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Wednesday, 4 February 2009

Speculative patents with added M.A.D.

One way to get a patent, which many applicants amazingly still rely on, is to first have a good idea for a new, useful and non-obvious invention, and describe it in enough detail in a patent specification for others to be able to reproduce it, as well as in such a way that describe why it is so new, useful and non-obvious. It should then be a relatively straighforward matter to get a patent granted and, if necessary, use it in case of any infringement.

Another way, however, is to take a wild guess at what an invention of the type you are vaguely interested in might possibly look like and then try to come up with a justification for it to be new, useful and non-obvious later on.  In such cases, "later on" would ideally be before the patent specification is written, but can often be well after this date, and sometimes not even before a patent is granted. Of course, the skills of a well-trained patent attorney come in very handy in getting this kind of application over the high bar at the EPO.

The latter approach is what at least one party took in the recent case of  Laboratorios Almirall SA v Boehringer Ingelheim International GmbH [2009] EWHC 102 (Pat), the judgment of which was issued last week by His Honour Judge Fysh QC.  The case related to two patents, EP1651270 and GB2419819, the first of which was granted to Boehringer, the second to Almirall.  Both related to combination medicines for respiratory disorders, which included an anticholinergic compound together with a beta agonist.  Boehringer's treatment was marketed under the trade name Combivent, and was apparently quite successful.  


Almirall applied to revoke Boehringer's patent, on the grounds that the invention was either anticipated or was obvious.  In return, Boehringer counter-claimed that, if their patent was invalid, then so was Almirall's for the same reasons, resulting in mutually assured destruction of the patents in question.  Presumably this strategy made some kind of sense at the time.  

One further odd feature about this case was that Almirall argued that Boehringer's patent was obvious in light of two posters presented at a conference that was held a short time before Boehringer made their applications, one of which eventually led to the patent.  Almirall alleged that Boehringer had seen the poster, photographed it, and then gone ahead on this basis to apply for their patents.  This turned out to be true, as photographs of the poster were uncovered during disclosure.  Regarding Boehringer's patent, HHJ Fysh found it strange that, for a company with the resources available to Boehringer, there was next to nothing in the patent about why the claimed invention was inventive, as the skilled person would not be able to figure out exactly what the technical contribution would be.  Regarding the technical contribution, the judge stated,

"In my judgment, the addressee would simply be left guessing. This is of course an unsatisfactory conclusion but since the public has a right to know what technical contribution has been made by the patent, this is no place for indulgence. Speculative statements, guesses and unsupported predictions are not good enough. In my judgment, this finding has a decisive resonance in the resolution of this entire case." (paragraph 173)
He further went on to say:
"[S]ufficient justification for the solution to a technical problem must be found in the patent as filed. Experiments performed thereafter cannot be relied on at law to make good an initial deficiency of disclosure. It is not even enough that the teaching of the patent is such that it is 'at least plausible' that what was proposed was capable of solving the problem it purports to solve." (paragraph 175)
Although there was a huge amount of expert analysis and pontification (apparently a common feature nowadays in patents court judgments, if the last few are anything to go by), the end result was pretty clear.  Both patents were found to be mutually invalid, confirming the MAD hypothesis. 

As a point of interest, which other patent attorneys might like to comment on, the IPKat wonders what exactly the point is in including passages in patent specifications that go like the following extract from Boehringer's patent (click on the picture to enlarge, or go to paragraph 28 of the patent in question, linked above):

Any ideas? 

10 comments:

Anonymous said...

It may be done on the belief that it would be harder for a subsequent party to claim a subset of your original range as an improvement patent if your original specification indicates the exact amount they later claim. The burden for the subsequent party to claim a 'suprising result' for the subrange of 250-300 would possibly be higher in the face of specific claims for 250, 255, etc., than if the previous patent simply claimed dosages in the range of 7.5-1102.5.

This proably shouldn't make any difference, but it does at least indicate that the patentee considered each possible dose range (or their agent did anyhow), as opposed to simply the end points of a broad range.

Mike said...

The point? Well, it gives you clear basis for amendment to avoid any pesky prior art that might come up, rather than having to go down the more difficult route of a disclaimer. Of course, like a disclaimer, it is really only useful for novelty-only prior art. I would go so far as to say it might counteract any suggestion of inventive step, if the invention is alleged to work in dosages from 7.5 up to 1102.5 µg...

