Contributions from Intellectual Property Consultant Anna McKay

I thought I would add to Leighton’s recollections of John Woolfe and tell you a little of the cases on which John worked, and their importance for the Generic industry.

John was unique.  I worked with him very closely in many patent and other actions – I acted for Norton Healthcare and he briefed me. 

Litigation can be a very intense experience, especially when one is acting for a generic company which is attacked by a weighty originator with seemingly unlimited resources.  One often has to act very fast, under great pressure:  it is stressful and a kind of environment in which one really comes to know one’s colleagues.  John could be curmudgeonly and kind at the same time. He rarely gave compliments.  His glasses were not rose tinted, but some shade of grey, and he expressed his regard and affection through curious terms of endearment (he called me “Chuck”, which seemed to me quite improbable) and criticisms of everybody else.  Like all of us, he had his flaws.  I had a very soft spot for him, not least for his intelligence and decisiveness.  He tended to be a little apologetic about both of those qualities. 

John’s biggest contribution to the generics industry was probably in relation to licences of right and early litigation which preceeded my involvement with him.

Before the 1977 Patents Act, UK patents lasted for sixteen years.  With the 1977 Act, they were extended to 20 years from the date of application, and there was a transitional period during which the final four years of the patent were “endorsed licenses of right”.  In other words, it was possible for a generic company to obtain a “licence of right” to use an invention during the final four years of the patent.  The legislation provided for reasonable royalties to be paid, but gave no guidance as to what these should be, and debate and opinion varied widely as to whether these should be the very low royalty figures which applied to licenses of right in, for example, Canada (around 4%) or extremely high percentages.  In fact, relatively high royalties were eventually determined to be appropriate.  It was the ability to obtain a licence of right which gave momentum to the generics industry, and John’s ability to pick molecules that could be manufactured easily enough, yet were difficult enough to deter competitors, and for which there was sufficient commercial opportunity, and possibly other patents which needed to be removed or avoided before marketing was possible, helped make Harris Pharmaceuticals (later called Norton, and then part of IVAX) the success it was at that time.  Harris/Norton had an enviable reputation.  It was quick to manufacture and quick to defend its position, and often first on the market.

When I first met John, I had had a non-contentious background, and I expected to do commercial work for pharma companies.  Instead, I began to work with John on the Terfenadine case (Marion Merrell Dow –v- Norton).  John was good to work with, on what was my first patent case – and it was an extraordinary case, and legally, very important.  The molecular patent for Terfenadine had expired, and Norton was selling Terfenadine preparations.  A later patent, which claimed a metabolite of Terfenadine, was still in force.  That metabolite was made in the patient’s body after he had swallowed a tablet containing Terfenadine itself.  Merrell Dow claimed that Norton were providing the means to patients to infringe the patent (s 60 (2) Patents Act 1977).  In other words, they were providing a product for patients which inevitably produced a product which infringed the metabolite patent.  Before the date of application for the metabolite patent, the fact that chemical activity resulted from the metabolite was not known.  However, patients had already been generating metabolite unknowingly:  clinical trials had already been carried out.  It had always been the case that once something had gone into the public domain, others were free to do it.  That principal was established many hundreds of years ago.  We claimed that the metabolite patent was invalid for lack of novelty. Merrell Dow claimed that with the 1977 Patent Act the law had changed and that later patents could be used, in certain circumstances, to prohibit activities which had occurred in the past.  To show anticipation and lack of novelty, it was necessary, argued Merrell Dow to show that the product had been ‘made available’ – and that did not invariably occur with use.

The case went to the House of Lords.  It was the first patent case involving issues of substantive law to go to the Lords for around ten years.  The House of Lords did decide that the law had changed, Lord Hoffmann saying;

"An invention is a piece of information. Making matter available to the public within the meaning of section 2(2) therefore requires the communication of information. The use of a product makes the invention part of the state of the art only so far as that use makes available the necessary information."

However, the direction that Terfenadine could treat hayfever was sufficient disclosure to knock out the metabolite patent. Lord Hoffmann again :

"[K]nowledge of the acid metabolite was in my view made available to the public by the terfenadine specification under the description ‘a part of the chemical reaction in the human body produced by the ingestion of terfenadine and having an anti-histamine effect.’ Was this description sufficient to make the product part of the state of the art? For many purposes, obviously not. It would not enable anyone to work the invention in the form of isolating or synthesising the acid metabolite. But for the purpose of working the invention by making the acid metabolite in the body by ingesting terfenadine, I think it plainly was. It enabled the public to work the invention by making the acid metabolite in their livers. The fact that they would not have been able to describe the chemical reaction in these terms does not mean that they were not working the invention. Whether or not a person is working a product invention is an objective fact independent of what he knows or thinks about what he is doing."

Had this case not been won, life for generic companies might have been a lot more difficult:  it is often not apparent what metabolite, enantiomer or polymorph creates activity, and there would have been scope for later patents covering use of all of these elements (not just their manufacture) even if prior products had already used them, and absent any special advantage.

After the Terfenadine case,  John and I worked on a series of cases relating to aerosols.  These covered all sorts of applications.  The first was on the use of non-CFC gases for medicinal aerosols and involved us reviewing a vast body of literature relating to the effect of CFCs on the ozone layer, and the extent to which that had been known, as well as the potential effect on medicinal aerosols, at the time of the patent.  We also dealt with patents on various aerosol formulations, and aerosol technology.  John’s  perceptiveness was remarkable.  Amongst a stack of documents he would quickly identify the most relevant matter and if I, or one of the barristers handling the matter failed to take this as seriously as he thought it merited, he would continue doggedly, until we had seen his point.  He was invariably correct.

Had we not managed to revoke the patent relating to use of non-CFC gases for aerosols, generic companies would effectively have been unable to market any aerosol products at all, since by that time use of CFC gases had been prohibited.

I also worked with John on the Paclitaxel case (Bristol-Myers Squibb Co v Baker Norton Pharmaceuticals Inc and Napro).  That too was both legally and commercially, an important case.  It established that the selection of a dosage range was not patentable. It was not really a ‘swiss claim’ for a new use, although it was worded as such, rather, it was a disguised method of treatment.  Of course, in some circumstances, where as a matter of fact, a dosage range is inventive or not obvious, it might possibly be patentable, but such circumstances would be rare.  In this case, BMS claimed that the dosage range chosen was counter-intuitive, in that it was a range which would have been regarded as having an unwelcome side effect profile.  We were able to show that with such a drug, a natural way of working was to seek to minimize side effects in other ways, and that it was obvious to try different dosage ranges.

I shall certainly miss John – and it seems to me that the UK Generics industry could be quite different had it not been for his contribution to it.