Pharmaceutical patent decision: cold remedies

Boult Wade Tennant has been involved in one of the few patents cases concerning pharmaceutical compositions to reach the Court of Appeal in 1997. The case was Reckitt & Colman Products Ltd. v. Richardson-Vicks, Inc. and judgement was handed down on 23 April 1997.

Richardson-Vicks, Inc. were the proprietors of European (UK) Patent No.180,597. Reckitt & Colman Products Ltd., assisted by Boult Wade Tennant, petitioned for revocation of the patent. The High Court revoked the patent and that decision was upheld on Appeal. The House of Lords gave Richardson-Vicks provisional leave to appeal. However, the company has now withdrawn.

The Patent
The patent concerns pharmaceutical compositions for treating the symptoms of colds and influenza. Claim 1, after initial amendment by the High Court, relates to a composition comprising (i) a specific non-steroidal anti-inflammatory non-narcotic analgesic (NSAID), in combinatory admixture with (ii) a decongestant selected from three well known and used decongestants.

The Prior Art
Compositions containing an analgesic such as aspirin or paracetamol and one of the decongestants were well known and used for treating the symptoms of a cold or flu prior to the priority date. The specific NSAIDs were well known and one in particular (ibuprofen) was extensively used before the priority date. The advantages of using ibuprofen and other NSAIDs were well established by the priority date and are significant.

In 1983, prior to the priority date, ibuprofen, became an OTC (over-the-counter) drug. It was sold under the Trademark NUROFEN as being effective for the relief of cold and flu symptoms.

In effect, claim 1 related to the substitution of a well known newer NSAID, such as ibuprofen, for aspirin or paracetamol in pharmaceutical compositions which comprised one of the three well known decongestants. The other independent claim, claim 6, was a 'Swiss form' claim for the manufacture of such a composition for the treatment of cough, cold and flu symptoms.

Inventive Step
Although there were a number of issues discussed in front of the High Court, the Court of Appeal only had to consider the question of inventive step of the amended claim. This question turned on what is meant by the term 'skilled person'. Under United Kingdom law, like many other countries, a claim is not inventive if it is obvious to a person 'skilled in the art. It is accepted by the Courts that the skilled person may be a team.as not an obstacle to the manufacture of the composition but rather an obstacle to marketing the composition. Thus, once it was conceded that it was obvious to consider the claimed composition and the way to manufacture the composition was well known, the conclusion that the invention was obvious was inevitable.

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