Monthly Archives: July 2020

Competing Paragraph IV Cases

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The competing PIV cases Last December, a PIV case involving several ANDA filers concluded its trial in Delaware involving Tecfidera®(dimethyl fumarate). A few months later in West Virginia, a trial in a PIV case involving the product’s 8,399,514 patent concluded  against Mylan. Both cases involved the same product, same patent, and same defense – lack … Continue reading →

2020 PIV First-Filings, thus far

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In my Annual Review post earlier this year, I suggested that the PIV Market is working towards market correction. Over the past few years, many ANDA filers filed PIV certifications, and some products became “hypercompetitive” with 10 or more ANDA filers filing on Day 1.  For example, the market saw 6 hypercompetitive products in 2018. … Continue reading →