Bristol-Myers Squibb Company v Baker Norton Pharmaceuticals Inc & Anor

A Swiss-type claim for using a known medicine is patentable only where the novelty lies in a genuinely new therapeutic purpose. A change in dosage or administration which produces a beneficial side-effect is not a second medical use. A claim must be construed according to its substance and cannot avoid the exclusion for methods of medical treatment merely through its form. For novelty, prior disclosure anticipates a claim where it gives clear and unmistakable directions enabling the public to carry out the claimed act, with the claimed result occurring inevitably. An invention is obvious where the skilled person would carry out disclosed clinical trials and inevitably discover the claimed result.

The appellant owned a UK patent concerning the administration of taxol for treating cancer with reduced neutropenia. The patent was challenged by Baker Norton Pharmaceuticals Inc and Napro Biotherapeutics Inc, following clinical trials using three-hour taxol infusions at dosages within the claimed range.

Jacob J held the patent invalid and ordered revocation. The appellant appealed. The respondents cross-appealed against an order limiting their recoverable costs to one set from February 1998. The issues included construction of the claim, second medical use patentability, industrial application, novelty, obviousness and costs.

The appeal was dismissed, the patent was revoked, and the respondents’ cross-appeal on costs was allowed.

1. Construction. The words “for treating cancer” meant suitable for trying to treat cancer. Suitability was a question of fact; a medicine need not succeed in every patient, but a medicine with no beneficial effect would not qualify. “Reducing neutropenia” meant lessening the amount of neutropenia compared with administration over 24 hours.
2. Second medical use. The court adopted the approach in Eisai, as supported by John Wyeth and Merrell Dow. Novelty in a Swiss-type claim must lie in a new therapeutic purpose, not merely in a different method of administering a known treatment. The patent concerned the same drug, disease and therapeutic purpose, with only a shorter infusion and reduced side-effect. It was therefore not a second medical use.
3. Method of treatment and industrial application. The claim was directed in substance to the clinician’s selection and administration of taxol and premedication for an individual patient. Its apparent manufacturing language did not alter its effect. It therefore claimed a method of medical treatment excluded by section 4(2) of the Patents Act 1977 and Article 52(4) of the EPC.
4. Novelty. Applying General Tire and Rubber Company v The Firestone Tyre and Rubber Company Limited and others and Merrell Dow Pharmaceuticals Inc v H.N. Norton & Co Ltd, the Winograd lecture gave clear and unmistakable directions for the three-hour infusion with premedication. The reduced neutropenia was an inevitable consequence of carrying out the disclosed treatment. Claim 1 therefore lacked novelty.
5. Obviousness. The disclosed trial made it obvious to continue testing the three-hour infusion. Routine monitoring would inevitably reveal the comparative neutropenia. The claim therefore also lacked an inventive step.
6. Costs. Successful parties were ordinarily entitled to costs reasonably incurred. Any duplication or unreasonable expenditure was for the costs judge to assess, rather than being presumed from separate representation.

• Court of Appeal (Civil Division): dismissed the appeal from Jacob J’s decision, upheld revocation of European Patent (UK) No 0,584,001, allowed the respondents’ cross-appeal on costs, and ordered the appellant to pay costs subject to detailed assessment.