Минобрнауки предлагает разрешить производство ЛС без согласия правообладателя
25 июня 2019
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№185, июнь 2019
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Минобрнауки предлагает разрешить производство ЛС без согласия правообладателя
Поправки в Гражданский кодекс, предложенные Министерством науки и высшего образования, позволят производить в России лекарственные препараты, защищенные патентом, без согласия правообладателя. Для этого должен быть соблюден ряд условий. Проект соответствующего документа опубликован на портале нормативных актов.
Ведомство предлагает дополнить статью ГК «Использование изобретения, полезной модели или промышленного образца в интересах национальной безопасности». По задумке министерства, Правительство РФ сможет выдавать производителям разрешение на производство лекарств без согласия держателей патента на препарат. При этом такие ЛС можно будет производить только для экспорта. Правообладатель в таком случае должен получить «соразмерную компенсацию». Размер компенсации устанавливает Правительство РФ.
В пояснительной записке указано, что инициатива согласована со статьей 31 bis «Соглашения по торговым аспектам прав интеллектуальной собственности» (Agreement on Trade-Related Aspects of Intellectual Property Rights или TRIPS), подписанного Россией в рамках вступления в ВТО. Согласно ей, члены организации могут производить лекарства без согласия патентообладателя, если эти ЛС будут направлены на экспорт в страны, где нет технических мощностей для их производства.
Отметим, что подобный законопроект о введении принудительного лицензирования в соответствии со статьей 31 bis TRIPS Минобрнауки предлагало еще в мае 2018 года. Тогда министерство предлагало внести правки в другие статьи Гражданского кодекса. Согласно первой версии документа, право на выдачу принудительной лицензии и размер компенсации должен был устанавливать суд. В итоге документ получил отрицательные отзывы Минэкономразвития и от его дальнейшего развития отказались.
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