Fordham IP Conference 2018 The Latest Developments on Plausibility 6 April 2018 Brian Cordery Partner, Bristows LLP

Agenda UK developments in the law of plausibility – pregabalin in the Supreme Court What’s going on at the EPO? Plausibility and inventive equivalents

Where we left off in 2017’s conference…

2017 Sunrise Seminar on Plausibility (21 April 2017 07.30) Moderator Brian Cordery, Bristows Speakers Nicola Dagg Allen & Overy Lord Justice Floyd Panellists Christine Kanz Hoyng Rokh Monegier Judge Rian Kalden Court of Appeal The Hague Ute Kilger Boehmert & Boehmert Jürgen Dressel Novartis Pharma AG Miquel Montana Clifford Chance

Take Home Message from Fordham 2017 Wholly speculative patents should not be granted and it does not really matter which legal principle we use to prevent them from being granted/invalidate them Plausibility is a low threshold test

Pregabalin in the Supreme Court

Pregabalin in the UK Supreme Court Pfizer’s patent with Swiss-type claims to the use of pregabalin for the treatment of pain held largely invalid by the English Patents Court (September 2015) and the Court of Appeal (October 2016) Supreme Court heard a further appeal in February 2018 – three main issues: (i) construction of Swiss-type claims; (ii) the role of plausibility in patent law and (iii) abuse of process and amendment Pfizer’s Advocates Actavis’/Mylan’s Advocates

Plausibility in the Supreme Court – the Issues In the Supreme Court, the question was whether the claim of Pfizer’s patent to the use of pregabalin in the treatment of neuropathic pain, was valid The lower courts had found that the skilled person would recognise two types of neuropathic pain: peripheral and central The lower courts had held that the teaching of the patent made it plausible that pregabalin could be used to treat peripheral neuropathic pain but the skilled person could make no such prediction for central neuropathic pain Therefore the claim was held invalid and Pfizer’s application after the judgment to amend the claim to restrict it to the treatment of peripheral neuropathic pain was not permitted

Pregabalin in the Supreme Court – Arguments of the Parties Plausibility is not a ground of revocation; to hold patents invalid for want of plausibility is inconsistent with statute Plausibility is not a stand-alone ground of invalidity. It’s part of insufficiency and, in other contexts, other grounds for challenge Plausibility is to do with the pre-grant issue of support The Court has power to revoke patents where the scope of the monopoly exceeds the technical contribution The claim should be analysed at the level of generality at which it is written, to divide the claim up into its constituent parts and to analyse each part separately is inappropriate; if part of the claim is plausible, post-filed data should be permitted to make good the rest of the claim. The categories of peripheral and central neuropathic pain were known at the priority date and both had to be justified otherwise a patentee could obtain a broad claim where it could not get two narrow ones

Plausibility in the Supreme Court – the Result

Significant developments at the EPO since last year

What’s Going on at the EPO? T0488/16 – Dasatinib – TBA – Compound Claim Markush formula patent to compounds with PTK activity revoked for obviousness Lack of any data in the patent meant that it was not plausibly demonstrated that the inhibitors were suitable for their claimed use Post-published data could not be taken into account Limitation to the dasatinib molecule itself did not save the patent

Dasatinib (continued) T0950/13 – Dasatinib (again) – TBA – Use Claim Swiss-type Claim for the use of dasatinib in the treatment of CML was not held insufficient by the TBA Patent based on dasatinib’s functional equivalence to imatinib which was well established as the gold standard to treat CML What can we draw from the two cases?

Plausibility and Inventive Improvements

Plausibility and Inventive Improvements – Illumina v Premaitha Decision of Henry Carr J. dated 21 November 2017 relating to non-invasive pre-natal diagnosis – an invention held to be “of great public benefit” One of the numerous points raised by a challenge against one of the patents in issue was that if the claim extended to its Polymorphic Assay of Harmony, then the approach was not enabled by the priority document and if priority was not maintained, the patent was accepted to be invalid The patentee argued that the patent disclosed a principle of general application which opened up a new field. As such, it did not have to enable improvements nor anticipate future technology

Plausibility and Inventive Improvements (cont.) Henry Carr J. took a pragmatic approach Relied on the wisdom of Judge Kalden from the Netherlands: “Infringement by equivalence is not limited to foreseeable variants only” “…the Harmony Test is an inventive improvement over the priority document and the technology for putting it into effect and not exist at the priority date… It would not have been thought possible at the time… This does not deprive the patent of priority, nor render any of its Claims insufficient”

Thank you Bristows LLP 100 Victoria Embankment London EC4Y 0DH brian.cordery@bristows.com This document is for information purposes only and any statements or comments it contains relating to matters of law are not intended to be acted on, or relied upon, without specific legal advice on the matters concerned. To the fullest extent permitted by law, we disclaim all liability and responsibility for any reliance on the statements or comments contained in this document. Bristows LLP is a limited liability partnership registered in England under registration number OC358808 and is authorised and regulated by the Solicitors Regulation Authority (SRA Number 44205). 30783542