Anonymous said...

This appears to be an attempt to disclose all the specific values of the range to avoid grant of any later "selection inventions" in the range.

Anonymous said...

It does seem a bit of a con though. Suppose someone later discovers that there is some unexpected advantage at 250. Should they be denied a patent for it, just because the earlier people happened to stick this value in their spec, despite clearly not having spotted anything special about it?

Indeed, as an examiner, I let one case go by, where the invention had features X and Y, and a citation mentioned X as one of about twenty possibilities for one part and a few pages later mentioned Y as one of about twenty possibilities for another part. I didn't feel that the combination was disclosed in any meaningful sense.

Anonymous said...

It is an attempt to scupper later 'selection patents', as the earlier posters suggest.

Including lots of basis for amendment is obviously a consideration, but listing every individual value within a range is unlikely to give you this - stating progressively narrower ranges, with increasing chances of being able to show inventive step over the whole range, would be a more valid strategy.

I had a case where the prior art disclosed a polypeptide sequence and suggested, generally, that mutated forms of the peptide could be of interest - then went on to list the 'possible sites of mutation' - which were every single amino acid in the molecule, listed individually, over about 15 pages.

Our claim, to a genuinely useful mutant polypeptide ('..wherein the polypeptide contains a mutation at position X...') because under EPO practice, it lacked novelty over this earlier 'specific' disclosure of a mutation at this position...

Anonymous said...

Thank you David, for the alert. I see that "plausible" isn't enough. So how does that square with Angiotech/Conor in the House of Lords, and the "settled" caselaw of the EPO chemical boards? I'm very curious. So, must read the Decision toute de suite.

Anonymous said...

The judge makes his "Does the app as filed deliver the goods" point so many times that one is left with the feeling that savaging these patents was not the most unpleasant job Michael Fysh has ever done. In Angiotech/Conor, I liked Pumfrey and Jacob's tough line on identifying the OTP (objective technical problem), less so Lord Hoffmann's "make plausible is enough". But, since then, I thought Applicant had only to make it plausible, in his app as filed, that the claimed subject matter was a solution to the OTP, and he was home and dry. Perhaps what really got Fysh J.'s dander up was the ubiquitous presence of that dubious drafting boilerplate "Surprisingly, it (has been/can be) observed that...." when, in actual fact, whatever it is that is "surprising" has yet to emerge. After all, learned counsel have endured 20 years or so of taking instructions, from such clients, to urge that line upon a sceptical judge, and of having to absorb the resultant flak. Once they are up at the front, in a judge's robe and looking down on such clients, it's payback time.

Norman said...

The decision on the 270 patent looks to me very like an application of the “sound prediction” doctrine from Olin Mathieson v. Biorex [1970] R.P.C. 157 (Ch. D.), though the case and doctrine aren’t mentioned by name - I suppose because utility as such disappeared from UK law soon after that decision. (“Sound prediction” doctrine is still very much alive in Canadian law and is surely how the 270 patent would have been handled.) It will be interesting to see whether “at least plausible” eventually (re-)evolves to “sound prediction.”

Anonymous said...

Anonymous - I'd always thought that the word "surprisingly" in a specification meant that the inventors had discovered some unexpected new effect and were trying to patent a suitable application of that effect. As opposed to the (more common?) sort of invention, where the invention has arisen due to the invetor bringing his flash of genius to a situation where all the facts were, at least in outline, known.

The epitome of this (ie the former) approach to me seems to be US 5156114. The inventor is trying to tell us that if you take some petrol (or gasoline as they call it) and add water to it - as much as 80% of the mixture, it nevertheless works just as well (or almost as well) as if you just used pure petrol. With remarkable understatement, they comment "This is indeed surprising". It seems clear from the description that they're none too clear why it works, but they have (they say) found a repeatable method of using the effect and so they want a monopoly for it.

Anonymous said...

One thing that concerned me slightly with this decision was the conclusion that use claim 20 of Almirall's patent was invalid on the ground that it related to a method of treatment by surgery or therapy. It seems to me that in principle there should be no objection to a medical use claim limited by the group of subjects to be treated. Perhaps the wording of claim 20 was the problem. I would be interested to hear the views of others on this point.

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