England and Wales Court of Appeal (Civil Division) Decisions

IN THE SUPREME COURT OF JUDICATURE CHPCF 95/1096/B

IN THE COURT OF APPEAL (CIVIL DIVISION )

(MR JUSTICE JACOB )

Royal Courts of Justice

Strand

London W2A 2LL

Wednesday 23rd April 1997

B e f o r e

LORD JUSTICE STUART-SMITH

LORD JUSTICE HENRY

LORD JUSTICE ALDOUS

RECKITT & COLMAN PRODUCTS LIMITED Respondent

v.

RICHARDSON-VICKS INC Appellant

(Handed down transcript of

Smith Bernal Reporting Limited, 180 Fleet Street

London EC4A 2HD Tel: 0171 831 3183

Official Shorthand Writers to the Court)

MR SIMON THORLEY QC and MR DANIEL ALEXANDER (instructed by Messrs Simmons & Simmons, London EC2M 2TX) appeared on behalf of the Appellant (Defendant).

MR CHRISTOPHER FLOYD QC and DR PIERS ACLAND (instructed by Messrs Bird & Bird, London EC4A 1JP) appeared on behalf of the Respondent (Plaintiff).

J U D G M E N T

(As approved by the court)

©Crown Copyright

LORD JUSTICE ALDOUS: Richardson-Vicks Inc are the registered proprietors of European Patent no. 0180597 entitled "Cough/Cold Mixtures Comprising Non-steroidal Anti-Inflammatory Drugs". It claims priority of 9 April l984.

On 8 February l994, Reckitt & Colman Products Ltd petitioned for revocation of that patent. Richardson-Vicks accepted that the patent was invalid as published and applied to amend. That application to amend and the petition for revocation came before Jacob J on l0 May l995. He gave judgment on 26 May holding that the amendments were allowable, but concluded that even as sought to be amended the patent was invalid as it was obvious.

Richardson-Vicks appealed. Reckitt & Colman did not contest the Judge's conclusion that the amendments were allowable. It follows that the sole issue before this Court is - was the invention claimed in the claims as proposed to be amended obvious as of 9 April l984? (See sections l(1)(b) and 3 of the Patents Act l977.) If the answer is "Yes" then the Judge was correct to refuse the amendments and revoke the patent.

The Judge's description of the relevant background was not challenged by either party. He said (1995 RPC 568 at p 570):

"The common cold, 'flu and like ailments are caused by a range of different viruses and there is no cure. One has to wait until the body's own defence mechanisms develop appropriate antibodies. Whilst that is happening one experiences a range of unpleasant symptoms: head and joint ache, runny or blocked nose, cough and fever. A wide range of medicaments which treat various of these symptoms have been known for years.

Cough and cold mixtures containing different drugs aimed at several of the symptoms have long been sold over the counter ("OTC") for the public to self-medicate. Doctors do not generally like this sort of mixture. When they prescribe they like to specify each drug individually (eg an analgesic and a decongestant) in appropriate doses. Mixtures do not permit this individual variation.

It has long been common in these mixtures to include an analgesic of the kind safe (or reasonably safe) for sale to the general public. Particularly common analgesics were and are paracetamol and aspirin. They were used in mixtures (liquid or solid) with antihistamines, decongestants, cough suppressants and expectorants. Some mixtures contained just two ingredients, some more. The analgesics form part of a class of drugs known as by the collective name non-steroidal anti-inflammatory drugs ("NSAIDs"). They not only help with pain but also with fever and with inflammation and were used, for instance, to help alleviate arthritis.

By and large people thought (rightly) that when these cough/cold mixtures were used the individual drugs acted individually: that the presence of one did not affect the action of the other(s). They acted "additively" not "synergistically" (ie where the presence of one would improve the action of another) or "antagonistically" (where the presence of one would impair the action of another).

The l960s and l970s saw the advent of new NSAIDs. They too were used for conditions such as arthritis. They too were only available on prescription and, at least for the most part, were patented. The new NSAIDs included ibuprofen, naproxen and some others. The patent particularly acknowledges eight such compounds altogether, all of which were well-known by the priority date of the patent, April l984. Ibuprofen (originally invented and patented by Boots) was the most important.

The advantages of the new NSAIDs over the old are significant. They have less side effects: for instance ibuprofen does not have the tendency to cause stomach bleeding of aspirin nor the tendency to cause liver damage of paracetamol. They are also in some respects more effective at pain killing.

In l983 ibuprofen came off the list of drugs which could only be supplied on a doctor's prescription. It became an OTC drug, initially for sale only in pharmacies. It was first so sold by a Boots subsidiary under the trade mark Nurofen. It was specifically sold as being effective for the relief of cold and 'flu symptoms, as well as being effective by way of an analgesic, an anti-inflammatory and a reducer of fever (antipyretic)."

