гФЗеПЙ ЗбдУОЙ ЯЗгбЙ : Биапенем Ё 29
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Борьба за медикаменты: медикамент индийского происхождения выпустили на российский рынок по подложным документам. Фармацевтическая компания уверяет, что не выдавала разрешение на применение своего препарата.
Индийского производителя лекарств «Джодас Экспойм» обвинили в незаконной регистрации в России антибиотика с широким спектром действия «Биопенем», как выяснили «Известия». Другая индийская компания — «Копран Ризерч» — утвердила, что была подделана переписка, дающее разрешение на использование произведенного ими ингредиента. Подала иск, с требованием отозвать регистрацию лекарства. Ранее уже «Джодас Экспоим» обвиняли в поставке бракованных препаратов в больницы России. О том, как индийская фармкомпания пыталась продавать тяжелые антибиотики в РФ по фальшивым документам, — в журналистском расследовании «Известий».
Конфликт из-за ингредиентов
Индийская компания «Копран Ризерч лабараториз лимитед», которая производит фармацевтические ингредиенты и завершенные лекарственные средства, в феврале текущего года подала жалобу в Арбитражный суд Москвы с судебным иском против российского Минздрава. В данном иске она заявила о нарушении патентных прав на эксплуатацию своего вещества для препарата «Биапенем».
В своем иске компания настаивала на отмене регистрации «Биапенема» в России. Держателем регистрационного удостоверения на него является «Jodas Expoim — юридическое лицо, зарегистрированное в России другой индийской фармфирмы, JODAS Expoim Pvt. Ltd..
«Копран Рисерч» в своем заявлении указала, что при оформлении документов на регистрацию в Минздрав представители компании «Джодас» из России подделали официальное согласие «Kopran Research на использование произведенного ими действующего вещества. Оно является частью «Биапенема» (документ имеется у «Известий»).
Скандальная компания
Для «Jodas Expoim» это не первое разбирательство на предмет нарушения патентных прав на препараты и действующие вещества. Так, в мае этого года против компании был подан иск в арбитражный суд американская компания Pfizer. Pfizer беспокоилась, что «Джодас Экспойм» начнет продажу дженерик с действующим веществом «авибактам+цефтазидим» до истечения срока патента на оригинальный препарат, то есть до 26 июля 2026-го.
Спорный момент
Согласно данным из открытых источников, ООО «Джодас Экспойм» отличается высокой активностью участия в судебных разбирательствах: в качестве истца — в 196 делах, ответчик — в 65 делах. Об этом рассказал «Известиям» представитель юридической компании «Соничев, Казусь и партнеры» Александр Казусь.
Для регистрации лекарства на российском фармацевтическом рынке нужно пройти регистрацию, с получением регистрационного удостоверения, — объяснил он.
Регистрация — это экспертиза, проводимая государством и ожидаемой пользы к возможному риску применения лекарства, с целью последующего разрешения медицинского применения препарата.
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