11 July 2017
Reporter: Mark Dugdale

UK Supreme Court backs validity of Eli Lilly’s vitamin regimen patent for Alimta

The UK Supreme Court has upheld the validity of and adjudged as infringed Eli Lilly’s vitamin regimen patent for Alimta.

With the launch of a generic version of Alimta, Teva Pharmaceuticals-owned Actavis would also, in the absence of direct infringement, indirectly infringe Eli Lilly’s patent for the the safe and efficacious use of a cancer drug, pemetrexed, in co-therapy with vitamin B12, the UK Supreme Court concluded ahead of issuing its full judgement on 12 July.

The UK Supreme Court’s decision on direct infringement overturns the earlier High Court and Court of Appeal decisions, which had held that Actavis's products did not directly infringe Eli Lilly's patent.

Michael Harrington, senior vice president and general counsel at Eli Lilly, commented: “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 prior to June 2021.”

“We continue to emphasise that protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve. Intellectual property rights provide assurances of market exclusivity that help support the development of the next generation of innovative medicines to treat unmet medical needs.”

The base compound patents to Alimta expired in 2015 in most European markets, forcing Eli Lilly to rely on the rights to pemetrexed’s co-administration with vitamin B12 to fight off generic competition until 2021—when they too are due to expire.

Actavis originally sought declarations of non-infringement in relation to the UK, French, German, Italian and Spanish patents in UK courts. Actavis removed the German patent from the UK litigation in 2014 after a Düsseldorf court found that it would be infringed.

The UK High Court previously held that the remaining patents were not infringed and granted declarations of non-infringement to Actavis.

On appeal, the Court of Appeal refused to grant the declarations sought by Actavis on the grounds that its proposed products would indirectly infringe Eli Lilly's patent. However, the Court of Appeal did find that the patent would not be directly infringed.

Daniel Brook, partner at Hogan Lovells, which represented Eli Lilly, said: “This conclusion vindicates Eli Lilly's position after five years of hard-fought litigation and we look forward to receiving the reasoned judgement next week. We are delighted at the outcome for our client.”

The UK Supreme Court’s decision follows the January ruling of the US Court of Appeals for the Federal Circuit, which upheld the validity of Eli Lilly’s US vitamin regimen patent for Alimta and ruled that Teva and other manufacturers, in planning to produce generic versions, infringed it.

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