Inference, proof and patent invalidity

Novartis AG v Ivax Pharmaceuticals UK Ltd [2006] EWHC 2506 (Pat), decided by Mr Justice Pumfrey in the Patents Court on Monday, is available on BAILII.

Novartis, a pharma company, sold a formulation of cyclosporin which was useful in inducing immunosuppression for allogenic organ transplant patients. After Ivax announced its plan to sell its own cyclosporin formulation in the United Kingdom under the brand name 'Equoral', Novartis claimed it would infringe two patents for the formulation of cyclosporin and sued accordingly. The first patent, for a microemulsion, claimed priority from September 1988 while the second patent claimed priority from 1998. Ivax, denying infringement on the facts, also challenged the validity of the microemulsion patent on the basis of one piece of prior art (a US patent) and common general knowledge, which included an earlier product called Sandimmun.

In a decision that was long on facts and short on law, Pumfrey J found the microemulsion patent valid but that the second patent was invalid - not that this mattered from the point of view of Novartis, since neither patent was actually infringed. He did however have this to say:
"Validity is challenged on the basis of US 4,146,499 (Rosano) and the common general knowledge. The common general knowledge included Sandimmun. In summary, the problem is to improve on Sandimmun so as to improve its qualities, as for instance stability of the resulting dispersion or bioavailability. Rosano is a general description of how to formulate microemulsions. It contains no suggestions relating to formulation of cyclosporin. Unless the skilled person sees that a microemulsion is the way to go, I cannot see how Rosano supports an allegation of obviousness. It is not a document that the skilled person will greet with 'That gives me what I want' unless he already appreciates the merits of a microemulsion formulation. This is a good example of hindsight reasoning. It is not surprising that Ivax concentrated at trial on the case based on common general knowledge alone.

Against the case based on the common general knowledge, the patentee put a submission that can be summarised in the contention that had the alleged invention been obvious, one or more formulators would have made the invention earlier than it was, in fact, made. The earliest priority date claimed for '770 is 1989, and Sandimmun had been on the market since 1982/3. So, says the patentee, the 6 years or so must be explained away.

A difficulty with arguments of this sort is that one cannot be confident of arriving at a fair answer without being aware of the history of the developments as they in fact took place. There was no evidence of the history in this case. A patentee will invoke industry's failure to act because it will be assumed that had the alleged invention been obvious it would have been made by someone else, and in some cases this assumption is entirely justified — see Vickers v Siddell (1890) 15 App Cas 496, 7 RPC 292, a good example where the invention contributed to safety in forges and the need for safety would have contributed a strong incentive. Where a patent like the present one is under consideration, one must be careful before assuming that the skilled person is free to do the obvious thing. Until patent protection on the active ingredient (or the use of the active ingredient in a pharmaceutical preparation) has expired, the skilled person will be less inspired to do further formulation work, unless he or she is an employee of the relevant patentee. Where there is relevant patent protection, in other words, the actual behaviour of the industry cannot provide any sort of reliable guide to help provide a rational resolution of the question whether the invention is obvious or not. The behaviour of the patentee's employees may help (see Pharmacia v Merck [2002] RPC 410). As Sir Donald Nicholls V-C said in Mölnlycke v Procter & Gamble [1994] RPC 49, 113 secondary evidence of this kind is merely an aid in assessing the primary evidence of inventive step, which will be provided by the expert witnesses. Often it will help in eliminating the baleful effects of hindsight".
The IPKat notes that inference is never going to be more than a second-best proof in the absence of actual evidence, particularly where the same state of affairs allows disputing parties to draw different inferences. That's very well, says Merpel, but you need pretty good hindsight to recreate an accurate and relevant version of the past from what, when you're living through it, is a pretty hazy present.

The cyclosporin story here

News from the CFI

Here's the latest news of Community trade mark litigation before the Court of First Instance (CFI) for the European Communities

. In Case T-499/04 Hammarplast AB v OHIM, Steninge Slott AB, an application was made to register the words STENINGE SLOTT as a Community trade mark for glass and porcelain design products in Class 21. Steninge is a town in Sweden which has a castle; slott is Swedish for castle and keramik is easy to guess. Hammarplast opposed, citing its earlier Swedish STENINGE KERAMIK registration for ceramic flowerpots in Class 21 and pleading a likelihood of confusion. The Opposition Division upheld the opposition; Steninge Slott, deleting porcelain goods from its specification, appealed successfully to the Board of Appeal. Hammarplast appealed to the CFI, which dismissed the appeal. Quite simply there was insufficient similarity between the goods and marks in question to sustain the argument that confusion was likely to arise.

GALZIN/CALSYN. In Case T-483/04 Armour Pharmaceutical v OHIM, Teva Pharmaceutical Industries, Teva applied to register GALZIN as a Community trade mark for Class 5 pharma preparations for Wilson's Disease. Armour opposed, citing a likelihood of confusion with its earlier French registration of CALSYN for calcium-based preparations in Class 5. The Opposition Division upheld the opposition. The Board of Appeal allowed Teva's appeal, since the marks were insufficiently similar and were for the treatment of different conditions. The CFI has now allowed Armour's appeal and re-upheld the opposition. In its opinion the marks were sufficiently similar and, on the facts, there was a likelihood of confusion.

Good news for Slovaks. Last week's ruling in Case T-302/03, PTV v OHIM (on the non-registrability as a Community trade mark of the word map&guide), was originally available on the Curia website in all EU official languages except English and Slovak. Well, it's now available in Slovak too ... For earlier IPKat post with helpful summary by SMP click here.

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