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Purple Book America Invents Act

Goodwin

Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

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As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more

Goodwin

USPTO Outlines New Initiatives Regarding Drug Pricing

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On July 6, 2022, Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published her response to the letter sent by Janet Woodcock (former acting FDA Commissioner) to the former...more

Mintz - Intellectual Property Viewpoints

PTAB statistics show interesting trends for Orange Book and biologic patents in AIA proceedings

The Patent Trial and Appeal Board (“PTAB”) regularly tracks statistics regarding administrative trials conducted under the processes created by the America Invents Act (“AIA”), which provide insight into recent trends...more

Goodwin

An Interview with Prof. Arti Rai about the Role of “Patent Thickets” in U.S. Biosimilar Market Entry

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Last week, Big Molecule Watch sat down with Professor Arti Rai to discuss an article she recently co-authored, “How logically impossible patents block biosimilars.” The article, published earlier this month in the...more

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