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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. But Aquestive’s petitioning activity was protected conduct under the anti-SLAPP statute, and Neurelis didn’t show a likelihood of prevailing on the merits on that, including the malicious prosecution claim in its entirety.

Designs 56
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Biosimilars 2020 Year in Review

Fish & Richardson Trademark & Copyright Thoughts

For the first time since FDA licensed the first biosimilar, Sandoz’s Zarxio ® (filgrastim-sndz), in 2015, the United States saw a decrease in annual biosimilar approvals in 2020. Figure 1, below, provides a snapshot of FDA approval and biosimilar product launch trends from 2015 through 2020. 2015; resubmitted Feb. March 6, 2015.

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Intellectual Property Tools for Protecting Fashion Goods

Above the Fold

A novel design is entitled to a patent unless it is has been (1) described in a printed publication; (2) in public use; or (3) on sale more than one year prior to the date of the application of the patent. [9]. The essential elements of a design patent are that the new creation be “new, original and ornamental.” [8].

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Intellectual Property Tools for Protecting Fashion Goods

LexBlog IP

A novel design is entitled to a patent unless it is has been (1) described in a printed publication; (2) in public use; or (3) on sale more than one year prior to the date of the application of the patent. [9]. The essential elements of a design patent are that the new creation be “new, original and ornamental.”