H318 Norton (Waterford) Ltd t/a Teva Pharmaceuticals Irl -v- Boehringer Ingelheim Pharma GMBH & Co KG (No 2) [2015] IEHC 318 (27 March 2015)

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Cite as: [2015] IEHC 318

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Judgment

Title:
Norton (Waterford) Ltd t/a Teva Pharmaceuticals Irl -v- Boehringer Ingelheim Pharma GMBH & Co KG (No 2)
Neutral Citation:
[2015] IEHC 318
High Court Record Number:
2014 2 PAP & 2014 1 PAP
Date of Delivery:
27/03/2015
Court:
High Court
Judgment by:
Cregan J.
Status:
Approved
    ___________________________________________________________________________



Neutral Citation [2015] IEHC 318

THE HIGH COURT
[2014 No. 2 PAP]

IN THE MATTER OF IRISH PATENT NUMBER EP (IE) 1379220 FILED ON THE 27th DAY OF MAY 2002 AND REGISTERED IN THE NAME OF BOEHRINGER INGELHEIM PHARMA GMBH & CO KG IN RESPECT OF AN ALLEGED INVENTION FOR “INHALATION CAPSULES”




BETWEEN

NORTON (WATERFORD) LIMITED T/A TEVA PHARMACEUTICALS IRELAND
PETITIONER
AND

BOEHRINGER INGELHEIM PHARMA GMBH & CO KG (No.1)

RESPONDENT

[2014 No. 1 PAP]


IN THE MATTER OF IRISH PATENT NUMBER 622528 FILED ON THE 14th DAY OF SEPTEMBER 1990 AND REGISTERED IN THE NAME OF BOEHRINGER INGELHEIM INTERNATIONAL GMBH IN RESPECT OF AN ALLEGED INVENTION FOR “NOVEL THIENYLCARBOXYLATES OF AMINO ALCOHOLS, THEIR QUARTERNARY PRODUCTS AND THE PREPARATION AND USE OF THESE COMPOUNDS”

AND

IN THE MATTER OF SUPPLEMENTARY PROTECTION CERTIFICATE NUMBER 2002/021 FOR THE SAID PATENT FILED ON THE 14th DAY OF AUGUST 2002 AND DUE TO EXPIRE ON THE 13th DAY OF MARCH 2016 FOR A PRODUCT IDENTIFIED AS “QUARTERNARY SALT FORMS OFSCOPINE DI- (2-THIENYL) GLYCOLATE, ESPECIALLY SALTS OF TIOTROPIUM- PREFERRED TIOTROPIUMBROMIDE MONOHYDRATE”





BETWEEN

NORTON (WATERFORD) LIMITED T/A TEVA PHARMACEUTICALS IRELAND
PETITIONER
AND

BOEHRINGER INGELHEIM INTERNATIONAL GMBH (No. 1)

RESPONDENT

JUDGMENT of MR. JUSTICE CREGAN delivered (ex tempore) on 27th day of March, 2015

THE FIRST PROCEEDINGS - RECORD NO. 2014/ 2 PAP

Introduction
1. This is an application by the Petitioner in these proceedings seeking discovery of certain categories of documents from the Respondent in relation to patent proceedings brought by the Petitioner in proceedings, Record No. 2014/No. 2 PAP.

The pleadings
2. In these proceedings the Petitioner seeks to have the grant of Irish Patent No. (IE) 179220 to Boehringer Ingelheim revoked. The Particulars of Objection set out in the Notice of Objections filed on 23 October 2014, by the Petitioner, set out the following Particulars of Objection to this patent:

      "1. None of the claims of the Patent is in respect of a patentable invention in that the subject matter thereof did not involve an inventive step in that the same was obvious to a person skilled in the art having regard to the matter forming the state of the art at the priority date of the Patent."
3. In that regard the Petitioner relies upon two articles as forming part of the state of the art;
      "2. That insofar as the claims of Patent are not obvious in the light of the prior art, the Petitioner will say that the claims of the Patent represent an arbitrary selection of a level of moisture content in the claimed capsules.

      3. Thirdly, that the specification of the Patent does not disclose the alleged invention clearly and completely enough for it to be performed by a person skilled in the art."

4. Points of defence have been filed by the Respondent and all of the allegations have been denied and put in issue.

5. The Petitioner wrote a letter on 12 January 2015 requesting discovery of five categories of documents. The Respondent replied on 26 January 2015 rejecting all five categories. On 4 February 2015 the Petitioner issued this motion, grounded on the affidavit of Gerard Kelly and various replying affidavits were furnished by the respondents.

The legal principles applicable to discovery applications in patent cases
6. The legal principles applicable to an application of this nature have been set out in a number of cases. In Medtronic Inc. [2007] IEHC 37, Kelly J dealt with a discovery application in a patent case and at page 7 of his decision he reviewed the legal principles applicable in a case of this type. He referred to his earlier decision in PJ Carroll v Minister for Health (Unreported High Court 9 December 2005). (His decision on this issue was upheld on appeal by the Supreme Court where Geoghegan J recorded that the parties had accepted that Kelly J had set out the correct principles. These principles have been reproduced in full and applied by Finlay - Geoghegan J in Schneider Europe v Conor Medical Systems, 2006 IEHC 63).

7. Under Order 31 Rule 12 of the Rules of the Superior Courts an application for discovery must establish that the documents sought are relevant and necessary for the fair disposal of the case or to save costs.

8. On the question of relevance, as Kelly J points out (at page 8 of his decision)

      "On the question of relevance the judgment of Brett LJ in the Peruvian Guano case remains the guiding norm.”

      He said that the following are relevant:

      'Every document relating to the matters in question in the action, which not only would be evidence upon any issue, but also which it is reasonable to suppose contains information which may not which must either directly or indirectly, enable the party requiring the affidavit either to advance his own case or to damage the case of his adversary'."

9. In Ryanair v Aer Rianta, [2003] 4 IR 464, Fennelly J, in the course of his judgment, described that statement as remaining: "The universally accepted test of what is the primary requirement for discovery, namely the relevance of the documents sought."

10. In Framus v CRH [2004] 2 ILRM 439 the Supreme Court approved the approach of McCracken J in Hannon v Commissioner of Public Works [2001] IEHC 59, where he dealt with the question of relevance as follows:

      "1. The court must decide as a matter of probability as to whether any particular [document] is relevant to the issues to be tried. It is not for the court to order discovery simply because there is a possibility that documents may be relevant.

      2. Relevance must be determined in relation to the pleadings in the specific case. Relevance is not to be determined by reasons of submissions as to alleged facts put forward in affidavits in relation to the application for further and better discovery unless such submissions relate back to the pleadings or already discovered documents. It should be noted that Order 31 Rule 12 of the Superior Court Rules specifically relates to discovery of documents 'relating to any matter in question therein'.

      3. It follows from the first two principles that a party may not seek discovery of a document in order to find whether the document may be relevant. A general trawl through the other party's documentation is not permitted under the rules.

      4. The court is entitled to take into account the extent to which discovery of documents might become oppressive and should be astute to ensure that the procedure of discovery is not used as a tactic in the war between the parties."

