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Wednesday, 11 July 2012

Breaking news: glatiramer acetate patent valid and infringed

Once again the IPKat is indebted to the skill and industry of recently-retired guest Kat Darren Smyth (EIP), this time for his impromptu rendering of this morning's 104-page, nearly 50,000 word ruling of Mr Justice Arnold (Patents Court, England and Wales) in Generics (t/a Mylan) v Yeda and Teva [2012] EWHC 1848 (Pat).  As Darren explains:

"Yeda’s patent EP 07862888 (of which Teva is exclusive licensee) has been found valid (although certain claims are not entitled to priority) and infringed by Mylan’s proposed product of generic glatiramer acetate. Teva’s glatiramer acetate product is marketed under the trade mark Copaxone. The patent relates to “Copolymer 1”, a polymer composed of units of alanine, glutamic acid, lysine and tyrosine (four naturally occurring amino acids) in particular ratios. The claims relate to Copolymer 1 having a specified molecular weight range, and use of this for the treatment of multiple sclerosis.

A whole host of issues were raised – entitlement to priority, obviousness (both in relation to prior art and as allegedly making no technical contribution, but being an arbitrary selection), insufficiency (classical, because of ambiguity, and because no technical contribution), added matter, and non-infringement. So the trial took 13 days.

One interesting point of law is noteworthy, in relation to the issue of whether the patent makes a technical contribution (relevant to inventive step and insufficiency). Both sides accepted the proposition that if the patent, when read with the skilled person’s common general knowledge, did not “disclose enough to make the invention plausible”, i.e. plausible that the invention solved the technical problem, then that was the end of the matter, and it was not permissible for the patentee to rely upon evidence which post-dated the patent to demonstrate the technical effect (the “first point”). However Mylan argued further that, even if the patent did make the invention plausible, it remained open to the other party to cast doubt on this by post-dated evidence. Yeda/Teva disputed that post-published evidence could be used against the patent. Arnold J decided (at 350 and 351):
In short [yes, really, says Merpel], post-dated evidence may be relied on to confirm that the disclosure in the patent either does or does not make it plausible that the invention solves the technical problem. Post-dated evidence may not be relied upon either to establish a technical effect which is not made plausible by the specification in order to rebut an allegation of obviousness or to contradict a technical effect which is made plausible by the specification in order to found an allegation of obviousness. In my view it would be bizarre if, as counsel for Mylan submitted, a patent which at the time it was applied for disclosed what everyone thought was a good invention could be revoked 20 years later because subsequent advances in science had revealed that in fact the invention did not solve the technical problem.

Furthermore, to return to the first point, if the specification does make it plausible that the invention solves the technical problem, I do not consider that it is open to an applicant for revocation to rely upon post-dated evidence as casting doubt on this so as to place an evidential burden on the patentee to demonstrate affirmatively that the invention does solve the technical problem.
However, evidence extrinsic to the patent, but contemporaneous with it (i.e. before the effective priority date), may be relied on".
There is every prospect of more to come, so watch this space.

Fellow David Brophy has also pointed out that, as he puts it, the hinterland of this case has given rise to an earlier ruling, noted by the IPKat here.


hollyipltd said...

If something that one alleged in the patent turned out to be incorrect based on a subsequent finding, then surely it does not matter when that subsequent finding happened. This is particularly important for product claims given that the monopoly covers all uses of the product. It can be plausible at the priority date for a protein, for example, to have a particular function based on its sequence. If that turns out to be incorrect then surely a patent to the protein is not deserved. A scientific truth cannot be ignored just because it came to light after the priority date.

MaxDrei said...

Holly, where in the Act does it talk about patents being "deserved". It's hard enough deciding whether or not some claimed matter is obvious, without you werreting on about whether the exclusive right is "deserved". The way Arnold has it, at least we have good legal certainty on obviousness. Robin Jacob always used to stress that business, to plan, needs legal certainty.

Should the Statute include a "deserved" requirement? What do you say? Germany used to have a "technical progress" requirement but when they wrote the EPC they decided it was superfluous to requirements.

