Today, the PTO announced proposed rulemaking to change the claim construction standard applied by the PTAB in IPR, PGR, and CBM proceedings. In particular, the PTO proposes replacing the broadest reasonable interpretation standard for construing unexpired patent claims with the standard applied in federal district courts and ITC proceedings as…
Amneal Pharmaceuticals LLC and Impax Laboratories, Inc. announced today that they have completed their business combination to form Amneal Pharmaceuticals, Inc. (“Amneal”). According to the press release, with the completion of this business combination, Amneal is now the 5th largest generics business in the United States. Amneal also states that,…
Last June, we reported that Coherus BioSciences had received a Complete Response Letter (CRL) from the FDA for CHS-1701, a proposed biosimilar to Neulasta® (pegfilgrastim). Later, in August, we reported that Coherus had anticipated resubmitting its BLA in response to the CRL. Today, Coherus announced that it has resubmitted its BLA…
Yesterday, Sandoz announced that the FDA has issued a Complete Response Letter (CRL) regarding its aBLA for its proposed biosimilar of Rituxan® (rituximab). Sandoz states that it “stands behind the evidence that it submitted to the FDA and that, “[w]hile disappointed, Sandoz remains committed to further discussions with FDA in…
As we reported last month, many state legislatures have passed or are considering biosimilar substitution bills. Alaska, Connecticut, New Hampshire, and Vermont are the latest states to join this list. Last week, the Alaska legislature passed SB 32, entitled “Prescriptions for Biological Products,” which allows substitution of “an interchangeable biological…
We previously reported that on December 21, 2017, Genentech filed suit against Sandoz in the District of New Jersey based on Sandoz’s proposed rituximab biosimilar, Rixathon/GP2013. On April 23, 2018, Judge Renee Marie Bumb held an in-person status conference and set forth a preliminary injunction briefing schedule. The Court ordered the motion for preliminary…
As we reported earlier this week, the Supreme Court held in SAS Institute Inc. v. Iancu that when the PTAB institutes an IPR, it must decide the patentability of all challenged claims. The U.S. Patent and Trademark Office yesterday issued guidance on the impact of SAS. The guidance explains that going forward: …
We previously reported that in the ongoing Genentech v. Amgen litigation regarding Amgen’s proposed bevacizumab biosimilar, Mvasi™, Amgen moved to dismiss Genentech’s declaratory judgement counts relating to when Amgen could begin commercial marketing of its product. In particular, Genentech had sought a judgment that Amgen could not market its product…
Today, in the Immunex v. Sandoz patent litigation under the BPCIA concerning Sandoz’s Erelzi™ (etanercept-szzs) biosimilar, New Jersey District Judge Claire C. Cecchi issued an order that trial will commence on September 11, 2018. (Trial had originally been slated to begin this month.) The Court also ordered the parties to…
AbbVie recently announced positive results for upadacitinib, a small molecule Janus Kinase (JAK) inhibitor, in a phase 3 clinical trial of patients with rheumatoid arthritis (RA). According to AbbVie, upadacitinib met all primary and secondary endpoints in the study, including superiority versus adalimumab, the anti-TNFα antibody that Abbvie markets as…