The case involves the ‘method-of-use’ patent (or the ‘209 patent), which covers administration of two nutrients – folic acid and vitamin B12 – to patients before they receive Alimta, to prevent side effects of the drug.

The validity of the ‘209 patent is being challenged by generics manufacturers, including APP Pharmaceuticals, Barr Laboratories and Teva Pharmaceutical Industries. The generics makers claim that the patent is an obvious extension of existing patents and therefore does not warrant additional patent protection.

The US Court of Appeals in Washington upheld the validity of the patent on the chemical structure of Alimta in 2011. This decision protected the drug from generics until January 2017. If US-based Eli Lilly wins the case in the Indianapolis Federal Court, generics would be prevented from entering the market in the US until 2022.

Alimta, which is indicated for the treatment of pleural mesothelioma and non-small cell lung cancer, has annual sales of US$2.6 billion per year.

In Europe, Eli Lilly has patent protection on the chemical structure of the drug until 2015. A ‘method-of-use’ patent was challenged by the European Patent Office with a ruling issued in the company’s favour. This decision, however, is being appealed.

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