Actavis Group Ptc EHF and Another v Eli Lilly and Company

JurisdictionEngland & Wales
JudgeMr Justice Henry Carr
Judgment Date16 November 2015
Neutral Citation[2015] EWHC 3294 (Pat)
CourtChancery Division (Patents Court)
Docket NumberCase No: HP-201400027
Date16 November 2015

[2015] EWHC 3294 (Pat)

IN THE HIGH COURT OF JUSTICE

CHANCERY DIVISION

PATENTS COURT

Rolls Buildings

7 Rolls Buildings

Fetter Lane

London

EC4A 1NL

Before:

Mr Justice Henry Carr

Case No: HP-201400027

Between:
(1) Actavis Group Ptc EHF
(2) Actavis UK Limited
Claimants
and
Eli Lilly and Company
Defendant

Michael Tappin QC, Isabel Jamal and William Duncan (instructed by Pinsent Masons LLP) for the Claimants

Tom Mitcheson QC and Jeremy Heald (instructed by Simmons & Simmons LLP) for the Defendant

Hearing dates: 6,7,8,9,13 and 14 th October 2015

Mr Justice Henry Carr

Introduction

1

This is the expedited trial of a claim brought by the Claimants ("Actavis") seeking revocation of EP (UK) 0 721 777 ("the Patent"), the registered proprietor of which is the Defendant ("Lilly"). Lilly has counterclaimed for threatened infringement by Actavis. The Patent claims a priority date of 11 January 1995. Lilly has obtained a Supplementary Protection Certificate which expires on 26 May 2019.

2

The Patent discloses a second medical use of the drug atomoxetine (also known as tomoxetine). Claim 1 is in Swiss form and claims:

"Use of tomoxetine for the manufacture of a medicament for treating attention-deficit/hyperactivity disorder."

3

The validity of the patent is challenged on the basis of lack of inventive step in the light of two prior art citations. In addition, Actavis alleges that the disclosure of the Patent lacks plausibility and is therefore insufficient or obvious on the basis of lack of technical contribution. Actavis also challenges entitlement to priority on the basis of lack of plausibility of the Priority Document. Lilly accepts, for the purpose of these proceedings, that the Patent is invalid over intervening prior art if priority is lost. Finally, Actavis submits that there is a squeeze between lack of inventive step and lack of plausibility. It alleges that the Patent makes no more than a bald assertion that atomoxetine is effective and safe for the treatment of ADHD. It claims that insofar as the Patent discloses a theory or principle to support that assertion, such principle was known from the prior art. Accordingly, Actavis submits that if the skilled person was unconvinced by prior art, he/she (hereafter "he") would be equally unconvinced by the Patent.

4

In answer to these submissions, Lilly argues that the prior art gives no hint that atomoxetine could be used in the treatment of ADHD. Both prior art citations were published more than a decade before the priority date, and both assert that atomoxetine could be used in the treatment of depression. There is no evidence that this suggestion was acted on before the priority date and the skilled person would view the prior art as paper proposals with no obvious application to ADHD.

5

As to plausibility, Lilly submits that the Patent contains, for the first time, a disclosure of the utility of atomoxetine for the treatment of ADHD. According to Lilly, this is supported by credible evidence, expressly referred to in the Patent, and the disclosure has been confirmed by the fact that subsequent to the priority date, atomoxetine has proved to be safe and efficacious in the treatment of ADHD. Lilly has been selling atomoxetine in the UK under the brand name "Strattera" for the treatment of ADHD since 2004. Strattera was first authorised for the treatment of ADHD in the USA in 2002 and was the first non-stimulant approved by the FDA to treat this condition. Annual sales of Strattera in the UK are in excess of £10 million. There is no dispute that Stattera is a valuable drug in the treatment of the serious and distressing effects of ADHD. This says Lilly, is a complete answer to Actavis' attacks of insufficiency, Agrevo obviousness and lack of entitlement to priority, all of which stand or fall together. Finally, Lilly claims that there is no squeeze, because the prior art fails to disclose or render obvious the invention of the Patent, namely the use of atomoxetine for the treatment of ADHD.

6

The Reply and Defence to Counterclaim admits that the Second Claimant intends to launch in the UK a generic atomoxetine product for the treatment of ADHD before the expiry of the SPC. Actavis has commenced this claim in order to clear away for the launch of its generic product, which would otherwise infringe the Patent.

