Lilly has won a legal judgment in the US that could protect its big-selling cancer drug Alimta from generic competition until 2022.
The US District Court for the Southern District of Indiana ruled that a method-of-use patent covering a vitamin dosage regimen used to prevent side effects with Alimta (pemetrexed) treatment was valid and enforceable, turning down a petition to invalidate it filed by several generic drugmakers including Teva, Barr and Pliva.
A combination of vitamin B12 and folic acid is given to patients prior to Alimta administration to reduce treatment-related haematological and gastrointestinal toxicity, and the generic drugmakers had argued that this use was not patentable on the grounds of obviousness.
In response, Lilly maintained that the finding was unexpected and Alimta was under threat of being dropped from development until the method of limiting its toxicity was discovered.
Welcoming the verdict, Lilly’s general counsel Michael Harrington said: “The significant scientific research that Lilly performed in support of the vitamin dosage regimen patent deserves intellectual property protection.”
The verdict is subject to appeal, but Lilly has already successfully defended its substance patent for Alimta in the US, winning an appeal in 2012 that provides protection from generic competition until 2016, extended to 2017 with paediatric exclusivity.
Lilly also claims patent protection for the drug in the EU and Japan until 2021 thanks to method-of-use patents, although its substance patents expire next year in those markets.
The ruling is a critical win for Lilly, which is still struggling with a patent cliff that has just seen it lose protection for osteoporosis therapy Evista (raloxifene). The company is also due to lose protection for blockbuster antidepressant Cymbalta (duloxetine) in Europe later this year, a year after patents in the US.
Alimta was Lilly’s second-largest product in 2013 behind Cymbalta, with total sales of $2.7bn, including $1.2bn from the US market.