11. Kelly J also dealt with the question of necessity in this decision where he stated that:
      "The topic of necessity can be summarised as follows; The court in exercising the discretion conferred upon it by Order 31 Rule 12 must have regard to the issues in the action as they appear from the pleadings and the reasons furnished by the applicant to show that the specified categories of documents are required. The court should also consider the necessity for the documents having regard to all the relevant circumstances, including the burden, scale and cost of the discovery. It should also be willing to confine categories of documents sought to what is genuinely necessary for the fair disposal of the litigation. Alternative means of proof which are open to the applicant should also be considered. In some circumstances an order which is too wide can constitute an obstacle to the fair disposal of proceedings rather than the converse. As was said by Murray J in the Framus case:

        'I think it follows that there must be some proportionality between the extent or volume of the documents to be discovered and the degree to which the documents are likely to advance the case of the applicant or damage the case of his or her opponent in addition to ensuring that no party is taken by surprise by the production of documents at a trial. That is not to gainsay in any sense that the primary test is whether documents are relevant to the issues between the parties. Once that is established it will follow in most cases that their discovery is necessary for the fair disposal of those issues."
12. Kelly J then goes on, at page 12 of his decision, to say as follows:
      "These general principles are applicable to discovery in patent actions as much as in any others. Such was the case in England as was clear from the observation of Oliver LJ (as he then was) in SKM SA v Wagner [1982] RPC 497 at 499 where he said:

        'Discovery in a patent action is no different in principle from discovery in any other action'.

      The Civil Procedure Rules in England have introduced a new approach on the topic there but the old rubric continues to apply here."
13. In Schneider Europe GmbH v Conor Med Systems Ireland Ltd., [2006] IEHC 63 Finlay Geoghegan J also considered a discovery application in a patent case. In the course of her judgment Finlay Geoghegan J also set out the general principles to be considered in an application of this nature.

14. At page 5 of her report the learned judge quotes Kelly J in PJ Carroll & Company and also refers to the words of Fennelly J in Ryanair v Aer Rianta where he said that:

      "It may not be wise to substitute a new term of art 'litigious advantage' for the words of the rule. Nevertheless, the discussion gives guidance as to the context in which the matter has to be considered. Within that context, the court has to reach a conclusion as to the likely effect of the grant or refusal of the discovery on the fair disposal of the litigation.

      The change made to Order 31 Rule 12 in 1999 exemplifies, however, growing concerns about the danger of unnecessarily costly and protracted litigation and, in particular, the burdens on parties and the courts arising from excessive resort to automatic blanket discovery. The public interest in the proper administration of justice is not confined to the relentless search for perfect truth. The just and proper conduct of litigation also encompasses the objectives of expedition and economy."

15. In my view those statements of Fennelly J are of particular relevance in the present case i.e. that: "The public interest in the administration of justice is not confined to the relentless search for perfect truth. The just and proper conduct of litigation also encompasses the objectives of expedition and economy."

16. In Medinol Ltd. v Abbott Ireland, [2010] IEHC 6, Finlay Geoghegan J. also considered another discovery application in a patent case. Again Finlay Geoghegan J. recited the general legal principles which are applicable to such applications (at page 3 of her decision).

17. In AstraZeneca v Pinewood Laboratories Kelly J [2011] IEHC 159 again referred to the legal principles which are applicable to cases of this nature. Importantly Kelly J stated at page 4 of his decision that:

      "The court, in considering an application for discovery, must also bear in mind the concept of proportionality. That involves a consideration of the extent or volume of the documents to be discovered and the degree to which the documents are likely to advance the case of an applicant or damage the case of his opponent. The public interest in the proper administration of justice is not confined to the relentless search for perfect truth. (See the observations of Fennelly J in Ryanair v Aer Rianta and Murray J in Framus v CRH.)"
18. Finally, there is a decision of Barrett J in AstraZeneca [2014] IEHC 189 which also restates the applicable legal principles.

19. It is clear therefore that discovery in patent cases in this jurisdiction is no different to discovery in other types of cases. The principles for such discovery are well established - that the documents must be relevant and necessary and also proportionate.

20. In this case there are certain aspects of the above principles which are particularly relevant. These are, firstly, the statement of McCracken J in Hannon, (as approved by the Supreme Court in Framus), that the court is entitled to take into account the extent to which discovery might be oppressive; secondly, the statement by Fennelly J in Ryanair that the public interest in the administration of justice is not confined to the relentless search for perfect truth; thirdly, the statement by Murray CJ in Framus that in certain cases a too wide ranging order for discovery might be an obstacle to the fair disposal of proceedings rather than the converse.

21. As Fennelly J pointed out: "The critical question is whether discovery is necessary for disposing fairly of the cause or matter. There must be some proportionality between the extent or volume of documents to be discovered and the degree to which the documents are likely to advance the applicant's case."

Commercial background to this case
22. In an affidavit sworn on behalf of the Respondents, Ms. Laura Scott sets out the commercial background to this case. From paragraphs 4 to 13 of her affidavit she says as follows:

      "4. Teva seeks an order for revocation of the Irish designation of the European Patent No. 1379220 entitled 'Inhalation Capsules' (the 220 Patent).

      5. Teva's interest in challenging the 220 Patent arises out of the fact that the 220 Patent protects the Spiriva product that the Boehringer Ingelheim Group manufactures and sells for use with its Handihaler device.

      6. The Spiriva product is used for the treatment of chronic obstructive pulmonary disease (COPD) (a term used to describe a number of progressive and irreversible lung conditions including chronic obstructive airways disease, chronic bronchitis and emphysema). With no current cure for COPD, treatments like Spiriva are focused on relieving symptoms and reducing exacerbations so that patients can have as normal a life as possible. The Spiriva product has been one of the most successful treatments for COPD and it is a very important product for Boehringer Ingelheim.

      7. In my affidavit of 4 February 2015 sworn on behalf of Boehringer Ingelheim Pharma's application for discovery in this case, I outlined the two methods in which the Spiriva product is currently taken in inhaler form. Briefly, the first is by way of the Spiriva 18 microgram inhalation powder hard capsule, which is used with Boehringer Ingelheim's Handihaler device. In that method a capsule containing dry powder dry formulation of Spiriva is inserted into the centre chamber of the Handihaler device where it is then pierced, releasing the powder which is then inhaled by the patient. The second method of delivery is by virtue of the Spiriva Respimat Soft Mist inhaler which does not use the capsules described. This inhaler was the first generation of new inhalers containing an aqueous form of Spiriva.

      8. In developing its Spiriva product, Boehringer Ingelheim focussed on the action of a substance called tiotropium which acts as a muscarinic receptor antagonist that is a smooth muscle relaxant yielding bronchodilatory effects when it is introduced into the lungs. Other products on the market with bronchodilatory effects include SEREVENT (marketed by GSK) which uses salmeterol as the active substance and FORADIL (marketed by Novartis) which uses fometerol as the active substance. However, the Spiriva product using tiotropium as the cation as the active substance is the most prescribed COPD treatment worldwide and generated annual global sales of 3.552 billion euro in 2012.

      9. The 220 Patent covers the formulation of the medicinal product containing tiotropium in a capsule for inhalation that ensures the stability of the active ingredient and the release of the active ingredient with high metering accuracy.

