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29 August 2019Big PharmaSaman Javed

PTAB institutes IPR of Nalox-1 opioid overdose treatment

The US Patent Trial and Appeal Board ( PTAB) has instituted an inter partes review (IPR) into a patent covering an opioid overdose treatment owned by Nalox-1 Pharmaceuticals.

In a decision on Tuesday, August 27 PTAB said it would review claims 1-29 of the patent (US number 9,211,253 B2) following a petition by a competitor, Opiant Pharmaceuticals, which said the claims were obvious over prior art.

Opiant had also filed petitions for two additional IPRs challenging the same claims of the ‘253 patent with additional prior art, but these were denied.

The patent in dispute concerns the treatment Narcan (naloxone), which is an opioid receptor antagonist that was initially approved for use by injection for the reversal of opioid overdose.

According to the ’253 patent, administering naloxone via injection requires trained medical personnel and imposes the risk of exposure to bloodborne pathogens through needlestick injuries.

The invention covered by the patent relates to devices adapted for nasal delivery of an “effective amount” of the treatment.

In support of its IPR petition, Opiant cited doctoral research by two individuals as prior art.

In its decision, PTAB said Opiant had demonstrated a “reasonable likelihood of showing the unpatentability” of the disputed claims.

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More on this story

Americas
31 July 2019   Biopharmaceutical company Alkermes has entered into a settlement and licence agreement with generic maker Amneal Pharmaceuticals to resolve an inter partes review.
Big Pharma
15 July 2019   The US Court of Appeals for the Federal Circuit has upheld an earlier ruling that Indivior cannot stop two competitors from making a generic version of one of its drugs.