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ARTICLE · 13 DECEMBER 2021

Federal Circuit Finds Written Description For A Claimed Range Not Met By Specific Examples Within The Range

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In a recent decision issued in Indivior UK Limited v. Dr. Reddy's Laboratories, the Federal Circuit affirmed a decision from the PTAB

United StatesIntellectual Property
Rachel J. Elsby
Rachel J. Elsby
Megan Mahoney
Megan Mahoney
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In a recent decision issued in Indivior UK Limited v. Dr. Reddy's Laboratories, the Federal Circuit affirmed a decision from the PTAB that a limitation to range of polymer weight percentages lacked written description support even though the specification contained specific examples within the range.  

The patent at issue, Indivior's U.S. Patent No. 9,687,454 (the "'454 patent"), generally relates to orally dissolvable films containing therapeutic agents.  The '454 patent issued as a continuation from an application originally filed in 2009.  In 2018, Dr. Reddy's Laboratories petitioned for inter partes review of claims 1-5 and 7-14 of the '454 patent.  The challenged claims  were directed to dissolvable films that include therapeutic agents with a polymeric matrix defined according to its weight percentage.  Specifically, claim 1 recites a polymeric matrix of about 40-60 percent of weight of the film.  Claims 7 and 12 recite a range of 48.2-58.6%, and claim 8

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