The Court of Appeal has reversed the grant of a declaration of non-infringement (DNI) of a patent, refusing to hold there was no indirect infringement.
Article 69(1) of the European Patent Convention (EPC), and the Protocol on the Interpretation of Article 69, provide that the extent of the protection conferred by a European patent or application is determined by the claims. However, the description and drawings may be used to interpret the claims. For the purpose of determining the extent of protection conferred by a European patent, account may be taken of any element that is equivalent to an element specified in the claims.
Indirect patent infringement occurs where an invention is not put into effect by the defendant himself, but by someone who was supplied with means relating to an essential element of the invention (essential means) (section 60(2), Patents Act 1977) (section 60(2)).
Pemetrexed, a cancer treatment marketed by a US company, L, was protected by a basic patent extended by supplementary protection certificates (SPCs) expiring in December 2015 (the basic patent). L also owned a patent for the use of pemetrexed disodium in combination with vitamin B12, which would not expire until June 2021 (the patent).
A wished to enter the market, on expiry of the basic patent, with a generic product. L was concerned that this product would infringe the patent. A wanted to resolve this issue in a single trial and in good time to enter the market on expiry of the SPCs in relation to the French, German, Italian, Spanish and UK designations of the patent.
A sought DNIs of each of those designations of the patent. A did not challenge the validity of the patent in these proceedings. L applied for declarations that the High Court did not have jurisdiction in respect of the French, German, Italian and Spanish designations of the patent.
The High Court granted the DNIs, holding there was neither direct nor indirect infringement. It also held that, where there was no challenge to the validity of the patent, the English court had jurisdiction to try an action claiming DNIs of counterparts in other European countries, as well as claiming a DNI of the UK European patent.
As the law applicable to the question of whether A was entitled to a DNI was English law, A was entitled to a DNI for the UK, French, Italian and Spanish designations of the patent. Even if English law was not applicable, the national laws of French, Italian and Spanish law would permit the grant of a DNI for each jurisdiction. L appealed.
The court allowed the appeal. It held that there was no direct infringement by A,but in relation to indirect infringement it was not possible to grant a DNI.
Two general issues of construction were considered:
- In the US, and in some European countries, the courts apply a doctrine of equivalence which extends the scope of protection outside the scope of the claims. The UK prefers a principle of construction which gives effect to what the person skilled in the art would have understood L to be claiming. In arriving at the skilled person’s understanding of the language of the claim, it could not be right to provide him with information which he could not derive either from the specification or his common general knowledge.
- It was not useful to examine the prosecution history to discover that L accepted a restriction to its claim against an objection of lack of support in the specification. It was always open to a party attacking the patent to argue that the claims as sought to be construed by the patentee lacked support in the specification. Patent offices were concerned with patentability, not scope of protection. If an applicant stated that he did not accept that by accepting a limitation he was necessarily restricting the scope of protection, in practice no inference could be drawn from his conduct in accepting it.
L’s case on indirect infringement was that A was supplying an essential means for the doctor or pharmacist who makes up the solution to put the invention into effect. Section 60(2) did not require the supply of an element of the claim, but a means relating to an essential element. A means for releasing pemetrexed ions into solution related to an essential element of the invention where the invention called for pemetrexed ions and sodium ions in solution, particularly as the presence of the pemetrexed ions in the manufactured medicament was essential for its efficacy. The invention was then put into effect when the pharmacist made up the solution using pemetrexed dipotassium, because there came a stage in the course of that activity when pemetrexed disodium was present and was used. Therefore the facts in this case may give rise to indirect infringement.
As there was no difference in the laws of France, Italy and Spain on the approach to indirect infringement, the DNIs should also be refused in respect of those countries. Applying the laws of those countries, there would also be no direct infringement.
This case attracted most attention for the High Court’s earlier decision on the conditions for granting DNIs for foreign counterparts of a UK European patent. The other issue of wide interest is that the prosecution history should not be used as an aid to claim construction in the UK.
In post-appeal submissions, A applied to remit a further issue on infringement to the High Court. As the parties disagreed on whether acts done in relation to a product recommended for reconstitution in dextrose infringed the patent, it was held there would be procedural advantages, in terms of minimum formality and expense, in that issue being decided in the present proceedings.
Although it was not necessary to decide the issue, as it was an important point, the Court gave its view that the conditions for applying for a DNI were procedural, and so subject to English law as the law of the forum.
Case: Actavis UK Ltd and others v Eli Lilly & Co  EWCA Civ 555.
First published in the August 2015 issue of PLC Magazine and reproduced with the kind permission of the publishers. Subscription enquiries 020 7202 1200.