Merck Sharpe v Clonme Health Care Ltd
| Jurisdiction | Ireland |
| Judge | Mr. Justice Robert Haughton |
| Judgment Date | 17 May 2018 |
| Neutral Citation | [2018] IEHC 277 |
| Court | High Court |
| Docket Number | [2018 No. 3485 P.] |
| Date | 17 May 2018 |
[2018] IEHC 277
THE HIGH COURT
COMMERCIAL
Mr. Justice Robert Haughton
[2018 No. 3485 P.]
IP – Patents – Supplementary Protection Certificate –Treatment for high cholesterol – Application for interlocutory relief
Facts: The plaintiff held a patent for Ezetimibe, and Ezetimibe and Simvastatin, in relation to the treatment of high cholesterol. The patent had expired but supplementary protection certificates (SPC) had been granted to protect the plaintiff’s exclusive rights. The plaintiff contended the defendant had launched a generic product which infringed its rights and applied for interlocutory relief.
Held by Haughton J, that the application would refused. The Court was persuaded that a bona fide point as to the validity of the SPC had been raised for trial. Whilst the plaintiff may well have been forced to reduce prices or exit the market if relief was refused, the Court was satisfied that that damages were an adequate remedy.
The ex parte injunction granted earlier was therefore discharged.
This judgment concerns an application by the plaintiff (also referred to as ‘MSD’) for interlocutory relief. Following a lengthy hearing on 27 th April, 2018 I refused to grant the reliefs sought, discharged the interim junction previously granted by McGovern J. and reserved the question of costs. This judgment sets out my reasons for refusing relief.
The plaintiff is the registered proprietor of Irish Patent No. 0720599 (the ‘599 Patent’). The 599 Patent addresses high levels of cholesterol in the blood which is the main cause of cardiovascular disease. It covers:-
(i) Ezetimibe, which is the generic name of the active ingredient in Inegy and other plaintiff products, and
(ii) the combination of Ezetimibe and Simvastatin, a combination which allows for reduced doses of the statin with the benefits described in an affidavit sworn by Mr. Brennan on behalf of the plaintiff.
The 599 Patent expired on 14 th September, 2014 and the plaintiff's exclusive rights in respect of the medicinal product Ezetrol which contains Ezetimibe as an active ingredient were extended until 16 th April, 2018 by the related Irish Supplementary Protection Certificate 2003/014 (‘the 014 SPC’). Accordingly, up until 16 th April, 2018 the 014 SPC ensured exclusivity to the plaintiff in respect of its medicinal products which contained Ezetimibe as an active ingredient.
The plaintiff's exclusive rights in respect of products containing Ezetimibe in combination with Simvastatin (branded “Inegy”) were extended until 1 st April, 2019 by Supplementary Protection Certificate No. 2005/2001 (‘the SPC’). Inegy is a major product in the plaintiff's portfolio of products for Ireland, with approximately 15,000 patients prescribed the medicine each year.
On 17 th April, 2018 the defendant launched a new generic product being a form of Ezetimibe in combination with Simvastatin (the ‘Clonmel Generic Products’) which the plaintiff claims infringe the SPC. These are marketed at a very substantial discount on the price of Inegy – indeed the introductory offer from the defendant of their generic is at a discount of some 92%. On 18 th April, 2018, the Clonmel Generic Products appeared on the online ordering site of a pharmaceutical supplier, Uniphar. The defendant is a successful Irish pharmaceutical manufacturer, and is a subsidiary of the multinational Stada Group.
On 20 th April, 2018 the plaintiff obtained ex parte on interim injunction from McGovern J. in the following terms:-
‘IT IS ORDERED that the defendant, whether acting by itself or by its servants or agents, or any company or entity under the direction or control of the defendant, be restrained until after the return date of the Plaintiff's Motion seeking interlocutory relief herein or until further Order in the meantime from infringing the Plaintiff's Supplementary Protection Certificate No. 2005/2001 (‘the SPC’) offering or putting on the market products containing ezetimibe and simvastatin as form the subject matter of the SPC.
