Samsung Bioepis and Fujifilm Kyowa Kirin Biologics are in the UK High Court of Justice this week disputing secondary indication patents for AbbVie’s bestselling monoclonal antibody Humira (adalimumab).
But the trial is only taking place due to UK judge Mr Justice Henry Carr who, in a judgement made late last month, refused to allow the lawsuit to be dropped despite AbbVie voluntarily offering to invalidate the patents in question.
Mr Justice Carr 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 then throwing in the towel just before its patents are scrutinised by the court.”
AbbVie has been vocal about its objective to protect Humira’s exclusivity through the mAb’s extensive IP , and the judge cited recent comments made to investors by CEO Richard Gonzalez “to vigorously defend all of [its] IP against anyone that potentially infringes it.”
However, the judge stated: “It is important to remember that Mr Gonzalez’s threats of worldwide litigation are intended to have, and are likely to have had, a chilling effect on competition from biosimilars, including on third-party suppliers.”
Mingi Hyun, a spokesman from the South Korean claimant Samsung Bioepis, told Biopharma-Reporter the judge’s decision to go to trial is important in breaking AbbVie’s protectionism.
“We believe that AbbVie has been attempting to obstruct the market entry of competing products by applying for a large number of overlapping patents around Humira, which could affect patient access to affordable, high-quality medication. We believe competition should take place in the market, and not through such misuse of the patent system.”
Lawful, but costly
But AbbVie’s tactics are neither unlawful nor uncommon, according to Kevin Noonan, biotech expert and partner at Chicago-based IP law firm McDonnell Boehnen Hulbert & Berghoff.
“While the type of litigation strategy AbbVie appears to be using looks vexatious, it should be remembered that each of these actions complained of by the court had consequences,” he told Biopharma-Reporter.
These include the loss of opportunity to assert a patent in the UK, and filing of divisional applications and letting allowed applications lapse. These not only delay the opportunity to seek damages for infringement but are also very costly due to annual costs associated with keeping patents in force from the European Patent Office (EPO).
“It is not the case that AbbVie is abusing the judicial or patent system; rather they are ‘playing by the rules’ and incurring the costs of doing so. Those like the learned judge may not like this, because it can have the effect of preventing cheaper drugs from coming to market,” Noonan said.
“But that isn’t AbbVie’s fault and isn’t even a patent fault; it is a distribution problem that requires drug makers to assume all the cost and risks of developing drugs and getting them approved but does not supply patients with the means to afford them.”
AbbVie – which reported worldwide sales of $14bn (€13.1bn) for Humira in 2015 – did not respond to a request for comment when contacted by this publication.