Boehringer Ingelheim Pharma Gmbh & Company & The Patents Act
| Jurisdiction | Ireland |
| Judge | Mr Justice Max Barrett |
| Judgment Date | 10 April 2018 |
| Neutral Citation | [2018] IEHC 165 |
| Docket Number | 2014 No. 2 PAP |
| Court | High Court |
| Date | 10 April 2018 |
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"
AND
IN THE MATTER OF THE PATENTS ACT 1992
AND THE PATENTS (AMENDMENT) ACT 2006
[2018] IEHC 165
2014 No. 2 PAP
THE HIGH COURT
Intellectual Property – The Patents Act 1992 – The Patents (Amendment) Act 2006 – O.94, r.16 of the Rules of the Superior Courts 1986 – Amendment in patent claim – Leave to amend statement of opposition.
Facts: The applicant sought leave pursuant to o.28, r.1 and/or o.63A, r.5 and/or o.94, r.16 of the Rules of the Superior Courts 1986, or the inherent jurisdiction of the Court to amend the statement of opposition. The respondent had filed an application to amend its patent claims, in response to which the applicant desired leave to amend its statement of opposition.
Mr. Justice Max Barrett held that the applicant was not required to seek leave to amend its statement of opposition, and if the applicant continued to desire such leave, it could be granted. The Court held that its jurisdiction to permit the amendment of a patent could not be equated with the adjudication of conventional inter partes disputes requiring pleadings. The Court found that the two previous statements of opposition delivered by the applicant were not pleadings as envisioned by the Rules of the Superior Courts 1986 and were not furnished by way of response to any pleadings that had emanated from the respondent.
This application follows on the judgment of the court in the above-titled proceedings delivered on 26th July last ("the principal judgment"). In that judgment the court explained why it would not accede to the application made by Norton (Waterford) Ltd t/a Teva Pharmaceuticals Ireland ("Teva"), which is also the applicant in the within application, to revoke the Irish designation of European Patent No (IE) 1379220 entitled "Inhalation Capsules" which patent is owned by Boehringer Ingelheim Pharma GmbH & Co KG ("Boehringer"), the respondent to the within application. As the court mentioned in the opening paragraph of its principal judgment, application had also been made by Boehringer to amend its patent claims. However, the court had been asked in the first instance to address the revocation application on the basis of the proposed amended claims, with the application for amendment to be prosecuted at some future stage. In advance of that latter application coming on for hearing, Teva, in an abundance of caution, seeks an order pursuant to O. 28, r.1 and/or O.63A, r.5 and/or O. 94, r.16 of the Rules of the Superior Courts 1986, as amended ("RSC"), and/or the inherent jurisdiction of the court, granting Teva leave to amend the statement of opposition in the within proceedings and certain ancillary reliefs. (For the reasons identified hereafter, such an application is not in fact required). The detail of the proposed amended text is set out in the appendix hereto.
It may assist for the court to commence with a number of general observations concerning the nature of the within application and the relationship of the claims amendment application to the revocation application that was the subject of the principal judgment:
(1) Distinct Application. The claims amendment application sits separately from the invalidity claim. Whether it is provoked by the invalidity proceedings or not is irrelevant.
(2) Burden. The putative invalidities contended for in the revocation application do not define or limit the extent of the obligation on Boehringer as the applicant in the claims amendment application.
(3) Issues. The specific issues that Teva has raised and seeks to raise regarding lack of support and added matter concern issues that would in any event have to be considered by the court in the claims amendment application.
(4) Findings. Neither as a matter of general principle or patent law does a finding in an inter partes revocation application restrict the court in an associated patent claim application.
(5) Pleadings. Where, as here, there is an obligation on Boehringer to satisfy the court that the proposed amendments to the patent are appropriate and lawful, there is no place or provision for pleadings. (And, if one sits back for a moment, how could matters be otherwise? The obligation placed on Boehringer is not defined by a pleaded case but by its statutory obligation to satisfy the court that amendments are proper.) This is an aspect of matters that is considered in more detail hereafter.
