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

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

3. Where we left off in 2017’s conference…

4. 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

5. 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

6. Pregabalin in the Supreme Court

7. 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

8. 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

9. 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

10. Plausibility in the Supreme Court – the Result

11. Significant developments at the EPO since last year

12. 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

13. 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?

14. Plausibility and Inventive Improvements

15. 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

16. 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”

17. Thank you Bristows LLP 100 Victoria Embankment London EC4Y 0DH
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