H318
Judgment
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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 The pleadings
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." 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 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)
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'." 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:
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."
'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."
'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." 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:
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." 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:
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
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)." 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:
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."
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." 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:
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."
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 34. At paragraph 7 of his affidavit he states as follows:
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." 36. Then at paragraph 20, dealing with the complexity and range of Boehringer systems and physical repositories, he states as follows:
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." 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
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."
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." Categories of discovery sought by the petitioner Category 1 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 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:
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 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
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
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 72. In that decision Finlay Geoghegan J stated:
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." 74. That is my judgment on the first matter. THE SECOND PROCEEDINGS - RECORD NO. 2014/ 1 PAP Introduction 76. In its Notice of Objections the Petitioner pleads:
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." Motion for discovery 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
(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." 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 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
(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." Categories 4, 5 & 6. (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
(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." 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
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." 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 9 102. 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 10 104. 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 11 106. 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. |