The skilled addressee

7

It is well established that a patent specification is addressed to those persons likely to have a practical interest in the subject matter of the invention; Catnic v Hill and Smith [1982] RPC 183 at 242 per Lord Diplock. Such persons will have practical knowledge and experience of the kind of work in which the invention is intended to be used. Although the skilled person/team is a hypothetical construct, its composition and mind-set is founded in reality; Schlumberger v Electromagnetic Geoservices [2010] EWCA Civ 819; [2010] RPC 33 at [42] per Jacob LJ.

8

In the present case, it is common ground that the skilled addressee includes a clinician, and in particular a child and adolescent psychiatrist with expertise in treating ADHD and a research interest in ADHD, who was interested in the development of new treatments for ADHD at the priority date. The primary difference between the parties is whether the skilled addressee would have comprised a team which would also have included a psychopharmacologist, as Actavis submits. Lilly contends that at the priority date, psychopharmacologists did not have experience in ADHD. Professor Peter Hill, who gave evidence on behalf of Lilly, explained that he did not recall the presence of psychopharmacologists on advisory boards to the pharmaceutical industry on which he had sat at the priority date. However, it was pointed out by Professor Philip Cowen, a psychopharmacologist who gave evidence on behalf of Actavis, that pharmacologists and pyschopharmacologists were often employees of drug companies which sponsored advisory boards, and they would contribute during the course of drug development to discussions with clinicians.

9

In my judgment, a pyschoparmacologist would have been a member of the notional skilled team. [0008] of the Patent cites a paper by Gehlert et al., published in 1993, "for a discussion of the mechanism of tomoxetine's activity as a norepinephrine reuptake inhibitor". This paper, together with a paper by Wong et al. which is referenced by Gehlert, is relied upon by Lilly in support of its argument that the disclosure of the Patent is plausible. It was common ground between the experts that these publications are addressed to a psychoparmacologist, whose expertise would be required in order to evaluate their contents. Therefore, such expertise is required by the skilled team to whom the Patent is addressed. Furthermore, Prof. Hill agreed that the skilled team would need someone with knowledge of the pharmacology of the existing drug treatments of ADHD. He said that he would have welcomed a person with knowledge of how drugs worked onto the skilled team "with open arms".

10

I accept Prof. Hill's evidence that psychopharmacologists in 1995 did not have knowledge and experience of ADHD. However, in my judgment, this was not necessary for inclusion in the skilled team, as the required knowledge of ADHD would come from the skilled clinician. However, I consider that this evidence is relevant to the respective roles of the clinician and psychopharmacologist within the skilled team. In the present case I consider that, as of 1995, the clinician would have taken a leading role on the team. Having obtained information about the pharmacology of existing drug treatments for ADHD, it would be for the clinician to evaluate the significance of this information on the basis of his knowledge and experience of ADHD.

11

There is a subsidiary dispute about whether the relevant member of the skilled team would be a "basic" or a "clinical" psychopharmacologist. Prof. Cowen explained that pharmacologists without clinical training, who are sometimes referred to as basic pharmacologists, specialise in the testing of drugs in animal models. They have a deep scientific knowledge of the pharmacological effects of psychotropic drugs, but, unlike clinical psychopharmacologists, do not have clinical experience. Actavis contends that a clinical psychopharmacologist would be a member of the team. I disagree. Given that there were no psychopharmacologists with clinical expertise in ADHD at the priority date, I consider that the expertise of a basic psychopharmacologist would be sufficient for the skilled team.

The witnesses

12

Each side called eminent technical experts. I have already mentioned Profs. Hill and Cowen. Dr Ronald Steingard is a child psychologist called on behalf of Actavis, and Prof. Trevor Sharp is a psychopharmacologist called on behalf of Lilly. I found the evidence of all the experts most instructive and I am grateful to them for providing it.

Dr Steingard

13

Dr Steingard is Professor of Psychiatry at the University of Massachusetts Medical School and is the Associate Medical Director of the Child Mind Institute in New York. In January 1995 he was Assistant Professor of Psychiatry at Harvard Medical School, Assistant in Psychiatry and Director of Psychopharmacology in the Department of Psychiatry, Boston Children's Hospital and Research Associate in Psychiatry, Brain Imaging Center, McLean Hospital, Belmont, Massachusetts. He is currently in private practice in New York as an Associate Medical Director and Senior Paediatric Psychopharmacologist. He is also Professor of Psychiatry at University of Massachusetts Medical School, Worcester, Massachusetts.

14

Lilly accepts that Dr Steingard...

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