The patent opens by stating that the invention relates generally to novel pharmaceutical compositions comprising one or more NSAIDs in combination with at least a named nasal decongestant, optionally in combination with a suitable carrier or excipient. It then draws attention to the new NSAIDs that had been developed which had the advantage of minimal side effects compared with such drugs as aspirin. The patent goes on to list, by way of example, a number of prior art cough/cold formulations containing aspirin or acetaminophen and states:

"These formulations generally contain in addition to aspirin or acetaminophen, one or more antihistaminics, decongestants, cough suppressants, antitussives and expectorants.

While aspirin and acetaminophen have been utilised in these previous compositions, it has not been heretofore proposed to use any of the newer non-steroidal anti-inflammatory drugs (ie excluding aspirin, acetaminophen and phenacetin) in the preparation of advantageous cough/cold pharmaceutical compositions."

There then follows the summary of the invention which is in similar terms to the proposed amended claim l which is as follows:

"A pharmaceutical composition of matter for use in the treatment of cough, cold-like and/or 'flu symptoms in a mammalian organism, and adapted for unit dosage oral administration, said composition comprising (i) at least one non-narcotic analgesic constituent which is a non-steroidal anti-inflammatory drug (NSAID) which is a propionic acid derivative, or pharmaceutically acceptable salt thereof, in a combinatory admixture with (ii) at least one sympathomimetic decongestant selected from pseudophedrinem, phenylpropanolamine or a pharmaceutically acceptable salt thereof."

That claim, shorn of its words, covers a pharmaceutical composition consisting of a known NSAID with one of three known decongestants or their salts. In effect the patent relates to the substitution of a well-known NSAID, such as ibuprofen , for aspirin or paracetamol in a pharmaceutical composition with one of three well-known decongestants. The patent does not teach that the combinations claimed have a synergistic effect. Such teaching as there is on synergy relates to combinations not claimed and from the information in the patent it was not possible to predict that the claimed combinations had any synergy.

The Judge held that Richardson-Vicks had not established that there was any synergistic effect between the compositions claimed in the amended claim. There is no appeal against that finding. He also held that the patent could not be defended on a selection basis because the patent did not contain teaching to enable that to be done. Again Richardson-Vicks do not on this appeal suggest that that conclusion was wrong. Upon that basis, the Judge came to consider the issue of obviousness at p. 579 line 21. He said:

"Now this is a very odd case. For it is conceded that it was obvious to a skilled man to consider such a mixture - to consider replacing the aspirin or paracetamol with ibuprofen. The concession amounts to no more than giving way to the inevitable: the new NSAIDs were superior to the old and therefore invited consideration by way of substitution in the old cough/cold remedies. Moreover it is not suggested that the patent solves any problem. Technically the mixtures would occur to the skilled man.

The concession is confirmed by what happened in practice at R & C. It had (and still has) a product called Lemsip. It consists of a mixture of paracetamol and phenyl propanolamine hydrochloride (a decongestant) and some other things. When ibuprofen had just become OTC Dr Joliffe of the formulation department made a mixture by substituting ibuprofen for paracetamol. Since Lemsip is made to be dissolved in hot water the experiment was aimed at such a product. It worked all right, (after overcoming a solubility of ibuprofen problem) but tasted disgusting. So the experiment went nowhere. It is, of course, the case, that the patent in suit offers no help on solubility or taste.)

The argument for RVI is that although the claimed mixtures would be considered, they would be rejected. They say that the skilled team in a pharmaceutical company would have included not only a pharmacologist and a formulator (and probably a medical doctor) but also an expert on drug regulatory affairs. When the mixture was proposed he would have said that it could not get regulatory approval unless some form of synergy were shown. I think this argument is hopeless. Even if it were true that that is what the regulatory man would have said (and the evidence only goes as far as indicating that the regulatory pathway would have been seen as difficult, perhaps impossible) I cannot see that it has anything to do with obviousness. All the argument amounts to is that it would have been impossible or difficult to get permission lawfully to sell the mixtures of the alleged invention.

Nor can I see that the position would have been any different if the skilled team (the man skilled in the art) had actually got the patent in their hand. The regulatory man would still say "you can't sell without proof of synergy" and the pharmacologist would say "the patent does not teach us there is."

Mr Thorley referred me to a number of cases where the courts in considering obviousness have asked whether it was obvious "to do" something. For instance Lord Reid in Technograph Printed Circuits Ltd v Mills & Rockley Electronics Ltd (1972) RPC 346 said at page 355:

"Whether or not it was obvious to take a particular step is a question of fact; it was formerly left to a jury".

