Re Boehringer Ingelheim Pharma GmbH & Company Kg & Patents Acts

JudgeMr Justice Max Barrett
Judgment Date26 July 2017
Neutral Citation[2017] IEHC 495
Docket Number2014 No. 2 PAP
CourtHigh Court
Date26 July 2017



[2017] IEHC 495

2014 No. 2 PAP


Intellectual Property – The Patents Act 1992 – The Patents (Amendment) Act 2006 – Revocation of patent – Lack of obviousness – Insufficiency – AgrEvo attack – Anticipation by prior publication – Onus of proof

Facts: The applicant sought an order for the revocation of an Irish Patent granted for the product entitled 'Inhalation Capsules' to the respondent/owner of the patent. The applicant had presented three grounds of challenge on the validity of the claim of that patent. The applicant claimed that the steps formulated for the making of the said product was obvious to the notional person skilled in art and that it had been anticipated by prior publications. The applicant also argued that the patent had made no technical contributions to the state of art. The respondent objected to the grounds of the challenge.

Mr. Justice Max Barrett declined to make an order for the revocation of the patent. The Court held that the onus of proof for the revocation of the patent laid on the applicant and the applicant had failed to discharge that onus. The Court took into account the expert testimonies in relation to the publications of formulations that were used in the making of that product. The Court concluded that the said experts did not encounter prior art in relation to the use of subject capsules for inhalation purposes. The Court further found that the use of said capsules containing cellulose derivative was not known in the market until recently. The Court noted that the invention of inhalation capsules containing tiotropium preparations for inhalation in reduced-moisture hydroxypropylmethylcellulose (HPMC) capsules was not obvious. The Court noted that the question of obviousness should be considered on the facts of each case and it might include the intended solution to the problem that the subject patent was seeking to find and the extent of research that went with it. The Court opined that there was a divergence of opinion as to how a notional person would have approached the formulation of an inhaled medicine on the priority date.

JUDGMENT of Mr Justice Max Barrett delivered on 26th July, 2017.

(Numbers in square brackets are paragraph numbers).

I. Background [1]
II. The Patent [3]
III. Revocation of a Patent [7]
IV. Grounds of Challenge [8]
V. Onus of Proof [13]
VI. Comity [14]

(i) Proceedings in Other Jurisdictions. [14]

VII. Inventive Step/Obviousness: Some General Observations [26]

(i) Overview. [26]

VIII. The Notional Person Skilled in the Art [38]

(i) General Attributes. [38]

IX. Common General Knowledge of Notional Skilled Person [40]

(i) General. [40]

X. Identifying the Inventive Concept of the Claim at Issue [97]
XI. Differences Between State of Art and Inventive Concept; Obviousness [101]

(i) Overview. [101]

XII. Regulatory Matters [142]
XIII. Statistical Evidence [148]
XIV. Plausibility [150]

(i) Overview. [150]

XV. Barnes, Maesen, and Casaburi [182]

(i) Overview. [182]

XVI. Expert Witnesses [191]
XVII. Conclusion [192]
Appendix: The Clinical Evidence [193]

(i) Introduction. [193]

I. Background

Norton (Waterford) Limited t/a Teva Pharmaceuticals Ireland ("Teva") has come to court seeking an order for the revocation of the Irish designation of European Patent No. (IE) 1379220 entitled "Inhalation Capsules" (the "220 Patent"), which patent is owned by Boehringer Ingelheim Pharma GmbH & Co. KG ("Boehringer"). Application has also been made by Boehringer to amend the patent claims. However, the court has 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, if at all, at some future stage. Teva reserves its position in relation to any such future application. As part of the pleadings, two notices of experiments have been served; the response to each from Teva has been that for the purposes of the within proceedings, but without any wider concession or admission, it does not contest the results arising (if the steps prescribed in the protocols to those notices are taken) and does not require repeat performance of the experiments.


The invention that is challenged in the within proceedings comprises capsule-based powdered formulations of tiotropium for inhalation where the capsules are made from a cellulose derivative (hydroxypropylmethylcellulose or "HPMC") of reduced moisture content. Tiotropium comes within a class of medicaments known as "anti-cholinergics" and is a medication for chronic obstructive pulmonary disease ("COPD") and asthma. More particularly, the 220 Patent protects Boehringer's SPIRIVA® product. SPIRIVA® is an important product on the market for the relief of symptoms of persons with COPD. Back in 2012, for example, SPIRIVA® was the most prescribed COPD treatment worldwide and generated annual global sales of a remarkable €3.552bn.