For the avoidance of any doubt, this injunction is not to prevent the delivery by the defendant of such products to purchasers in pursuance of an existing contractual obligation incurred by the defendant before the notification of this Order.’
In the Notice of Motion issued on 20 th April, 2018, seeking interlocutory reliefs the primary relief sought by the plaintiff is an injunction in similar terms to that made by McGovern J. ‘… and without prejudice to the generality of the foregoing, by the making, offering, putting on the market or using products containing Ezetimibe and Simvastatin as described in the SPC or importing or stocking such products for those purposes.’ The plaintiff also seeks ancillary orders for the delivery up by the defendant of ‘all articles, products or other matter in the possession or control which fall within the subject matter of the SPC’, and for disclosure on oath of persons to whom the defendant may have supplied such product. The application was grounded on the affidavit of Gerard Brennan sworn on 20 th April, 2018. An affidavit sworn by James Hanlon on 24 th April, 2018, on behalf of the defendant was filed in response, and to that there was a further affidavit sworn by Mr. Brennan on 26 th April, 2018. In addition the court had the benefit of written and oral submissions.
The grant of a supplementary protection certificate is governed by Regulation (EC) No. 469/2009 of the European Parliament and of the Council of 6 th May, 2009, which in Article 1 contains a definition of ‘medicinal product’, and in Article 1 (b) defines ‘product’ to mean ‘the active ingredient or combination of active ingredients of a medicinal product’. Article 3 sets out the conditions for obtaining a certificate:-
‘Article 3
Conditions for obtaining a certificate
A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.’
It was not contested that the plaintiff is currently the holder of the SPC.
Article 15 provides:-
‘Article 15
Invalidity of the certificate
1. The certificate shall be invalid if:
(a) it was granted contrary to the provisions of Article 3;
(b) the basic patent has lapsed before its lawful term expires;
(c) the basic patent is revoked or limited to the extent that the product for which the certificate was granted would no longer be protected by the claims of the basic patent or, after the basic patent has expired, grounds for revocation exist which would have justified such revocation or limitation.
2. Any person may submit an application or bring an action for a declaration of invalidity of the certificate before the body responsible under national law for the revocation of the corresponding basic patent.’
The defendant contests the validity of the SPC and intends to seek a declaration of invalidity under Article 15 in a counterclaim in these proceedings.
Much of the affidavit evidence put before the court by Mr. Brennan consisted of materials and argument in support of the continuing validity of the SPC. A substantial part of Mr. Hanlon's affidavit was directed at supporting the contention that the SPC was granted contrary to the provisions of Article 3. In essence and in reliance on jurisprudence of the CJEU it was contended that the core inventive advanced of the 599 Patent was Ezetimibe, which basic patent expired on 16 th April, 2018, and that it could not be used as the basis for the SPC for a combination of that drug with Simvastatin, which was founded on a patent which expired on 5 th May, 2003.
On the basis of this dispute the first legal issue raised by the defendant was whether the threshold test for the granting of an interlocutory injunction was ‘a serious question to be tried’, or the more exacting standard of showing ‘a strong arguable case that is likely to succeed at trial’. The basis upon which the more exacting threshold was proposed was that the order which the plaintiff was seeking was in substance a mandatory order, or an order that might well produce an outcome in the litigation in favour of the plaintiff. Firstly it was argued that the interim relief granted and the interlocutory order sought were mandatory in effect because they required the defendant to dismantle the launch of the Clonmel Generic Products that has already taken place. Secondly, it was argued that as the SPC will expire on 1 st April, 2019 it was in the plaintiff's interest to obtain an interlocutory order that would preserve its position for as long as possible up to the expiry date, effectively determining the issue as to whether the defendant is entitled to be in the market sooner.
The arguments for a higher threshold did not find favour with the court. Having determined that the appropriate test was whether there was a fair or serious question to be tried, and that there was such a question, I went on to refuse interlocutory relief on the basis that damages would be an adequate remedy. The substance of my ruling appears in the Transcript at p. 227 as follows:-
‘MR. JUSTICE HAUGHTON: First of all, in relation to the threshold argument, I am not...
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