Teva UK Ltd and Another v Leo Pharma A/S Leo Laboratories Ltd (Third Party)

JurisdictionEngland & Wales
CourtChancery Division (Patents Court)
JudgeMr. Justice Birss,Mr Justice Birss
Judgment Date06 October 2014
Neutral Citation[2014] EWHC 3096 (Pat)
Docket NumberCase No: HP13E02404

[2014] EWHC 3096 (Pat)

IN THE HIGH COURT OF JUSTICE

CHANCERY DIVISION

PATENTS COURT

Royal Courts of Justice, Rolls Building

Fetter Lane, London, EC4A 1NL

Before:

Mr Justice Birss

Case No: HP13E02404

Between:
(1) Teva UK Limited
(2) Teva Pharmaceutical Industries Limited
Claimants
and
Leo Pharma A/S
Defendant
Leo Laboratories Limited
Third Party

Daniel Alexander QC and Mark Chacksfield and Joe Delaney (instructed by Pinsent Masons LLP) for the Claimants

Henry Carr QC and Tom Alkin (instructed by Simmons & Simmons LLP) for the Defendant and Third Party

Hearing dates: 15th — 18th and 21st July 2014

Approved Judgment

I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.

Mr. Justice Birss Mr Justice Birss
1

This case is about the treatment of psoriasis using an ointment comprising a combination of a corticosteroid such as betamethasone and a vitamin D analogue such as calcipotriol. The defendant and third party ( LEO) have a successful product marketed in the UK as Dovobet Ointment. Its sales are substantial. The claimants (TEVA) wish to sell a generic version of that ointment.

2

LEO have two patents: EP 1 178 808 entitled " Non-aqueous pharmaceutical composition for dermal use to treat psoriasis comprising a vitamin, a corticosteroid and a solvent component" and EP 2 455 083 entitled " Pharmaceutical composition for dermal use comprising calcipotriol and betamethasone for treating psoriasis". The 083 patent is a divisional of the 808 patent. LEO contend that TEVA's proposed product would infringe these patents. A (confidential) product description has been provided. TEVA have no positive defence to the allegation that their product would fall within the relevant claims. TEVA contend that both patents are invalid on three grounds: obviousness, insufficiency and added matter. TEVA's obviousness case involves a single attack based on a combination of the common general knowledge and a prior US patent 4,083,974 entitled " Topical, steroidal anti-inflammatory preparations containing polyoxypropylene 15 stearyl ether" assigned to Upjohn naming Joseph Turi as the inventor (Turi). LEO have applied to amend the claims. LEO contend that the claims in their amended form are valid.

3

TEVA have opposed both Patents before the EPO. The 808 Patent has also been opposed by Sandoz and Pentapharma. It was subject to oral proceedings in prosecution and three rounds of third party observations. Oral proceedings are now due to be heard by the Opposition Division on 20 October 2014. The 083 Patent was opposed by TEVA, Pentafarma and Mylan in June 2014 and no oral hearing date has yet been set. There are also parallel proceedings in the USA and in Canada.

The witnesses

4

TEVA called Professor David Gawkrodger and Professor Patrick Crowley. LEO called Professor Peter van der Kerkhof and Professor Marc Brown.

5

Professor Gawkrodger is Professor Emeritus in Dermatology at the University of Sheffield having been a consultant dermatologist at the Royal Hallamshire Hospital, Sheffield from 1988 until 2012. He fully retired in 2012 and today does no clinical work. His clinical work focussed on general dermatology including all types of skin disease including psoriasis. His research interests have been wide ranging but have included some research on psoriasis although LEO are right that his research interest in psoriasis was limited.

6

LEO pointed out that Professor Gawkrodger had not worked in a drug development team whereas Professor van der Kerkhof had extensive experience in that area. I will take that into account.

7

LEO submitted that the fact Professor Gawkrodger was unfamiliar with the fact that calcipotriol was a delicate product, sensitive to degradation at the acidic pH levels at which corticosteroids are most stable and that this unfamiliarity was a result of his lack of interest in calcipotriol formulations at the time. They submitted this reinforced the artificiality of his position in this case and showed that he had to speculate about his participation in a drug development team. The Professor was indeed unaware of these characteristics of calcipotriol but I do not accept that this means he was not in a position to help the court. His position shows that not all dermatologists knew or were interested in such characteristics. I will return to this below. As I have already said, I will take into account the different experience in drug development of the two clinical experts.

