Reckitt & Colman Products Limited v Richardson-Vicks Inc

Patent obviousness asks whether the claimed technical advance would have been obvious to the person skilled in the art. The inquiry is not whether lawful marketing approval could be obtained or commercial exploitation would be worthwhile. The skilled addressee comprises those directly involved in producing the claimed product or process; a regulatory specialist is not included merely because approval may be difficult. Regulatory difficulties known to a specialist but not shown to form part of common general knowledge cannot alter the analysis. A claim that merely substitutes a known NSAID for a known analgesic in a known combination with a decongestant is obvious where manufacture involves no technical ingenuity and the skilled person would expect the combination to work.

Richardson-Vicks Inc owned a European patent for pharmaceutical compositions combining an NSAID with a nasal decongestant. After Reckitt & Colman Products Ltd petitioned for revocation, Richardson-Vicks applied to amend the patent. Jacob J allowed the amendments but held the amended patent invalid for obviousness and ordered revocation ([1995] RPC 568).

On appeal, the only issue was whether the amended claim was obvious at the priority date under sections 1(1)(b) and 3 of the Patents Act 1977. The appellant argued that a skilled team would include a regulatory expert and would reject the combination because regulatory approval would be difficult or impossible. The central issue was whether that consideration affected the statutory obviousness inquiry.

Disposition. Lord Justice Aldous delivered the leading judgment. Lord Justice Henry and Lord Justice Stuart-Smith agreed. The appeal was dismissed.

1. The judge’s findings that the claimed combinations showed no synergy and could not be defended as a selection invention were unchallenged. The inventive concept was the claimed combination itself: a known NSAID, such as ibuprofen, with a known decongestant. It was not a research project based on perceiving that such a project might be worthwhile.
2. Under section 3 of the Patents Act 1977, the person skilled in the art must possess the skills directly concerned with producing the product described in the patent or carrying out the claimed process. A team may be appropriate where the patent draws on several technical disciplines, as explained in General Tire & Rubber Company v Firestone Tyre & Rubber Company Ltd (1972) RPC 457. A regulatory-approval specialist was not part of the skilled team because that person was not directly involved in producing the combination drug.
3. The court distinguished common general knowledge from knowledge that was merely public or known to a regulatory specialist, applying Beloit Technologies Inc v Valmet Paper Machines Inc (unreported CA 12 February 1997). The evidence did not establish that regulatory obstacles formed part of the common general knowledge of the skilled pharmacologist or formulator.
4. The four-step approach in Windsurfing International Inc v Tabur Marine (Great Britain) Ltd (1985) RPC 59 was used, although its more elaborate form was unnecessary where the issues had been clearly addressed. The difference between whether the skilled person would or could take a step was treated as a semantic argument, consistent with Molnlycke AB v Procter & Gamble Ltd (1994) RPC 49. Substitution of ibuprofen for aspirin or paracetamol required no technical ingenuity and was obvious.
5. Regulatory approval was an obstacle to marketing, not to manufacture. Commercial consequences were irrelevant to technical obviousness. The approach in Hallen Co v Brabantia (UK) Ltd (1995) RPC 195 and the relevant observation in Windsurfing were applied. Authorities such as Johns-Mansville Corporation’s Patent (1967) RPC 479 were distinguishable because they concerned technical difficulty in perceiving the result. The appeal was dismissed with costs, subject to the stated stays and undertaking concerning any petition to the House of Lords.

• Court of Appeal (Civil Division): appeal dismissed with costs. Leave to appeal to the House of Lords was refused. The revocation order was stayed on the terms stated in the order.
• High Court of Justice, Chancery Division, Patents Court: Jacob J allowed the proposed amendments but held the patent invalid for obviousness and ordered revocation ([1995] RPC 568).