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Competition Patents Patent Trial and Appeal Board

Fish & Richardson

Biosimilars 2022 Year in Review

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2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more

Goodwin

USPTO Outlines New Initiatives Regarding Drug Pricing

Goodwin on

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

Haug Partners LLP

FDA Acting Commissioner of Food and Drugs Seeks Collaboration Between FDA and USPTO to Address Pharmaceutical Patent-Related...

Haug Partners LLP on

On September 10, 2021, Janet Woodcock, Acting Commissioner of the U.S. Food and Drug Administration (FDA), sent a letter to Andrew Hirshfeld, Director of the U.S. Patent and Trademark Office (USPTO), which raised several of...more

Goodwin

FDA’s Woodcock Reviews Patents Practices as a Way to Effect Drug Pricing

Goodwin on

On September 10, 2021, Janet Woodcock, the acting FDA Commissioner of Food and Drugs at the FDA, sent a letter to Andrew Hirshfield, Under Secretary of Commerce for Intellectual Property and Director of the United States...more

McDermott Will & Emery

No Competitor Standing for Appeal of IPR Decision Upholding Claims

Again addressing the question of appellate standing for inter partes review (IPR) decisions, the US Court of Appeals for the Federal Circuit held that an IPR petitioner did not show a sufficient injury to confer Article III...more

Fenwick & West LLP

JTEKT v GKN: Lacking Standing, Competitor Cannot Appeal PTAB IPR Ruling

Fenwick & West LLP on

The Federal Circuit further restricted a petitioner’s ability to appeal a decision by the Patent and Trademark Appeal Board upholding the validity of a patent. The court this month found in JTEKT v. GKN Automotive that a...more

Patterson Belknap Webb & Tyler LLP

Senators and court complain of ‘anti-competitive’ transfer of patent rights to American Indian tribe

We have previously discussed antitrust implications of pharmaceutical companies’ efforts to maximize patent protection for their drugs. Consumers and generic drug makers, for instance, have alleged antitrust violations based...more

McDermott Will & Emery

2017 Intellectual Property Law Year In Review

Though politics ruled the headlines in 2016, the year still brought big changes in intellectual property law and its application, most notably in patent subject matter eligibility, inter partes review institution and appeal...more

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