Napp Pharmaceutical Holdings Ltd v Dr Reddy's Laboratories (UK) Ltd and Another
| Jurisdiction | England & Wales |
| Judge | Mr Justice Arnold |
| Judgment Date | 28 June 2016 |
| Neutral Citation | [2016] EWHC 1517 (Pat) |
| Court | Chancery Division (Patents Court) |
| Date | 28 June 2016 |
| Docket Number | Case No: HP-2016-000013 |
[2016] EWHC 1517 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NL
Mr Justice Arnold
Case No: HP-2016-000013
James Abrahams QC and Henry Ward (instructed by Powell Gilbert LLP) for the Claimant
Michael Silverleaf QC and Benet Brandreth (instructed by Bird & Bird LLP) for the First Defendant
Justin Turner QC and Anna Edwards-Stuart (instructed by Olswang LLP) for the Second Defendant
Hearing dates: 7–9 June 2016
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.
Contents
| Topic | Paragraphs |
| Introduction | 1–12 |
| Witnesses | 13–25 |
| Transdermal delivery experts | 14–17 |
| Statisticians | 18–22 |
| Factual witnesses | 23–25 |
| Technical background | 26–40 |
| Skin structure and function | 26–27 |
| Drug delivery across the skin | 28–29 |
| Transdermal delivery systems | 30–32 |
| Considerations in TDS design and development | 33–36 |
| The manufacture of TDSs | 37–40 |
| Hille | 41–53 |
| The Patent | 54–76 |
| The skilled team | 77–79 |
| Common general knowledge | 80–88 |
| Skin depots | 82–85 |
| Volatility of levulinic acid during drying | 86–88 |
| Construction | 89–125 |
| The law | 89 |
| Numerical ranges | 90–95 |
| "About" and similar expressions | 96 |
| Example 1 in the Patent | 97–102 |
| The skin depot hypothesis | 103 |
| Input or outputs? | 104–110 |
| The numerical limits | 111 |
| General points | 112–125 |
| Infringement by Sandoz | 126–200 |
| The law | 135 |
| The de minimis principle | 136–149 |
| Quia timet claims | 150–153 |
| The burden of proof for future acts | 154 |
| The standard of proof for future acts | 155–167 |
| Remedies | 168–170 |
| The statistical evidence | 171–200 |
| Infringement by Dr Reddy's | 201–222 |
| Overall conclusion | 223 |
| Confidential Annex A: The Sandoz product | |
| Confidential Annex B: The Dr Reddy's product |
Introduction
The Claimant ("Napp") is the proprietor of European Patent (UK) No. 2 305 194, the specification of which is entitled "A buprenorphine transdermal patch for use in the treatment of pain for a dosing interval of at least 7 days" ("the Patent"). Napp is also the proprietor of European Patent (UK) No. 1 731 152 ("152"). Napp contends that the First Defendant ("Dr Reddy's") and the Second Defendant ("Sandoz") threaten to infringe the Patent and 152 by marketing branded generic 7 day buprenorphine transdermal patches which Dr Reddy's and Sandoz propose to launch. It is common ground that the allegation of infringement of 152 adds nothing to the allegation of infringement of the Patent, and accordingly attention may be concentrated on the Patent.
The Patent and 152 are two members of a family of (so far) one parent and eight divisional patents and applications. The parent patent, European Patent No 0 964 677, was revoked by the Technical Board of Appeal of the European Patent Office, although there are outstanding petitions to the Enlarged Board of Appeal for review on the ground of alleged serious procedural irregularity. Another granted patent, European Patent No 1 570 823, has been revoked by the Opposition Division, a decision which is under appeal to the Technical Board of Appeal. On the other hand, three oppositions to the Patent were rejected by the Opposition Division for the reasons given in a written decision dated 22 December 2014, which is also under appeal. Five further applications remain in prosecution. In the present proceedings there is no challenge to the validity of the Patent save for an allegation of insufficiency advanced by Dr Reddy's by way of a squeeze on construction. Nor is there any challenge to the earliest claimed priority date of 24 February 1997. The Patent and 152 will expire on 24 February 2018.
Buprenorphine is an opioid indicated for the treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia. Examples of the clinical uses of 7 day buprenorphine transdermal patches include the treatment of chronic back pain and osteoarthritis. The fact that such patches last for 7 days makes them more convenient and cost-effective to use than patches which last a shorter period.