But this is to take (one might even say rip) words right out of their context. Lord Reid was considering a man taking a step to see if the idea worked. Here the skilled team would know of the idea and expect it to work, even if the regulators said it could not be sold. As the Court of Appeal observed in Molnlycke AB v Procter & Gamble Ltd (1994) RPC 49 at p ll2, the difference between whether a man 'would' or 'could' take a particular step is a 'semantic argument'.

I think the concession, which was rightly made, leads to a conclusion of obviousness."

Mr Thorley's main submission on behalf of Richardson-Vicks was that the Judge had failed to appreciate the relevance of his conclusion that the regulatory pathway would have been seen as difficult, perhaps impossible. That fact meant that the skilled addressee, which he submitted was a team, would have rejected the prospect of a useful or worthwhile result from the claimed combination even though it was obvious to consider the combination. It followed, he submitted, that it was not obvious to try to produce the combination claimed in Claim l.

Richardson-Vicks in their written submissions suggested that one reason why the Judge may have arrived at the wrong result was that he had failed to adopt the structured approach to obviousness suggested by Oliver LJ in Windsurfing International Inc v Tabur Marine (Great Britain) Ltd (1985 RPC 59 at p 73.) For myself, I do not believe that the Judge can be criticised for not adopting the structured approach as the issues raised in this case were not those that normally arise in a patent action. They were concisely and clearly dealt with by him and there was no need to adopt the rather more elaborate procedure suggested by Oliver LJ. However I will do so as Richardson-Vicks suggested that it was the correct way to analyze the case. I therefore turn to the four steps suggested in Windsurfing.

1. What is the inventive concept embodied in the patent in suit ?

Richardson-Vicks submitted that it was - perceiving that it was worthwhile to embark on a research project in respect of a combination as claimed in Claim l with the belief that it was likely to produce a useful result.

I am unable to understand where that concept, if it be a concept, is embodied in the patent. The patent claims a mixture of two well-known products, a NSAID and a decongestant. That is the inventive concept embodied in the patent. It is the concept of a combination drug consisting of a NSAID, of which ibuprofen is the best example, with a known decongestant.

2. The adoption of the mantle of the skilled but unimaginative

addressee so as to clothe him with the common general knowledge

Richardson-Vicks submitted that in this case the skilled addressee comprised a team which included a person, such as Mr Oldfield, who was an expert on the regulations governing marketing of drugs. That team typically would consist of a development pharmacist, a pharmacologist, a clinician and a registration specialist such as Mr Oldfield.

Mr Floyd who appeared for Reckitt & Colman accepted that in certain circumstances the notional skilled addressee would consist of more than one person. In this case, he submitted, the patent was directed to scientists, such as formulators and pharmacologists. They were the notional skilled addressees.

Section 3 of the l977 Act states that

"An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art ...."

It is therefore clear that the relevant person must have skill in the art with which the invention described in the patent is concerned. In some cases the patent may include within it information derived from or utilising more than one aspect of science or technology and in such cases the notional skilled addressee, the person skilled in the art, will consist of a combination of scientists or technicians having those skills (see General Tire & Rubber Company v Firestone Tyre & Rubber Company Ltd (1972) RPC 457 at 485). Each case will depend upon the description in the patent, but there is no basis in law or logic for including within the concept of "a person skilled in the art", somebody who is not a person directly involved in producing the product described in the patent or in carrying out the process of production. A person such as Mr Oldfield is skilled in the art of obtaining regulatory approval for drugs. He is not skilled in the art of producing new combination drugs of the type with which the patent is concerned. I therefore reject Richardson-Vicks submission that the person skilled in the art consisted of a team which included a regulatory expert.

Richardson-Vicks submitted in the alternative that, if the skilled addressee was a pharmacologist and/or a formulation expert, he would know, as part of his common general knowledge, that it would at the priority date of the patent be impossible or particularly difficult to get permission to sell a mixture as claimed in Claim l.

It is important to distinguish between the knowledge of the notional skilled addressee, called common general knowledge, and that knowledge which is known by some, public knowledge (see Beloit Technologies Inc v Valmet Paper Machines Inc (unreported CA 12 February l997 at p 18). In this case the evidence does not establish that the notional skilled pharmacologist or formulator knew, as part of his common general knowledge, that there would be no point in making a combination drug as claimed because it would be impossible to obtain regulatory approval or approval would be so difficult to obtain as to make it stupid to try. That might have been the view of a regulatory expert, but it was not established as being part of the common general knowledge of the skilled addressee. In fact it seems to me,from reading the evidence, that no serious attempt was made to prove that the alleged obstacles in obtaining regulatory approval formed part of the common general knowledge of the skilled man in the art as I have defined him. Richardson-Vicks case was that the regulatory expert formed part of the team of skilled addresses to which the patent was directed.

