Insufficiency attacks under the microscope – Supreme Court appeal

As the Supreme Court considers the law of sufficiency this week in Regeneron v Kymab, we look at a recent decision which will feature in the consideration.

12 February 2020

Publication

Background

Near the end of 2019, the Court of Appeal rejected two forms of insufficiency attack 1 . This endorsed the Patents Court’s finding that Rhodia’s patent – concerning catalysts used to clarify exhaust gases – was valid and infringed by Neo (see our article here, discussing the perils of hindsight when arguing obviousness and how ‘fuzzy boundaries’ can defeat insufficiency attacks).

One of the rejected attacks in Rhodia was breadth of claim (aka Biogen) insufficiency, which the decision considered at length, dissecting the leading precedents and giving useful guidance. In doing so, the Court of Appeal endorsed their decision to find the patent valid in Regeneron v Kymab, the appeal of which is being heard by the Supreme Court this week 2 .

The second rejected attack was what used to be called ‘ambiguity’ insufficiency, which the Court of Appeal reclassified as ‘uncertainty’ insufficiency.

We look at how this case has developed the law in these areas.

‘Excessive breadth’ insufficiency

As is common, Neo based this attack around technical contribution: arguing that the patent’s only contribution was the particular method of achieving an essentially pure product and that it was unjust to have a monopoly over that end result however achieved.

Lord Justice Floyd set out 4 fundamental points for running this type of argument:

  1. The burden is on the party seeking revocation;
  2. There is no general rule that one method of making is enough and a patent must enable the claim across its breadth;
  3. Not every infringement must be enabled (especially ‘improvement inventions’); and
  4. Claims may include broad terms based on inventions of general principle, including embodiments that may arise from following the patent or other embodiments which may come along (termed ‘components of the future’).

The decision goes on to draw out 6 more key teachings from dissecting the different outcomes in Biogen and Lundbeck, the existing House of Lords precedents. Of particular note is the point that product claims can offend this principle, in particular where they are functionally defined. Therefore, Rhodia’s argument that its product claim was immune to this attack was rejected.

However, while Neo was allowed to pursue the attack in principle, the Court held it was not supported by the evidence. Neo did not positively establish that there were structures covered by the claim which could not be made with the benefit of the patent’s teaching. The decision suggests that Neo should have identified the offending products/structures in question, shown that they fell within the claim (so to be accountable to exceeding the contribution) and then proven that those products could not be replicated by Rhodia’s method (either as set out or with tweaks based on common general knowledge). Neo’s evidence was said not to take them “nearly far enough”.

‘Uncertainty’ insufficiency

This issue revolved around a critical claim integer: “consisting essentially of”. The construction of this term was not appealed, settling the issue that the EPO approach provided appropriate and sufficient guidance on its construction. Nonetheless, Neo maintained that this term rendered the claim insufficient as a matter of ‘ambiguity’, based on the seminal House of Lords decision in Kirin Amgen.

At the outset, the Lord Justices were keen to reclassify this attack as ‘uncertainty’ insufficiency. Supporting Lord Justice Floyd’s leading judgment, this particularly came out in the shorter judgment of Lord Justice Lewison (these two forming what looks to set to be a new ‘patent power pairing’ following the ascension of Lord Kitchin to the Supreme Court). In this respect, they endorsed the approach in Kirin Amgen, and the (now) Arnold LJ’s decisions in Sandvik and Generics v Yeda.

Emphasising also that a fuzzy boundary may be acceptable and sufficient, the decision went on to dismantle Neo’s attack and surmised that it failed on principle, pointing out: (i) this is not a case where the criterion to apply was unclear such that the task faced was impossible; (ii) part of the attack did not appropriately take into account that the person trying to work the invention was skilled in the art; and (iii) there was a lack of evidence that attempts to work the invention were in fact an undue burden at all.

An uphill battle for ‘uncertainty’ insufficiency attacks?

The decision emphasises the high evidential burden for success of an ‘uncertainty’ insufficiency attack, as well as the importance of pleading the right point of principle to be able to pursue it. While the Court was quick to dismiss the patentee’s submission that simply being able to do something within the claim was enough, the party seeking revocation nonetheless faces the uphill task of showing a sufficiently “large territory (more than a fuzzy boundary) where the claim is uncertain”. They may even need to go so far as to prove that the skilled person seeking to work the invention would think that he or she “was being asked to perform the impossible”.

Need for clear evidence to support excessive breadth insufficiency

A high evidential burden is again significant for success under ‘excessive breadth’ insufficiency, which is emphasised by how far Neo is held to have fallen short. This strikes a chord with the EPO approach, where the well-established phrase of “serious doubts, substantiated by verifiable facts” commonly appears in respect of a party failing to make a successful Article 83 EPC attack. Questions will no doubt be asked as to whether the UK is now (if it has not always been) more on a par with EPO practice, as there have been a number of cases where the UK Courts have found patents insufficient which have been upheld at the EPO.

Regeneron v Kymab was an example of this as the Patents Court first held that Regeneron’s patent was insufficient. This was at odds with the EPO until the Court of Appeal overturned the first instance decision. Lord Justice Floyd refers to and endorses his (and the now Lord Kitchin’s) decision in Regeneron as a ‘components of the future’ case, where claims may include broad terms and avoid insufficiency where they are based on inventions of general principle. That issue is now being debated in the UK’s highest court.

The burden lies with the attacking party

Something that is notable in the Rhodia decision is the absence of any detailed discussion of what the technical contribution of Rhodia’s patent actually was, or how it was not exceeded. The decision emphasises the importance of the first of Lord Justice Floyd’s opening 4 points, namely that the burden lies with the party seeking revocation. Where a challenger is able to build prejudice (for example, by proving the existence of ‘inoperative embodiments’), a patentee may be forced to articulate what its patent does (or did) contribute. This can sometimes result in the patentee offering up multiple positions in a form of target practice for an eager challenger to try to shoot each one down. However, where such inroads are not achieved, as was the case here, a patentee may avoid having to face down these barrels.

The importance of the Rhodia decision

The Rhodia decision looks set to become a significant precedent, not least for laying the foundations for what will now be called ‘uncertainty’ insufficiency. As for ‘excessive breadth insufficiency’, its importance will be influenced by the upcoming Supreme Court ruling in Regeneron v Kymab. That decision will be eagerly awaited to shed further light on this area of law.


1 Anan Kasei Co. Ltd & Rhodia Operations S.A.S. v Neo Chemicals and Oxides Limited & Neo Performance Materials Inc, Court of Appeal, London, 9 October 2019, [2019] EWCA Civ 1646
2 Regeneron Pharmaceuticals Inc (Respondent) v Kymab Ltd (Appellant) - UKSC 2018/0131

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