Teva UK Ltd v Boehringer Ingelheim Pharma Gmbh & Company KG
| Jurisdiction | England & Wales |
| Judge | Mr Justice Morgan |
| Judgment Date | 21 October 2015 |
| Neutral Citation | [2015] EWHC 2963 (Pat) |
| Docket Number | Case No: HP-2014-000002 |
| Court | Chancery Division (Patents Court) |
| Date | 21 October 2015 |
[2015] EWHC 2963 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice, Rolls Building
Fetter Lane, London, EC4A 1NL
Mr Justice Morgan
Case No: HP-2014-000002
Mr Daniel Alexander QC and Mr Mark Chacksfield (instructed by Pinsent Masons LLP) for the Claimant
Mr Michael Tappin QC and Mr Douglas Campbell (instructed by Allen & Overy LLP) for the Defendant
Hearing dates: 7 – 10 and 14–17 July 2015
The claim in outline
The Defendant is the patentee in respect of European Patent (UK) 1 379 220. The patent relates to capsules to be used in a dry powder inhaler for the purpose of delivering a particular active ingredient (tiotropium bromide) to the lung of a patient suffering from chronic obstructive pulmonary disease ("COPD") or asthma.
On 3 June 2014, the Claimant issued a Claim Form seeking a declaration that the patent was invalid and an order for its revocation. The grounds of invalidity put forward were that the subject matter of the patent lacked an inventive step in the light of two pieces of prior art and common general knowledge. It was also said that: (1) certain integers in the claims were arbitrary; (2) there was no disclosure in the patent to suggest that the claimed capsules possessed any technical benefits or solved any technical problem; (3) there was no data in the patent to make it plausible that the claimed capsules solved any technical problem; and (4) the patent did not disclose the invention clearly enough to enable it to be performed by a skilled person. The Defence denied these allegations.
On 19 February 2015, the Defendant applied for permission pursuant to section 75 of the Patents Act 1977 ("the 1977 Act") to amend the claims in the patent. The proposed amendments were extensive resulting in the Defendant putting forward 11 new claims. The amendments to the claims were sought unconditionally and it was stated that the Defendant would not contend that the original claims were valid, although the Defendant made no formal admission on that point.
The Claimant served notice of opposition to the proposed amendments to the claims. The opposition focussed on the new claims 5 to 11. It was said that "at least" claims 5 to 11 would be invalid. The grounds of invalidity were essentially the same as the grounds put forward by the Claimant in relation to the original claims (although the Claimant now relied on three pieces of prior art). Further, in relation to the new claim 6, it was said that the claim involved added matter. The Claimant then stated that it would not put forward a positive case of invalidity in relation to new claims 1 to 4 although it believed that those claims would also be invalid.
On 17 June 2015, the IPO responded to the application to amend the claims. It stated that it did not wish to be represented at the trial unless the court so directed. I did not direct it to appear at the trial. The IPO considered that claims 1 and 5 would not be allowable under sections 14(5) and 76 of the 1977 Act because they were unsupported, lacked clarity and added matter. The IPO did not refer to claim 6.
The trial of this action began on 7 July 2015. On 9 July 2015, the Defendant made an amended application to amend the claims in the patent. The Defendant continued to rely on its original application to amend the claims but it added conditional applications to amend. The further amendments were to introduce claim 6A or claim 6B. The application to introduce claim 6A was made in the event that claim 6 was not allowed. The application to introduce claim 6B was made in the event that claim 6 and claim 6A were not allowed.
The trial proceeded. As foreshadowed in its notice of opposition, the Claimant did not address claims 1 to 4 but focussed on claims 5 and 6 and claims 6A and 6B, to the extent that claims 6A and 6B raised the same issues as claims 5 and 6. By the end of the trial, the Claimant had not served a response to the amended application to introduce claims 6A and 6B. The IPO took no part in the trial although its response to the Defendant's revised application to amend (made on 9 July 2015) was awaited. By the last day of the trial, the parties had not received a response from the IPO to that application. The parties then submitted to me the following:
(1) I should adjourn further consideration of amended claim 1 (and the claims dependent upon it) to allow the Defendant to file evidence to deal with the points raised in relation to it, unless I considered that the point could be summarily decided in favour of the Defendant;
(2) I should not finally decide the issues in relation to claims 6A and 6B and the matter should be further considered following any response from the IPO.
