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Biosimilars Law Blog
Posted in Biosimilars Patent Exchange, Biosimilars vs. Generics

If you missed the Maximizing Patent Life Cycles panel discussion, you may want to read this

I recently participated in the American Conference Institute panel discussion “Maximizing Patent Life Cycles,” which was moderated by Pfizer Associate General Counsel Geoffrey Levitt. In case you missed it, “The Pink Sheet” covered the event in its article “FDA Denies Veramyst NCE Exclusivity, Revokes Torisel Exclusivity,” which expands upon several recent decisions from FDA on whether certain types of chemical compounds, known as “stable esters,” are eligible for non-patent exclusivity from FDA.

It also published the article “ANDA Changes May Require Paragraph IV Recertification, New 30-Month Stay,” which includes my comments from the event on the trend in the amending of generic drug applications to adjust to developments in ongoing patent litigation.