El-Tawil v The Comptroller General of Patents

A patent application for a second medical use must disclose more than a bare assertion that the proposed treatment works. The specification must contain enough material to enable the skilled person to conclude that the medicament treats the claimed condition; appropriate tests may be rudimentary. Newly discovered information about how a known treatment works, or its clinical effects, does not itself supply novelty where it merely describes a discovery or further information about an existing use. Prior art is assessed by what it discloses, not by its scientific quality. Dosage regimes are generally obvious unless the circumstances are unusual. An appeal from an IPO hearing officer is a review, not a rehearing.

The claimant appealed from a decision of Dr S Brown, a hearing officer in the Intellectual Property Office, who refused an application for a patent concerning the use of zinc sulphate in treating inflammatory bowel disease. The application claimed zinc added to existing treatment, zinc sulphate enemas for distal disease, and zinc sulphate infusions for severe disease.

The hearing officer found lack of support, lack of novelty and lack of inventive step. The claimant also alleged procedural unfairness, including that supporting material had been submitted with the application and that he had been led to believe that amendments would be permitted. The central issues were whether the claims were supported, novel and inventive, and whether the IPO process had been unfair.

1. Appeal dismissed. The appeal was a review of the hearing officer’s decision, not a rehearing. The court nevertheless considered the merits sufficiently to resolve the issues raised.
2. Claim 1 failed insofar as it relied on newly identified mechanisms of action or clinical effects of zinc. The application concerned a second medical use. Information about how a known treatment works, without more, is a discovery rather than an invention capable of supplying novelty. The claimed effects, including restoration of mucosal integrity, reduction of intestinal permeability and immune modulation, were not patentable on that basis.
3. Under section 14(5)(c) of the Patents Act 1977, read with section 14(2)(b), the description had to provide adequate support. The application contained only assertions and no tests or other material supporting the alleged therapeutic effects. The hearing officer was correct. Material said to support the science, but not forming part of the application or not supplying evidence of the claimed treatment, could not cure the defect.
4. Sturniolo disclosed the use of zinc with other treatment for Crohn’s disease and the relevant therapeutic benefits. Its status as a clinical trial and any imperfections in its scientific reasoning did not alter what it disclosed. The word “and” in claim 1 was properly read disjunctively as “or”, so Sturniolo anticipated the claim despite addressing Crohn’s disease rather than ulcerative colitis.
5. Claim 2 was obvious over the Spanish Application. Rectal administration, substitution of a pharmaceutically tolerable zinc salt, treatment of distal disease and the specified dosage regime did not involve an inventive step. Dosage regimes were generally obvious, exceptional circumstances being required for validity. Claim 2 was not shown to be obvious over Sturniolo because the material did not establish that an enema was an obvious route starting from its oral administration.
6. Claim 3 was obvious over both the Spanish Application and Sturniolo because infusion was an obvious alternative route. The procedural complaints failed: the alleged additional material had not been shown to form part of the application, the examiner’s email did not promise a substantive amendment, and the IPO was not under a duty to provide full advice. Publication of the hearing officer’s decision was lawful.

• High Court (Chancery Division): appeal from the decision of Dr S Brown, an Intellectual Property Office hearing officer delivered on 5 August 2011. The appeal was dismissed.