Bristol Myers Squibb Company Ono Pharmaceutical Compnay Ltd v Sharp ors

• Jurisdiction: Ireland
• Judge: Ms. Justice Costello
• Judgment Date: 05 October 2016
• Neutral Citation: [2016] IEHC 540
• Docket Number: [2015 No. 10250 P.]
• Court: High Court
• Date: 05 October 2016

BETWEEN

BRISTOL MYERS SQUIBB COMPANY ONO PHARMACEUTICAL COMPANY LIMITED

AND

TASUKU HONJO

PLAINTIFFS

AND

MERCK SHARP AND DOHME CORP

AND

SCHERING PLOUGH (IRELAND) COMPANY TRADING AS S/P BRINNY COMPANY

AND

MSD INTERNATIONAL GMBH TRADING AS MSD (CARLOW)

AND

MERCK SHARP AND DOHME IRELAND (HUMAN HEALTH) LIMITED

AND

MERCK SHARP AND DOHME LIMITED

DEFENDANTS

[2016] IEHC 540

Costello J.

[2015 No. 10250 P.]

THE HIGH COURT

COMMERCIAL

Intellectual Property – Infringement of patent – Revocation of patent – Practice & Procedures – Discovery of documents – Relevant documents

Facts: In the present proceedings, both the plaintiffs and the defendants sought discovery of certain category of documents in support of the main claim concerning patent infringement proceedings wherein the plaintiffs sought certain declaration to the effect of invalidity of patent and its infringement by the defendants.

Ms. Justice Costello made an order of discovery of documents to a limited extent based on the relevancy of the documents sought by both the parties. The Court directed that the defendants would make discovery of the relevant category of documents that should include publicly available third-party documents within the defendants' updated US discovery, but not marketing material. The Court refused to make an order for discovery of other categories of documents. The Court held that the documents sought must be necessary for the fair disposal of the issue between the parties.

JUDGMENT of Ms. Justice Costello delivered on the 5th day of October, 2016.

1 These proceedings are patent infringement proceedings in which the defendants have counterclaimed for revocation of the patent relied upon by the plaintiffs. The patent at issue is patent no. EP (IE) 1 537 878 entitled 'Immunopotentiating compositions' ('the Patent').

The invention comprises the use of antibodies which inhibit an immunosuppressant receptor known as PD-1 for the treatment of cancer. The plaintiffs issued these proceedings as they say that the manufacture and supply of a product called ' KEYTRUDA' in Ireland involves the defendants in activities amounting to infringement of the Patent in Ireland. KEYTRUDA comprises an anti PD-1 antibody called Pembrolizumab.

2 The first named plaintiff is a company incorporated in the State of Delaware in the United States. The second named plaintiff is a Japanese company which is engaged in the research development and manufacture of pharmaceuticals and the third named plaintiff is the inventor of the invention, the subject of the Patent.

3 The invention had been patented in many countries including the United States, as well as Ireland, the United Kingdom and other contracting States of the European Patent Convention ('the EPC'). The Patent and the UK patent are identical in that they both devolve from the central application process afforded by the EPC. The specification in drawings of the related US patents are identical to the Patent and the UK patent, since all patents devolved from the same international patent application, but the claims of the US patents differ in some respects. The Patent is co-owned by the second and third named plaintiffs and licensed exclusively to the first named plaintiff.

4 The defendants are all members of the same group of companies ultimately owned and controlled by Merck & Co. Inc, a company incorporated in the United States. They are all involved in healthcare and in the manufacture and supply of pharmaceuticals. The first named defendant is a company incorporated under the laws of the State of New Jersey. The second and fourth named defendants are companies incorporated in Ireland, carrying on business in Ireland. The third named defendant is a company incorporated in Switzerland but registered in Ireland as an external company having a branch situated in Carlow. The fifth named defendant is a company incorporated in the United Kingdom carrying on business in the area of healthcare and pharmaceuticals.

5 The plaintiffs have taken patent infringement proceedings in respect of the manufacture and use by various Merck companies of KEYTRUDA and the antibody of which it is composed, Pembrolizumab, in certain countries under the specific patent register for those countries, including the United States of America and the United Kingdom. These proceedings were issued in circumstances where it became apparent to the plaintiffs that Schering Plough (Ireland) and MSD International were making the KEYTRUDA product in Ireland and were held out as doing so for or on behalf of, or in conjunction with, the first named defendant. The fifth named defendant is the holder of a European marketing authorisation for KEYTRUDA and the fourth named defendant is named as the local representative for the fifth named defendant for supply of KEYTRUDA in Ireland.

