Novartis AG & Anor v Johnson & Johnson Medical Ltd & Ors

For a patent claim defined partly by the result to be achieved, sufficiency is assessed across the claim’s whole scope. The specification must enable the skilled person to achieve that result without undue experimentation or inventive skill. Trial and error is permissible only where the patent and common general knowledge provide adequate guidance towards success. A claim is insufficient where it covers a vast range of materials but gives no reliable means of predicting which combinations, proportions or treatments will satisfy the functional requirement, so that a research programme and extensive testing are required. A functional threshold that adds little practical guidance cannot cure the defect.

Novartis AG and Cibavision AG appealed from Kitchin J’s decision concerning European Patent (UK) No. 0,819,258. The judge held that Johnson & Johnson’s Oasys contact lenses fell within claims 1 and 24, but that the patent was invalid for insufficiency. He rejected attacks based on obviousness and lack of novelty.

On appeal, Johnson & Johnson supported the insufficiency decision and raised contingent challenges concerning obviousness and anticipation. The central issue was whether the broad, functionally defined claim enabled the skilled person to make ophthalmically compatible extended-wear lenses across its whole scope.

The Court of Appeal dismissed the appeal and upheld the conclusion that the patent was insufficient. The contingent challenges concerning obviousness and novelty did not arise. The patent should be revoked in its entirety.

1. Applicable standard. The sufficiency requirement under Article 83 of the EPC applies whether an invention is defined structurally or by reference to a desired function. The disclosure must enable the skilled person to perform the whole subject matter within the claim without undue burden or inventive skill, and the monopoly must correspond to the technical contribution. The court applied the principles stated in Detergents/UNILEVER (T 0435/91) and Plant gene expression/MYOCGEN (T 0494/92), and treated amorphous silica/INEOS (T 1743/06) as a closely analogous application of the test.
2. Claim 1. The claim effectively covered a lens made from two very broad classes of polymerisable materials, provided that the lens satisfied the functional requirement of ophthalmic compatibility. The Ionoton threshold was confusing and practically unhelpful, while the Ionoflux threshold was so low that it offered little meaningful limitation. The patent’s examples did not establish that the lenses were ophthalmically compatible, and the specification gave no adequate guidance on selecting materials, proportions or surface treatments.
3. Undue burden. A skilled person could make lenses falling within the physical wording of the claim and test them clinically, but the patent gave no reliable basis for predicting success. Testing successive combinations and learning nothing useful from failure would amount to a research programme. Predictability was relevant because the functional limitation was central to the claim. A fortuitous successful combination would be attributable to the skilled person’s luck, not to the patent’s teaching.
4. Additional observations. The court noted that lack of compliance with Article 84 of the EPC was not itself a ground of invalidity, although clarity and support considerations could overlap with sufficiency. It also observed, obiter, that if success with almost any claimed combination were likely, the patentee could face a squeeze between obviousness and insufficiency.

• Court of Appeal (Civil Division). The appeal was dismissed. The court upheld the finding of insufficiency and concluded that the patent should be revoked in its entirety.
• Chancery Division, Patents Court. Kitchin J, on 10 July 2009, held that the Oasys lenses fell within claims 1 and 24 but that the patent was invalid for insufficiency, while rejecting obviousness and novelty attacks: [2009] EWHC 1671 (Pat).