Monday, December 20, 2004

Sanofi-Aventis to get re-issue on Lovenox patent

from Reuters:

Sanofi-Aventis has clearance from the U.S. patent office to obtain reissue on a patent for Lovenox, an anti-thrombosis drug threatened by competition from generic versions, the world's third-largest drugmaker said on December 20, 2004.

Based on the United States Patent Office's decision, the "618" [5,389,618] patent of the blockbuster drug could be reissued towards the middle of 2005 in the United States, Sanofi-Aventis said.

The first claim of US '618 recites:

A heterogeneous intimate admixture of sulfated heparinic polysaccharides, such sulfated polysaccharides having a weight average molecular weight less than that of heparin and said admixture consisting essentially of from 9% to 20% of polysaccharide chains having a molecular weight less than 2,000 daltons from 5% to 20% of polysaccharide chains having a molecular weight greater than 8,000 daltons, and from 60-86% of polysaccharide chains having a molecular weight of between 2,000 and 8,000 daltons, the ratio between the weight average molecular weight and the number average molecular weight thereof ranging from 1.3 to 1.6 said admixture (i) exhibiting a bioavailability and antithrombotic activity greater than heparin and (ii) having an average molecular weight of between approximately 3,500 and 5,500 daltons.

The summary of invention of US '618 includes:

Accordingly, a major object of the present invention is the provision of novel combinatory immixtures of particular heparinic polysaccharide fractions, such novel immixtures being especially useful for the prophylaxis and treatment of acute thrombotic events/episodes.

Indeed, it has now surprisingly and unexpectedly been found that mixtures of both high and low molecular weight heparinic polysaccharides, nonetheless having an average molecular weight less than that of heparin, exhibit desirable balance of antithrombotic/anticoagulant activity. Contrary to the direction of the prior art, a certain fraction of relatively high molecular weight heparinic polysaccharides and a certain degree of heterogeneity are required to provide such balance of biological activity.


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