The active ingredient is Melatonin. After it obtained regulatory approval, and following the same logic as the UK Patent Office, the Israel Patent Office refused to allow the drug to benefit from a patent term extension as Neurim’s earliest patent IL 103411 was not the first patented treatment to obtain regulatory approvial for the active agreement which is also the basis of Regulin, a treatment for sheep that causes them to enter the breeding season early.
Following the Appeal to the European Court of Justice which upheld Neurim’s claim that the regulatory approval for a different purpose in animals was irrelevant, Neurim appealed to the Israel District Court which over-ruled the Israel Patent Office’s decision.
On 30 September 2012, the Israel Patent Office issued a temporary extension of one month, and, barring oppositions, this will be followed by a patent term extension.
We have been following this case with interest as the patent was written by the late Dr Stanley Davis, my former partner. The case hinges on whether the law should be interpreted narrowly and literally or whether to encourage (retroactively) basic research and to make developing pharmaceuticals worthwhile, a more flexible approach is warranted.
It seems that the Israel Patent Office came to the correct decision in the circumstances, and the District Court was correct to over-rule them. We congratulate Professor Zisapel, and note that apart from Teva’s Copaxone and Seasonique, this is probably the only time an Israeli company has brought a new drug treatment to market.