8

Professor Gawkrodger's report referred to the 1997 Guidelines on the management of psoriasis to which he had contributed. However LEO rightly pointed to an error in his report about this, for which the Professor apologised. The mistake was not deliberate but it showed that he had not checked the whole of his report as carefully as he ought to have.

9

Professor Crowley is a Visiting Professor at The School of Pharmacy, King's College, London. He founded Callum Consultancy LLC which provides consultancy services in drug development, dosage form development and regulatory filings. He retired from GlaxoSmithKline in 2008 having worked there and in its predecessor companies since starting at Beecham in 1971. His specialism was in pharmaceutical formulation development. This included some topical formulations but his experience of topical formulations is more limited than that of Professor Brown. It was put to him that he had never succeeded in producing a stable topical formulation containing more than one active ingredient, which he accepted. Nevertheless this point cannot be taken too far in the context of topical formulation development generally since many formulations attempted by Professor Brown did not succeed either.

10

LEO submitted that Professor Crowley's report contained sweeping generalisations which he was unable to maintain in cross-examination. There were specific instances of this and I will take them into account but their existence does not mean I did not find Professor Crowley's views of assistance in other areas. The specific instances were (i) the idea that pH dependent instability would simply not be an issue in a non-aqueous formulation, (ii) that apparent pH was an unknown concept and (iii) that reducing irritancy caused by propylene glycol would be a major requirement of a development project. These points are addressed further below in context but at this stage I can state that pH dependent stability will always be something for the skilled person to consider, even in a nominally non-aqueous environment; apparent pH was a concept known to topical formulators; and irritancy by propylene glycol was not regarded as significant by topical formulators. A further alleged sweeping generalisation related to the likelihood of regulatory approval for polyoxypropylene 15 stearyl ether. Again the issue is addressed below but in any case I reject this as a criticism of Professor Crowley.

11

Professor van der Kerkhof is Head of the Department of Dermatology and Venerology at the Radboud University Medical Centre (UMC), Nijmegen, The Netherlands. He became a resident in dermatology at the Radboud UMC in 1983 and has remained there ever since. As well as treating patients, Professor van der Kerkhof has worked for 30 years carrying out research into the pathogenesis and treatment of psoriasis. He has worked with a number of pharmaceutical companies in the field in relation to the development of new drugs, including LEO.

12

TEVA submitted that Professor van der Kerkhof was a cheerleader for the LEO cause and in some respects came across as promulgating the party line. I reject that criticism. The Professor gave his evidence enthusiastically, for which I am grateful. In my judgment it was a reflection of his clear and genuine passion for the subject and not a sign of a partisan witness.

13

A point arose on his opinion about the Papp paper on the efficacy of the formulation the subject of this action. The Papp paper essentially publishes the same clinical data (in more detail) as is in the patents. The paper shows that the co-formulation produces better clinical results than either monotherapy alone. In cross-examination I took Professor van der Kerkhof's opinion to be one of real surprise that a single formulation of the two compounds was possible since before he had understood it was not possible. He accepted that if the clinician assumed the co-formulation was stable, the clinical results achieved would be expected. In re-examination he emphasised that the clinical result was a new result and that to predict such a result before doing the clinical test would have been "pure speculation". I do not believe the Professor was seeking to change his evidence in a material way, he was just answering questions from a different perspective. I will return to the Professor's views below.

14

TEVA also criticised Professor van der Kerkhof for his evidence about a prejudice concerning corticosteroids. I deal with this issue below.

15

TEVA rightly pointed out that Professor van der Kerkhof was at the "top end" of specialist dermatologists and that this accounted for his negative views about combination products. I will take the Professor's professional position into account.

16

Professor Brown has held the Chair in Pharmaceutics at the School of Pharmacy at the University of Hertfordshire since 2006. He has also taken up professorships in pharmaceutics at Reading and Dundee universities. In the 1990s Professor Brown worked as a researcher at King's College, London and part time as a Director of Pharmaceutical Development in industry. In 1999 he co-founded a spin-out company called MedPharm Ltd. It is a contract research organisation specialising in the formulation of topical drug delivery systems....

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