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Lawfare in the orphan drug space

43(B)log

Neurelis received orphan drug designation from the FDA for its Valtoco for management of ARS in 2015. It then received fast strack designation, which allowed it priority review, and filed an NDA for Valtoco in 2018; this was pending at the time of the operative complaint.

Designs 56
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Biosimilars 2020 Year in Review

Fish & Richardson Trademark & Copyright Thoughts

The biosimilar pathway was designed to increase competition for biologics and reduce healthcare costs. Yet 2020 saw a slowdown in biosimilar activity with the lowest number of annual biosimilar approvals since 2016 and fewer product launches than 2019—as well as a decrease in district court litigation and post-grant proceedings.

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Intellectual Property Tools for Protecting Fashion Goods

LexBlog IP

Below are three possible situations in which you can use intellectual property tools with respect to a product’s nature, originality, consumer driven features, and potential for growth. In the event that infringement occurs, a designer must show that the infringer copied the designers copyrighted work. [5] ” [8]. .”

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Intellectual Property Tools for Protecting Fashion Goods

Above the Fold

Below are three possible situations in which you can use intellectual property tools with respect to a product’s nature, originality, consumer driven features, and potential for growth. In the event that infringement occurs, a designer must show that the infringer copied the designers copyrighted work. [5]