Eli Lilly will defend its patent for lung cancer drug Alimta in court on Monday, which includes a patent for the method of administering the drug to patients with certain vitamins designed to mitigate side effects.
A win would prevent generic drug makers from selling cheaper versions of the drug until 2022.
The case is pivotal for the future of the company after it lost patent protection for its former top product, the antipsychotic Zyprexa, in 2011 and because it will soon lose patent protection for its new top drug, antidepressant Cymbalta.
The company hasn’t produced enough newer drugs to cover revenue lost from these drugs.
The patent Eli Lilly is fighting to keep covers the method of administering Alimta, while a different patent covers the basic chemical composition of the drug, which can also treat mesothelioma, a rare cancer linked to asbestos exposure.
The company will fight for the patent in an Indianapolis court this Monday.
Previously generic drug makers claimed in court papers that the patent was invalid because previous research would lead an ordinarily skilled oncologist or nutritionist to conclude that the drug should be administered with folic acid and B12.
A patent can become invalid if it is deemed its claims are obvious.
Eli Lilly then filed a patent-infringement lawsuit against the companies in 2010. The suit says the generic companies infringed the patent, and they therefore should be barred from selling copies of Alimta until the patent expires.
The company adds that when an Eli Lilly scientist proposed administering folic acid with B12 to mitigate safety risk it initially met stiff resistance from experts, including the FDA, who said it would diminish the efficacy. However, after trying the regime in clinical testing it was shown that Alimta’s efficiency wasn’t compromised.
"We believe this patent is valid and enforceable and we are prepared to defend our intellectual property," a Lilly spokesman told The Wall Street Journal.
"The significant scientific research that Lilly performed in support of the vitamin-dosage-regimen patent deserves intellectual-property protection."
Image: A win would prevent generic drug makers from selling cheaper versions of the drug until 2022. Photo courtesy of foxumon.