance provisions have been followed.… Continue reading this entry

Federal Circuit Finds Biosimilar Patent Dispute Resolution Procedures Optional

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

Federal Circuit Hears Oral Arguments In Neupogen Biosimilar Case

On June 3, 2015, the Federal Circuit heard oral arguments in Amgen v. Sandoz regarding the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). As reflected in Judge Lourie’s comments, this case requires the court to interpret a statue that should win “a Pulitzer Prize for complexity.”… Continue reading this entry

Amicus Briefs On Biosimilar Patent Litigation

Amgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. (I wrote about the court’s decision in this article.) The appeal is on an expedited briefing schedule at the Federal Circuit, and three amicus briefs have been filed. All of the amicus … Continue reading this entry

Judge Finds Biosimilar Patent Procedures Optional

Judge Seeborg of the U.S. District Court for the Northern District of California issued an order in Amgen, Inc. v. Sandoz, Inc., ruling that the patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA) are optional. If this interpretation is upheld, will any parties go through the complicated biosimilar patent dance of 42 USC § 262(l)?… Continue reading this entry

Federal Circuit Finds No Biosimilars Application Means No Case Or Controversy For Sandoz

In Sandoz Inc. v. Amgen Inc., the Federal Circuit upheld the district court decision dismissing Sandoz’s declaratory judgment action for lack of jurisdiction. Although this may be the first Federal Circuit decision relating to a possible “biosimilar” product, the court was careful to steer clear of the biosimilars statute. Apparently the judges aren’t the only … Continue reading this entry

Licensees Obtaining Data from Other Licensees

When a drug candidate is licensed to different licensees in different territories, the ability of each licensee to obtain marketing approval for the product may depend on access to data generated by the other. While license agreements do not always address this issue, there are some terms that can be useful in this type of situation. Case Study … Continue reading this entry