It is accepted that the skilled addressee knew, as part of his common general knowledge, all about the drugs with which the claimed invention is concerned. For example, he would know of the relative advantages and disadvantages of aspirin, acetaminophen and paracetamol as against other NSAIDS such as ibuprofen. He would know that drugs for the alleviation of symptoms of colds and 'flu had been marketed which contained a combination of NSAIDs and decongestants. An example was Reckitt & Colman's "Lemsip" which contained in combination paracetamol and a decongestant. He would also know of the techniques required to make a combination drug of the type claimed.

3. What, if any, differences exist between the matters

cited as being known or used and the alleged invention ?

A number of drugs and articles were pleaded, but there is no need to consider them as it is not in dispute that the question of obviousness can be considered upon the basis that the only difference between Claim l and the matters cited was the substitution of ibuprofen for aspirin or paracetamol in a combination drug consisting of aspirin or paracetamol and a decongestant.

4. Did the difference constitute a step which was

obvious to the skilled man at the priority date ?

That question has to be answered in the affirmative. Ibuprofen had over the years been established as an alternative to aspirin and paracetamol for a number of indications including

The relief of symptoms of colds and 'flu. Substitution required no technical ingenuity. It was in my view obvious.

That conclusion was supported by the evidence of Dr Jolliffe who is now the Group Leader in the formulations department of Reckitt & Colman. In l983 he thought of and made a combination of ibuprofen and a decongestant as claimed in Claim l. At that time he worked as a scientist in the formulation department and he carried out a feasibility evaluation of incorporating ibuprofen into a "Lemsip" type formulation. It resulted in a product which was not commercial due to taste. He did, as he said, the obvious. His evidence was not challenged, but it was suggested that he was not a typical skilled addressee as he was not aware of the regulatory difficulties. That suggestion is wrong for the reasons I have given. He is the sort of man to whom the patent is directed.

Richardson-Vicks sought to avoid the conclusion that the patent was obvious by relying upon the difficulties of obtaining regulatory approval. That was an obstacle in the path along the road to the conclusion that the patent was obvious which, they submitted, meant that, even though it was obvious to consider substitution of ibuprofen for aspirin, a skilled addressee would have realised that it was not worth trying. They were the first to perceive that it was obvious to try the substitution and therefore, relying upon cases such as Johns-Mansville Corporation's Patent (1967 RPC 479), there was invention.

That submission fails for four reasons. First the alleged obstacle in the path of the skilled addressee did not form part of his common general knowledge and therefore was not an obstacle in fact. Second, Claim l of the patent purports to monopolise the manufacture of the combination of ibuprofen and a decongestant. The alleged obstacle was not an obstacle to manufacture. It was an obstacle to marketing the combination. Thus the alleged obstacle did not prevent the manufacture of the combination being obvious. Once it was conceded that it was obvious to consider the claimed combination and the way to manufacture the combination was well-known, the conclusion that the invention was obvious was inevitable. Third the alleged obstacle only prevents commercialisation being obvious. That is not relevant to the issue of obviousness. As stated by Slade LJ in Hallen Co v Brabantia (UK) Ltd (1995 RPC 195 at p 213):

"As cases such as Technograph and Beecham show, he (the skilled man) is not to be expected to take steps or try processes which he would not regard as worthwhile. In using the word "worthwhile", we mean worthwhile as a possible means of achieving or assisting in practice the objective which he has in view. This, we infer, was what the judge had in mind in saying that the word "obvious" in section 3 is directed to whether or not an advance is "technically or practically obvious". We do not think that the hypothetical technician must also be taken as applying his mind to the commercial consequences which might follow if the step or process in question were found in practice to achieve or assist the objective which he had in view. As Oliver LJ said in the Windsurfing case (1985) RPC 59 at 72, "What has to be determined is whether what is now claimed as invention would have been obvious, not whether it would have appeared commercially worthwhile to exploit it." We thus agree with the judge that the word "obvious" in section 3 is not directed to whether an advance is "commercially obvious".

Fourth, the cases such as Johns-Mansville have no application. They were all concerned with patents where it was alleged that there was a technical difficulty in perceiving the result. In this case there was no such technical difficulty.

Despite the submissions advanced by Mr Thorley on behalf of Richardson-Vicks, I have not discerned any finding of fact or any part of the reasoning of the Judge that can be faulted. I agree with him that the patent as amended was obvious. In my view the

appeal should be dismissed.

LORD JUSTICE HENRY: I agree.

LORD JUSTICE STUART-SMITH: I also agree.

Order: Appeal dismissed with costs; costs be taxed if

not agreed; application for leave to appeal to

the House of Lords refused; revocation order of

court below be stayed for 21 days pending petition

to the House of Lords; revocation order be further

stayed pending outcome of petition; if granted,

revocation order be stayed until after judgment;

plaintiff's solicitors to undertake to repay costs

if defendant's final appeal is allowed.