A landmark case concluded Friday with the UK High Court ruling in favour of Fujifilm Kyowa Kirin Biologics and Samsung Bioepis in respect of the validity of various dosing regimens for rheumatoid arthritis, psoriasis and psoriatic arthritis of AbbVie’s bestselling monoclonal antibody Humira (adalimumab).
Both companies welcomed the result in statements sent to Biopharma-Reporter.com, with Fujilfilm spokeswoman Kana Matsumoto telling us that while the ruling is specific to the UK, “we expect it to be influential in other European countries.”
This was supported by Mr Justice Henry Carr who hinted in his final judgement (paragraphs 411 and 412) that his decision may have influence in other markets. However, Kevin Noonan – partner at Chicago-based IP law firm McDonnell Boehnen Hulbert & Berghoff – said this is not necessarily the case.
“The effect of the UK court’s decision is restricted to the UK and AbbVie’s UK patent rights,” he told us. “The decision will likely provide the basis for [Fujifilm and Samsung’s] challenges in other jurisdictions but it isn’t binding.”
And AbbVie remained resolute the trial result will not have implications outside the UK.
“AbbVie has already surrendered its UK patents which would expire after October 2018. The UK result is not relevant to the US litigation nor is it predictive of the result,” spokeswoman Adelle Infante told us in an email.
Fujifilm is looking to bring its adalimumab biosimilar FKB327 to market, and reported success in Phase III trial in October 2016. Samsung Bioepis’s version, SB5, was accepted for review by the European Medicines Agency last July.
The proceedings took place despite AbbVie voluntarily invalidating the questioned patents on orders from Justice Carr who accepted a contention made by the claimants that AbbVie has a “well-established strategy of dragging out proceedings for as long as possible, causing maximum expense and inconvenience to its opponents.”
And while in January he further criticised the reference drug maker for using vexatious litigation to stave off biosimilar competition, Noonan told us the final judgement is unlikely to change AbbVie’s conduct regarding future IP litigation.
“AbbVie didn’t do anything wrong and the argument could be made that they were paying a price in terms of protection – and risking that protection – by pursuing this strategy. The strategy may require a re-think, at least with regard to perception, but it isn’t that earth-shattering.”
Genetech vs Amgen
In related biosimilar legal news, the US District Court of Delaware has dismissed Genentech’s Complaint against Amgen regarding the latter’s failure to comply with the patent dance provisions of the Biologics Price Competition and Innovation Act (BPCIA) by providing a copy of its aBLA referencing Avastin (bevacizumab) within 20 days.
“The case was dismissed without prejudice because the district court felt bound by the Federal Circuit’s Amgen v Sandoz decision, which is before the Supreme Court,” Noonan said.
“The thinking is that we should have the Court’s decision by the end of June. Genentech was pressing the district court for a speedy resolution, which the court was not willing to do.”