Me, I enjoyed the Arnold treatment of "Synthetical Prpensity". I had not realised it went back to 1886 and had received judicial interpretation in Canada. Bravo.

Anonymous said...

MaxDrei - the Act requires that the claims are supported by the description. In Schering Biotech it was set out what this means, in particular that it means more than simply that the wording of the claim appears in the description somewhere. "The word 'support' means more than that and requires the description to be the base which can fairly entitle the patentee to a monopoly of the width claimed."

I'm afraid I agree with Holly. Should my patent for "holding festivities on 22nd December" continue in force once people have discovered that it's something else that makes the days get longer again? What have I actually provided that would make this monopoly fair?

MaxDrei said...

Thanks for replying. It makes fun.

No need to be afraid though. I too think that rewards should be deserved, that the world should be fair and that claims should be supported.

If it belatedly emerges that the shortest day is December 21st, and everybody wants to celebrate then, who is going to infringe your exclusive right to celebrate on Dec 22? As far as I can see, excluding Art 84 EPC from the grounds of invalidity hasn't hurt anybody yet. What's that expression I need here, something like "No hurt, no foul"?

Anonymous said...

@anonymous at 10:47 on Wednesday - "the Act requires that the claims are supported by the description"

Once the patent is granted, however, lack of support for the claims is not a ground for revocation. As far as I am aware, we used to have the notion of 'fair basis' under the old Act, and the Aussies still have it. Insufficiency is not the same as 'lack of support'. This point is discussed in the Lundbeck judgments.

Caveat - I haven't read the Schering case to which you refer.

hollyipltd said...

In response to MaxDrei's most recent comment: I assume what you are saying, at least in part, is that if your invention does not work then others will not be concerned because your monopoly over a defective invention won't affect anyone else. That is true for devices, but not in the case of molecules, because in many cases molecules will have other uses unrelated to the invention. This is particularly true for human genes and proteins for which the EPO seems to consider the plausibility of whether the problem has been solved most often. My person opinion is that a plausibility test is required in biotech and chemical practice, but also the EPO and the Courts must develop this test thoughtfully (e.g. the date on which it applies and use of post-filing documents etc), treating it as 'new' test and so accepting that some of the criteria used for old tests such as prior art based inventive step, sufficiency or support might not apply.

MaxDrei said...

Good point from Holly. For some time I have been troubled by the thought that what the Germans call "absoluter Stoffschutz" (ie protection for the molecule per se) conflicts with the EPO's Problem and Solution Approach.

In EPO-PSA, one of the early mandatory steps is to check that the claimed subject matter really does solve the objective technical problem (OTP). Here, it now seems, it doesn't. Absent that solution, the molecule is just another obvious molecule.

But as you say, if in your appln you can make it "plausible" that the problem is solved, your claim gets recognised as inventive. Making it "plausible" is how you show that you deserve a patent. (Perhaps the drafter of the specification is the true deviser of the "invention"). I agree with you, when it turns out that the molecule is useful only because it solves a different problem, not mentioned in the appln as filed, the dismissal of obviousness attacks is troubling.

It troubles me because I had supposed that a complex molecule in a claim of today could be useful ONLY to solve the technical problem relied upon in the appln as filed. I had thought to be vanishingly small the likelihood that it would treat quite another disease condition, not made plausible in the app as filed, and so as a practical matter the failure to solve the OTP would not matter. Now you say it does matter. Perhaps you are right. Not being a pharma guy, I don't know.

hollyipltd said...

In response to MaxDrei and whether molecules solve more than one technical problem: one of the reasons the 'second' medical use claim came into existence through EPO case law was because molecules can often be used to treat more than one condition. So having only a 'first medical use' claim was unfair to discoverers of subsequent medical uses.

I also share your concerns about product claims to molecules, but I don't think the patent world will be seriously considering the issue in the near future.

MaxDrei said...

My impression too. But what goes around comes around, and until the 1970's Germany declined to give absolute Stoffschutz to those claiming a new molecule, per se.

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