Actavis and Novartis

ACTAVIS’ “EXPECTATION OF SUCCESS” AFFIRMED

ACTAVIS UK vs NOVARTIS AG

The High Court, Court of Appeal has recently upheld a decision on Appeal from the High Court, Patents Court, that the Novartis’s European Patent (UK) 0948320, a sustained release formulation of Fluvastatin (a Cholesterol lowering drug), is invalid on the ground of obviousness.

Earlier in the Patents Court

Actavis claimed for the revocation of Novartis patent on grounds of obviousness and insufficiency in the Patents Court. There was also a counterclaim by Novartis for infringement of its patent. Novartis conceded that the claims as granted could not be granted and applied for their amendment.   The claim and counterclaim before Justice Warren is reported at Actavis UK Ltd v Novartis AG [2009] EWHC 41 (Ch) (16 January 2009) . The teaching of the patent was compared to the pleaded prior art and common general knowledge and the judge found that the patent was obvious. The claim on insufficiency however failed.  The Actavis’ preparation would have infringed the defendant’s patent had it been valid but in view of the finding of obviousness the counterclaim failed.

Advances In A Case And Analysis

 

Solubility: high and very high

Fluvastatin was a well-known statin available in an immediate release formulation in 1996 (priority date of the patent is October 1996). A dosage regime of a 40 mg capsule to be taken twice a day was well known by that date plus there was extensive knowledge of sustained release formulations generally. The patent suggests that there is a need for a sustained release formulation of Fluvastatin and in creating such a formulation, there is a problem of its high water solubility and that any of the conventional methods would not work.

Judge Lloyd says “the problem presented in the Patent was illusory”.

Patent is seeking to deal with a problem of high water solubility of Fluvastatin. However, there would be problem only at very high and very low solubility. The solubility of the drug is high and not very high and therefore Fluvastatin is not so highly soluble that the skilled person would expect it to be impossible or difficult to make a sustained release form.

Common General Knowledge and an Expectation of success

Although there was lurking in the Patents Court about some arguments about other claims namely 2, 3, 10 too, however, the only claim which really matters is claim 1, which is permitted to be amended by Justice Warren.

Claim 1 is as follows:

“A sustained release pharmaceutical composition comprising a water soluble salt of Fluvastatin as active ingredient and being selected from the group consisting of matrix formulations, diffusion-controlled membrane coated formulations and combination’s thereof, wherein the sustained release formulation releases the active ingredient over more than 3 hours.”

Actavis advanced a case that a sustained release form of Fluvastatin would be expected not only to be a more convenient formulation for patient compliance (the common perception in October 1996 was that a reduction from 2 doses daily to a single dose would result in improved patient compliance) but would be likely to have significant medical advantages, namely improved therapeutic effect and fewer side effects and hence there was a strong motive to create a sustained release form and a strong expectation that all three types of benefits would be obtained, the two medical and the convenience. The Judge rejected the “medical advantage” but accepted the “more convenient” advantage point.

The fact that an immediate release formulation was already available which could be taken at a dose of up to 40 mg once a day and up to 80 mg per day in two doses, was a part of the common general knowledge of the skilled team. As a result, the skilled team would have an expectation of being able to develop an 80 mg sustained release formulation with some clinical efficacy. It would however be uncertain about clinical efficacy, and there would be no strong expectation that it would be achieved. It would be unable to predict with anything approaching certainty that any reduction in the risk of side-effects would be achieved. The team might get better efficacy or fewer side effects, but it would certainly get better compliance.

The problem and solution gave the same answer and the Judge affirmed the invalidity of the Novartis Patent on the ground of obviousness. The problem was to produce a sustained release of fluvastain. And the solution was provided by any of the standard methods for such formulations, which was obvious. The problem is not to look for better medical effect as discussed above and thus the decision of the Patents Court was rightly upheld.

There was some dispute between the parties about the effect in the case of the decision of the in Conor Medsystems Incorporated v Angiotec Pharmaceuticals Incorporated.

In Conor, The patent claim in question was a taxol coated stent for treating restenosis and prior art claimed a use of stent coated with one of the drugs of the class of drugs to which taxol belonged to. The House of Courts held the patent to be not obvious as it was not obvious for taxon to show the same therapeutic effect.

However, this should always be kept in mind that the obviousness is a question of fact and is a multifactorial question. “The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success.” Generics v Lundbeck[2007] RPC 32.

In Pozzoli terms the only difference between the prior art and the claim is the idea of making a sustained release formulation and for that there was a technical motivation. [Pozzoli v BDMO [2007] FSR 37)].  The “Problem and Solution approach” gave the same answer. The problem was to produce a sustained release form of Fluvastatin, which would be solved by any of the standard methods for such formulations. The problem was not to look for better medical effects and the Judge affirmed the invalidity of the Novartis Patent on basis on the ground of obviousness. Since this was one of the first cases after Conor, it is to be seen further whether the Conor would make any change in interpreting the issue of obviousness or not.

Case No: A3/2009/0675

About the Author: Ms. Meenakshi Khurana, a Senior Patent Consultant in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: meenakshi@iiprd.com.

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