      10. Quite separate and distinct from the 220 Patent is supplementary protection certificate No. 2002/021 (the SPC) which was granted to another company in the Boehringer Ingelheim group, Boehringer Ingelheim International GmbH, and which protects the forms of the tiotropium compound contained in the Spiriva product. By proceedings (under Record No. 2014/PAP 1) initiated the same date as the proceedings herein, Teva has applied for revocation of the SPC.

      11. Teva's objective in seeking an order for revocation of the 220 Patent and the SPC can only be so that Teva can make and/or market tiotropium product that will compete with Boehringer Ingelheim's Spiriva product and in particular with the Spiriva product used in conjunction with the Handihaler device.

      12. Accordingly, if Teva succeeds in its actions, it will be able to make and/or market in Ireland a product that directly competes with the Spiriva product and, as a generics company, without having had to carry out the research and development work necessary to originate the product.

      13. These two sets of proceedings in Ireland have followed two sets of parallel proceedings taken by Teva in the UK in which Teva seeks revocation of the UK equivalent of the 220 Patent and the supplementary protection certificate protecting the Spiriva product in the UK (the UK SPC)."


The UK proceedings
23. A factor in this application is that the Petitioner is bringing two sets of identical proceedings against the Respondent in Ireland and in the UK. The proceedings in the UK have not yet come on for hearing but are being actively case managed in the UK. Both parties prepared for the case management conference in the usual way.

24. As part of this preparation the Respondent, Boehringer, was preparing to make discovery under the standard disclosure rules in the UK. A summary of the standard disclosure rules in the UK is set out in the affidavit of Ms. Laura Scott at paragraph 36 where she says:

      "36. I am informed by Boehringer Ingelheim Pharma's UK lawyers and believe that in the UK 220 Patent case, Teva UK included provision in its proposed draft directions for standard disclosure under Rule 31.6 of the UK Civil Procedure Rules as modified by the time limits set out in rule 63.9 of the UK Civil Procedure Rules which are applicable to patent invalidity actions. My understanding is that the UK standard disclosure requires a party to disclose (a) the documents on which he relies and (b) the documents which (i) adversely affect his own case; (ii) adversely affect another party's case; or (iii) support another party's case; and (c) the documents which he is required to disclose by a relevant practice direction, and that the normal time limits applicable to standard disclosure in patent invalidity actions in the UK result in a 'four year disclosure window' where only documents created two years before the priority date of the relevant impugned patent and ending two years after the priority date are disclosable."
25. At paragraph 37 of her affidavit Ms. Scott states as follows:
      "37. I am informed by Boehringer Ingelheim Pharma's UK lawyers and believe that, on the assumption that standard disclosure may be given by the English High Court, Boehringer Ingelheim Pharma did not object to this proposal but it proposed a staged approach to disclosure with a defined and limited number of documents to be reviewed for relevance and potential disclosure under standard disclosure obligations as a first stage and provision for a possible second teenage. Teva UK agreed to this two staged approach and directions to that effect were made by Birss J of the English High Court at a case management conference on 1 October 2014.

      38. A dispute subsequently arose between the parties to the UK proceedings in relation to the confidentiality restrictions to be applied in respect of documents to be disclosed by Boehringer and an application in this regard was brought by Teva and heard by Arnold J of the English High Court on 19 December 2012."

      Ms Scott exhibits a transcript of that hearing in her affidavit.

      "39. At that hearing, Arnold J concluded that no discovery whatsoever was necessary in the 220 case and, as is clear from page 3 to 7 of the transcript, counsel on behalf of Teva did not demur in respect of Arnold J's assessment.

      40. Arnold J expressed himself to be 'utterly baffled' as to why the documents in question in the UK discovery were alleged to be disclosable. Arnold J went on to say at page 3 of the transcript:


        'So far as the revocation is concerned [namely of the UK 220 Patent] the ordinary obviousness case, as I see it, the position is straightforward, viz that we have an allegation of obviousness over two prior art documents' and:

        'It is expressly acknowledged that there is no claim of obviousness over common general knowledge alone and therefore your client's disclosure, the U Reports that are talked about in Mr. Cordell's evidence, I cannot begin to see that they are of relevance. The only other validity plea is the AgrEvo plea also run on the base of insufficiency which is all about plausibility on the face of the patent. So again the U Reports are not relevant there. So far as I can see, the U Reports are simply not disclosable'.


      41. I believe that Arnold J's characterisation of the attitudes of the parties to discovery in the UK 220 Patent case is of relevance to the court's consideration of this matter, not least because neither party took issue with it. In that regard Arnold J stated:

        'Let me just generalise a little because one of the things that concerns me is, time after time in the Patents Court, I see parties agreeing to give disclosure at considerable expense when it turns out it is of no relevance. I think if this carries on we are soon going to move to a régime where there is no standard disclosure and it is only disclosure on application, not least to save the disclosing parties from themselves. What I find so baffling is that this is yet another case where it turns about on inquiry that the receiving party [Teva] is not that bothered. Yet the disclosing party [Boehringer], who you might think would not be wanting to give disclosure, turns out to be the one that is actually falling over itself to give disclosure'.

      42. The learned judge posed the question why should that be and I am informed by Boehringer Ingelheim Pharma's UK lawyers and believe that the reason resides in the arrangement for standard disclosure that I have referred to above in UK proceedings, and where, in anticipation that an order for standard disclosure would be made at the case management conference, the parties made steps to agree the scope of such a disclosure exercise. I say the standard disclosure was not willingly being given by Boehringer as I believe is evident from the very strict confidentiality obligations that it is sought to make the said disclosure subject to and which, I am informed, Boehringer felt constrained to seek in the light of the highly sensitive nature of the documents sought and the uses to which such information could be put in circumstances where it is to be received by generics competitor and where, in reality, information cannot be unlearned."
26. At paragraph 44 Ms. Scott says:
      "As with the different stance taken by Teva's sister company in respect of discovery in the UK SPC proceedings on the one hand and that taken by Teva in the SPC proceedings before this court on the other, I say and believe that in respect of the case concerning the 220 Patent also, that no rational distinction can be made between what can be considered by a petitioner in proceedings to be relevant and necessary for the fair and cost effective disposal of the issues in one jurisdiction and what can be considered by a sister company of that petitioner to be relevant and necessary for the fair and cost effective disposal of the same issues in identical proceedings conducted in a neighbouring jurisdiction, applying rules that are in the same terms in all material respects. I accept that courts may differ and law that is not harmonised can lead to different results in different courts and jurisdictions, but I cannot see a rational basis for a different argument to be made by the respective Teva entity in each jurisdiction as to the principles to be applied in such circumstances.

      45. I say as an originator company facing a discovery request from a generics competitor that encompasses its entire conception, development and reduction to practice of a product being targeted by the generics competitor, Boehringer believes that the different positions of Teva and its sister company respectively in this and the neighbouring jurisdiction merit attention."

27. The submission of Mr. Howard SC for the Respondent is this: Firstly, that the Petitioner is bringing identical proceedings in Ireland and the UK against the Respondent; secondly, the Petitioner in the UK has accepted in the 220 revocation proceedings that, in the light of Arnold J’s comments, no discovery is relevant or necessary; thirdly, however, the Petitioner in this jurisdiction is not only seeking discovery, it is seeking discovery of a vast amount of documents; and, fourthly, that the court should take note of this situation and ask itself, is it the case that documents can be relevant in one jurisdiction and not in the other.

