Eli Lilly And Co v Human Genome Sciences Inc

For Article 3(a) of Regulation No 469/2009, whether an active ingredient is protected by a basic patent is determined by the rules governing the extent of the invention and the scope of the claims. The infringement test is irrelevant. A functional claim can suffice, provided that, construed under Article 69 of the EPC and its Protocol, it relates implicitly but necessarily and specifically to the active ingredient. The test is not met merely because a product would infringe the patent, particularly where general wording brings additional active ingredients within the claims. The SPC scheme does not discriminate between stages of pharmaceutical research or according to who carried out later research.

Eli Lilly sought a declaration concerning whether tabalumab was protected by Human Genome Sciences’ patent for antibodies binding to Neutrokine-α, so that the patent could support a supplementary protection certificate under Article 3(a) of Regulation No 469/2009. The issue followed a reference to the Court of Justice, which held that structural identification was unnecessary, but that a functional claim must relate implicitly but necessarily and specifically to the active ingredient, interpreted in the light of Article 69 of the EPC and its Protocol. The national court had to determine the scope of the claims under the applicable patent law.

1. Declaration dismissed. Tabalumab fell within claim 13 of the patent, properly construed. The claim therefore related to tabalumab implicitly but necessarily and specifically.
2. Article 3(a) is concerned with whether the product falls within the extent of the invention covered by the basic patent. In the United Kingdom, the relevant rules are contained in sections 125(1), 125(3) and 130(7) of the Patents Act 1977. For a European patent, Article 69 of the EPC and its Protocol govern the construction of the claims. The infringement rules in section 60 of the Act do not determine whether the product is protected.
3. A functional definition may in principle be sufficient. The claims must be interpreted in the light of the description as required by Article 69, but the court rejected the submission that a more detailed structural definition had to be found in the description. The relevant focus remains the claims.
4. The rule is subject to the approach in Medeva BV v Comptroller General of Patents, Designs and Trade Marks. Where general words such as “comprises” extend the literal scope of a claim, an additional active ingredient or combination is not protected merely because it falls within that extended scope. The ingredient must be specified or identified by the claims in the relevant sense.
5. The purpose of the SPC Regulation supports protection for pharmaceutical research generally. It does not justify distinguishing between early and later research, or between research undertaken by the original patentee and a third party. The observations concerning the patent holder’s investment in paragraph 43 of the Court of Justice judgment did not qualify the test in paragraph 39 and were not applied as an additional requirement.
6. Since tabalumab was within claim 13, Lilly’s application for a declaration failed. The claim was dismissed.

The judgment followed a reference to the Court of Justice concerning the interpretation of Article 3(a) of Regulation No 469/2009. The national court retained the task of determining whether the claims covered tabalumab under the applicable patent-law rules.

• Earlier High Court decisions: the judgment was to be read with [2012] EWHC 2290 (Pat) and [2012] EWHC 2857 (Pat).