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Thursday, 18 April 2013

Double Jeopardy for H Lundbeck - Escitalopram SPC back in Court and no speedy Resolution


Multi blogmeister Jeremy posted a report of this decision   [Resolution Chemicals Ltd v H. Lundbeck A/S [2013] EWHC 739 (Pat) (12 April 2013)] from last week of Mr Justice Arnold on everyone’s favourite niche IP blog, THE SPC BLOG.  But the case is much too interesting to languish there, and, although it does relate to an SPC (Lundbeck's SPC/GB02/049 for escitalopram, since you ask), the pleaded allegation of invalidity is the invalidity of the underlying patent, and the judgment is actually mainly concerned with privity.

The IPKat learning about privity
This Kat must have been in bed the day that they taught about privity, so his whiskers twitched at such a clear exposition of the concept and the jurisprudence set out at length and in detail by Arnold J.  As is his custom, this Kat records that the decision to decide a preliminary point and reject an application for summary judgement extends to 164 paragraphs, or, if you look at the old-fashioned version, 43 pages.

Readers who experience a sense of déjà vu hearing about an alleged invalidity of an SPC for escitalopram will have apprehended the point about this judgment.  Lundbeck’s defence of its SPC against proceedings for revocation commenced by Generics (UK), Arrow Generics, and Teva, has already been all the way to the House of Lords (as it then was), noted by the IPKat here.  This Kat has a special interest in the case, because asymmetric synthesis was the subject of his doctoral research, and, indeed, his DPhil supervisor Prof Stephen Davies acted as expert witness for Lundbeck.  The IPKat would like to take this opportunity to clarify that the HoL decision did not, contrary to reports by some commentators at the time, establish a general rule going forwards that enantiomers are patentable, because the factual underpinning of the decision is very much tied to the priority date in the late 1980s, and the reasoning would not in general apply to cases with a significantly later priority date.

Escitalopram
Having fought off three combined challenges to the validity of the SPC and underlying patent, and the battle having already been to the UK’s highest court, one can imagine that Lundbeck was a bit miffed to find itself on the receiving end of another invalidation action, this time by Resolution Chemicals Limited, not least because Resolution had at one stage, from 2001 to 2009, been part of the Arrow Group, the same as Arrow Generics, one of the claimants in the earlier proceedings.

Lundbeck therefore sought judgment that Resolution was precluded from bringing the action by reason of cause of action estoppel, issue estoppel and/or abuse of process, namely estoppel per rem judicatam because Resolution was privy to the earlier proceedings.  This was ordered to be the subject of a trial as a preliminary issue, resulting in the present judgment.

The legal meat of the judgment on privity is in para 81 to 100, which conclude:

The conclusions which I draw from this survey of the authorities are as follows:
i) The test for privity of interest is whether, having due regard to the subject of the matter of the dispute, there is a sufficient degree of identification between the relevant persons to make it just to hold that the decision to which one is party should be binding in the proceedings to which the other is party: Gleeson v Wippell approved in Johnson v Gore Wood.
ii) Where someone who has knowledge of the earlier proceedings and a legal interest in their outcome sits backs and allows another person with the same legal interest in the outcome to fight his battle, he will be a privy with the other person: House of Spring Gardens. But this is a narrow exception to the general rule that a person will not be bound by the outcome of proceedings to which he is not a party: Skyparks v Marks, Powell v Wiltshire, Seven Arts v Content.
iii) A direct commercial interest in the outcome of the litigation is insufficient to make someone a privy: Kirin-Amgen v Boehringer Mannheim.
iv) Whether members of the same group of companies are privies or not depends on the facts: Special Effects.

On the facts, Arnold J decided that Resolution was not bound by privity of interest with any of the earlier parties.

Moreover, he declined the summary judgment, requested by Lundbeck on the basis that Resolution's claim had no real prospect of success.  He considered that, despite the earlier UK judgments,  “Resolution has a real prospect of successfully contending that all the claims of the Patent are obvious over US 4,650,884 and that claims 1-5 are obvious over Bigler.” (“Bigler” is an article entitled "Quantitative structure-activity in a series of selective 5-HT uptake inhibitors" by Allan J. Bigler et al. published in the May/June 1977 edition of the European Journal of Medicinal Chemistry).  The former allegation, the same one rejected in the earlier UK case, was held to have a more than fanciful chance of success because the Dutch court had reached an opposite view from the UK courts, preferring the evidence of Professor Baldwin to that of Professor Davies.  The latter allegation, suggesting that a different route to escitalopram from that invented by Lundbeck was obvious, was a new allegation requiring a trial for a proper determination.

Directions apparently lead to a trial date in November 2013, to which the IPKat greatly looks forward.

4 comments:

Anonymous said...

I 2 look forward to November. It'll be nice to have 2 judgments with arguments from 2 (different)parties on whether resolving the same mixture into 2 enantiomers is patentable, given 2 different national courts have taken 2 different views of 2 different experts and 2 different routes of resolution are possible.

Anonymous said...

Anon needs to remember the point made in the blog. This is a test of what was patentable many moons ago. It is not a test of whether enantiomers are patentable today.

I'm note sure who was going around telling people the House of Lords decision established a general rule that enantiomers were patentable. This would certainly have been incorrect. Irrespective of this decision, enantiomers were patentable and are still patentable. It all depends on the facts of the case. The same facts that would have supported patentability in the 80s are less likely to support patentability today. Science moves on and patent law is always playing catch up.

The HoL decision is a long long way behind the curve, but it is still possible to make a prediction today based on the specific facts of a new case.

Anonymous said...

If something is new, the question of whether it's obvious is one of fact - on which evidence will be required. We don't have a priori rules about what is or isn't obvious - unlike the Indians.

Anonymous said...

That's not fair on the Indians. They have rules on what or is not new. Even if not know before, something may still be known to the Indians. A little difficult to get one's head around such a position. Just how can a country that can only copy consider something unknown to them to be new? Do Indian photocopiers take a blank piece of paper and create a work of Shakespeare, for example, I wonder?

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