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European IP Bulletin, Issue 35, October 2006 - Patents

4. Extending Pharmaceutical Monopolies

This action included consolidated cases against two patents owned by Akzo NV, Arrow Generics and Norton Healthcare, manufacturers of generic pharmaceuticals.  The case in the Scottish Court of Session was heard by Scotland’s principal IP judge Lord Glennie.
The patents concerned claims to the pharmaceutical product tibolone used in treating menopausal complaints, in modulating the immune system and for combating osteoporosis.  Tibolone as such was well known since the 1960s.

Akzo’s claimed invention concerned the ability to produce a particular form of the product with increased reliability in a greater purity. The first patent ‘035 (priority March 1989) claimed the product in a particular form, known as Form 1.  The second patent ‘375 (priority October 1998) claimed the same product but in greater purities from that said to have been achieved.  The commercial advantage to Akzo of this technology clearly lay in being able to produce, in tablet form, a product that would remain stable for longer.

The basis of the attack on the ‘035 patent was an article published in 1984 in which some of the Form 1 product had been produced by experiment.  Akzo argued that its patent required large quantities of the product to be produced for pharmaceutical use whilst purity was maintained, and not just a single crystal. The Court answered however that the patent made a standard claim to the product as a pharmaceutical preparation, but that nothing indicated the conversion into a pharmaceutical was the point of the monopoly claimed.  Instead, the product itself had been claimed but was found to have been made before.

The basis of the attack on the ‘375 patent was case law from the European Patent Office (EPO) in which a rule of general application appeared to be established that unless there was some new way of achieving greater purity then the product of greater purity did not have the requisite novelty.  The Court found that conventional means, albeit tedious, could achieve the increased purity.  Akzo argued that the case law of the EPO did not have to be followed as precedent by the Scottish Court.  Nonetheless, the Court accepted the EPO’s approach and found that despite Akzo having found another way of achieving purity more speedily, the claim to the product was not novel.  An amendment put forward by Akzo to limit the claims by reference to an improved method for achieving the purity claimed was rejected.  The product achieved by such means had no additional identifiable novelty and thus could not rely on the new means to protect the product itself.

The robust dealing with these two patents demonstrates both the flexibility of the law on novelty to borrow from the approach of the EPO and the determination of the Scottish Court to take a practical approach in deciding questions of IP enforcement and allowance of amendments during litigation.

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