28. In relation to this issue the respondents rely on certain dicta of Clarke J in Ranbaxy Laboratories Ltd & Ors v Warner Lambert Company [2007] IEHC 256, where he talks about the respect due to other courts and states at paragraph 4.7:

      "An entirely separate consideration has to be given to the result of foreign litigation which touches upon the same actual matters, (rather than the same legal principles). The principle of the comity of courts requires that the courts in one jurisdiction should not likely depart from a decision on the same issue made by a court of competent jurisdiction in another country which had to deal with that issue as part of litigation properly under its consideration. Thus, for example, where the courts in one jurisdiction have interpreted a contract in a particular way and where the same contract comes to be interpreted, in a separate dispute between the same or similar parties, in the courts of another jurisdiction, then the comity of courts requires that the interpretation of the contract in the second proceedings should not likely depart from the interpretation given to the same contract in the first proceedings."
29. At 4.8:
      "This latter principle, it seems to me, ought also to apply, though obviously to a more limited extent, where the issue, while not identical, is very similar. For those reasons it seems to be appropriate, subject to the caveats relating to differences in statutory law, jurisprudence, the patents themselves, and the evidence which I have already identified, to pay appropriate regard to the international decisions in related cases.

      4.9. However it is also important not to lose sight of the fact that the international decisions in this case, and in particular the decisions taken by the courts of the UK which derive from an almost identical statutory régime and analogous jurisprudence, have also the status as to their principles of persuasive authority. If the decision of the United Kingdom Court of Appeal in the proceedings between these parties had been between wholly separate parties then, nonetheless, the comments of Jacob LJ on 'business common sense' would be a persuasive authority in this jurisdiction. It would of course be open to any party to suggest that this court should not be 'persuaded' because the case was wrongly decided. Such a course of action is always open to any party. However, that decision, like any decision of the Court of Appeal in the UK in this field, is likely to be regarded as persuasive by our courts in the absence of a good reason for not doing so. For the reasons which I have already analysed I am satisfied the decision of the United Kingdom Court of Appeal in the proceedings between these parties is persuasive as to the principles to be applied and I propose following it."

30. By contrast, the petitioner relies on the decision of Barrett J in AstraZeneca [2014] IEHC 189 where Barrett J, in considering the issue of discovery in Ireland and England, stated at paragraph 2 of his decision:
      "A distinct feature of the proceedings to which the present application for discovery relates is that almost equivalent proceedings will soon be adjudicated upon in England. Indeed, the English court of trial will have regard to substantially the same pleadings as arise in the present case. Moreover, the jurisprudence by which the English proceedings will be decided is substantially the same as that which will apply in the Irish proceedings when those proceedings come to trial. However, there is at least one significant difference between the two sets of proceedings: The rules of discovery in Ireland and England are not the same. Though they are directed to a common end, which is to advance the interests of a fair and proper determination of a hearing between the parties, the Irish rules appear more liberal in terms of what may be discovered."
31. In my view, the words of Arnold J in the transcript exhibited in these proceedings should be treated with the greatest of respect as he is an eminent patent judge, but it should also be treated with caution in this case for a number of reasons: firstly, his dicta are not given in the context of an application for discovery where he made a decision not to grant discovery on grounds that it was neither relevant nor necessary; secondly, his dicta were given in the context of a confidentiality agreement in respect of certain documents; thirdly, it appears that his remarks may only have referred to a couple of documents; fourthly, the discovery rules in the UK and Ireland are different; fifthly, the case management procedures of such cases is different; sixthly, the petitioner in Ireland with its Irish legal advisors is entitled to run its case in the usual way and to seek discovery if it believes it is necessary to do so under the Irish rules of discovery.

32. However, having said that, I think a court in Ireland can have regard to the fact that identical proceedings in the UK are being run without any discovery being sought. In those circumstances I do not believe that it would be appropriate to order a vast amount of discovery in Ireland where no discovery at all is being sought in the UK.

The affidavit evidence of the respondent
33. Mr. Jan Christian Redel has sworn two affidavits for the Respondent in these two sets of proceedings. In these affidavits he sets out in great detail the enormous burden which the petitioner's request for discovery would impose upon the Respondent.

34. At paragraph 7 of his affidavit he states as follows:

      "7. In the light of my preliminary investigations, I say and believe that making discovery of the categories sought would, having regard to the scope and nature of the categories, be a very burdensome, time consuming and expensive exercise for Boehringer to undertake.

      9. For reasons which I explain further below, the scope of discovery sought by Teva implicates several decades of activity.

      10. The amount of potentially discoverable documentation falling within the broad categories sought by Teva during such a long period is enormous, particularly where an organisation the size of Boehringer is concerned. The initial quantity of documents that would need to be gathered in the first instance by Boehringer in order to be reviewed for potential relevance to the categories is even larger still. Further, there would be significant challenges for Boehringer in trying to identify and gather that initial quantity of documents for review from the disparate sources in which they might be or could have been sent to over such a significant period of time, which challenges inevitably result from the effluxion of such a significant period of time and include:


        (i) difficulties in identifying all the potential persons that might have been involved in creating documents falling within the categories at various stages over the relevant period, particularly in circumstances where many employees are either no longer with Boehringer or have moved roles and where Boehringer has gone through a number of internal restructures and organisational changes including the restructure and/or closure of many of the laboratories and departments that were involved in the development of the Spiriva product;

        (ii) difficulties in mapping and navigating what has been necessarily a changing and developing landscape of IT systems and physical storage systems for the organisation over the same period in order to identify where potentially relevant documents may be held."

35. At paragraph 17, in dealing with other data sources, Mr. Redel states that: "The scope of discovery sought by Teva would also require the search and review of documents created during the relevant period over a range of other departments within Boehringer other than those directly concerned with product development including, but not limited to, the regulatory patent and legal functions and across various Boehringer sites."

36. Then at paragraph 20, dealing with the complexity and range of Boehringer systems and physical repositories, he states as follows:

      "20. There are a large number of systems and repositories, both electronic and physical, which may contain documents falling within the categories sought by Teva. Boehringer does not have a single universally searchable IT system and it currently maintains over 2,800 separate systems including several electronic storage systems. It also has a number of different repositories of physical records. Preliminary investigations have been undertaken to try and identify at least the most applicable electronic systems and repositories that would need to be searched in order to gather the initial corpus of documents that could potentially fall within the categories sought by Teva and which corpus would then be reviewed for that purpose."
37. At paragraph 23 he states:
      "IDEA International Document Management and Electronic Archiving System. This is one of a group of computer systems used at Boehringer for the storage of documents. Documents can be created in IDEA directly, imported into the system from other electronic sources or may comprise a physical document that is scanned into one of the systems. I believe, having regard to the nature of the categories sought by Teva, that at least the following two systems within this group would need to be searched in the event that Boehringer were directed to make discovery of documents."
38. And at 1 he says:
      "IDEA for Sub: * This is a sub archive within the IDEA system for all official documents that are relevant to any submission for regulatory approval for any medicinal product. The IDEA for Sub system includes what are known as 'U Reports' within Boehringer. U Reports are internal official reports and comprise both technical and non technical reports which are highly confidential. The technical reports include those which are used for the purpose of preparing the necessary dossiers submitted in applications for regulatory approval for the relevant product. Other U Reports are of a non technical nature and include clinical reports and country by country marketing authorisation reports.

