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Eli Lilly has welcomed a decision by the UK Supreme Court that alternative salt forms of its cancer drug Alimta, marketed by Teva's Actavis, directly infringe on its vitamin regimen patents in the UK, France, Spain and Italy, overturning previous High Court and Court of Appeal judgements.
The basic compound patents for Alimta (pemetrexed) expired in December 2015 across most European markets, but its vitamin regimen patents - which concern the drug’s co-administration with vitamin B12 to protect against side effects - remain in force until June 2021.
In 2015, the UK High Court ruled that Lilly’s method-of-use patents for Alimta were not were not infringed by Actavis’ product. The Court of Appeal subsequently found that Lilly’s patent would be indirectly - but not directly - infringed.
Now the Supreme Court has sided with Lilly, not only by agreeing that Actavis’ products directly infringe its patent, but also affirming the UK Court of Appeal’s judgement that its Alimta vitamin regimen patent would also be indirectly infringed when the generic product is reconstituted or diluted in saline.
In an unusual move, the UK Supreme Court has given its key conclusions in the long running case ahead of giving the full judgment, which is due on Wednesday 12 July.
"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," said Michael J. Harrington, senior vice president and general counsel for Lilly.
"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."
Daniel Brook, partner at Hogan Lovells, which acted for Lilly throughout the case, added: “This conclusion vindicates Lilly's position after five years of hard-fought litigation and we look forward to receiving the reasoned judgment next week.