Last week, the Patent Trial and Appeal Board issued a final written decision in IPR2016-01771, filed by Hospira to challenge U.S. Pat. No. 7,622,115. The Board invalidated all 5 claims…
Last week, the Patent Trial and Appeal Board issued a final written decision in IPR2016-01771, filed by Hospira to challenge U.S. Pat. No. 7,622,115. The Board invalidated all 5 claims…
Last week, the Patent Trial and Appeal Board (“Board”) denied institution of four IPR petitions on biologics-related patents. First, the Board denied institution of IPR2017-01987…
JHL Biotech Inc. announced last week that it received approval from the Bulgarian Drug Agency for a Phase I clinical trial of its proposed bevacizumab (Avastin) biosimilar, JHL1149. The trial,…
Genentech v. Pfizer (trastuzumab): On February 12, 2018, the parties filed a joint status report. Among other things, the parties offered their competing proposals for discovery deadlines. The…
According to a Celltrion press release, this week investigators presented twelve-month data from a UK-wide, three-year prospective observational study showing comparable efficacy between…
The American Society of Clinical Oncology (ASCO) recently issued a statement on use of biosimilars in oncology. According to ASCO, “[a]s many biosimilars come to market in the next…
As we previously reported, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and…
After a committee hearing on the price of rheumatoid arthritis drugs last week, Senator Susan Collins (R-ME) announced that she is working on a bill designed to lower drug costs….
The PTAB has denied institution of inter partes review of two Abbvie patents that relate to HUMIRA (adalimumab). On February 9, 2018, the PTAB denied Sandoz’s IPR2017-01824 on U.S. Patent…
On February 7, 2018, Lupin announced positive results from a Phase III clinical trial for its etanercept biosimilar candidate, YB113. YB113 is being developed by YL Biologics, a joint venture…