In the case of Glenmark Generics (Europe) Limited & others v The Wellcome Foundation Limited and Glaxo Group Ltd ([2013] EWHC 148 (Pat)) the High Court has found that Wellcome's patent for the anti-malarial drug Malarone is invalid and hence should be revoked.
In order for a patent to be valid the invention which it covers must (amongst other things) be: (i) new; and (ii) involve an inventive step.
Malarone is a pharmaceutical composition which is comprised of a combination of the drugs atovaquone and proguanil in the ratio 5:2. It was this combination of the drugs which was protected by the patent rather than the drugs themselves.
The Judge found that combining the drugs in the above ratio to treat malaria was not inventive over studies that had been performed and disclosed to the public in articles and presentations before the date of the patent. Although the exact ratio of the drugs was not disclosed, the Judge found that the relevant skilled team (the standard which is applied when patent validity is being considered) would have found it obvious to try a 5:2 ratio and hence the invention lacked the required inventive step.
Combination products are common in the pharmaceutical industry and this decision highlights the vulnerability of the patents protecting such products where the molecules themselves are not protected.
Combination products are common in the pharmaceutical industry and this decision highlights the vulnerability of the patents protecting such products where the molecules themselves are not protected.
Glenmark Generics reportedly launched the first generic atovaquone proguanil combination as soon as the Malarone patent was revoked.
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