Laboratorios Almirall SA v Boehringer Ingelheim International GmbH

A patent specification must identify the technical benefit said to support the invention. A general assertion of an unexpectedly beneficial therapeutic effect, without identifying the benefit or providing supporting disclosure, leaves the skilled reader guessing. Later experiments cannot cure that deficiency or establish inventiveness where the alleged advantage was not disclosed in the patent as filed.

Known combinations of complementary medicines are not rendered inventive merely because a later-discovered advantage is asserted. For obviousness, the court must apply the structured inquiry in Pozzoli v BDMO [2007] EWCA Civ 588, assessing the common general knowledge and the expectation of success. A Swiss-type claim may nevertheless be invalid if its substance is the clinician’s treatment of a particular patient rather than the manufacture of a medicament.

The claimant sought revocation of European Patent (UK) No 1 651 270, owned by the defendant, concerning pharmaceutical compositions combining a particular anticholinergic compound with one or more beta-agonists. The patent asserted an unexpectedly beneficial therapeutic effect but did not identify it or provide supporting data.

The defendant also counterclaimed for revocation of the claimant’s GB Patent No 2 419 819, concerning aclidinium combined with a long-acting beta-agonist, particularly for patients with pre-existing heart conditions or conditions aggravated by tachycardia. The issues included novelty, obviousness, insufficiency, amendment, and whether claim 20 was an excluded method of treatment under the Patents Act 1977.

1. Patent ‘270. The phrase in paragraph [0008] referring to an unexpectedly beneficial therapeutic effect did not identify the nature of the alleged benefit. The skilled reader would be left guessing whether the benefit concerned bronchodilation, reduced side effects, or something else. The word “observed” also implied an actual experimental observation, which had not been made. The lack of a specified technical contribution was decisive across the validity issues.
2. Combination treatment with anticholinergics and beta-agonists was part of the common general knowledge. Additive bronchodilation, reduced dosage and side effects, and improved compliance were expected benefits. Later experiments did not clearly prove a super-additive effect, and the S-enantiomer covered by claim 1 was substantially devoid of relevant therapeutic activity. The alleged effect therefore could not support the claims across their breadth.
3. Applying the structured approach in Pozzoli v BDMO [2007] EWCA Civ 588, the claims were obvious over Forner and over Schelfhout I and II, whether considered separately or together. Forner expressly taught the use of its antimuscarinic compounds with beta-agonists for respiratory diseases. The skilled team would naturally investigate its most promising compounds in the established combination therapy.
4. The patent was also insufficient under section 72(1)(c) because the specification did not disclose the alleged therapeutic effect clearly and completely, and the claims extended beyond any supported contribution. Post-published evidence could not repair the deficiency.
5. The proposed amendment of ‘270 was not pursued because the patent was invalid. If considered independently, the amendment would not cure the substantive defects; confining the alleged benefit to selected beta-agonists would add matter, while an arbitrary selection would remain obvious.
6. Patent ‘819. Claim 20 was obvious. The claimed patient group and the use of the combination were within the skilled clinician’s pragmatic, stepwise approach, although the cardiac-sparing advantage was useful and unexpected. The claim was also invalid under section 4A(1)(a) of the Patents Act 1977. Its substance was the clinician’s treatment of a patient with a specified condition, not merely the manufacture of a medicament.
7. The court ordered that both ‘270 and ‘819 be revoked. The court reserved the form of order and costs.