Eli Lilly has suffered a setback in its efforts to prevent generic competition to its big-selling lung cancer treatment Alimta.
The UK High Court has ruled that a patent held by Lilly on a vitamin regimen for Alimta (pemetrexed disodium) – a series of vitamin B12 injections used to reduce the drug’s side effects – is not infringed by a generic version of the drug sold by Allergan’s Actavis unit.
Lilly has said it will seek permission to appeal the verdict as it tries to defend one of its biggest brands from generic competition in Europe.
Specifically, the High Court has concluded that Actavis’ pemetrexed trometamol product – a different salt form of the drug which is sold in the UK, France, Italy and Spain with instructions to dilute the product only with dextrose solution – does not infringe Lilly’s intellectual property.
That follows a Court of Appeal decision last June, which held that if Actavis were to market its product with instructions to dilute the drug in saline it would infringe the vitamin regimen patent. That court did not however deliver a verdict on whether an alternative salt form with instructions to dilute only in dextrose solution would infringe.
Alimta is used to treat non-squamous non-small cell lung cancer (NSCLC) and was Lilly’s second-biggest product last year – bringing in almost $2.5bn – although sales have started to decline in the face of reduced demand as well as competition and reduced pricing.
The compound patent on pemetrexed disodium expired in December 2015 in most European markets, but Lilly has endeavoured to protect its franchise with the vitamin patent, which extends to June 2021.
Last year, the validity of Lilly’s vitamin regimen patent was upheld by a prior European Patent Office (EPO) ruling; an appeal against that decision was upheld towards the end of 2015.
In addition to the UK setback, Lilly’s efforts to block Alimta generics also stumbled in Germany last year, after the Dusseldorf Court of Appeal ruled the Alimta vitamin regimen patent would not be infringed by yet another salt – Actavis’ pemetrexed dipotassium – after the December 2015 compound patent expiration.
Now however Lilly says it has been granted leave to appeal that ruling in the Federal Supreme Court in Germany and expects that case to be heard later this year. The company says it has also been granted an injunction against another would-be competitor in Germany.
Maintaining Alimta’s revenue stream is a priority for Lilly as it weathers the loss of patent protection for other brands, including osteoporosis drug Evista (raloxifene) and antidepressant Cymbalta (duloxetine) and brings new products through its late-stage pipeline and onto the market.
The company has high hopes for oral rheumatoid arthritis candidate baricitinib – just filed in the US – and recently-approved NSCLC therapy Portrazza (necitumumab).