Life after Actavis – questions answered
16 November 2017
In July 2017 the Supreme Court judgment in the Actavis v Eli Lilly case (“Actavis”) changed the way we will assess the scope of patent claims in the UK (see here for an overview). The Actavis judgment did not touch on whether the change to the way that scope of claims is determined for the purposes of infringement, specifically the enhanced consideration of equivalents, has any impact on the assessment of prior art in relation to novelty. This issue arose for the first time in the recent judgment by Arnold J in Mylan v Yeda and Teva (see here).
The claimants, “Mylan” and “Synthon”, were seeking revocation of a European patent for which the defendant, “Yeda”, is the patent proprietor, and the third party, “Teva”, is the exclusive licensee. The patent is directed to a dosage regimen for the administration of glatiramer acetate (GA) for the treatment of multiple sclerosis.
To give some commercial context, Teva markets GA under the trade mark Copaxone. Worldwide sales of Copaxone last year were about $4.2 billion, representing nearly a fifth of Teva’s worldwide sales and a significantly higher percentage of its profits.
Prior to the Actavis case, it was settled law that a claim should be interpreted in the same manner, and has the same scope, for the purposes of considering both novelty and infringement. In the Actavis judgment, the Supreme Court held that a claim could be infringed on the basis of a doctrine of equivalents even though the allegedly infringing act did not fall within a traditional interpretation of the claim. In trying to reconcile these facts, Arnold J noted that the question arises of what effect, if any, Actavis has on the law of novelty.
Mylan was of the opinion that it remains the law that a claim lacks novelty if a prior publication discloses subject matter which, if performed, would necessarily infringe the claim. In other words, the doctrine of equivalents must apply to the scope of the prior art in the assessment of novelty in the same way that it applies to the scope of the claims in the assessment of infringement. The reasoning was that if this was not the case, a novel claim could be infringed by a person who did exactly what the prior art taught, which would be a radical departure from English patent law as it has been understood for many decades.
Conversely the defendants, Yeda and Teva, argued that a traditional approach to novelty should be maintained, and that the doctrine of equivalents is not relevant in this context.
Arnold J agreed with the defendants, maintaining a traditional view on the assessment of novelty, but potentially leading to a situation where equivalents are considered for infringement which would not be considered for validity.
Interestingly, however, for the event of appeal Arnold J went on to assess novelty under the alternative view and concluded that if it is legally possible for a claim to be deprived of novelty by virtue of the doctrine of equivalents, then the claim in this case would lack novelty over one of the prior art documents. This point was not ultimately decisive as the patent was held to be invalid for lack of inventive step.
Arnold J also tackled another question that arose following the Actavis judgment. In particular, before coming to the question of equivalents, does it remain the law that patent claims should be given a purposive construction? The wording in Actavis referred in this respect to “normal” interpretation.
Yeda and Teva’s view was that purposive construction should not be used, and instead a patent claim should be interpreted literally in the first instance, in the same manner as a clause in a commercial contract. On the other hand Mylan submitted that it remains the law that a patent claim should be given a purposive construction, having due regard to the patentee’s purpose.
Arnold J concluded that, although Actavis referred to a case concerning contract law in relation to “normal” interpretation, there are important differences between a contract and a patent, which means that one cannot rationally interpret a patent without taking the context into account. Accordingly, he judged that the claim should be given a purposive construction in the first instance, despite Lord Neuberger eschewing this expression in the Actavis judgment.
In conclusion, in this case Arnold J has given the first answers to some important questions following the landmark Actavis judgment. For both issues his approach seems to be sensible, especially in avoiding making changes to the assessment of novelty. To ensure that something done before the priority date cannot infringe a valid patent, it seems that additional guidance on the approach laid down in Actavis will be settled upon by the courts in due course.
Elizabeth Swan
Life Sciences & Chemistry group
If you require further information on anything covered in this briefing, please contact Elizabeth Swan (eswan@withersrogers.com; 44 20 7940 3600) or your usual contact at the firm. This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.
© Withers & Rogers LLP, November 2017
