Boehringer Ingelheim Pharma GmbH v Norton (Waterford) Ltd

• Jurisdiction: Ireland
• Judge: Ms. Justice Finlay Geoghegan
• Judgment Date: 26 February 2016
• Neutral Citation: [2016] IECA 67
• Docket Number: Appeal No. 2015/278
• Court: Court of Appeal (Ireland)
• Date: 26 February 2016

The President

Finlay Geoghegan J.

Peart J

IN THE MATTER OF IRISH PATENT No. EP (IE) 1379220 FILED ON THE 27TH MAY, 2002 AND REGISTERED IN THE NAME OF BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG

IN RESPECT OF AN ALLEGED INVENTION FOR ?INHALATION CAPSULES?

AND

IN THE MATTER OF THE PATENTS ACT 1992 AND

THE PATENTS (AMENDMENT) ACT 2006

BETWEEN

BOEHRINGER INGELHEIM PHARMA GmbH AND CO KG

APPELLANT

AND

NORTON (WATERFORD) LIMITED t/a TEVA PHARMACEUTICALS IRELAND

RESPONDENT

[2016] IECA 67

Finlay Geoghegan J.

Appeal No. 2015/278

THE COURT OF APPEAL

CIVIL

Discovery – Revocation of patent – Order for discovery – Appellant seeking to appeal against order for discovery – Whether documents were necessary for the fair disposal of the proceedings

Facts: The respondent, Norton (Waterford) Ltd t/a Teva Pharmaceuticals Ireland, petitioned seeking revocation of Irish Patent No. EP(IE) 1379220 (?220 Patent?). At the time of the hearing of a discovery motion in the High Court the grounds of revocation were: 1) obviousness over three pieces of prior art referred to as ?Maesen? (a study from 1995); ?Ogura? (a paper from 1998) and ?Barnes? (a paper from 2001); and 2) lack of sufficiency and/or plausibility. Also at the time of the High Court discovery hearing there were proceedings between related companies of the appellant, Boehringer Ingelheim Pharma GmbH and Co KG, and Teva in the English High Court relating to the equivalent UK 220 Patent which were due to be heard in July 2015. The approach of the related parties to disclosure in England following exchanges at a case management conference with Arnold J were relied upon in the High Court by Boehringer. An order for discovery of five categories of documents was made by the High Court (Cregan J) on the 19th May, 2015. Boehringer appealed to the Court of Appeal against the substance of the order made in respect of categories 1 to 4 and the timing of the required making of discovery in respect of category 5. Boehringer submitted that Cregan J, in considering relevance and more particularly necessity of the individual categories of documents, had failed to take into account sufficiently the fact that Teva proceeded with its claim in England without seeking to obtain disclosure of any of the documents in categories 1 to 4. Teva stressed the difference in test for relevance between Ireland and standard disclosure in England, the fact that the trial judge had limited the categories of documents sought in particular in categories 1 and 2 and also reduced the periods sought, and the fact that similar categories of documents had been ordered by the High Court in patent discovery judgments.

Held by Finlay Geoghegan J that the trial judge was correct in concluding that categories 1 to 4 included documents which as a matter of probability were relevant in accordance with the test in Compagnie Financiere et Commerciale du Pacifque v Peruvian Guano Company (1882) 11 QBD 55 as disclosing a line of inquiry which may assist or damage Teva?s case. Turning to category 1 which was in substance a portion of the patent file, Finlay Geoghegan J held that the trial judge was correct in making an order of discovery and holding that the documents were both relevant and necessary for the fair disposal of the proceedings. In relation to categories 2 and 3 Finlay Geoghegan J formed the opposite view, considering Schneider (Europe) GbmH v Connor Med Systems Ireland Limited [2007] 2 ILRM 300; the proportionality between the potential advantage to Teva in obtaining those documents for use in these proceedings and the probable cost and time involved in Boehringer making discovery and taking into account the position in the UK proceedings was such that discovery of categories 2 and 3 was not necessary for the fair disposal of the proceedings. Finlay Geoghegan J formed a similar view in relation to category 4. Finlay Geoghegan J held that the trial judge was acting well within his discretion in determining that the documents which Boehringer had agreed to discover should be made available to Teva in advance of the preparation of its witness statements. Accordingly, Finlay Geoghegan J rejected the appeal against the trial judge?s determination of the timing of discovery in relation to category 5.

Finlay Geoghegan J held that the appeal would be allowed in part and the orders for discovery in relation to categories 2, 3 and 4 in the High Court order of the 19th May, 2015 would be vacated.

