By: Dominic Adair
(Dominic specialises primarily in patent litigation with a focus on life sciences - Dominic.Adair@bristows.com)
In a first-of-its-kind judgment in the UK, given on 3 March 2017, Mr Justice Henry Carr awarded biosimilar companies Fujfilm Kyowa Kirin Biologics (FKB) and Samsung Bioepis (SB) a declaration having the effect that their biosimilar adalimumab products are immune from future infringement suits concerning certain dosage regimen patent families. The immunity derives from the ruling having made clear that the products themselves were nothing more than obvious modifications of the state of the art at the priority date of the families concerned. Hence any patent family member which later granted under the same priority date could not be valid if it included the biosimilar products within its scope. Patent lawyers will appreciate that this deploys the well-known squeeze argument that forces a patentee to fail on either the infringement or validity argument by utilizing the prior art: any defendant working the prior art is always safe – if the patentee argues infringement on the basis that the prior art is within the scope of the patent, he loses on validity, and vice versa (to remain valid, the scope of the patent must avoid the prior art).
The reason why the relief granted was in this form relates to the fact that AbbVie had no granted patents in the UK which FKB and SB could revoke. Hence the declaration was aimed at protecting against pending applications which may grant in future. This is highly unusual. Normally, the court will say that a party must wait and see whether a patent grants before spending resources on hearing a case and giving judgment. The patent may not grant at all. Or it may grant with limited claims which no longer present an obstacle. The courts would be log-jammed if any party could apply at any stage for a declaration against pending applications. More seriously, the courts are not permitted by statute to adjudicate on the validity of pending applications. Only granted patents may be revoked by the courts; it’s the job of the patent offices to determine the validity of pending applications. The Fujifilm declarations sidestep this issue by being focussed on the products, not the patents, and deploying the squeeze instead.
Notwithstanding that the legal basis for awarding the declarations is sound, the court has made it clear that special reasons need to exist in any given case in order for the declaration to be granted. Again, this comes down to policy: normally parties are expected to wait and see, and the courts have finite resources. So what happened in this case? As the judgment makes clear, AbbVie was alleged to be shielding its patents from judicial scrutiny. Although, at the start of the UK litigation, a granted patent was in issue, FKB seeking to revoke, AbbVie pulled the plug on that patent at the European Patent Office by disapproving of the granted text. This left FKB without a target at which to shoot. Part way through the proceedings, another patent in the family granted at the EPO. This time, AbbVie cancelled the UK as one of the designated countries. AbbVie was alleged to have pursued similar tactics in a closely related set of proceedings between the same parties, dealing with another patent family. The result was the same – adjudication was avoided on the granted patents covering the UK. During the course of the two sets of proceedings, AbbVie aimed to strike out the claim for the declaration on the ground that there was no legal basis. These strike out claims were dismissed and the decision upheld by the English Court of Appeal on 12 January 2017.
Shortly before trial, AbbVie tried a different tactic and offered undertakings not to pursue any future patent protection in the UK for the patent families in suit. AbbVie then sought summary judgment on the basis that there was nothing left to fight for: FKB and SB had achieved the deep clearance that they were seeking. This final move by AbbVie was also rejected and the judge allow the case to go to trial, which was heard in early January. In the judgment that followed, Henry Carr J makes clear that AbbVie’s conduct is one of the reasons the declarations were granted. The biosimilar companies needed commercial certainty and AbbVie was seeking to perpetuate a state of uncertainty. Furthermore, themarket is large and valuable and the declarations give third parties some clarity. Yet further, the declarations will give greater security to FKB and SB’s supply chain for the UK market by making less likely the risk of a preliminary injunction abroad, owing to the export value of the English judgment. The judge also considered that the declarations might promote settlement.
Interestingly, although this judgment marks a first in English jurisprudence, the idea is not new. It was first put forward 10 years ago by Arrow Generics in the alendronate litigation with Merck (the case settled before trial). The declarations are often called Arrow declarations in homage to that case. But the idea then gathered dust for a decade before being re-born in the adalimumab litigation. In many ways, it is well suited to biosimilars litigation: the high value of the market and huge investment by both originators and biosimilars creates an environment in which dense thickets of patents exist, with deep roots into pending applications, but in relation to which the biosimilars have an real need for commercial certainty.
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