At the end of the trial, I reserved my judgment. I was later supplied with a letter dated 4 August 2015 from the IPO in response to the application to introduce claims 6A and 6B. The IPO stated that it considered that:
(1) claim 6 was clear, supported by the description and did not add matter;
(2) claim 6A also was clear, supported by the description and did not add matter;
(3) claim 6B was not clear, was not supported by the description across its full scope and added matter; and
(4) claims 6, 6A and 6B were dependent on claim 5 and because claim 5 was not allowable, for the reasons given by the IPO on 17 June 2015, the dependent claims 6, 6A and 6B were also not allowable.
Given the procedural background described above, this judgment deals with claims 5 and 6 and claims dependent on those claims. I will not determine the issues in relation to claim 1 and claims dependent on it. As to claims 6A and 6B, I will not formally determine the issues in relation to them but I consider that my conclusions in relation to claims 5 and 6 might be regarded by the parties as having an important bearing on the conclusion which I should reach in relation to claims 6A and 6B also. As to the legal basis for the challenge to the various claims, this judgment will focus on the questions as to whether the claims involve an inventive step and whether integers said to characterise the claims are arbitrary.
COPD
COPD is a diagnosis given to a person with narrowed bronchi i.e. the airways within the lungs. This narrowing is commonly caused by cigarette smoking, although it can result from other causes. Most COPD sufferers have a combination of chronic bronchitis, acute bronchitis and emphysema. The chief symptoms are cough, sputum production, breathlessness with wheeze and infective exacerbations. Together these cause disability, impaired health status and reduced quality of life. The severity of COPD is measured by spirometry, the frequency of exacerbations and the severity of symptoms. Spirometry involves measuring the volume of air that can be expired by the patient either in one second (forced expiratory volume) or in total (forced expiratory capacity). COPD is very common, especially in patients who are over the age of 50. Rough estimates as to the prevalence of COPD in the United Kingdom population are 10 – 50 per 1,000 and as to the rate of mortality attributable to COPD are 20 – 60 per 10,000.
Asthma
Like COPD, asthma is a respiratory disease involving the narrowing and inflammation of the airways of the lungs. The main symptoms are breathlessness, wheeze, chest tightness and cough. The symptoms can be acute and/or chronic. The symptoms are caused by a combination of contractions of the muscles surrounding the airways, known as bronchospasm, and also inflammation of the airways which causes swelling of the airway wall and blockage by inflammatory sections.
An earlier patent
I was told that the preparation of tiotropium bromide was the subject of European Patent EP 0 418 716. Professor Birchall exhibited an English translation of this patent but the translation did not disclose the identity of the patentee nor the date of grant nor the priority date. I assume that the patentee was the Defendant or an associated company. I was told that the Defendant has a supplementary protection certificate in relation to this patent. The certificate (if valid) expires in March 2016. There is a dispute as to the validity of this certificate but I am not asked to resolve that dispute. I did not receive any submissions as to the significance, if any, of this patent to the present dispute but I note that the description of the compounds which are the subject of this patent refers to them being novel compounds capable of use as active ingredients in medicaments. The description also states that the compounds are strong anti-cholinergic agents which have prolonged action, with toxicity in the same range as the commercial product ipratropium, but with a stronger therapeutic effect. The description stated that the compounds are suitable for the treatment of chronic obstructive bronchitis and slight to moderately severe asthma. The patent referred to the compounds being administered in a number of ways which included administration as inhalation powders in conventional inhalation apparatus.
The patent in suit
The patent in suit is European Patent (UK) 1 379 220 granted to the Defendant on 29 December 2004 with a filing date of 27 May 2002. The language of the patent is German although the claims are in German, English and French. I have been provided with an English translation of the patent which is agreed to be accurate. I need to mention a small point about the spelling of "gelatine" or "gelatin". The English translation of the patent refers to...
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