Novartis AG & Anor v Johnson & Johnson Medical Ltd (t/a Johnson & Johnson Vision Care) & Anor

A patent claim defined by functional results must be enabled across its full scope. It is insufficient to identify desirable parameters if the skilled person must undertake a research programme and extensive clinical testing to discover which products possess the claimed properties. A claim to a class of products with a useful activity requires a common principle permitting a reasonable prediction that substantially all claimed products share that activity. The patent was insufficient because its ion-permeability thresholds gave little practical assistance, and it disclosed no unifying principle enabling prediction of ophthalmic compatibility or co-continuous morphology.

The claimants, proprietors and exclusive licensees of a patent for extended-wear contact lenses, alleged infringement by the defendants’ Acuvue Oasys lenses. The defendants denied infringement and counterclaimed for revocation on grounds including lack of priority, lack of novelty, obviousness and insufficiency.

The court considered the validity of claims concerning oxygen and ion permeability, ophthalmic compatibility, co-continuous phases or pathways, and hydrophilic surfaces. It also considered whether Oasys fell within claims 1, 8, 11 and 24.

1. Priority and novelty. The first and second priority documents did not disclose the essential combination of ion-permeability thresholds and ophthalmic compatibility during extended wear. The claims therefore lacked the claimed priority. However, the defendants failed to establish that Hopken or Domschke disclosed lenses necessarily falling within the claims. The novelty attacks failed.
2. Obviousness. Although the skilled person knew of silicone hydrogels, oxygen permeability, water content and surface treatment, it was not obvious how to produce a silicone hydrogel lens that was ophthalmically compatible for extended wear. The attacks based on common general knowledge, Chang, Lai and Keogh failed.
3. Insufficiency. Under section 72 of the Patents Act 1977, the specification had to enable the invention across the full scope of the monopoly. The Ionoton threshold was confusing and unsupported by the experimental data. The Ionoflux threshold was so low that it provided little practical assistance. The skilled person could not predict which disclosed or undisclosed formulations would be ophthalmically compatible without clinical testing. Nor did the patent identify which examples had the required co-continuous phases or pathways, or provide adequate instructions for producing them. Implementing the claims required a research programme rather than routine trial and error. The patent was therefore insufficient.
4. Infringement. For the purposes of the action, the defendants accepted that Oasys satisfied most requirements of claim 1. The court found that Oasys also satisfied the oxygen-transmissibility requirement, and that its surface was more hydrophilic than its core for claim 24. Infringement of claims 8 and 11 was not established.
5. The patent was invalid for insufficiency. The attacks based on lack of novelty and obviousness failed. The claimants established infringement of claims 1 and 24, but not claims 8 or 11.

Not stated in the judgment.