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Tuesday, 18 December 2012

Population Patent Fails: Mr Justice Warren's Profession

Why is it that, when the words "population" and "warren" appear in close proximity, this Kat struggles to exclude from his mind the word which unites them: "rabbit"?  The two words were brought together in the Chancery Division of the High Court, England and Wales, in Population Diagnostics Inc v The Comptroller General of Patents, Designs and Trade Marks [2012] EWHC 3541 (Ch), a decision from last Thursday by Mr Justice Warren in an appeal against the refusal of Mrs Chalmers, on behalf of the UK's Intellectual Property Office, to grant two somewhat curious patent applications.

"Stop when you get to one thousand ...!"
Population Diagnostics' applications concerned an invention in the field of genetics which was aimed at producing a screening method for differentiating on the one hand between copy number variants (CNVs, these being repeated sections of DNA) that were associated with a particular condition or phenotype, and CNVs which were found in the population at large and did not cause disease. So far, so good -- but the rot began to set in with Claim 1, which referred to the provision of genome-wide CNV frequency data from a population of at least 1,000 individuals who did not possess the particular phenotype. Said Mrs Chalmers, this inventive concept was none other than a way of identifying a CNV that was relevant for a phenotype by identifying CNVs in a subject and comparing those variants to the results of CNVs in a "normal" population of at least 1,000 individuals without the phenotype:.  Given the knowledge which was already floating around in the prior art, the skilled person would have had ample motivation to try to increase the number of individuals in the normal control population when using higher resolution screening methods -- and would be obvious that this would filter out more of the polymorphic CNVs that were associated with the normal population, thereby helping to identify those CNVs that were relevant to a particular phenotype in an individual.   As if this wasn't bad news enough, Mrs Chalmers also refused the applications as including excluded material: a mental act and that increasingly rare beast, a computer program "as such".

No, said Population Diagnostics and appealed to the better nature of Warren J.  Mrs Chalmers had surely identified the wrong inventive concept and therefore erred in finding the lack of any inventive step [Merpel quibbles at this point that you can't find something if it isn't there -- she didn't find that there was an inventive step, rather than didn't find that there was one ...]. The respondent in this appeal, the splendidly-named Comptroller General of Patents, Designs and Trade Marks, disagreed: Population Diagnostics' applications had been hanged with their own rope, this being their own choice of wording of the claim itself. What's more, it certainly couldn't be inventive [except perhaps in the United States, where a cynic might suggest that the spirit of Cole Porter still haunts the USPTO] to increase the size of the sample of the normal population to achieve that, since that was basic experimental methodology and statistics, while the selection of a database of 1,000 individuals was arbitrary.

Mr Justice Warren dismissed the appeal, in some detail and a considerable degree of length, the 132 paragraphs of his judgment being a tribute to the fact that the appellant's legal team were a good deal more inventive than their patent-seeking patent.

This was never going to be a patent judgment for the rocket scientists, and the judge was not about to restate the entire law of inventive step.  He did however remind us that an invention's inventive concept was the gap between what was claimed in the application and what was already sitting there in the prior art.  For the purposes of patent law it was this that was important, not the contents of the application's specification. Mrs Chalmers had appreciated this when selecting her approach to the application and was right to identify the inventive concept the way she did.

Treading gingerly into the treacherous quicksands of patent law, Warren J then stated that, i f the only difference between a claim's inventive concept and the prior art was an arbitrary feature, the alleged invention had no inventive step. This being so, if the inventive concept contained within Population Diagnostics' claim was already apparent from the prior art, apart from specifying that the size of the control group had to be 1,000,  the feature of the invention which was the arbitrary statement that the control group should be at least 1,000 individuals did not actually add anything inventive -- and it certainly wasn't inventive to seek to bump up the size of the sample of the normal population in order to help identify CNVs which were relevant to a particular phenotype in an individual.  That was nothing other than basic experimental methodology and statistics. Oh yes and, in any event, the invention as claimed was excluded from patentability both by virtue of  it being a mental act and to the extent that it was an excluded computer program.

Merpel is most anxious for the good name of Mrs Chalmers -- and indeed all and any of the virtuous ladies who may at any time find themselves serving in the capacity of Hearing Officers. So far as she is concerned, the word "ho" is not a terribly polite term and, whether in capitals or small print, should not be used as an abbreviation for "Hearing Officer" in cases of this nature.

Mrs Warren's Profession, here

1 comment:

Anonymous said...

This is a nice decision, but I wonder whether it really needed to be this long. I think the EPO would have written it up much more concisely. OK, 1000 people is arbitrary, and therefore not inventive. That principle is already established in case law, so it doesn't need constructing from scratch. The part about mental acts/computer programs is a little bit irresponsible. Does Mr Justice Warren understand the chaos he would cause if his logic on this point became part of case law. When does a 'comparing' action become a mental act? That would cause a huge amount of uncertainty if it were introduced as a general test that should be applied to all inventions.

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