      I have been informed by my IT colleagues that there are approximately 7.2 terabytes of data, comprising 12.9 million documents that are archived within the IDEA for Sub system. I say that in order to investigate the potential amount of data within this system, which would have to be considered for review under the categories sought by Teva, and subject to the comments further below in relation to the difficulties in key word searching this system, a full text word search for the word tiotropium was carried out. The search returned over 569,000 responsive documents. This could easily amount to tens of millions of pages and indeed, given that some documents can be hundreds of pages long, this would potentially amount to hundreds of millions of pages in total.

      (ii) IDEA for GEN: * This is another sub archive within the IDEA group of systems for all official documents of a more general nature that do not fall to be archived within the IDEA for Sub or any other subsection of the wider IDEA group of systems.

      I have been informed by my IT colleagues that it is estimated that approximately 19.3 terabytes of data is archived within IDEA for GEN amounting to 31.5 million different documents. I say that in order to investigate the potential amount of data within this database, which would have to be considered for review under the categories sought by Teva, and subject to the comments further below in relation to the difficulties in key word searching this system, a full text word search for the word tiotropium was carried out by my IT colleagues. This search returned approximately 515,000 responsive documents. This could easily amount to tens of millions of pages."

39. Elsewhere in the affidavit Mr. Redel deals with other systems, file sharing, local drives and emails and the central paper archive of development in Germany, at Biberach.

40. In relation to the central paper archive Mr. Redel states as follows: "Hard copy documents which could potentially fall within the scope of the categories are also maintained in an offsite paper archive in Biberach an der Riss in Germany. This comprises approximately 162,000 documents, which documents fill 72,000 folders and which folders in turn take up a physical capacity of approximately five kilometres of shelving. It is estimated that currently 10,000 documents relate to Spiriva and, based on the foregoing figures, this could amount to approximately 300 metres of shelving."

41. The court must have regard to this affidavit evidence when considering issues of proportionality in relation to discovery in this case.

Respondent’s disclosure report
42. The Respondent had prepared a disclosure report dated 18 September 2014 for the UK proceedings. This report was prepared in accordance with the Civil Procedure Rules in the UK. At paragraph 2.2 the document states:

      "2.2 In accordance with the CPR Practice Direction 63, paragraph 6.12, the requirement for disclosure in relation to the validity of EP 1379220 is the disclosure of relevant documents created within the date range 1 June 1999 to 1 June 2003, the Validity Disclosure Window. The Defendant has carried out its investigations relating to disclosure on the issue of patent validity with a view to disclosing relevant documents within this window.

      2.3. The Defendant has considered the types of documents that it holds that may be relevant to the matters at issue. These include electronic document and hard copy documents.

      2.4. The Defendant has given extensive consideration to the repositories where and custodians with whom relevant documents may be located."

43. It is unnecessary for me to set out in full the entire contents of this report. However, at paragraph 2.14 the disclosure reports states as follows:
      "[Under the heading U Reports] the Defendant considers that its U Reports should be the starting point for the first round of disclosure with the Claimant. The U Reports are internal official reports signed off by the Defendant's lab heads during the development of a product. These reports are based on the lab reports created by the teams working on a product such as Spiriva's development and roughly 90% of the raw data which is in the lab report makes it into the final U Report. It is the U Reports that are/were submitted to the regulatory authorities by the Defendant as part of marketing authorisation dossiers for its products including Spiriva.

      2.15. Markus Weymann, the Defendant's patent attorney, who was responsible for the drafting of the 220 Patent and its prosecution during the Validity Disclosure Window, has confirmed that he would ordinarily refer to the U Reports as a primary point of reference if he needed any technical data to support his work in relation to the 220 Patent. It is this approach to the Defendant's data with an initial focus on the U Reports that the Defendant is proposing for the first round of disclosure.

      2.16. The content for the U Reports have been searched electronically on the Defendant's IDEA for GEN and IDEA for Sub databases. The Defendant has carried out an initial search to provide an estimate of the potentially relevant U Reports that fall within the Validity Disclosure Window and considers that approximately 460 U Reports held on its systems could be relevant. However, the Defendant believes that by conducting more complex targeted searches this number can be narrowed and it is currently working on the best way to carry out such searches.

      2.17. The content of the U Reports are confidential and contain the trade secrets of the Defendant. Therefore, any disclosure of the contents of those documents would need to be subject to strict confidentiality arrangements to be agreed between the parties. In particular the Defendant is concerned that providing the Claimant with the information in these reports can enable them to shortcut development of a generic version of the Spiriva product.

      Spiriva Product Folders

      2.18. The Defendant has to date identified two specific project folders relating to Spiriva that are held on the Defendant's IT system by the drug delivery department and that may contain relevant developmental information relating to the product. These folders can be searched electronically and considered for relevance by the Defendant.

      Hard Copy Files

      2.19. The Defendant is aware of around 20 hard copy files that remain in the possession of custodians from within the Validity Disclosure Window and is in the process of working out the relevance of the documents within those files and whether there are any other hard copy files held by the key custodians which it is not yet aware of.

      2.20. Any disclosure of the documents within the Spiriva project folders or the hard copy files referred to in paragraphs 2.18 to 2.19 above would also need to be subject to strict confidentiality arrangements being in place, in addition to any privilege that already applies.

      Documents Conclusion

      2.21. In the light of the above summary and the substantial analysis carried out by the Defendant to date, the Defendant is of the view that a first round of disclosure based on the U Reports, the Spiriva project folder and the hard copy documents listed at paragraphs 2.19 above, with the focus being on the U Reports, would represent a proportionate and reasonable approach for the first iteration of its proposed stage disclosure exercise, particularly given the ease with which the Defendant is able to retrieve these documents from the appropriate repositories and the consequential cost savings associated with such an approach."

44. Unusually, therefore, in cases such as this, the court has more information at its disposal at the motion for discovery stage than would perhaps normally be the case and I am of the view that the documents which have been identified in this disclosure report, namely the U Reports, the Spiriva project folders and the hard copy files may well be the documents that are most relevant, most necessary and most proportionate and I will deal with that in the relevant categories in which it comes up.

Categories of discovery sought by the petitioner
45. The Petitioner in this case has sought five categories of discovery.

Category 1
46. Category 1: "All documents relating to the patent application filed with the European Patent Office and with the Irish Patent Office as a designated State in respect of European Patent No. EP 1379220, together with the relevant national designated equivalents, referred to as the 220 Patent, and for German patent application 10126924 from which the 220 Patent claims priority as disclosed the state of the art prior to the priority date of the 220 Patent, namely 1 June 2001, including, but not limited to, the prior art documents pleaded by the Petitioner."