6 In advance of issuing the proceedings, solicitors for the plaintiffs wrote to all five of the then intended defendants on 25th November, 2015, notifying them of the intended proceedings and seeking clarification in respect of the activities connected with KEYTRUDA and/or Pembrolizumab in Ireland, so that the infringement claim could be framed precisely in respect of each of the Merck companies in question as to which acts of making, offering, putting on the market, or using KEYTRUDA and/or Pembrolizumab were being carried out by each defendant (whether singly or jointly) and which acts of stocking and importing for those purposes they were concerned with. As of the date of the hearing of the motion, most of these questions remained unanswered.

7 The proceedings issued on 8th December, 2015, and the plaintiffs delivered a statement of claim and particulars of infringement on 18th December, 2015, setting out the plaintiffs' case for infringement of the Patent against each of the five defendants. In paras. 11 – 15 of the statement of claim, they plead as follows:-

'11. The defendants, whether singly or jointly, or by the respective servants or agents, have infringed and continue to infringe the Patent by making, offering, putting on the market, using or importing, or stocking for those purposes, an anti-PD-1 antibody for use in the treatment of cancer falling within claims 1 to 4 of the Patent, as more particularly set out in the Particulars of Infringement delivered herewith, and/or by supplying the means for putting the invention the subject of claims 1 to 4 of the Patent into effect.

12. Further, or on the alternative and without prejudice to the foregoing, the infringing acts of each of the defendants pleaded herein and particularised in the Particulars of Infringement delivered herewith have been and are being carried out by the defendants in question acting as agent of one, or other, or all of the other defendants.

13. Further, or on the alterative and without prejudice to the foregoing, the infringing acts of each of the defendants pleaded herein and particularised in the Particulars of Infringement delivered herewith have been and are being carried out as a result of having been procured by the defendants and any of them, or as part of a common design between the defendants to do the said acts, and the defendants have acted in furtherance of that design by the doing of the said acts and the defendants are thereby jointly liable in respect of the acts of infringement of the Patent.

14. Further or in the alternative and without prejudice to the foregoing, the defendants or one or more of them have knowingly supplied or offered to supply one or more of their number in the State with means, relating to an essential element of the invention the subject of the Patent, for putting it into effect in the State.'

8 They say that the defendants have, therefore, infringed and are infringing rights conferred on the plaintiffs under ss. 40 and 41 of the Patents Act, 1992 (as amended) and they seek a declaration that the Patent has been infringed by the defendants and each of them (and their servants or agents) and other reliefs.

9 The defendants delivered a defence and counterclaim and particulars of objection on 29th February, 2016. The defendants challenge the validity of the Patent and counterclaim for its revocation. They seek revocation of the Patent on multiple grounds including lack of novelty, obviousness and sufficiency as well as asserting that the Patent, as granted, adds matter over the application filed. Specifically, there is an allegation that the invention goes no further than the prior art and/or that the claims of the Patent should be read as an invention encompassing the treatment of every anti PD-1 antibody of every cancer, that this is not plausible and that the Patent should, therefore, be condemned as not inventive or sufficient in respect of some of its scope.

10 As part of the defence, the defendants admit that KEYTRUDA is the brand name for the medicine containing an anti-PD-1 antibody called Pembrolizumab currently used in and approved for the treatment of advanced unresectable/metastic melanoma; that the manufacture of KEYTRUDA is carried out in the State by the second and third named defendants; that the fifth named defendant supplies KEYTRUDA in the State for compassionate use on a named patient basis without charge; that the fifth named defendant holds the marketing authorisation for the supply of KEYTRUDA (Pembrolizumab) product in the State and that the fourth named defendant is specified as the local representative. The rest of the pleas of infringement are denied.

11 The plaintiffs delivered a reply and defence to counterclaim on 11th March, 2016, putting the alleged grounds of invalidity into issue. Thus, the issues to be determined at the trial have been defined by the pleadings.

Scope of the trial

12 The plaintiffs seek a declaration that the Patent is invalid and a finding that the defendants have infringed the Patent. Given...