Teva Pharmaceutical Industries Limited & Anor. v Novartis AG & Anor.

For inventive step, the inventive concept is determined from the invention as claimed. Technical advantages disclosed only in the specification cannot be imported into a product claim if they are not claim limitations. A product claim is invalid if the claimed product was an obvious modification of the prior art, even if it has an unexpected bonus effect. Obviousness must be assessed without hindsight, but lack of commercial motivation does not prevent a finding of obviousness where the product was within the skilled person’s contemplation. Numerical ranges are assessed under the ordinary doctrine of equivalents. Where the range has technical significance in combination with other claimed features, strict compliance may be required.

Teva sought revocation of two patents concerning swallowable film-coated deferasirox tablets and declarations of non-infringement concerning Teva DFX. Novartis counterclaimed for infringement and applied to amend the claims.

The central issues were the inventive concept, obviousness over three items of prior art, the formal allowability of proposed amendments, and whether Teva DFX infringed literally or as an equivalent. The court also considered whether disclosed bioavailability and food-effect advantages formed part of the claimed invention.

1. Inventive concept. The inventive concept was the claimed combination: a swallowable film-coated deferasirox tablet containing 45–60% deferasirox, specified excipients, and no sodium lauryl sulphate or lactose. Increased bioavailability and reduced food effect, although disclosed in the specification, were absent from the claims and could not be imported into the inventive concept.
2. Inventive step. The relevant question was whether it was obvious to make the claimed tablet. A bonus effect cannot save a product claim where the product itself is obvious. The court applied the structured approach in [2007] EWCA Civ 588 and treated the warnings against hindsight as applicable, while recognising that lack of commercial incentive is not necessarily material. A skilled team would have considered a swallowable formulation an obvious goal and would have selected microcrystalline cellulose and poloxamer 188 as obvious alternatives to lactose and sodium lauryl sulphate.
3. Claims 1 and 2 of both patents lacked inventive step over Battung and Zadok. Séchaud added no relevant teaching beyond the common general knowledge and did not render the claims obvious.
4. The proposed conditional amendments did not alter the inventive concept or cure the lack of inventive step. Amendments introducing a non-functional coating added matter and were disallowed under Patents Act 1977, s 76(3). Other amendments were formally clear or supported but remained invalid for lack of inventive step.
5. Infringement. Teva DFX was outside the claims on normal construction. Applying [2017] UKSC 48, the 45–60% range had to be strictly complied with in the context of the specified formulation. Teva DFX was neither literally within the claims nor an equivalent.
6. The patents were invalid for lack of inventive step, and Teva DFX did not infringe.