Tagged as: Federal Circuit

Federal Circuit Affirms PTAB Finding that Rituxan® Biogen Patent is Invalid

As we previously reported, in October 2018, Pfizer persuaded the Patent Trial and Appeal Board (PTAB) that the claims of Biogen’s U.S. Patent No. 8,821,873, directed to a method of treating lymphoma with anti-CD20 antibodies and covering the cancer therapeutic RITUXAN (rituximab), were unpatentable on obviousness grounds. After appealing to…

Read More

Federal Circuit Affirms PTAB Finding that Dupixent® Immunex Patent is Obvious

As previously reported, in February 2019, the Patent Trial and Appeal Board issued final written decisions in two IPR proceedings initiated by Sanofi challenging the U.S. Patent No. 8,679,487 (the ’487 patent) owned by Immunex.  In IPR2017-01884, the Board held that the challenged claims of the ‘487 patent were unpatentable…

Read More

BREAKING NEWS: Federal Circuit Denies Genentech’s Appeal to Block Sales of Amgen’s MVASI (bevacizumab-awwb)

Today, in the Genentech v. Amgen BPCIA litigation concerning Amgen’s MVASI (bevacizumab-awwb) biosimilar product, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the district court’s denial of Genentech’s motions to enjoin sales of MVASI in the United States.  MVASI is an FDA-approved biosimilar of Genentech’s…

Read More

Divided Federal Circuit Affirms Result in Immunex v. Sandoz Etanercept Litigation

We previously reported on the decision by the District of New Jersey (Cecchi, J.) to uphold the validity of U.S. Patent No. 8,063,182, related to “the fusion protein etanercept, the active ingredient in Immunex’s product ENBREL” and U.S. Patent No. 8,163,522, related to ENBREL’s method of manufacture.  As we reported…

Read More

Supreme Court Denies Cert on 5th Amendment Constitutionality of Subjecting Pre-AIA Patents to IPR

Today, the Supreme Court denied three petitions for certiorari challenging the constitutionality of subjecting patents issued prior to the America Invents Act (“AIA”) to inter partes review (“IPR”).  See Celgene v. Peter; Collabo v. Sony Corp.; Enzo v. Becton, Dickinson and Company.  In all three underlying cases, the U.S. Court of Appeals for the Federal Circuit had…

Read More

Federal Circuit Finds Pfizer’s RUXIENCE Plans Insufficient to Establish Standing to Appeal IPR

On April 27, 2020, the Federal Circuit issued a non-precedential opinion ruling that Pfizer failed to establish Article III standing in a pair of IPR appeals.  At the PTAB, Pfizer had challenged the validity of Chugai’s patents (7,332,289 and 7,927,815) covering processes relevant to the manufacture of rituximab.  In support…

Read More

Federal Circuit Denies Hospira’s Petition to Rehear Safe Harbor Ruling in Epoetin Biosimilar Dispute

The Federal Circuit has declined to reconsider its December 2019 affirmance of the district court ruling in the Amgen v. Hospira (epoetin alfa) dispute.  As we have previously reported, that ruling upheld a jury verdict finding (among other things) that Hospira’s manufacture of certain drug substance batches was not protected…

Read More

Federal Circuit Hears Argument Regarding the Denial of Genentech’s Motion to Preliminarily Enjoin Amgen’s Sales of Trastuzumab

We previously reported on Genentech’s appeal of the district court’s denial of Genentech’s motion for a preliminary injunction against Amgen’s launch of trastuzumab. Yesterday, a Federal Circuit panel (Judges Prost, Wallach, and Bryson) heard argument regarding on Genentech’s appeal. The argument, much like the appellate briefing, focused on the issue…

Read More