|Jacques Derrida: out|
of favour with the Patents
Court, England & Wales
"How does one do justice to a 100-page decision in a few paragraphs? Especially one featuring no fewer than 11 experts and a wealth of technical detail.To Merpel it seems that Mr Justice Arnold's position, in seeking to construe the meaning of words in light of the inventor's intention, puts the interpretation of patent claims firmly at odds with the deconstructionist approach of French literary personality Jacques Derrida who declared that nothing exists outside the text itself. But that's not how we construe the scope of protection of registered trade marks, is it?
I think that the issue that will most interest practitioners is that relating to the interpretation and clarity of two features in the claims. Mylan claimed that the ambiguity of these terms led to insufficiency of the patent and also, in one case, non-infringement.
The judge remarked generally as follows:
"In the present case, two further principles are relevant. The first is that, as Chitty J said in Lister v Norton Brothers & Co (1886) 3 RPC 199 at 203, a patent "must be read by a mind willing to understand, not by a mind desirous of misunderstanding" [what wise words, murmurs Merpel. Should they not be repeated at every case management conference, and again before anyone thinking of interpreting a patent commits any expense to doing so?]. Binnie J delivering the judgment of the Supreme Court of Canada added in Whirlpool Corp v Camco Inc  FSR 46 at [49(c)] that "a 'mind willing to understand' necessarily pays close attention to the purpose and intent of the author." It follows that, as Pumfrey J said in Halliburton Energy Services Inc v Smith International (North Sea) Ltd  EWHC 1623 (Pat),  RPC at  "over-meticulousness is not to be equated to carefulness. Care in working out what the patentee was aiming at when he chose the words he used is absolutely necessary."The main claim which was at issue is as follows:
"The second is that it is necessary to distinguish between claims that are difficult to construe or that have a "fuzzy boundary" (in the words of Lord Hoffmann in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd  UKHL 46,  RPC 9 at ) on the one hand from claims that are truly ambiguous on the other. It is regrettably common for claims to be difficult to construe, but the court will nevertheless strive to give such claims a sensible meaning having regard to the inventor's purpose. It is also common for claims to have a fuzzy boundary, because an integer of the claim involves some question of degree or an imprecise functional limitation. It is well established that is not itself objectionable. If a claim is truly ambiguous, so that it is unclear what is the correct test to determine whether or not a product or process infringes, however, then the claim is insufficient, as discussed below."
"A copolymer-1 fraction wherein said fraction contains less than 5% of species of copolymer-1 having a molecular weight over 40 kDa and wherein 75% of said fraction is within a molecular weight range from 2 kilodaltons to 20 kilodaltons."One objection by Mylan was to the term "copolymer-1". The definition given in the description of the patent was as follows:
"Copolymer-1 is a mixture of polypeptides composed of alanine, glutamic acid, lysine and tyrosine in a molar ratio of approximately 6:2:5:1."The question for the Judge therefore was what is meant by "approximately 6:2:5:1". Given a narrow interpretation, the Mylan product would not infringe. It was also alleged to be ambiguous and therefore a cause of insufficiency.
It was common ground that the skilled reader would look to the documents cited in the patent. Having considered these, the Judge concluded:
"Accordingly, the skilled team would conclude that the claim was one that had a fuzzy boundary. It is therefore not possible to say precisely where that boundary lies. What can be said is that in my judgment the skilled team would not regard a relative difference in tyrosine of 29.6%, as in the case of batch GMA2 [one of Mylan's batches], as taking the batch outside the claim. Furthermore, I do not consider that the claim is ambiguous."The products of the Mylan product and process description were held to infringe, and the patent was not held to be insufficient in this respect.
Another important feature objected to was the molecular weight (referred to in some claims as "average molecular weight"). The patent nowhere said what molecular weight was referred to - and there are quite a few possibilities: weight average, number average, viscosity average, z-average, or peak molecular weight.
The judge commented:
"In my view the skilled team would be very surprised that the inventors had failed to explain such a basic matter, and rather cross at being presented with such a puzzle to solve. After all, the inventors could easily have specified which type of average molecular weight they meant. As I have pointed out above, however, the skilled team is deemed to read the specification with a mind willing to understand it. It follows that they would not throw up their hands when confronted with the problem, but would consider the specification with care to see if it was possible to work out what was meant by "average molecular weight"."Practitioners will probably be very surprised that the EPO allowed the application with such a basic issue unresolved. the judge considered, and eventually concluded:
"Although I confess that I have at times come close to concluding that the Patent is ambiguous, in the end I have come to the conclusion that the skilled team would interpret the Patent as using "average molecular weight" to mean Mp."His final word on sufficiency:
"In the circumstances, I do not consider that the claims are insufficient. Rather, they have a fuzzy boundary with respect to the average molecular weight criteria due to the inherent imprecision in the measurement technique specified. Perhaps slightly surprisingly, it has not been shown by Mylan that the inventors' failure to specify the calibration method to be used leads to significantly greater uncertainty in the average molecular weight than that which is inherent in the choice of measurement technique."I should probably add a word about post-published evidence, which is the most significant aspect of the judgment, commented on in last week's post. I do not understand the judge as saying that it is OK for the evidence in the patent to be wrong. The question is what that evidence renders plausible ("plausible" being the standard for showing a technical effect to counter an AgrEvo-type obviousness finding in UK and European Patent practice, as well as the standard to substantiate a selection invention under UK practice). In the pharmaceutical field, for example, a patent can be granted based on in vitro results. It may be that later on the compound proves toxic, or that a different in vitro test suggests that the compounds will not have in vivo activity. It may be that the in vivo data do not support the in vitro data. What I think that Arnold J was saying is that there is a cut-off point of the filing date, and that the plausibility has to be judged then. Otherwise, inventive step could oscillate, as more tests are performed. But if the data in the patent are themselves wrong, then that is a different question, which Arnold did not decide".