UK paves way for generics of Eli Lilly’s Alimta Posted 19/02/2016

The UK High Court ruled on 12 February 2016 that Eli Lilly’s vitamin regimen patent for its lung cancer blockbuster Alimta (pemetrexed disodium) is not infringed by a generic version of the drug sold by Allergan’s Actavis unit. 

The High Court concluded that Actavis’ pemetrexed trometamol product – a different salt form of pemetrexed which is sold in France, Italy, Spain and the UK with instructions to dilute the product only with dextrose solution – does not infringe Eli Lilly’s intellectual property.

The decision overturns an earlier ruling in June 2015, when the UK Court of Appeal held that Eli Lilly’s patent would be indirectly infringed by Actavis marketing certain alternative salt forms of pemetrexed with instructions to dilute the product with saline solution.

Alimta is used to treat non-squamous non-small cell lung cancer (NSCLC) and was Eli Lilly’s second biggest seller during 2015, bringing in almost US$2.5 billion. In major European countries, the compound patents for Alimta expired in December 2015. The Alimta vitamin regimen patents, which cover a series of vitamin B12 injections used to reduce the drug’s side effects, only expire in June 2021.

Eli Lilly is planning to seek permission to appeal the UK decision. The company is also appealing a decision made by the Dusseldorf Court of Appeal that the Alimta vitamin regimen patent would not be infringed by a generic drug competitor that has stated intent to market pemetrexed dipotassium in Germany.

Related article
Generics applications under review by EMA – December 2015

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Source: Eli Lilly

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