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Thursday, 22 May 2014

Dosage regime patent revoked in a Salesian judgment

That Kat can barely move for the number of interesting cases emerging from the Patents Court at the moment.  The latest offering, out today, is the Salesian (geddit?) judgment in the case of Generics (UK) Ltd (t/a Mylan) v Richter Gedeon Vegyeszeti Gyar RT [2014] EWHC 1666 (Pat) (22 May 2014).  Merpel has decided to use the term Salesian to refer to judgments that are in either the literal or figurative sense not Arnoldian.

No, not THAT Salesian...
But seriously, this brief validity-only decision of Mr Justice Sales relates to EP(UK) 1 448 207, directed to a dosage regimen for use of levonorgestrel as a method of emergency contraception.  Generics had applied for revocation of the patent.  The claims of the patent, in the name of Richter Gedeon Vegyeszeti Gyar RT were in the following terms:

1. Pharmaceutical composition as single application dose, characterized by containing 1.5+ 0.2 mg of levonorgestrel as active ingredient in admixture with known excipients, diluents, flavoring or aromatising agents, stabilizers, as well as formulation-promoting or formulation-providing additives, commonly used in the pharmaceutical practice.
2. Use of 1.5+ 0.2 mg levonorgestrel for the preparation of a pharmaceutical for emergency contraception.
3. The use as claimed in claim 2, wherein the pharmaceutical is for the administration of a single application dose up to 72 hours of the coitus.

Sales J applied the Pozzoli test (which judgment he also quoted at some length).  This can be set out briefly as:

(1)(a) Identify the notional "person skilled in the art";
(b) Identify the relevant common general knowledge of that person;
(2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;
(3) Identify what, if any, differences exist between the matter cited as forming part of the "state of the art" and the inventive concept of the claim or the claim as construed;
(4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?

After considering the person skilled in the art and their common general knowledge at some length in relation to Pozzoli step 1, he considered in relation to Pozzoli step 2 that

 "for emergency contraception" involves a claim that it will provide a reasonable level of effectiveness in achieving prevention of pregnancies, broadly comparable to other existing treatments which are available for that purpose, such as would make it potentially worthwhile to use it for that purpose, taking into account the other possible benefits associated with its use (such as avoidance of physically intrusive intervention, lesser side effects, greater prospect of successfully finishing the treatment etc). But, on proper interpretation, the claim does not go further than this. 
The state of the art consisted of the common general knowledge and an article ("the Killick article"), reporting, inter alia, research by Dr von Hertzen  for the WHO regarding  the effectiveness of a regimen involving a single dose of 1.5 mg of levonorgestrel, as compared (in particular) with the two-dose regimen which was in widespread use.  This article included a mis-statement of the dosage of levonorgestrel used in the one dose regimen in the project as 1.5 g rather than 1.5 mg.  The inventive concept of the claims, that differs from the state of the art under Pozzoli step 3, was thus judged to be the one dose regimen based on a 1.5 mg dose, supported by a claim of efficacy in light of the completed WHO study.

Following rather inevitably from this, under Pozzoli step 4 Sales J found that (despite the mis-statement of the dose):

In my judgment, the report in the Killick article about the WHO research project, as read by a relevant person skilled in the art, made it obvious that use of a single dose of 1.5 mg of levonorgestrel within 72 hours of intercourse was likely to be a viable method of emergency contraception. From that report, it was obvious that such a regimen could be pursued and investigated with a reasonable or fair expectation of success. 

This Kat was rather pleased to see that Sales J mentioned a "cross-check for my conclusion", which looks suspiciously like the "final sanity check" that this Kat earlier advocated.  The judge stated:

Looking at the matter more broadly in terms of the kind of contribution to human knowledge that the patent system is intended to incentivise and reward (cf Pozzoli  at [25]-[29]), as a cross-check for my conclusion, I consider that the additional research work (finalising the study which was already well advanced as reported at the time of the presentation in September 2000) and additional information (confirmation of the preliminary findings presented in September 2000) were not of the character or extent that one could reasonably describe them as a significant additional contribution to human knowledge such that one would expect them to attract protection in the form of a patent monopoly of exploitation. The possibility of using the single dose regimen involving levonorgestrel for emergency contraception had already been substantively revealed and attested by the extant research findings reported in September 2000 as an obvious likely way forward in the field of emergency contraception, notwithstanding the caveat regarding the need to finish the study mentioned at the end of the Killick article. 
An objection of insufficiency was not considered further by the judge in the light of the main conclusion on obviousness.  Although he was "impressed"  by the patentee's submissions, he concluded "it is unnecessary and inappropriate to say anything further about this."


Anonymous said...

Shouldn't sufficiency have been considered in case this gets found to be inventive on appeal?

Anonymous said...

I would be curious to know if there was any discussion about the meaning of the last word of claim 3.

Anonymous said...

We need serious judicial consideration like this on the 2nd law of thermodynamics; and the Lorentz transformation that Einstein clearly hi-jacked.

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