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Lilly wins on appeal in Alimta vitamin regimen dispute

UK Supreme Court rules in its favour over Actavis

Eli Lilly

The UK Supreme Court has ruled in favour of Eli Lilly in a long-running patent dispute with Actavis relating to its big-selling cancer drug Alimta.

The ruling finds that Actavis generics on sale in the UK, France, Italy and Spain infringe on Lilly's patents for Alimta (pemetrexed disodium), which has lost patent protection in several countries and saw sales slide 8% to just under $2.3bn last year.

While the basic patents on Alimta have expired, Lilly is still claiming protection for a regimen that makes use of a series of vitamin B12 injections to reduce the drug's side effects. The compound patent on pemetrexed disodium expired in December 2015 in most European markets, but Lilly has sought to protect its franchise with the vitamin patent, which extends to June 2021.

In June 2015 the UK Court of Appeal ruled the Alimta vitamin regimen patent would be indirectly infringed when Actavis' generic was is reconstituted or diluted in saline, but did not directly infringe the patents, a decision which was upheld the following February in the UK High Court.

In the meantime Actavis launched a different salt of the drug – pemetrexed trometamol – with instructions to dilute only in dextrose solution in an attempt to sidestep Lilly's intellectual property. The latest ruling "finds the Actavis product infringing, regardless of the diluent used in reconstitution or dilution", said Lilly in a statement.

The ruling is the latest in a series of judgments that have gone Lilly's way as it fights a rear-guard action to defend sales of Alimta, which is used to treat non-squamous non-small cell lung cancer (NSCLC) and is Lilly's third-biggest product.

Last year, the US Court of Appeals for the Federal Circuit upheld the decision of the U.S. District Court for the Southern District of Indiana and ruled in the drugmaker's favour regarding the validity of the vitamin regimen patent for Alimta.

Meanwhile, in Japan in February, a High Court backed Lilly's position and - If the patents are ultimately upheld through further legal challenges - the company says it could get protection for Alimta in Japan until June 2021.

Michael Harrington, general counsel for Eli Lilly, said that "while we do not yet know the court's reasoning, we are pleased with the UK Supreme Court's key conclusions that confirm the Alimta vitamin regimen patent would be infringed by these generic pemetrexed products in the UK, France, Italy and Spain".

Stemming the decline in Alimta will give Lilly more time to build sales momentum for newer products such as rheumatoid arthritis treatment Olumiant (baricitinib) and NSCLC therapy Portrazza (necitumumab).

A full judgment from the UK Supreme Court is scheduled to be handed down on July 12, according to Lilly.

Article by
Phil Taylor

10th July 2017

From: Regulatory



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