Teva survives Copaxone patent challenge

Teva has successfully defended two patents related to its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate) at the English High Court.

In a judgment issued yesterday (May 21), the court declared both patents valid and novel, dismissing a claim of obviousness filed by rival drug maker Synthon.

The case centred on two Teva patents, EP number 2 ,177,528 and EP number 2,361,924, both called “Process for the preparation of mixtures of trifluoroacetyl GA using purified hydrobromic acid”, which make improvements to the process for making the drug.

The patents are both divisionals of another patent, EP 1,799,703.

Synthon had claimed that both patents were invalid and had attempted to have them revoked.

Both patents are related to experiments aimed at demonstrating what effect different amounts of free bromine have when added to the drug.

Another aspect of the patents relates to the level of metal ions in the drug’s active compound that were found to have caused the drug to turn red when kept in storage.

But issuing the judgment, Justice Colin Birss said it was not obvious that the red colour was caused by metal ion impurities.

“The [patent] application teaches that metal complexes in TFA-glatiramer acetate and glatiramer acetate are the cause of the colour but I do not see any basis from which the skilled reader would take it that the levels at one stage necessarily followed from the levels at another stage,” Birss wrote.

Both patents were revoked by the District Court of The Hague in the Netherlands last month, but Birss said that court heard different evidence.

According to the judgment, Copaxone has made worldwide sales of $4.2 billion to date, representing 21% of the Teva’s total revenue.