AbbVie patent on Humira may be invalid, U.S. agency says
One of AbbVie Inc.'s patents on its top-selling arthritis drug Humira may be invalid, a U.S. agency said, agreeing to consider a challenge filed by Coherus Biosciences Inc.
Coherus has shown a "reasonable likelihood" that it will win the challenge, the Patent Trial and Appeal Board said in an opinion Tuesday instituting a formal review of the patent
The patent, issued in 2014 on an application first filed in 2002, covers methods of administering anti-TNFa antibodies to treat rheumatoid arthritis. The agency is still considering petitions Coherus has filed on three other Humira patents.
Coherus claimed the patent is invalid because the dosage regimen it covers was a "routine optimization of the therapy" that was known by researchers. It's made similar arguments seeking to cancel two other Humira patents. The third patent, subject of a petition filed May 9, covers a formula to make the drug.
North Chicago-based 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."
The patent office, in agreeing to review the patent's validity, said AbbVie's arguments are "best resolved during trial." A final decision in the case is expected in a year.
$14 Billion in Sales
"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.
Humira, given by injection, is AbbVie's biggest drug, generating $14 billion in 2015 sales, about 61 percent of the company's revenue.
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.
Coherus rose $3.41 to $19.68 before shares were halted. It had earlier jumped as much as 23 percent to $19.93. AbbVie fell $2.50, or 4 percent, to $59.95 at 10:38 a.m. after falling as low as $58.50.
Final Decision
Coherus said it's confident the final decision will end in the cancellation of the AbbVie patent. Chief Executive Officer Denny Lanfear said the decision to review the AbbVie patent, along with the company's new patents for its own formulation, is "clear validation" of the company's plans.
"We will continue to aggressively press forward with the development and commercialization of our Humira biosimilar consistent with our corporate strategy," Lanfear said.
Officials with AbbVie didn't immediately return messages seeking comment.