Napp is a company within the Mundipharma network of independent but associated companies. Napp's subsidiary Napp Pharmaceuticals Ltd ("NPL") has marketed a 7 day buprenorphine transdermal patch under the brand name BuTrans since 2005. There is no dispute that this has been a very successful product, with total sales now approaching 10 million patches a year. Since 1 February 2016 another Napp subsidiary, Qdem Ltd ("QL"), has sold a 7 day buprenorphine transdermal patch under the brand name Butec. For regulatory reasons, buprenorphine transdermal patches are required to be sold under brand names. Butec is identical to BuTrans and is in effect an originator's own branded generic which had been launched to protect Napp's commercial position in anticipation of loss of exclusivity. Both BuTrans and Butec are manufactured by LTS LOHMANN Therapie-Systems AG ("LTS") in Germany.
Sandoz intends to market a 7 day buprenorphine transdermal patch which is manufactured by Hexal AG in Germany under the brand name Reletrans. Sandoz obtained a UK marketing authorisation for Reletrans on 10 February 2016, and it has been ready to launch the product since about mid March 2016.
Dr Reddy's intends to market a 7 day buprenorphine transdermal patch manufactured by an unidentified manufacturer in an unidentified country. On 15 January 2016 Dr Reddy's solicitors wrote to the previous proprietor of the Patent setting out a description of the patch which Dr Reddy's proposed to market and seeking an acknowledgement that such marketing would not infringe the Patent. At that time, Dr Reddy's anticipated receiving a marketing authorisation "shortly" and planned to launch around the end of May 2016. As at the last day of the trial, however, Dr Reddy's had not yet obtained a marketing authorisation. Moreover, Dr Reddy's had only just got to the point of starting production. As I will explain, this has prompted Dr Reddy's to adopt an approach to this dispute which has led to certain complications.
There is no dispute that Sandoz has obtained its marketing authorisation, and Dr Reddy's is seeking its marketing authorisation, using BuTrans as the reference product. It follows that Sandoz's and Dr Reddy's products are intended to be bioequivalent to BuTrans. It is debatable whether BuTrans falls within the claims of the Patent, however. In any event, Sandoz contends that it has, and Dr Reddy's contends that it is able to, work around the Patent. There is nothing wrong in working around a patent. On the contrary, part of the point of patent claims is to enable third parties to know what they have to do to avoid infringement. As is often the case, the issue between the parties is whether the attempt to do so has been successful. As is also often the case, this turns primarily upon the correct interpretation of claim 1 of the Patent. But in the present case, it may also depend upon the variability in the products which are to be manufactured on behalf of Sandoz and Dr Reddy's. It is common ground that there is some degree of inherent variability, but the parties are disagreed as to the extent of such variability and as to the consequences of it.
Napp's claim against Sandoz is primarily a quia timet one and its claim against Dr Reddy's is a wholly quia timet one. I shall explain what is meant by quia timet, and the significance of this, below. In that regard, Napp relies on the fact that, if Sandoz and Dr Reddy's are permitted to market their respective products, it is likely that they will sell substantial quantities of patches before expiry of the Patent. Thus it is not unrealistic to suppose that they could each sell as many as 2–3 million patches in that period, although it is inevitably uncertain how many they will in fact sell.
Napp commenced the present claim on 19 February 2016. On the same date Napp launched an urgent application for an interim injunction against Sandoz, which led to Sandoz giving temporary undertakings on 22 February 2016. On 22 February 2016 Napp launched an application for an interim injunction against Dr Reddy's. On 15 March 2016 Dr Reddy's counterclaimed for a declaration of non-infringement. On 16 March 2016 I made an order for an expedited trial of the claim on 7 and 8 June 2016, as a result of which the Defendants gave undertakings not to launch their products pending the determination of the claim. At that stage, it was envisaged that expert evidence would only be required from experts in transdermal delivery systems ("TDSs").
On 21 April 2016 Dr Reddy's applied for permission to adduce a report from an expert statistician. On 9 May 2016 I gave all the parties permission to adduce evidence from experts in statistics and enlarged the trial to three days. With the benefit of hindsight, it should have been appreciated by the parties that statistical evidence would be required at an earlier stage. Be that as it may, the parties and their respective statisticians had to work very hard at very short notice in order to put the required statistical evidence before the court. This process was further complicated by the fact that data relating to Dr Reddy's proposed product became available shortly before the trial started. This not only required the experts to consider that data under considerable time pressure, particularly so in the case of Napp's expert, but also led to Dr...
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