In August 2017, the Supreme Court issued its much-anticipated decision in Actavis v Lilly, substantially revising the approach to determining the scope of protection of patent claims in infringement cases, including the role to be played by the doctrine of equivalents. The Patents Court has now considered the Supreme Court's decision in a case concerning validity (in Mylan & Synthon v Yeda & Teva), 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.
The decision also confirms the grant of Arrow declarations will be heavily dependent upon the patentee's conduct; simply filing divisional applications and making statements of strength in relation to a patent portfolio will not be sufficient. More will be required to demonstrate the need for the certainty provided by an Arrow declaration, likely involving clear attempts to shield a patent from scrutiny.
Background
Wishing to clear the way to market for the launch of their 40 mg generic glatiramer acetate (GA) products, Mylan and Synthon sought revocation of Yeda's dosage regimen patent for the administration of GA therapy (EP (UK) 2 949 335 entitled "Low frequency glatiramer acetate therapy"). This is the latest battle in an ongoing dispute relating to GA (marketed by Teva, as exclusive licensee under the Patent, as Copaxone), with a further trial scheduled to take place in April 2018 relating to an improved process for its preparation.
Mylan/Synthon attacked Claims 1 and 3 on the grounds of lack of novelty, lack of inventive step and insufficiency (there was no dispute that the intended acts would infringe). They also sought Arrow declarations in light of further divisional applications filed by Teva.
Arnold J accepted the attack against Claims 1 and 3 of the Patent on the basis of obviousness: it was obvious to try 40mg TIW (three times weekly) and the skilled person would have had a fair expectation of success - in the sense that it would be efficacious compared to placebo and that it would be comparable in efficacy to 20mg QD, i.e., every day. Even if the inventions were not obvious, he would have found that Claim 3 was also invalid for want of technical contribution and insufficiency because the claim that 40mg TIW would be as efficacious, and more tolerable than, 20mg QD was speculative.
Impact of Actavis v Lilly: claim interpretation
Of particular interest, however, is Arnold J's consideration of the Supreme Court's decision in Actavis v Lilly. First, he confirmed that, before considering the question of equivalents, the approach to the construction of patent claims should continue to be a purposive one. He rejected Teva/Yeda's argument that the 'normal interpretation' should now be a literal one, in the same manner as in a commercial contract, and without regard to the patentee's purpose. In particular, he reiterated that commercial contracts are different to patents: a contract is a bilateral statement agreed between the contracting parties (a patent is a unilateral statement by the patentee) and they also contain promises by the contracting parties to each other (a patent describes and claims a legal monopoly). 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.
Impact of Actavis v Lilly: Novelty
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).
In Actavis v Lilly, the Supreme Court had decided that claims can be infringed on the basis of a doctrine of equivalents but did not discuss the impact on the assessment of novelty. Given his decision on obviousness, Arnold J's consideration of this issue is obiter and, indeed, he suggested that a further Supreme Court decision will be needed to obtain a definitive answer. That said, he 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.
No Arrow declaration
Given the finding of obviousness, Mylan and Synthon sought Arrow declarations relying on the Court of Appeal's decision in the Humira litigation. The Patent stems from a divisional and Teva has filed two further pending divisional applications. However, clearly the circumstances before the Court were not of the same magnitude as those seen in relation to Abbvie; indeed, Arnold J stressed that the existence of pending divisional applications is not enough, on its own, to justify the making of an Arrow declaration. He also rejected the argument that Teva/Yeda had sought to shield the Patent's subject matter from scrutiny by the UK and Dutch courts, and also by the EPO Board of Appeal, and there was also nothing in the argument that Teva had made public statements that it would enforce its patent portfolio. In summary, he concluded, an Arrow declaration would provide no greater commercial certainty than the judgment of the court on validity of the Patent (the same point applying in respect of the alleged spin-off value of the Arrow declaration).