47. In the correspondence and in the affidavits both parties have set out their reasons as to why the documents should or should not be discovered. I note, however, that in the Medtronic decision, Kelly J noted in respect of one of the categories sought by the Respondent that the Petitioner had agreed to make discovery of the complete file in respect of their application before the Irish Patent Office and the European Patent Office. However, the court held in that case that the Respondent had failed to establish why any documents beyond that limited category were necessary in order to have a fair trial and he refused discovery in respect of that category.

48. In the present case the Petitioner has sought discovery of the patent file and the Respondent has refused to discover it. However, in my view, this patent file is clearly relevant and necessary and must be discovered. However, I am not satisfied that any of the documents beyond the patent application file are necessary and I will therefore limit it to this. The court must have regard to the proportionality requirements of discovery. The documents must be relevant and necessary for a fair trial of the issue.

49. In those circumstances I believe that what should be discovered in category 1 is: "All documents relating to the patent application filed with the European Patents Office and with the Irish Patent Office as a designated State in respect of the European Patent No. 220 and for German patent application No. 924 from which the 220 Patent claims priority."

50. I will hear further submissions from the parties on the exact wording in that regard.

51. I also propose limiting the time period to a four year window, i.e. for two years before the priority date and two years after the priority date. I propose to do this for a number of reasons. First, because this is standard practice in the UK and it is, therefore, reasonable to have regard to it; secondly, because in the Petitioner's second affidavit of Mr. Kelly, at paragraph 44, he accepts that most of the discovery documents would fall within this window; and, thirdly, because the Respondent was prepared to make such discovery - before the words of Arnold J in the UK. However, I will also hear the parties in relation to this limitation of time.

Category 2
52. Category 2 is as follows: "All documents howsoever described concerning the conception, development and reduction to practice of the subject matter disclosed or claimed in the 220 Patent and for the avoidance of doubt the earlier related German application No. 10126924 from which the priority date of the 220 Patent is derived including (but not limited to) all laboratory notebooks of the named inventors: Mr. Michael Trunk, Michael Walz, Karoline Bechtold Peters, Dieter Hochrainer, their laboratory technicians, correspondence, files, memoranda, notes, calendars and research of the said named inventors and any co worker who directly assisted them with regard to the subject matter of the 220 Patent in respect of each feature of the 220 Patent or any other equivalent patent."

53. I am of the view, having heard the careful submissions of counsel for the Respondent in this matter, that the discovery sought under this category is simply too broad. Firstly, it is necessary to break down this requirement into its constituent parts, of which there are three. The first part (a) is:

      "All documents concerning the conception, development and reduction to practice of the subject matter disclosed or claimed in the 220 Patent from which the priority date of the 220 Patent is derived."
54. The second part is: "The laboratory notebooks of the named inventors and their laboratory technicians." And the third part is: "The correspondence of the said inventors and any co worker who directly assisted them."

55. I note that in Medtronic and in SKM the discovery of inventors' notes, research and development and design files was ordered. I have also considered the dicta of Oliver LJ in SKM, the dicta of Laddie J in Hoechst v BP Chemicals and of Pumfrey J in Norton Healthcare where the courts noted the need for restraint in respect of such categories.

56. The Petitioner says this category is similar to category 2 in Schneider. A full analysis of this category of documents was made by Finlay Geoghegan J in Schneider and the court in that decision allowed the discovery of the documents at category 2.

57. The court in that decision reviewed the decisions of, 1. SKM v Wagner Spraytech; 2. Wellcome Foundation v VR Lab; 3. Eli Lilly v Apotex; 4. Hoechst Celanese Corporation v BP Chemicals; and, 5. Mölnlycke AB v Proctor.

58. The court noted that these decisions were not binding on this court but were deserving of great respect. The court, however, decided it would decide the issue on first principles and the court held that the documents were relevant and necessary and should be discovered.

59. Having said that, the first part of category two gives me considerable pause for thought. I am of the view that it is impossibly broad in scope and in time. It imposes an impossible burden on the Respondent, it increases the costs of the litigation and could make it almost unmanageable. Trials are not tribunals of inquiry, it is not a search for a perfect truth, in the words of Fennelly J.

60. I think, therefore, the documents which are relevant and material and proportionate to this part of the discovery are those documents identified in the Respondent's disclosure reports, i.e., No. 1, the U Reports; no. 2, the Spiriva project folders; no. 3 the hard copy documents at paragraph 2.19.

61. In relation to the second element of category 2, the laboratory notebooks, I am of the view that these laboratory notebooks of the named inventors and their laboratory technicians are relevant and material and should be discovered and I note in this regard that Finlay Geoghegan J in Schneider made discovery of this category.

62. In relation to the third element, the correspondence and files of the inventors and any co worker who directly assisted them, I am of the view that most, if not all, of these documents could well be captured in the category above at 2(b) and so therefore they are not necessary or proportionate to conduct this trial.

63. I also believe that the discovery of these documents should be limited in time and I will hear the parties on this. Indeed I believe all the categories should be limited in time and I will hear the parties on this issue.

Category 3
64. The third category of documents sought by the Petitioner is: "All documents which disclose or evidence the consideration (if any) given by the inventors of the 220 Patent, Mr. Michael Trunk, Mr. Michael Walz, Ms. Karoline Bechtold Peters and Mr. Dieter Hochrainer and/or their laboratory technicians and/or by or on behalf of the Respondent to the prior art referred to, or related to, that listed in the Particulars of Objections dated 23 October 2014, including any documents disclosing or evidencing any considerations or evaluation by the inventors and/or their technicians and/or by and on behalf of the respondent as to the potential effect of any such alleged prior art on the patentability of the subject matter disclosed in the 220 Patent or any other equivalent patent."

65. I note that category 3 in Schneider is similar to category 3 in this case, i.e. the consideration given by the inventors of the 220 Patent to the prior art.

66. Indeed in Schneider, Finlay Geoghegan J reworked the defendant's requested category in that case and made an order in terms of a revised category 3. It appears as if the petitioners in this case have tracked this rewording in their request for discovery. Of course each case is different and it is limited to the pleadings in each case. However, having said that, I am of the view that such documents are relevant and necessary for this case but they should be limited in time and I will hear the parties on this point.

Category 4

      "All documents which concern or refer to the issue of validity of the '220 Patent which have been shown to, provided to, sent to or received from any expert, consultant or in house counsel and/or patent attorneys who are or have been retained by the Respondent in respect of such an issue."
67. In my view such documents are relevant and material and should be discovered. I note that a similar category of documents was ordered in Medtronic and in AstraZeneca by Kelly J; however, it should be limited in time and I will hear the parties on this.

68. Finally, the fact that privilege may be claimed over some or all of these documents is not a reason why discovery should not be ordered.

Category 5

      "All documents that the Respondent will rely on to demonstrate that the '220 Patent is valid and should not be revoked, whether on the grounds of lack of inventive step and/or insufficiency or otherwise."
69. In this regard I note that the Respondent has agreed to provide this category of discovery; however, it believes that this category should be deferred until the witness statements have been prepared.

70. Whilst I have considered this argument, which was ably put by Ms. McNamara, I nevertheless believe that it is not appropriate for the proper case management of these proceedings that it should wait until then. In my view these documents are clearly relevant and necessary and material and they should be discovered. Given that they should be discovered, in my view they should be discovered forthwith.