As mentioned, the detail of the proposed amendment to the statement of opposition is set out in the appendix hereto. In essence, the amendment involves (i) the bringing of a challenge on the grounds of lack of support in respect of the proposed amended Claim 6 and the claims dependent thereon, and (ii) a fresh added matter challenge in respect of the same claims. The proposed amendment is grounded on two pieces of evidence: (a) an expert report of Professor Buckton (whose evidence features prominently in the principal judgment); and (b) an expert report of an expert not previously encountered in the proceedings, being Dr Kelly, a European patent attorney and registered Irish patent agent.
As regards (a), the court's especial attention has been drawn to paras. 4.1-3 of same, in which Professor Buckton observes, inter alia, as follows:
'4.1 In my first Irish expert report I made reference to two letters from the UK IPO which are set out at Appendix 2 to my report.
4.2 In the letter dated 17 June 2015, the Comptroller states that "there is not sufficient reference, explicit or implicit, to the special advantage obtained when hydroxypropylmethylcellulose that has a reduced moisture content as a TEWS or halogen drier moisture content of <=5% is used as a capsule material as claimed in the proposed new claim 5". New claim 5 in the UK is the equivalent of the proposed Amended Claim 6 in Ireland. The Comptroller notes that the specification states the moisture content for HPMC capsules is "preferably less than 8%, particularly preferably less than 5%...most preferably...less than 4%, particularly preferably less than 2% before being filled with the inhalable powder...". The Comptroller sees no support for why "5% which appears to be intermediate between the ranges discussed in the application as filed should be included into independent claim 5 [claim 6 in Ireland] as characterizing a feature of the invention".
4.3 I understand the Comptroller to be questioning what the merit is in having a moisture content of less than or equal to 5% in the Irish Amended Claim 6...'.
The above-quoted text touches on the "lack of support" argument that Teva now wishes to introduce into the pleadings. It was an argument that was always present in the evidence of Professor Buckton and, as he mentions at para. 4.1, he made reference to the two letters from the United Kingdom's Intellectual Property Office in his original witness statement. There was no application made at the hearing of the invalidity application to strike out the just-referenced portion of Professor Buckton's witness statement; it is evidence that he was free to give and intended to give on one of the two fresh issues that Teva want to introduce into the statement of opposition (and also, frankly, issues that would engage the court even if there were no statement of opposition, amended or otherwise).
As regards (b), Dr Kelly identifies the principles to be applied in the context of patent amendments, treats, inter alia, with the amended Claim 6 and concludes that ' the subject matter of Amended Claims 6, 7, 7(A), 7(B), 8, 8(A), and 8(B) of the Patent extends the subject matter disclosed in the Application as filed, contrary to the relevant principles applicable under the EPC and the Act.'
The foregoing is the key evidence sustaining the fresh added matter contention that Teva wishes to lead in the context of Boehringer's amendment application.
(i) Section 38 and Order 94.
There is no rule that requires or lays down a mechanism for the amendment of a document setting forth the basis for an objection to the amendment of a patent.
Section 38 of the Patents Act 1992, as amended, provides as follows:
'(1) Subject to the following provisions of this section, the Controller may, on an application made in the prescribed manner by the proprietor of a patent, allow the specification of the patent to be amended, subject to such terms as to advertising the proposed amendment and such other conditions, if any, as he thinks fit; provided that no such amendment shall be allowed where there are pending before the Court or the Controller proceedings in which the validity of the patent has been or may be put in issue.
[Court Note: in the claims amendment application the court is effectively sitting in the place of the Controller, discharging the obligation that otherwise the Controller would have, and with all of the responsibilities that the Controller has for the adjudication on the appropriateness of allowing any amendments.]
(2) In any proceedings before the Court or the Controller in which the validity of a patent is put in issue, the Court or, as may be appropriate, the Controller may, subject to the following provisions of this section, allow the proprietor of the patent to amend the specification of the patent in such manner, and subject to such terms as to advertising the proposed amendment and as to costs, expenses or otherwise, as the Court or the Controller thinks fit.
(3) An amendment of a specification under this section shall be invalid to the extent that it extends the subject matter disclosed...
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