First published in EPLAW, November 2017
Generics (UK) Limited trading as Mylan & Ors. v Yeda Research and Development Company Limited & Ors, High Court, London, UK, 26 October 2017, Neutral Citation Number: [2017] EWHC 2692 (Pat)
This case was brought by the Claimants (Mylan and Synthon) seeking revocation of EP (UK) 2,949,335 (“EP’335”), a patent owned by Yeda and exclusively licensed to Teva relating to a dosage regimen for the use of glatiramer acetate (“GA”, sold by Teva as Copaxone®) in the treatment of relapsing forms of multiple sclerosis. The Claimants argued that EP’335 lacked novelty and inventive step.
In the alternative, they argued that if EP’335 wasn’t obvious over the prior art put forward then it did not make any technical contribution, therefore lacking inventive step, and was insufficient. The Claimants also requested an Arrow Declaration in relation to their own products regarding two pending divisionals relating to the same dosage regimen.
The case focused on claims 1 and 3 of EP’335. The dosage regimen claimed was for three subcutaneous injection of 40 mg of GA per week, with at least one day in between each injection (“40 mg TIW”). The Claimants put forward three pieces of prior art, one of which – Pinchasi – was cited as novelty destroying. Pinchasi disclosed the use of 40 mg GA subcutaneous injections every other day (“QOD”).
When assessing whether or not this was novelty destroying, Arnold J discussed the law on claim interpretation for the purposes of validity, in light of the recent Supreme Court judgment in Actavis v Eli Lilly [2017] UKSC 48. Arnold J stated (obiter) that, until the Supreme Court looks again at patent validity, a purposive approach should be taken to assessing claim construction when assessing novelty; the doctrine of equivalence does not extend to novelty.
In coming to this conclusion, Arnold J considered EPO Board of Appeal jurisprudence and also pointed out that Actavis was based on Article 2 of the Protocol on the Interpretation of Article 69 EPC, relating to infringement not validity. However, in case the decision was appealed, Arnold J assessed anticipation from both points of view. If, as he believed, the doctrine of equivalents could not be applied to novelty assessments he held Pinchasi does not anticipate the claims. However, if there is a validity doctrine of equivalents, Pinchasi is anticipatory.
Arnold J then went on to assess obviousness over Pinchasi. He held that, from the disclosure of administering 40 mg GA every other day (QOD) and given that the skilled person had a clear motivation to reduce the frequency of injections, it would be obvious for them to consider 40 mg TIW. They would also have a strong/reasonable expectation that it would be efficacious compared to a placebo/20 mg every day, respectively. Therefore claims 1 and 3 were obvious over Pinchasi.
In light of this, Arnold J did not undertake a detailed analysis of validity over the other two pieces of prior art, Caon and Flechter. He did however, state that since both of these disclosed the use of 20 mg GA QOD, in his view, if claims 1 and 3 were not obvious over Pinchasi then they could not be obvious over Caon and/or Flechter. For completeness, Arnold J also assessed the Claimants’ alternative argument that if the claims were not obvious, they would be insufficient or lack technical contribution. He held that Claim 3 would be speculative and hence insufficient but that Claim 1 would not.
Finally, Arnold J did not feel it necessary to grant the Arrow Declaration sought by the Claimants. Upon consideration of the points set out by Henry Carr J in Fujifilm v AbbVie [2017] EWHC 395 (Pat), Arnold J held that, on the facts of the case, his judgment in relation to the validity of EP’335 and the reasons set out therein would be sufficient to allow the Claimants to meet any infringement claim brought against them in relation to the divisionals (if they grant) with a summary judgment application seeking their revocation.
A copy of the judgment can be found here.