The Ranbaxy principle
71. The Respondents sought to resist the Petitioner's application for discovery by relying on the principle of Ranbaxy Laboratories v Warner Lambert Company [2006] 1IR 193. However, a similar issue was considered by Finlay Geoghegan J in Schneider and the court held that the Ranbaxy decision dealt with the issues of admissibility of evidence, not the discovery of documents.

72. In that decision Finlay Geoghegan J stated:

      "I have considered the plaintiff's submissions in reliance upon the decisions of the Supreme Court and High Court in Ranbaxy Laboratories v Warner Lambert Company. Those decisions do not appear to me to assist the plaintiff in its defence of this application.

      The decisions were given on a preliminary issue in a patent action in which the principal issue is the proper interpretation of the claims in the defendant's patent. The plaintiff had brought a motion for discovery of documents which comprised correspondence between the patent agents of the defendant and the European Patent Office and Danish Patent Office. That correspondence was alleged to express a view on the proper construction of the Irish patent. The defendant objected to discovery on the basis that the documents would not be admissible in evidence in the proceedings. A preliminary issue was then set down on the admissibility of such documents in evidence in the substantive proceedings.

      On the preliminary issue the documents were determined both by the High Court and the Supreme Court to be inadmissible in evidence."

73. However, in my view, the documents, where they are ordered to be discovered, are relevant and material and should be discovered and the Ranbaxy principle cannot avail the Respondent.

74. That is my judgment on the first matter.

THE SECOND PROCEEDINGS - RECORD NO. 2014/ 1 PAP

Introduction
75. This is my decision on the discovery application in case, Record Number 2014/No. 1 PAP. In these proceedings the Petitioner is bringing a challenge to the Respondent's Supplementary Protection Certificate (“SPC”). The Petitioner claims that the supplementary protection certificate is valid for reasons set out in its Notice of Objections. Its claim is that the SPC should be revoked.

76. In its Notice of Objections the Petitioner pleads:

      "1. That the SPC was granted to the Respondent relying on the Irish patent 65528 as the basic patent.

      2. That the SPC was based upon marketing authorisation PA 775/2/1 dated 28 June 2002.

      3. That it was granted contrary to Article 3 of Regulation 469/2009 in that the products of the SPC are not predicted protected by the Irish patent."

77. These claims are denied in full by the Respondent.

Motion for discovery
78. By letter dated 12 January 2015 the Petitioner sought discovery of twelve categories of documents. By letter of 26 January 2015 the Respondent refused all categories. On 4 February 2015 the Petitioner issued this motion and there has been a similar exchange of affidavits.

79. It is argued by the Respondent that the discovery of documents in this case is even more unnecessary here than in the earlier case because it is essentially a construction case.

80. I turn now to consider the twelve categories of documents sought by the Petitioner in this case.

Category 1

      "All documents relating to the patent application filed with the Irish Patents Office in respect of Irish Patent No. 65528 and with the European Patent Office and designated States in respect of the European Patent EP 0418716 (together with the relevant national designated equivalents referred easy to the 'Basic Patent') and for German patent application No. 3931041.8 from which the Basic Patent claims priority as disclosed, whether all or any of the following are claimed, identified, specified, under or otherwise protected by the basic patent:

      (i) tiotropium bromide monohydrate;

      (ii) salts of tiotropium;.

      (iii) scopine di (2 thienyl) glycolate in the form of quaternary salts; and/or.

      (iv) any other product not listed in (i) to (ii) above."

81. I am of the view that the patent file filed with the Irish Patents Office in respect of Irish Patent 528 and with the European Patent Office in respect of European Patent 716 is relevant and material and is discoverable. However, I do not believe that the documents relating to the patent application that are filed with other designated States are relevant.

82. The patent file in relation to German patent application No. 041.8 from which the basic patent claims priority is also relevant, but any other documents which are sought in relation thereto are, in my view, not proportional to the claim that is being sought to be made in these proceedings by the Petitioner.

83. I also believe that, insofar as it is necessary, this discovery should be limited in time and I will hear the parties in relation to this matter.

Category 2
84. Category 2: "All documents howsoever described concerning the conception, development and reduction to practice of the subject mailer disclosed or claimed in the Basic Patent, and for the avoidance of doubt the earlier related German Application No. 3931041.8 from which the priority date of the Basic Patent is derived, including (but not limited to) all laboratory notebooks of the named inventors, Dr. Rolf Banholzer, Dr. Rudolf Bauer and Dr. Richard Reichl and their laboratory technicians, correspondence, files, memoranda, notes, calendars and research of the said named inventors and any co worker who directly assisted them with regard to the subject matter of the Basic Patent in respect of each feature of the Basic Patent or any other equivalent patent."

85. This category is similar to category 2 in the earlier proceedings and in my view it is too broad. The first four lines are in my view far too broad and are not proportionate and, therefore, I do not propose to make discovery of all documents in relation to the conception, development and reduction to practice of the subject matter disclosed or claimed in the basic patent and, for the avoidance of doubt, the earlier related German application from which the priority date of the basic patent is derived.

86. However, in relation to the second element of this, all laboratory notebooks of the named inventors, I will make discovery of this. I think it is relevant and necessary and material and I note that a similar order has been made by Finlay Geoghegan J in Schneider.

87. In relation to the third element, correspondence, files, etc., between the inventors and any co worker, I do not believe that these documents are necessary and I do not propose to permit discovery in relation to them.

88. Again I propose that such discovery should be limited in time and I will hear the parties on this.

Category 3
89. In relation to category 3, which is:

      "All documents which disclose or evidence the consideration or evaluation (if any) given by the inventors of the Basic Patent, Dr. Rolf Banholzer, Dr. Rudolf Bauer and Dr. Richard Reichl and/or their laboratory technicians, and/or by or on behalf of the Respondent to products claimed, identified, specified and/or protected by the Basic Patent as are alleged by the Respondent to form the subject matter of the SPC and in particular whether any or all of the following are claimed, identified, specified under or otherwise protected by the Basic Patent:

      (i) Tiotropium bromide monohydrate;

      (ii) Salts of tiotropium;

      (iii) Scopine di (2 thienyl) glycolate in the form of the quaternary salts; and/or

      (iv) Any other product not listed at (i) to (iii) above."

90. I think that, to the extent that these documents are relevant, they are already covered by categories 1 and 2. Beyond that, they are not relevant to this case because they are not either necessary, or proportionate, to the essential construction claim which is being made by the Petitioner in these proceedings.

Categories 4, 5 & 6.
91. Category 4: "All documents relating to the patent application filed with the European Patents Office and the Irish Patents Office (as a designated state) in respect of European Patent No. EP 1326862 entitled 'Crystalline monohydrate of tiotropium bromide, method for producing the same and the use thereof in the production of a medicament' (together with the relevant national designated equivalents referred to as the '862 Patent'), and for German patent application number 10050621 from which the 862 Patent claims priority, as disclose whether any or all of the following are claimed, identified, specified under or otherwise protected by the 862 Patent:

(i) Tiotropium bromide monohydrate;

(ii) Salts of tiotropium;

(iii) Scopine di (2 thienyl) glycolate in the form of the quaternary salts; and/or

(iv) Any other product not listed at (i) to (iii) above."

