Patents: insufficiency
The Court of Appeal has held that two patents for the production of human antibodies using transgenic mice were not invalid for insufficiency.
Background
A patent may be revoked on the ground of insufficiency if the specification of the patent does not disclose the invention clearly and completely enough for it to be performed by a person skilled in the art (section 72(1)(c), Patents Act 1977). A European patent application must disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art (Article 83, European Patent Convention 1973) (EPC). The claims must be clear and concise and supported by the description (Article 84, EPC).
The skilled person or team must be able to perform the invention without undue effort. The sufficiency of the description will be assessed having regard to the nature of the invention, the character of the technical field in which the invention was made and the abilities of the skilled team.
Facts
R brought an action against K alleging infringement of two patents relating to the production of human antibodies using transgenic mice.
The High Court held that the patents were invalid for insufficiency, but that, if they had been valid, K infringed some of the claims. Both parties appealed.
Decision
The court held the patents were valid and that K's mice infringed the product, although not the process, claims of the patents.
The legal issue at the heart of the insufficiency allegation was the extent to and the manner in which an invention had to be enabled across the whole scope of the claim.
According to EPO case law, a specification did not necessarily have to enable the skilled person to make or perform all of the embodiments of a claimed invention. A claim might embrace variants which might be provided or invented in the future and which achieved the same effect in a manner that could not have been envisaged without the invention. The assessment of insufficiency had to be sensitive to the nature of the invention and the particular facts. If the character of the invention was one of general methodology, or the invention was of general application, then it might be permissible to claim it in general terms, even though the specification did not enable every way of arriving at its subject matter. It was a general principle that the protection afforded by the claims had to correspond to the technical contribution to the art made by the disclosure of the invention. The patentee was entitled to fair protection having regard to the nature and character of the invention described.
According to UK case law, the extent of the patent monopoly, as defined by the claims, had to correspond to the technical contribution to the art its disclosure had made for it to be justified. The specification had to enable the invention to be performed to the full extent of the monopoly claimed. But if the invention disclosed a principle capable of general application, the claims might be in correspondingly general terms. If the patentee had found a new product that had a beneficial effect, but could not demonstrate that there was a common principle by which that effect would be shared by other products of the same class, he would be entitled to a patent for…
