Tercica Inc v (1) Avecia Ltd. Insmed Inc Genentech Inc

Summary judgment should not determine disputed patent construction or prior-art meaning where the issue requires the perspective of the skilled person and fuller expert evidence, unless the answer is sufficiently clear on the material available. For a Swiss-type claim, prior art must disclose the claimed therapeutic use with clear and unmistakable directions. A mere signpost or speculative suggestion is insufficient. Where the scope of an expression such as producing an anabolic state remains genuinely arguable, the court should leave construction and anticipation to trial. The interaction between Swiss-form novelty and the exclusion of methods of treatment under the Patents Act 1977 may likewise require determination at trial.

These were linked patent proceedings concerning a patent for the use of IGF-I and IGFBP-3 to produce an anabolic state in mammals. Tercica, as licensee, claimed infringement against Avecia and Insmed. In the related action, Avecia and Insmed sought revocation against Genentech, the patentee.

Avecia and Insmed applied for summary judgment on their revocation claim and for the infringement claim to be struck out. They relied on alleged lack of novelty over Binkert, Spencer II and Maack, and on the contention that the patent claimed a method of treatment contrary to section 4(2) of the Patents Act 1977. The central issues were whether the patent’s expression producing an anabolic state included wound healing, whether the prior art clearly disclosed the claimed combination and use, and whether dosage or administration features affected novelty or fell within the treatment exclusion.

1. Summary judgment principles. The applicant had to show that the respondent had no real prospect of success. A real prospect was more than fanciful or merely arguable. The court could not conduct a document-based trial without disclosure or cross-examination. Those principles, summarised in Celador Productions v Melville [2004] EWHC 2362, applied to the linked applications.
2. Construction. Construction of the patent and prior art required consideration of how the skilled person would understand the documents. The definition of producing an anabolic state in the patent pointed towards total body weight gain and statural growth, but competing textual and expert arguments remained. The court’s provisional view favoured the narrower construction, but it was inappropriate to reach a final conclusion on summary judgment.
3. Anticipation. The Swiss-type claim was concerned with the use to which the combination was put. Applying General Tire v Firestone Tyre & Rubber Co [1972] RPC 457 and Hills v Evans (1862) 31 LJ Ch 457, anticipation required clear and unmistakable directions enabling the skilled person to perform the claimed use. Maack disclosed wound healing, but it was not sufficiently clear that wound healing fell within the patent’s use of producing an anabolic state. Binkert and Spencer II contained arguable suggestions concerning IGFs and binding proteins, but did not sufficiently clearly disclose the specific IGF-I/IGFBP-3 combination with the claimed effect. The alleged disclosures were potentially speculative and required further expert evidence.
4. Dosage, administration and treatment exclusion. The court left unresolved whether the claimed molar ratio and subcutaneous bolus administration formed part of the relevant new use for a Swiss-type claim, and how that issue interacted with section 4(2) of the Patents Act 1977. The reasoning in Bristol-Myers Squibb v Baker Norton [2001] RPC 1 and Merck & Co Inc’s Patent [2003] FSR 498, approved on the relevant point at [2004] FSR 330, raised issues unsuitable for final determination on these applications.
5. The applications for summary judgment and striking out were dismissed.