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.