Wednesday 14 May, 2008

perindopril tert-butylamine: UK Supreme court slammed patent ever greening attempt of innovator

In a significant decision by The Lord Chief Justice of England & Wales in a patent dispute between Apotex (generic) V/S Servier (innovator) w.r.t Perindopril, the court sided with Apotex and slammed patent ever greening attempts by innovator Servier. Innovator Servier had a patent EP1296947, which covers a new crystalline polymorphic form α of perindopril tert-butylamine salt, and a process for its preparation and pharmaceutical compositions containing it. This patent claimed priority from a French application published in 2000, but the original perindopril compound was patented as EP0049658 in the early 1980s and another earlier patent for the compound patent EP0380341 for the industrial synthesis of perindopril
from 1988.
The patent was lucrative: Servier's turnover in the UK alone was £70 million and generics manufacturer Apotex had sold £4 million worth of perindopril in the short period before Servier, alleging infringement, secured interim injunctive relief.
Apotex challenged the validity of the patent, while Servier sought permission to amend it. HIGH COURT OF JUSTICE CHANCERY DIVISION (PATENTS COURT) The Hon Mr Justice Pumfrey, held that Servier's EP1296 947 was invalid for lack of novelty and obviousness. He gave permission to appeal applying the Pozzoli test. But he also refused to continue an interim injunction pending appeal on the grounds that he considered there was no real prospect of success. An application to this court for continuation of the injunction was refused on the same basis.
The upshot of all this is that were the patent valid, Servier's monopoly in practice would last until 2020. But the judge held the patent invalid. In our view, The EPO did not properly check the patent. This decision firmly prohibits patent ever greening by innovator companies (court opinion here)

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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