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30 November 2021Big PharmaAlex Baldwin

Fed Circ says Indivior patent was anticipated

The US Court of Appeals for the Federal Circuit has affirmed a US Patent Trial and Appeal Board (PTAB) decision that held that claims of a patent for dissolvable films containing therapeutic agents were anticipated.

The patent at issue is Indivior’s US Patent 9,687,454, which covers “Sublingual and buccal film compositions”. The ‘454 patent was issued as the fifth continuation of US patent application 12/537,571, which was originally filed in August 2009.

The appeal to the Federal Circuit concerned whether Indivior can benefit from information disclosed in that 2009 filing date for the ‘454 patent claims at issue.

Dr Reddy’s, who had instituted the inter partes review of the ‘454 patent, alleged that the polymer weight percentage limitations in the patent do not have “written description support” in the ‘571 application and were therefore not entitled to benefit from its filing date in 2009.

As it argued that the patent was not entitled to the befits of the filling date, it alleges that the claims of the ‘454 patent were anticipated by US patent publication 2011/0033541, referred to as “Myers”.

Indivior argued that the polymer weight percentage limitations were supported by the ‘571 application and that the claims were therefore entitled to the ‘571 application’s priority date.

In an opinion handed down on Thursday, November 24, the Federal Circuit found Indivior’s arguments unpersuasive, affirming a prior decision from the US Patent Trial and Appeal Board (PTAB).

PTAB review

In PTAB proceedings, the board analysed whether claims 1, 7, 8 and 12 of the ‘454 patent have written description support in the ‘571 application.

Regarding claims 1, 7 and 12, the board found that tables in the ‘571 application did not “discuss or refer to bounded or closed ranges of polymer weights” and that a person of ordinary skill would have been led away from the range by the ‘571s teachings.

The board also determined that claims 1-5, 7 and 9-14 do not have written description support in the ‘571 application and therefore determined that Myers was prior art to the claims.

Linn’s dissent

Providing a short dissent to the majority opinion. Circuit Judge Linn argued that the board’s decision that claims 1,7 and 12 do not have written description support in the ’571 application should be reversed.

Linn claimed that the Federal Circuit’s majority’s decision rests on an “improper reading” of tables disclosed in the ‘571 application, which led them to apply an “overly demanding” standard for written description for ranges.

Also, Linn claimed that the majority rejected the precedent in Wertheim and its failure to address prior case law in Nalpriopion, which both concerned written description requirements involving ranges.

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