Tag Archives: bio

BIO Provides Supplemental Comments on PTO s.101 Guidelines

BIO recently generated a letter to the PTO on the March 6th Guidelines on the patent-eligibility of subject matter in the life sciences, particularly “natural products.” BIO invited a group of in-house and private practitioners to comment on the Guidelines … Continue reading

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FDA Publishes “Purple Book” for Biologicals/Biosimilars

In a major move to get organized for the oncoming wave of biosimilar applications, the FDA has published a “Purple Book” listing licensed (e.g., approved) biologicals and licensed interchangeable biosimilars. Rather than summarize the contents table of the book, linked … Continue reading

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101 Rejections Under the Guidelines: Mayo and Myriad “Go Viral”

This is a guest post from Hans Sauer, Deputy General Counsel, Intellectual Property for BIO. “Recently, I set out to find real-world examples of recent rejections under the USPTO Guidance, to do my own sampling rather than rely on reported … Continue reading

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BIO’s Modest Proposal – Eliminate Rule 56

BIO recently sent Director Kappos 13 pages of comments on the PTO’s proposed revisions to 37 C.F.R. §1.56(b). (A copy of the comments is available at the end of this post.) BIO clearly is struggling to reconcile the differing views  … Continue reading

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