Last June, Amgen challenged two patents of Humira – US Patent No. 8,916,157 and 8,916,158 both granted in 2014 – on the grounds that the re-formulations of the biologic described were not significantly different from earlier antibody formulation patents.
Since then, Amgen made headlines by filing what it believed to be the first biosimilar version of Humira (adalimumab) in the US , ABP 501.
But a decision last week by the Patent Trial and Appeal Board (PTAB) has rejected Amgen’s inter partes review (IPR) challenge, saying:
“Amgen has not persuaded us, on this record, that it is reasonably likely to prevail in establishing that a skilled artisan would have had a reasonable likelihood of success in combining Salfeld and Heavner [two antibody-engineering techniques] to arrive at the claimed antibody formulation.”
But according to Lisa Mueller, an life sciences IP lawyer at Michael Best & Friedrich LLP, although the decision is a disappointment for Amgen and a win for AbbVie, “the game is far from over.”
“While it would have beneficial for Amgen to get the two patents knocked out using the IPR procedure, it seems like these patents Amgen and AbbVie are headed for a knock-down drag them out fight in court over these patents,” she told Biopharma-Reporter.com.
Dancing the dance
Amgen has been involved in patent litigation issues from the other side of the biosimilar fence, entering a series of litigation provisions in the build-up of Sandoz’s biosimilar challenge to its the neutropenia drug Neupogen (filgastrim).
The correspondence and good-faith negotiations between a reference product sponsor and the biosimilar applicant has been termed the "patent dance." Sandoz’s Zarxio was launched in September last year, and became the first biosimilar on the US market.
But going forward, “it will be very interesting to see what Amgen decides to do about participating in the patent dance,” Mueller said. “Will they or won’t they dance? Given that they have argued that the dance is mandatory, will they change their tune now that they are on defense instead of offense?”
AbbVie, meanwhile, has continued to assure its shareholders its extensive patent maze will keep biosimilar competition away until at least 2022. However, the firm is still facing three IPRs from Coherus Bioscience over three of its method of treatment patents, Mueller said.
“Is Abbvie safe from biosimilar protection until 2022? I think that it is way too early to tell.”