92. Category 5: "All documents howsoever described concerning the conception, development and reduction to practice of the subject matter disclosed or claimed in the 862 Patent, and for the avoidance of doubt the earlier related German Application No. 10050621 from which the priority date of the Basic Patent is derived, including (but not limited to) all laboratory notebooks of the named inventors, Rolf Banholzer, Peter Sieger, Christian Kulinna, Michael Trunk, August Ludwig Manfred Graulich, Peter Specht, Helmut Meissner, Andreas Mathes and their laboratory technicians, correspondence, files, memoranda, notes, calendars and research of the said named inventors and any co worker who directly assisted them with regard to the subject matter of the 862 Patent in respect of each feature of the 862 Patent or any other equivalent patent."

93. Category 6: "All documents which disclose or evidence the consideration or evaluation (if any) given by the inventors of the Basic Patent, Rolf Banholzer, Peter Sieger, Christian Kulinna, Michael Trunk, August Ludwig Manfred Graulich, Peter Specht, Helmut Meissner, Andreas Mathes and/or their laboratory technicians, and/or by or on behalf of the Respondent to products claimed, identified, specified and/or protected by the 862 Patent as are alleged by the Respondent to form the subject matter of the SPC and in particular whether any or all of the following are claimed, identified, specified under or otherwise protected by the 862 Patent:

(i) Tiotropium bromide monohydrate;

(ii) Salts of tiotropium;

(iii) Scopine di (2 thienyl) glycolate in the form of the quaternary salts; and/or

(iv) Any other product not listed at (i) to (iii) above."

94. These documents relate to the patent application filed with the EPO in relation to European Patent No. 1326862. Having regard to the submissions of Ms. McNamara, I am not satisfied that these documents are relevant or material or necessary. It relates to a different patent and no relationship between these patents is apparent. Therefore it is not relevant to the question of construction which is raised in the SPC proceedings and I will therefore refuse these categories 4, 5 and 6.

Category 7
95. Category 7 is: "All documents relating to the SPC application filed with the Irish Patents Office and in other Member States of the European Union in which the European patent, the basic patent, is designated."

      All documents relating to the supplementary protection certificate application filed with the Irish Patents Office in respect of the SPC (No. 2002/021) and in other Member States of the European Union in which European Patent No. EP 0418716 (i.e. the Basic Patent) is designated and in which a supplementary protection certificate has been applied for and which discloses whether any or all of the following are claimed, identified, specified under or otherwise protected by the Basic Patent and/or covered by the marketing authorisation relied upon in respect of such application for the SPC:

      (i) Tiotropium bromide monohydrate;

      (ii) Salts of tiotropium;

      (iii) Scopine di (2 thienyl) glycolate in the form of the quaternary salts; and/or

      (iv) Any other product not fisted at (i) to (iii) above.

      For the avoidance of doubt, this category includes all such documents related to the application for the grant of extension of duration of the SPC under Article 13(3) of Regulation (EC) No. 469/2009 concerning the supplementary protection certificate for medicinal products / Article 36 of Regulation (EC) No. 1901/2006 on medicinal products for paediatric use, i.e. the paediatric extension."

96. Again in my view, given that the issues in these proceedings are essentially matters of construction, I believe that the category of documents which is sought here is overbroad. In the circumstances I believe that the only documents which are relevant and necessary are the documents set out in the first two lines of the category: "All documents relating to the SPC application filed with the Irish Patent Office in respect of SPC 2002/021."

97. The documents in respect of other Member States of the EU are not relevant or necessary; even if they were, they were not proportionate.

Category 8
98. Category 8: "All documents relating to the marketing authorisation application filed with the Irish Medicine Board."

      "All documents relating to the marketing authorisation application filed with the Irish Medicines Board (now the Health Products Regulatory Authority) in respect of Irish marketing authorisation No. PA 775/2/1 and filed with the relevant office for the marketing authorisation application number RVG 26191 (The Netherlands Authorisation date 9 October 2001) from which the Irish marketing authorisation is grounded based on the mutual recognition procedure under Directive 75/318/EEC as amended (since replaced by Directive 200 1/83/EC as amended) (the 'Marketing Authorisation'), as disclose whether any or all of the following products are covered under the Marketing

      Authorisation:

      (i) Tiotropium bromide monohydrate;

      (ii) Salts of tiotropium;

      (iii) Scopine di (2 thienyl) glycolate in the form of the quaternary salts; and/or

      (iv) Any other product not listed at (i) to (iii) above.

      For the avoidance of doubt, this category Includes a copy of Irish marketing authorisation No. PA 775/2/1 as granted and marketing authorisation application number RVG 26191 as granted and, if relevant, a copy of such marketing authorisations as amended from time to time since grant."

99. I note, in this regard, that the Respondent has in fact agreed to make discovery of Irish marketing authorisation PA 775/2/1 and Dutch marketing authorisation RVG 26191, subject to the suitable redaction of any element thereof that is irrelevant to the issues in dispute and subject to agreement being reached as to the obligations as to confidentiality attending the products of the highly commercially sensitive documents pursuant to discovery.

100. I note that all other documents in relation to the marketing authorisation are extremely sensitive. In any event, in my view, all of the other documents are not necessary in a construction suit such as this. It would also be entirely disproportionate having regard to the issues in the case. In those circumstances I believe that the discovery which has been offered by the Respondent is sufficient and I will make an order in those terms.

Category 9
101. Category 9: "All documents which concern or refer to the issue of validity of the SPC which have been shown to, provided to, sent to or received from any expert, consultant or in house counsel and/or patent attorneys who are or had been retained by the Respondent in respect of each such issue."

102. I am of the view that these documents are relevant and material and should be discovered. Whilst there may well be an issue about the admissibility of such documents at a later stage on the Ranbaxy principles, nevertheless I believe that the appropriate course of action for me to follow at this juncture in relation to a discovery application is to make an order that such documents should be discovered. However, I will also hear submissions in relation to a limitation of time on this.

Category 10
103. Then category 10: "All documents which concern or relate to any consideration or decision by the Respondent, including advice related thereto, to select the Basic Patent for the purpose of the SPC application in Ireland and/or other EU Member States designated under the Basic Patent."

104. In my view it is difficult to see how these documents are relevant or material or necessary and, therefore, I refuse discovery of this category.

Category 11
105. Category 11: "All documents which concerns or relates to any consideration by the Respondent, including advice related thereto, to select the marketing authorisation for the purpose of the SPC application in Ireland and/or other EU Member States in which an SPC was applied for under the Basic Patent."

106. Again in my view, having regard to the fact that this is a construction suit, I do not believe that these documents are relevant or material and I refuse that category.

107. In relation to category 12: "All documents that the Respondent will rely on to demonstrate the SPC is valid and should not be revoked."

108. I note that the Respondent has agreed to this category but state that it is premature and wishes to await the exchange of expert reports to make discovery of this category of documents. For the reasons that I have set out in my earlier judgment on the related case I do not believe that this is an appropriate course of action. I believe that these documents are relevant, clearly relevant and material and they should be discovered forthwith without waiting for the exchange of expert reports.




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