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Wednesday, 18 July 2012

Putting the fizz into fuzz and debunking Derrida -- or how to be nice to patent claims

Jacques Derrida: out
of favour with the Patents
Court, England & Wales
Last week, when posting a masterly instant piece on Generics (t/a Mylan) v Yeda and Teva [2012] EWHC 1848 (Pat), the IPKat's respected friend and former guest Kat Darren Smyth (EIP) dangled the prospect of a further report on the content of Mr Justice Arnold's mammoth decision. Well, never one to disappoint the adulating masses, Darren has delivered his considered opinion, which the IPKat is pleased to share with you. Writes Darren:
"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.

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 [2001] 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 [2005] EWHC 1623 (Pat), [2006] RPC at [60] "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 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 [2004] UKHL 46, [2005] RPC 9 at [126]) 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."
The main claim which was at issue is as follows:
"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".
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?

4 comments:

Anonymous said...

To pick up on the most important point here, I'm not sure the judge's approach is actually at odds with Derrida's? While the author's (not the inventors!) intention is considered, it doesn't actually mean the specific author and what he actually intended when writing the specification. You couldn't provide, for example, diary entries that a patent attorney who drafted an application made at the time of drafting, or other applications he wrote where he mixed up words, to support the fact that when he wrote something he actually intended something else.

Rather, it's the intention of a notional "author", and deciding what that notional author intended based on the common general knowledge and the content of the specification as a whole.

In other words, in this case too the text is all that matters, not what was actually crossing the mind of the author when writing the text.

(In any case, as it says in the wikipedia article you link to, when Derrida said "there is nothing outside the text", he meant "'there is no such a thing as out-of-the-text', in other words, the context is an integral part of the text". Derrida didn't mean that you're only allowed to consider the written words and nothing else. Considering the inventor's intention doesn't take you outside the text, rather the inventor's intention is part of the text.)

Or that's what I reckon, anyway.

Anonymous said...

I'm not sure that Derrida went as far as Barthes in his essay "The Death of the Author" in which he wrote that "a text's unity lies not in its origin [i.e. the author] but in its destination. [i.e. the reader]." That appears to chime somewhat with our notion of the "skilled addressee". However, one evil that Barthes is targeting is the idea that there can be a single authoritative interpretation of a text (which is surely the converse of what patent law aims to achieve). By contrast, Derrida explains his statement quoted in the blog as follows: "The phrase, which for some has become a sort of slogan, in general so badly understood, of deconstruction ("there is nothing outside the text"), means nothing else: there is nothing outside context." The Wikipedia link provides a fair summary: "in other words, the context is an integral part of the text." Derrida writes "an author ... can always say more, less, or something other than what he would mean [or would want to say]." This leads Royle to the informative comment that "Derrida is not uninterested in 'authorial intention': on the contrary, he argues that trying to take it into account is a crucial element in any critical reading. But... the writer is always susceptible to being taken by surprise [i.e. saying something that was not intended]. A writer can never have complete command or mastery over what s/he writes. Neither can a reader." In the sphere of patent law, one could interpret the concept of the "skilled person" as a notional reader as an attempt to deal with this imperfection on the part of the author to write what was meant and on the part of the reader to understand what has been written. At the end of the day, Derrida doesn't seem to be disagreeing with Wittgenstein when he writes "meaning is a function of context". And this is closely related to the latter's concept that meaning *is* use, in the sense that words are not defined by real world things that they may relate to nor by the mental representations of them, but instead by how they are used. That seems like a pretty useful touchstone for both trade mark and patent lawyers alike.

Anonymous said...

My views on Derrida are eloquently expressed at http://www.elsewhere.org/pomo/

hollyipltd said...

The sufficiency/clarity aspects of the case seem to be a very good example of the problems that arise when the standard measurements in the art are not done very precisely. Courts just have to cope and not be strict in a way that would disadvantage parties working in a particular technical area.

With reference to the previous discussion on plausibility, my comments did not assume a situation where the data in the patent was wrong, but I was thinking of the situation where the in vitro data is correct and makes it plausible it will work in vivo (e.g. it binds the correct receptor), but later work provides very good reasons as to why it would not work (e.g. it does not bind tightly enough). Should the patentee continue to get the benefit of the doubt if plausibility is undermined in this way by post-filing evidence?

In regards to the excellent and perhaps slightly mischievous reference to Derrida, from my scant knowledge of his work, nothing is simple or easily summarisable. If one thinks they have understood deconstruction they probably haven't

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