IVAX, ARROW SPEARHEAD PATENT ATTACK; SPYROS GETS HIS CHAIR

1960s polymorphs anticipate 3G patent

The IPKat notes that Ivax is back in court again. Today it was Ivax Pharmaceuticals UK Ltd v Akzo Nobel NV and Arrow Generics Ltd v Akzo Nobel NV [2006] EWHC 1089 (Ch), two conjoined decisions of Mr Justice Lewison in the Patents Court today. This case has been noted on Butterworths' All England Direct subscription service but was not, at time of posting, available on BAILII.

Above, right: in the 1960s, weren't we all polymorphs?

Way back in the 1960s Akzo invented tibolone, a steroid used in hormone replacement therapy for women. Being polymorphous, it existed in more than one crystalline form. Tibolone had been widely marketed under the trade name Livial and was originally patented as of 1964. A second generation formulation patent, ‘035, was published in 1990, which claimed a monopoly in the formulation of tibolone in two forms, each crystalline pure. Akzo then came up with a third-generation patent, ‘278, with priority from 2003: this was for an ‘immediate-release pharmaceutical dosage form comprising polymorphous tibolone’, its inventive concept being the use of polymorphous tibolone in an immediate-release pharmaceutical dosage form of less than the specified particle sizes, so that it had bioequivalence with Livial. ‘278 was addressed to chemistry, pharmaceutical science or formulation science graduates in the pharmaceutical industry who wanted to formulate drugs. Such people would be generally familiar with the properties of steroids.

Ivax and Arrow both attacked ‘278 on the ground that the invention was obvious in the light of common general knowledge both at its priority date and in the light of prior art. ’035 supported the notion that a formulator who sought to formulate a dosage of tibolone would find that the path to formulating a pure crystalline form was blocked by the claimed monopoly since he would of necessity have gone down the path of formulating a polymorphous compound containing both forms of tibolone.

Lewison J allowed Ivax's and Arrow's applications and revoked the patent, holding that ‘278 would be obvious to a person skilled in the art. On the evidence, once the decision had been taken to formulate polymorphous tibolone, finding a particle size with bioequivalence to the marketed product had been no more than a matter of routine testing. The particle sizes claimed were nothing out of the ordinary and it would have been obvious to the skilled but unimaginative formulator that he would formulate polymorphous tibolone of the claimed particle sizes.

The IPKat marvels at the ingenuity expended by patent agents in finding ways of stretching innovations from generation to generation, but wonders whether it's really worth the effort. Merpel thinks it is, since even a short-term patent grant will have provided some temporary shelter from competition before revocation sets in.


Spyros gets his Chair

The IPKat congratulates his friend Spyros Maniatis on being appointed to a Chair in Intellectual Property Law in the Centre for Commercial Law Studies, Queen Mary, University of London. Spyros, formerly Senior Lecturer at the same institution, is a notable scholar, author and a teacher in the field of trade marks and elsewhere. He is also a gentleman and a friend of the IPKat (and Merpel ...). Well done, Spyros!