Generics (Mylan) & Anor v Yeda: sufficiency and the extent of the doctrine of equivalence
14 December 2017
The ongoing dispute regarding patents relating to Teva’s multiple sclerosis drug Copaxone® was the subject of a judgment of Mr Justice Arnold in the High Court in November 2017 [see note 1 below].
Yeda’s patent EP2949335B under which Teva have an exclusive licence, relates to a 40mg three-times-a-week dosing regimen for Copaxone as an improvement over the originally approved 20mg once-daily dosing schedule. It was found invalid over a prior suggestion of administering 40mg every-other-day in an earlier patent application. Similar claims in the parent patent had been upheld by the Opposition Division of the EPO. EP2949335B is itself presently the subject of opposition proceedings.
The case involved two legal points of current interest – equivalence and plausibility.
Mylan and Synthon (the co-claimants) argued that in the light of the Supreme Court decision in Actavis UK v Eli Lilly [see note 2 below] concerning infringement by “equivalents”, the same considerations should be applied to the assessment of novelty and the claim should therefore lack novelty over the prior disclosure.
Three lines of defence were offered. Referring to comments by Lord Hoffmann in Synthon BV v SmithKline Beecham [see note 3 below] concerning the infringement test for novelty the defendants maintained that this test did not extend to anticipation by equivalents as these comments were made prior to Actavis UK v Eli Lilly, ie, the change in the assessment for infringement provided by Actavis UK v Eli Lilly should not be extended to the question of novelty. This was supported by the fact that in Actavis UK v Eli Lilly, Lord Neuberger did not refer to Synthon BV v SmithKline Beecham. The judge felt that a further decision would be required from the Supreme Court to resolve this issue.
Secondly, the Guidelines for Examination at the EPO (G-VI.2) based on decisions of the Technical Boards of Appeal specifically state that equivalents are not to be taken into account when considering novelty.
Thirdly, the Supreme Court in Actavis UK v Eli Lilly was not considering novelty but infringement and the guidance provided by Article 2 of the Protocol on the Interpretation of Article 69 of the European Patent Convention ie, that the extent of protection provided by a claim should take “equivalents” into account. Justice Arnold concluded that these points were correct, but also concluded that if it was possible to lack novelty by virtue of a doctrine of equivalence, the claim would lack novelty.
The other topic of interest concerned the threshold requirements for sufficiency of disclosure as the patent included a clinical trial protocol but no specific results. The judgment confirmed the UK approach that the plausibility threshold in the UK is a low one - confirming the decision of the court in Actavis Group v Eli Lilly [see note 4 below] (atomoxetine). The judge asked to hear arguments based on recent case law of the EPO Boards of Appeal and heard presentations on T448/165 and T950/13, seemingly opposing decisions of the same board concerning plausibility in the context of inventive step and sufficiency, respectively, which issued within two days of each other in February 2017.
Both the above decisions were discussed in our European biotech patent case law webinar on 14 November 2017.
November patent biotech case law webinar recording
Listen to our November webinar recording.Listen to our webinar
As always, the facts of a particular case will influence the outcome, but given the common general knowledge at the priority date, the judge concluded that claim 1 met the requirements of sufficiency.
These arguments will possibly continue into the Court of Appeal and the Opposition Division of the EPO where D Young & Co represents the patentee.
- Generics (UK) Limited and others v Yeda Research and Development Company Limited and others  EWHC 2629 (Pat).
- Actavis UK Limited and others (Appellants) v Eli Lilly and Company (Respondent)  UKSC 48.
- Synthon BV v SmithKline Beecham plc  RPC 10.
- Actavis Group PTC EHF v Eli Lilly and Co  EWHC 3294 (Pat),  RPC 12 at  (Henry Carr J).
- See www.dyoung.com/knowledgebank/articles/t48816-plausibilitydenied.
Case details at a glance
Jurisdiction: England and Wales
Decision level: High Court (Patents Court)
Parties: Generics (UK) Ltd (t/a Mylan) & Anor v Yeda Research and Development Company Ltd
Date: 26 October 2017
Citation:  EWHC 2629 (Pat)
Link to full decision: http://dycip.com/ewhc2629