Intellectual property

Implausible declarations?

Published on 17th Oct 2022

What a recent English Patents Court judgment suggests for the future of litigation

Users of the English Patents Court will be aware of the many forms of relief available when faced with the threat of patent infringement. In the recent decision of Sandoz v BMS [2022] EWHC 822 (Pat) litigators may have been handed another arrow to their bow. In giving judgment, Mr Justice Meade concluded that the patent in suit (for apixaban and also for its use as a factor Xa inhibitor to treat a thromboembolic disorder) was invalid "by reason of lack of plausibility". This was despite acknowledging that a lack of plausibility is not itself a ground of revocation (which are comprehensively set in the European Patent Convention 1973 and enacted in the UK by the Patents Act 1977). 

Technical contributions and plausibility

Back in the early 1990s, in AGREVO/Triazole (T-939/92), the European Patent Office's Technical Boards of Appeal made it clear that "the patent monopoly should correspond to and be justified by the technical contribution to the art". A patent is a public monopoly granted by the state: the patentee is required both to make some technical contribution and disclose that contribution to the public in exchange for the monopoly. In AGREVO, this was expressed in terms of making a "credible" contribution but, over time, that has been replaced by a requirement that the contribution be "plausible', or that the patent "make a technical contribution".

The same has long been the case under English law with the House of Lords and Supreme Court confirming in a series of decisions that a patent must make a technical contribution in order to be valid, starting with Conor v Angiotech [2008] UKHL 49 (in the context of obviousness) through to Warner Lambert v Generics [2018] UKSC 56 (sufficiency) via HGS v Eli Lily [2011] UKSC 51 (industrial application).

If one is faced with a speculative patent that claims (or the patentee may argue claims) your product and there is a real risk of a patent infringement claim being brought, the message is clear: that patent can be invalidated for failing to make a technical contribution. But what if the patent, or series of patents, posing the threat haven't yet been granted and you are concerned that an injunction may prevent or reverse a planned product launch? A patent application can take many years to be processed and section 74 of the Patents Act 1977 means that a patent cannot be invalidated until after it has granted.  

Forms of relief

Fortunately, in parallel with these developments in patent law, the English courts have shown themselves to be adaptable in creating many novel forms of relief over the years. This has especially been the case for declaratory relief, an inherent power of the court whether or not any other remedy is claimed (Civil Procedure Rule 40.20) and declarations have been sought and granted for a wide range of purposes.

The grant of declaratory relief is discretionary. In order to engage the court's discretion it must be shown, among other things, that the requested declaration would serve a useful purpose. If a useful purpose can be shown then even a negative declaration can in principle be granted (see Messier-Dowty v Sabena [2001] 1 All ER 275, which made clear that declaratory relief in relation to commercial disputes should not be constrained artificially by artificial limits wrongly related to jurisdiction). For example, the Court of Appeal confirmed in Nokia v InterDigital [2006] EWCA Civ 1618 that it was prepared to grant a "declaration of non-essentiality" in the context of telecommunication patents that had been declared to the standard setting organisation the European Telecommunications Standards Institute.

Those practicing in the life sciences field will be particularly familiar with "Arrow declarations", named after the decision in Arrow v Merck [2007] EWHC 1900 (Pat). Arrow declarations came about initially to solve the problem created by the English courts' requirement for a generic manufacturer to "clear the path" of patents that may be infringed ahead of launching a product, under sufferance of a preliminary injunction whilst at the same time not being able to challenge a patent until it grants. Such a problem can be exacerbated by an innovator holding numerous patent rights that need to be invalidated before launch, creating a thicket impossibly thick to clear.

An Arrow declaration neatly circumnavigates such problematic patents by asking the court to state that the relevant product (or its use) was obvious at the priority and/or filing date of the patents. If successful, this gives the would-be infringer certainty that its intended launch can go ahead.  Either the patent in question will be invalid (because the product or use was obvious at the relevant date) or, if valid, cannot cover the product or use in question. It is effectively a Gillette defence without putting the validity of the patent in issue.

In Fujifilm v AbbVie [2017] EWCA Civ 1, Lord Justice Floyd in the Court of Appeal at paragraph 98 summarised why the court considered it right to grant Arrow declarations in appropriate cases, concluding that whether a declaration is justified depends on whether a sufficient case can be made for the exercise of the court's discretion in accordance with established principles.

This relief is not limited to the life sciences field – in Mexichem v Honeywell [2020] EWCA Civ 473, which concerned refrigerant gases, the Court of Appeal made clear that whilst the declaration must be formulated with clarity, "there is no threshold requirement for the grant of an Arrow declaration that the party seeking it must have a fully formulated product description, far less that it must have a product in actual production." What needed to be established was that it would be useful for the specified features of the relevant product to be declared old or obvious.

Declarations of implausibility?

How does all this relate to Sandoz v BMS, in which a speculative patent was invalidated for making no plausible contribution?

What about if the patent in suit had instead still been at the application stage, such that a direct challenge to its validity was not possible? The putative infringer would still need to know where it stood in the face of a patent application which had made no technical contribution but which could yet grant and be asserted. The claimed invention may not have been obvious at the priority date, so a court would not grant Arrow declaratory relief.

In the right circumstances, why not ask the court for a "declaration of a lack of plausibility" (or implausibility), or a "declaration of a lack of technical effect"?  If the resultant declaration would serve a useful purpose and if the patent's priority document or filing made no technical contribution such that any patent emerging from it should be held to be invalid, then it seems to this author that Sandoz v BMS leaves the door wide open to the English court entertaining such a request.

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* This article is current as of the date of its publication and does not necessarily reflect the present state of the law or relevant regulation.

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