II. The Patent

The first part of the 220 Patent sets out a general description of the invention, being in essence powdered preparations of tiotropium in capsules for inhalation where the moisture content of the capsules is reduced. This part of the 220 Patent outlines the benefits of the invention, viz. the stability of the active ingredient, the high metering accuracy of the dose released during inhalation, the efficient emptying of the capsule, and the good perforation qualities, good stability, and low brittleness of the capsule.


The detailed description of the 220 Patent notes that it has been found that desired capsule properties can be attained by using capsule material with reduced moisture content. Having outlined the methodology used to measure moisture content, the description proceeds to discuss the materials from which the capsule can be made. These include: gelatin in admixture with polyethyleneglycol; and HPMC. The moisture content for those materials is prescribed and methods of manufacturing and filling the capsules outlined.


The patent then gives instructions for (i) the proportions of tiotropium or recommended salts of tiotropium in the powdered preparation, (ii) the type and particle size of carrier, (iii) the type of inhaler that can be used, (iv) the amounts of inhalable powder to be loaded into the capsules, (v) the process of preparing homogenous mixtures of the inhalable powder, (vi) the drying of the capsules to the required moisture content (pre- or post-filling). The patent also gives instructions for the preparation of the materials used in the examples of the invention given in the patent.


The priority date of the 220 Patent, and hence the date by reference to which its patentability falls to be assessed, is 1st June, 2001.

III. Revocation of a Patent

Section 57(1) of the Patents Act 1992 provides, inter alia, that '[A] ny person may apply to the Court or the Controller for revocation of a patent'. Section 58 provides that an application for revocation of a patent may be made on the grounds that, inter alia, ' (a) the subject-matter of the patent is not patentable under this Act' and '(b) the specification of the patent does not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art'. The essence of what is patentable is stated in s.9(1) of the Act of 1992, as amended by s.3 of the Patents (Amendment) Act 2006; this provides that ' An invention, in all fields of technology, shall be patentable under this Part if it is susceptible of industrial application, is new and involves an inventive step.' Section 13 of the Act of 1992 provides, inter alia, as follows: ' An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art'. Of relevance also are ss. 19(1) and 20 of the Act of 1992 which respectively provide as follows: ' 19.–(1) A patent application shall disclose the invention to which it relates in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art'; '20.–The claim or claims shall define the matter for which protection is sought, be clear and concise and be supported by the description.'

IV. Grounds of Challenge

Broadly, Teva has levelled a three-fold attack on the validity of the claims in issue, being (1) an obviousness attack, (2) an insufficiency attack, and (3) an AgrEvo attack, all of which grounds of attack have been resisted by Boehringer.


The last of these grounds of attack, the AgrEvo attack, is a ground of challenge that has been developed at the European Patent Office. It takes its name from the decision of a Board of Appeal of the European Patent Office in AgrEvo/Triazoles (Case No. T0939/92, 12th September, 1995) and has been accepted as a ground of challenge in the courts of the neighbouring jurisdiction. (See, e.g., Generics (UK) Ltd (t/a Mylan) v. Yeda Research & Development Co. Ltd [2013] EWCA Civ. 925 and Idenix Pharmaceuticals Inc. v. Gilead Sciences Inc. [2016] EWCA Civ. 1089). It applies where a development may not be obvious but where the elements of the development which distinguish it from what went before make no technical contribution to the subject-matter. These features are adjudged "arbitrary" and incapable of contributing to inventiveness. Plugged into the European Patent Office's problem-solution approach ("PSA") to identifying inventive step, such features solve no technical problem and thus fail on that ground.


So far as obviousness is concerned, Teva claims that the...

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    ...of their particular specialisation. I bear in mind, in this context, the observation of Barrett J. in Boehringer Ingelheim's Patent [2017] IEHC 495 at para. 38 where, in the context of considering the attributes of the notional person skilled in the art, Barrett J. observed: “… the notional......
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    ...of any authority in the State before the High Court judgment in Re Boehringer Ingelheim Pharma GmbH & Co. KG & Patents Acts, Ireland [2017] IEHC 495 [a decision of my own] and has not been dealt with in any other Irish case. 50. Second, I did not assert that the Court of Appeal decision in ......
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