AbbVie faces challenges to Humira patents
Coherus has shown a “reasonable likelihood” that it will win the challenge, the Patent Trial and Appeal Board said Tuesday, instituting a formal review of the patent.
The patent, issued in 2014 on an application filed in 2002, covers the biweekly dosing of Humira to treat rheumatoid arthritis.
Coherus claimed the patent is invalid because the dosage regimen it covers was a “routine optimization of the therapy” that was known by researchers.
AbbVie had urged the board not to review the patents, saying Coherus “merely rehashes the same arguments thoroughly considered by the examiner” during the application process and uses hindsight to ignore “critical efficacy and safety issues.”
“At this stage of the proceeding, and based on the current record, we are persuaded that there is a reasonable likelihood” that Coherus would prevail in its argument, the three-member panel of administrative patent judges wrote.
Loss of patent protection or the entrant of a biosimilar version of the drug could have a “material adverse impact” on AbbVie’s operations, the company said in its annual report.
The review process at the agency has been criticized by the pharmaceutical industry because it has a high rate of decisions invalidating patents.
The company owns patents for “all aspects of its manufacture, formulation and indications and the patents are the result of AbbVie’s investment in biologic innovation and the unique attributes of Humira,” the company said in a statement.