Validity and infringement update

Posted on 09 January 2018

Validity and infringement update

Supreme Court re-writes rules on scope of patent protection

In its groundbreaking decision in July 2017 between Eli Lilly and Actavis relating to pemetrexed, the Supreme Court fundamentally revised the UK approach to the scope of protection of patent claims, and confirmed the role to be played by a doctrine of equivalents. In doing so, the Court considered and re-formulated the Improver questions on patent infringement, and also clarified the 'sceptical, but not absolutist, attitude' that should be taken to the prosecution history of a patent when determining its scope. As a result of its more generous approach to construction, compared to the High Court and Court of Appeal, the Supreme Court overturned those courts' findings on direct infringement, finding that Actavis's generic product would directly infringe Lilly's pemetrexed disodium patent (and would also indirectly infringe). Actavis's product did not include the disodium salt referred to in claim 1 of the patent, but included as the active ingredient (a) pemetrexed itself (i.e., the free acid), or pemetrexed with the hydrogens on the two -CO2H units replaced by (b) tromethamine, or (c) potassium.

The Supreme Court's judgment has already had significant ramifications in determining the scope of protection in future infringement and validity cases, and in its impact on the drafting of patent claims.

The proper approach to the scope of protection and variants (per Lord Neuberger)

  1. Does the variant infringe any of the claims as a matter of normal interpretation? 
    Whilst not considered by the Supreme Court, this has been understood in subsequent cases to mean purposive construction, not literal construction. 
  2. If not, does the variant nonetheless infringe because it varies from the invention in a way or ways which is, or are, immaterial?
    This is to be assessed by reference to the revised Improver questions.

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Patents Court considers new approach to scope of claims

The Patents Court has considered the Supreme Court's approach to scope of claims in a number of cases already. The first was a case concerning validity (Mylan & Synthon v Yeda & Teva relating to copaxone), suggesting, subject to a definitive further ruling from the Supreme Court on the issue, that the approach to assessing the scope of a claim for novelty and infringement purposes no longer remains the same. Consequently, whilst a claim could be infringed by a person doing exactly what the prior publication teaches, it could still be novel over that publication.

Reviewing the Supreme Court's approach, Arnold J considered that, before considering the question of equivalents, the approach to the construction of patent claims remains a purposive one. Whilst Lord Neuberger may have 'eschewed' the expression 'purposive construction' in Actavis v Lilly, he had clearly not intended to have meant that the purpose of the document, namely to describe and claim an invention, should no longer be considered.

Before Actavis v Lilly, it had long been settled law that the scope of a claim was the same for both novelty and infringement (a patentee should not be able to claim a broad scope for the purposes of infringement, but a narrower one for the purposes of validity). Arnold J agreed with Yeda/Teva that it is now no longer the law that a claim lacks novelty if the prior publication disclosed subject matter which, if performed, would necessarily infringe the claim. Instead, a claim will only lack novelty if the prior art publication disclosed subject matter which fell within the claim on its proper interpretation. It is not sufficient if the subject matter would infringe the claim applying the doctrine of equivalents. 

The decision also confirms the limited role for Arrow declarations, which will depend upon the facts of the case and the patentee's conduct.

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Arnold J's approach was subsequently followed in Fisher & Paykel Healthcare v ResMed Ltd, in a claim concerning CPAP devices – albeit the Deputy Judge noted these points were arguable, and would no doubt be considered afresh by the Court of Appeal and possibly the Supreme Court in due course.

It was also followed in Illumina v Premaitha, a substantial dispute involving five patents, concerning non-invasive prenatal diagnostic testing. The Judge, Henry Carr J's, decision concerning the first patent (Lo 1) raises a host of further interesting issues including:

  • Obviousness: the Judge considered the Actavis v ICOS decision on when steps can be characterised as so routine that the skilled person would carry them out irrespective of any prospect of success. Here, however, the prior art presented fundamentally flawed data and there was no fair expectation of success in the light of it.
  • Priority/enablement: the Judge reviewed statements by Lord Hoffman in Kirin-Amgen and Lord Neuberger in Actavis v Lilly and concluded that "…  fairness to the patentee may require that unforeseeable variants, enabled for the first time by new technology, fall within the scope of protection, although the patentee is less likely to succeed where the variant was unforeseeable at the priority date. A variant which represents an inventive step may nonetheless infringe … It would not make sense if, in those circumstances, the patent was found to be insufficient solely because such an inventive variant, which it did not enable, fell within the scope of its claims"
  • Scope of protection: the Judge agreed with Arnold J that the first limb of the Supreme Court's test in Actavis v Lilly, that of 'normal interpretation', meant purposive interpretation. 
  • Infringement: one of the issues on infringement was Premaitha's argument that the steps of detection and analysis, which were crucial to the inventive concepts of the patents, took place outside of the UK. The Judge identified that the crucial question was where, in substance, was the process to be used? The answer was that it would be performed, in substance, by laboratories in the UK. Any other result would make it easy to avoid infringement, given the ease of digital transmission and off-shoring of computer processing. A further issue related to the status of Illumina as an 'exclusive licensee'.

It seems likely that this wide-ranging dispute will be heard by the Court of Appeal.

Most recently, in Saab Seaeye Limited v Atlas Elektronik & ECS Special Projects, the Court of Appeal, when considering the approach to claim construction, noted that the impact of the Supreme Court's decision in Actavis v Lilly was that "...at least when considering the scope of protection, there is now a second question, to be asked after the patent claim has been interpreted, which is designed to take account of equivalents".  However, the Court noted that the question of whether the doctrine of equivalence could be relied upon for the purposes of supporting an expansive scope of claim in the context of invalidity would have to await argument in another case.

Plausibility goes to the Supreme Court: Court of Appeal finds pregabalin second medical use patent invalid

In October 2016, the Court of Appeal delivered its much-anticipated decision in the dispute concerning Warner-Lambert's second medical use patent for the use of pregabalin for the treatment of pain, including neuropathic pain, and skinny labelled generic products. The Court of Appeal rejected Warner-Lambert's appeal, finding that the relevant claims were invalid on the grounds of insufficiency: they were not plausible across their breadth. Plausibility will now be considered by the Supreme Court in February 2018: given the considerable public policy interest in the role for plausibility in relation to sufficiency, inventive step (technical contribution) and industrial application, the Supreme Court's guidance will be crucial. 

The Court also considered (obiter, as it was not necessary for the determination of the case) the important issue of infringement of second medical use patents: it affirmed the basic objective test i.e., whether Actavis knew or could foresee that at least some of the prescriptions written generically for pregabalin to treat pain would in fact be fulfilled by its product. However, once the existence of intention has been made out on this test, it may be negatived if the manufacturer had taken all reasonable steps within its power to prevent the foreseen consequences occurring.

The law is struggling on the one hand to give the patentee a proper reward for his contribution to the art by elucidating the new use for the drug, whilst at the same time not excluding the competing manufacturer from making and marketing the drug for its known purpose. The issue is complicated by the interaction with the law relating to, and the practice in, prescription medicines".

 

Floyd LJ

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No interim injunction following obviousness ruling on tadalafil dosage patent

In a rare intervention, the Court of Appeal overturned a finding of inventive step in relation to ICOS/Lilly's tadalafil 5mg dosage regimen patent. Tadalafil is the generic name of the drug sold under the brand 'Cialis' for the treatment of male erectile dysfunction (ED).

The inventive concept of the patent was stated to be a smaller 5mg dosage of tadalafil, which remained effective but was combined with minimal side effects. However, the Court of Appeal found that there was no invention in a dose that was discovered by virtue of the dose ranging studies carried out as part of routine Phase IIb clinical studies. The claimed invention lay "at the end of the familiar path through the routine pre-clinical and clinical trials process" and the skilled team would embark on that process with a reasonable expectation of success, and would carry out Phase IIb dose ranging studies, including to find out the dose response relationship. It was very likely that, in doing so, they would test a 5mg daily dose and would find it safe and efficacious.

Lilly has applied for permission to appeal to the Supreme Court and applied for an interim injunction to stop generic products entering the market, pending any possible appeal. Given that an appeal to the Supreme Court can take some time to resolve (around one to two years from filing the petition to judgment), this would have meant generic manufacturers would potentially have to factor in the likely timing of an appeal to the Supreme Court when taking steps to clear the way. 

However, Henry Carr J rejected the application, as Lilly did not have a realistic prospect of success in a further appeal.

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