Appeal allowed.

Judgment delivered on the 26th day of February 2016 by Ms. Justice Finlay Geoghegan

1 Boehringer Ingelheim Pharma GmbH and Co KG (?Boehringer?) appeals against an order for discovery made by the High Court (Cregan J.) on the 19th May, 2015, in which he ordered discovery of five categories of documents. Boehringer appeals against the substance of the order made in respect of categories 1 to 4 and the timing of the required making of discovery in respect of category 5.

2 The order was made in a petition by Norton (Waterford) Limited t/a Teva Pharmaceuticals Ireland (?Teva?) seeking revocation of Irish Patent No. EP(IE) 1379220 (?220 Patent?).

3 At the time of the hearing of the discovery motion in the High Court (and upon the hearing of the appeal) the grounds of revocation were:

(i) Obviousness over three pieces of prior art referred to as ?Maesen? (a study from 1995); ?Ogura? (a paper from 1998) and ?Barnes? (paper from 2001).

(ii) Lack of sufficiency and/or plausibility.

4 The 220 Patent is part of the protection in place for Boehringer Spiriva ? product. The priority date for the 220 Patent is the 1st June, 2001 which it derives from German patent number 1012694.

5 In the High Court the discovery application was heard in conjunction with applications for discovery in parallel proceedings relating to a Supplementary Protection Certificate (SPC) granted to another company in the Boehringer Ingelheim group. Teva also applied for revocation of the SPC in the parallel proceedings. The order for discovery made in those proceedings was appealed to this court, but by reason of developments in the High Court due to the proximate expiry date of the SPC subsequent to the hearing of the appeal it is no longer necessary to deal with the appeal in the SPC proceedings.

6 Prior to the discovery hearing in the High Court Teva had confirmed in replies to particulars that it was not making a claim of obviousness over common general knowledge. This is of some relevance to the issues on appeal. Also, Boehringer had, shortly before the hearing, made an application by motion of the 11th March, 2015, to amend the 220 Patent. Teva has indicated an intention to object to the amendment. The issue of Boehringer's entitlement to amend will not be determined until the hearing of the petition. Boehringer at the discovery hearing indicated that it will not at the trial hearing seek to defend the 220 Patent as granted, but will only defend an amended form featuring the bifurcation of claims as between PEG Gelatin claims and HPMC claims reflected in the amendment applied for. Teva has indicated that no challenge will be brought in respect of claims 1 or 4 of the amended 202 Patent (presumably if granted).

7 It also relevant to the issues on appeal that at the time of the High Court discovery hearing there were proceedings between related companies of Boehringer and Teva in the English High Court relating to the equivalent UK 220 Patent which were due to be heard in July 2015. At the time of the hearing of this appeal judgment had been reserved. The approach of the related parties to disclosure in England following exchanges at a case management conference with Arnold J. were relied upon in the High Court and again on appeal by Boehringer.

8 Boehringer's Spiriva product is stated to be essentially a smooth muscle relaxant that is inhaled into the lungs and that yields bronchodilatory effects when it binds to the muscarinic receptors in the deep lung. The Spiriva product is currently taken in inhaler form by two methods. The 220 Patent is stated to protect 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 substance with high metering accuracy. It is also stated to protect the formulation when used with the Handihaler ? device so that it is delivered to the lung.

9 The trial judge having had a four day discovery hearing based upon a number of affidavits; having delivered an extensive ex tempore judgment on the 27th March, 2015, and having heard further submissions over two days, delivered a supplemental written judgment on the 6th May, 2015, pursuant to all of which he made the following orders for discovery by Boehringer of documents which are or have been in its possession, power or procurement:

?1. All documents contained in the patent application filed with the European Patent Office in respect of European patent number EP1379220 (the ?European 220 Patent?), the application filed with the Irish Patents Office in respect of the Irish designation of the European 220 patent (the ?220 patentrdquo;) and the German patent application number 10126924 filed with the German Patents Office from which the European 220 patent claims priority and all correspondence between the Respondent and/or its agents with the European Patent Office, the Irish Patents Office and the German Patents Office, in relation to the said patent applications, for the period between 1 June 2001 and 21 December 2005, as disclosed the state of art prior to the priority date of the 220 patent namely 1st June 2001 (including but not limited to the prior art documents pleaded by the Petitioner).

2. (a) (i) U Reports created during the period 1 June 1996 and 21 December 2005 which relate to the conception, development and reduction to...