Arrow declaration hits home - the Humira biosimilar litigation

Arrow declaration granted

Following the Court of Appeal’s decision on the availability of Arrow declarations, discussed here, the Patents Court has now followed up with the grant of a declaration. This will free up UK sales of biosimilar Humira-like products from the threat of patent litigation.

The court’s ruling that the biosimilar products and dosing regimes planned by Fujifilm Kyowa Kirin Biologics and Samsung Bioepsis/Biogen were obvious by the priority date of AbbVie’s patent application means that no future divisionals filed by AbbVie can impede sales. And while not effective beyond UK borders, a reasoned analysis like this can be influential, particularly in other European courts.

Analysing what was commonly known among rheumatologists with the appropriate pharmacological input, alongside research papers published by the inventing team, the judge concluded that the planned dosing regimen of 40mg once every two weeks by subcutaneous injection was obvious in June 2001.

Chilling behaviour

This kind of declaration will remain unusual. The main way to clear a path for a potentially infringing product will be to apply for revocation of any patents that stand in the way. This is the route provided by the Patents Act 1977, and should be followed in normal circumstances. But in exceptional cases the availability of the Arrow declaration will be important, and the fact that it exists as an option should deter patentees from strategic behaviour designed to ‘chill’ competition.

The judge’s negative comments on AbbVie’s strategy are telling:

"I consider that the intention and the objective effect is to shield its patent portfolio from examination of validity whilst continuing to file further divisionals and to threaten infringement proceedings against biosimilars, wherever they may be launched."

and

"subsequent events have confirmed, in my judgment, that AbbVie has abandoned all relevant UK patent protection in order to avoid scrutiny by the UK Court, and to prolong commercial uncertainty as to the validity of those patents."

Special reasons and a useful purpose

AbbVie contended that the declaration would not serve a useful purpose, because it had itself removed any UK patents which could cover the planned dosing regimes, and it had given undertakings to the court not to obtain future UK protection for the dosing regimes. This failed to convince. The declaration was not “the legal equivalent of shouting in an empty room” – it offered much-needed commercial certainty and could have wider benefits, such as promoting settlement.

"I consider that, on the most unusual facts of this case, there are special reasons which support the grant of the declarations. These include AbbVie’s conduct of threatening infringement whilst abandoning proceedings at the last moment (in order to shield its patent portfolio from scrutiny); the amount of money at stake for the Claimants in terms of investment in clinical trials and potential damages if they launch at risk; and the need for commercial certainty, having regard to AbbVie’s threats to sue for infringement throughout the world."

Tax-driven restructuring puts priority at risk

The decision also looks at questions around complex intra-group arrangements concerning IP ownership. A tax-driven restructuring after the acquisition of BASF Pharma by Abbott in 2001 involved transfer of IP assets into two Bermudan companies. Analysis under German contract law led the judge to conclude that, although there were errors and inconsistencies in the documents, Abbott Bermuda was “successor in title” to the priority filing at the time of filing the PCT application.  

Although the decision on this point is very fact specific, it does highlight the risks involved in moving IP around in corporate restructurings. If the decision had gone the other way the AbbVie patents would have been exposed to an additional year of prior art.

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