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German court overturns patent on Lilly blockbuster Alimta

Verdict means Actavis can launch generic after December

Eli Lilly HQ 

Eli Lilly has suffered a serious legal setback in Germany after a court cleared the way to market a generic version of its cancer drug Alimta later this year.

The patent challenge was not for the compound patent on pemetrexed disodium - the active ingredient in Alimta - but for a vitamin regimen used alongside the drug that is designed to limit side effects.

The German Court of Appeal upheld a challenge by Actavis of the patent on the vitamin regimen - which includes oral folic acid and vitamin B12 injections - which was not due to expire until June 2021.

Those challenging the patent maintain that giving the vitamins to Alimta is logical and obvious and so should not be patentable, although Lilly insists it required considerable research to identify a dose that protected against side effects without impairing the drug's anticancer activity, and so warrants protection.

The German verdict means that Actavis will be able to launch a generic version of the drug after its compound patent expires in December of this year, almost six years early, which would mean hundreds of millions of dollars in lost revenues for Lilly.

The generic drugmaker is developing a different salt for of the drug - pemetrexed dipotassium - that is the subject of separate patent litigation.

"We strongly disagree with the ruling by the German Court of Appeal regarding Alimta's vitamin regimen patent," said Michael Harrington, senior vice president and general counsel for Lilly, who confirmed that the company will now try to elevate the case Germany's Supreme Court.

"We continue to believe that Alimta's vitamin regimen patent would be infringed by the entry of generic pemetrexed products, including alternative salt forms," he asserted.

Alimta is used to treat non-squamous non-small cell lung cancer (NSCLC) and is Lilly's biggest-selling product with revenues of $2.8bn last year a 3% increase on the 2013 despite downward pricing pressure.

Lilly needs the drug to stay in patent as it is facing a difficult period punctuated by the onset of generic competition to key brands, including osteoporosis drug Evista (raloxifene) and antidepressant Cymbalta (duloxetine). 

The company also suffered setbacks in one of its late-stage R&D programmes recently when it was forced to delay a filing of insulin peglispro and extend a trial of cholesterol candidate evacetrapib by six months.

Last April, a court in the UK ruled that the alternative salt form of pemetrexed did not contravene Lilly's IP in the UK, Italy, France and Spain. The appeal of the decision in pending and is scheduled for hearing starting today (March 9).

Meanwhile, the validity of Lilly's vitamin regimen patent was upheld in a prior ruling by the European Patent Office (EPO), which has also been appealed.

Meanwhile, Lilly is also fighting several actions seeking to invalidate its intellectual property for Alimta in the US, where its vitamin regimen patient is due to expire in 2021, with a paediatric exclusivity extension to 2022.

Teva tried to overturn the vitamin regimen patent in the US but was knocked back in a federal court last April.

Article by
Phil Taylor

9th March 2015

From: Regulatory

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