Eli Lilly & Company v Human Genome Sciences, Inc

For sufficiency, the court must first construe the claim and identify the invention. For a product claim, the central question is whether the product can be made across the claim’s scope without undue burden. Where the claim contains no use limitation, the patentee need not teach which members of a broad class will have a valuable therapeutic or diagnostic use, or how to identify them. Downstream research to find particular uses does not necessarily make the upstream product claim insufficient. Pharmaceutical and diagnostic composition claims are product claims if properly construed; they need only be capable of being formulated in a suitable form, not tied to a specified disease or effect. An amendment extends protection only if the amended claim, compared with the original, confers more protection.

Kitchin J held HGS’s patent invalid on several grounds, but held claim 13 sufficient and claims 18 and 19 insufficient: [2008] EWHC 1903 (Pat). The Court of Appeal initially upheld the industrial-application finding: [2010] EWCA Civ 33. The Supreme Court reversed that decision, held the relevant claims capable of industrial application, and remitted three issues: [2011] UKSC 51.

The present appeal concerned whether claim 13 was insufficient, whether its amendment extended protection, and whether claims 18 and 19 were insufficient. The central issue was what the claims required the patent to teach a skilled person to make.

1. Disposition. HGS’s appeal was allowed in relation to claims 18 and 19. Lilly’s appeal concerning the alleged insufficiency and extension of protection of claim 13 was dismissed. The decision was unanimous.
2. Sufficiency. Article 83 of the European Patent Convention and section 72(1)(c) of the Patents Act 1977 require disclosure clear and complete enough for the skilled person to perform the invention. The court must first construe the claim and identify the invention. For a product claim, the relevant question is whether the product can be made or obtained, and whether the invention can be performed across the claim’s whole scope without undue burden. Formulations such as a workable prototype or apparatus that will work are useful only in appropriate cases and cannot replace the statutory test. This approach was consistent with Kirin-Amgen [2004] UKHL 46 and H Lundbeck [2008] EWCA Civ 311.
3. Claim 13. Claim 13 was construed as covering antibodies that specifically bind to Neutrokine-α, without a limitation to therapeutic or diagnostic usefulness. The judge had found that specific antibodies could be made and identified without undue effort. It was therefore irrelevant that further research might be needed to discover which antibodies had particular practical uses. The fact that the claim covered a large class, including members of differing utility, did not make it insufficient. Chiron v Murex [1996] RPC 535 supported the distinction between enabling a broad product class and enabling a narrower downstream use. Pharmacia [2001] EWCA Civ 1610 was distinguished, and the court doubted whether its reasoning would now be adopted in the same form.
4. Extension of protection. Under Article 123(3) of the European Patent Convention and section 72(1)(e) of the Patents Act 1977, the court must construe the claim before and after amendment and compare the protection conferred. The unamended claim may be taken into account; the question whether the prosecution file may otherwise assist construction was left open. In context, the word portion in the original claim referred to the Neutrokine-α sequence within a longer or different polypeptide. Its deletion did not change the meaning or widen the protection.
5. Claims 18 and 19. These were product claims, not claims to particular pharmaceutical or diagnostic uses. A pharmaceutical composition meant the claimed ingredient in a form suitable for pharmaceutical administration, and a diagnostic composition had the corresponding product meaning. The claims did not require the patent to identify a disease, condition, or particular medical effect. Since the products could be formulated without undue effort, the claims were sufficient.

• Supreme Court: Allowed HGS’s appeal on industrial applicability, held the relevant claims capable of industrial application and claim 1 sufficient, and remitted three issues: [2011] UKSC 51.
• Court of Appeal: Previously upheld Kitchin J’s industrial-application finding: [2010] EWCA Civ 33. On remittal, the present court allowed HGS’s appeal concerning claims 18 and 19 and dismissed Lilly’s appeal concerning claim 13.
• Chancery Division, Patents Court: Kitchin J held the patent invalid on several grounds, including insufficiency of claims 18 and 19, while holding claim 13 sufficient: [2008] EWHC 1903 (Pat).