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Printed Publication: Documents Made Available only to Customers

Patently-O

The court relied upon additional facts not found in the question presented–noting that the document in question was distributed to hundreds of customers over a span of years and without any confidentiality restrictions; and that product advertisements were designed to attract persons of skill in the art. 102(a)(1).

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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. Note that FDA still has not designated any biosimilar as interchangeable to its reference product. In February 2020, FDA and FTC took steps to encourage biosimilar competition , with a focus on truthful and non-misleading advertising.