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European IP Bulletin, Issue 32, June 2006 - Patents

PATENTS

3. IVAX Pharmaceuticals UK Ltd V AKZO Nobel UK

Ivax Pharmaceuticals UK Ltd v Akzo [2006] EWHC 1089 (Ch) was a patent action to revoke Akzo’s patent for a steroid used in the hormone replacement therapy for women, Tibolone.

Akzo was the proprietor of an earlier, now expired, patent on Tibolone, filed in 1964 which was marketed under the name ‘Livial’, and another, ‘035, published in 1990 which separately claimed the two crystalline forms of Tibolone. The patent in suit, ‘278, was a third generation patent on polymorphous Tibolone and claimed priority from 2003. The allegedly inventive concept embodied in ‘278 was the use of the polymorphous steroid in an immediate-release pharmaceutical dosage.  Because the particles were less than a specified size, the polymorphous Tibolone had the same bioequivalence as the pure crystalline Tibolone in the earlier patents.

Ivax claimed that the '278 patent was obvious based on the prior art in light of the common ground knowledge. Both parties relied on the earlier '035 Tibolone patent.  Akzo argued that the '035 patent taught that a pure crystalline form of Tibolone should be used, prejudicing the man skilled in the art from considering the use of a polymorphous form.  In contrast, Ivax argued that because this claimed a monopoly on substantially pure crystalline forms of Tibolone, the person skilled in the art would be likely to try polymorphous Tibolone for the commercial reason of avoiding the earlier ‘035 patent, hence making the patent in suit, '278 more obvious.  Akzo argued that this was not the correct approach, and that such a factor could not be taken into account.  However, the judge disagreed, stating that commercial reasons could be a valid motivation for the man skilled in the art to consider other methods and products.

When discussing the common general knowledge of the skilled addressee the evidence was that the average skilled man would have no knowledge of Tibolone.  Ivax argued that the general knowledge of steroids could nevertheless be applied to prior art comprising information on Tibolone, as in reality a skilled man would be provided with information on a specific drug, Tibolone for example, and then be asked to apply his general skills and knowledge.  The defendants argued that patent law forbade this approach, regardless of what might happen in a real situation.  The judge disagreed citing a prior decision in SmithKline Beecham plc and ors v Apotex Europe and ors [2005] FSR 23. The judge stated that if, in the real world, a formulator would apply ordinary principles of drug formulation to information he would acquire about Tibolone, there was no reason this should not happen under the law of patents.

The patent was found to be obvious to a person skilled in the art and was revoked. In finding the patent to be obvious, the court stated that producing polymorphous Tibolone of a specified size which was bioequivalent to the pure crystalline Tibolone claimed in earlier patents would require only routine tests. The particle sizes would be obvious to the skilled, but unimaginative, person in the art as he would have known to formulate particles of polymorphous Tibolone of that size.

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