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19 January 2023GenericsLiz Hockley

Jazz Pharma’s medical cannabis unit seeks to block generic

UK-based cannabidiol lab sues firms behind proposed ANDA | Feud centres on a cannabis treatment for epilepsy.

GW Research, a subsidiary of Jazz Pharmaceuticals, is suing Cipla and API Pharma Tech in a New York court over alleged infringement of patents that relate to cannabis-based treatment for epilepsy.

The complaint concerns some 20 of GW’s patents which cover the composition and methods of using Epidiolex, a cannabidiol treatment for seizures associated with rare diseases that cause early-onset epilepsy.

It is the first and only plant-derived cannabinoid medicine approved by the US Food and Drug Administration (FDA) and can be used for patients from the age of one.

Proposed generic

In the suit, filed on Friday, January 13, GW alleges that proposals by the defendants to manufacture and distribute a generic version of the drug in the US before the expiration of its patents will constitute infringement.

Invagen is a US subsidiary of  Cipla, an India-based pharmaceutical company.

Invagen has proposed a generic version of GW’s Epidiolex, which would be manufactured, sold or imported by API Pharma, according to the complaint.

API Pharma filed an Abbreviated New Drug Application (ANDA) for the product which was transferred to Invagen, according to the lawsuit.

GW alleges that “Invagen, Cipla and API Pharma will act in concert to make, use, offer to sell, or sell Invagen’s proposed product throughout the US, or import such a generic product into the US.”

Invagen claims that the patents-in-suit are invalid and/or will not be infringed by its ANDA.

GW Research alleges that unless blocked by the court, Invagen’s ANDA would infringe on its patents and “substantially and irreparably damage GW”. It states that the generic should not be approved until the patents have expired and has also asked for “attorneys’ fees, costs and expenses incurred in this action”.

Jazz Pharmaceuticals, a biopharma firm based in Ireland, acquired GW Research in 2021.

The firm stated: “GW Pharmaceuticals, now a part of Jazz Pharmaceuticals, established a world-leading cannabinoid science platform to develop a deep, innovative pipeline of early and late-stage cannabinoid product candidates and highly specialised growing and manufacturing expertise.

“Through these committed efforts, GW developed and commercialised the world’s first prescription medicine derived from the cannabis plant.”

The rare conditions that cause seizures which Epidiolex can be used to treat are Lennox-Gastaut Syndrome, Dravet Syndrome, and Tuberous Sclerosis Complex.

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4 May 2022   Two subsidiaries of Ireland-based Jazz Pharmaceuticals have failed in their bid to challenge the jurisdiction of the English High Court in a dispute with Tokyo-headquartered Otsuka Pharmaceutical over a cannabis sativa collaboration.
Big Pharma
4 February 2021   Jazz Pharmaceuticals has acquired UK medicinal cannabis company GW Pharmaceuticals in a takeover worth $7.2 billion.
Big Pharma
28 February 2023   Court finds no method-of-use in patent claims | Judgment is a win for rival firm Avadel.

More on this story

Big Pharma
4 May 2022   Two subsidiaries of Ireland-based Jazz Pharmaceuticals have failed in their bid to challenge the jurisdiction of the English High Court in a dispute with Tokyo-headquartered Otsuka Pharmaceutical over a cannabis sativa collaboration.
Big Pharma
4 February 2021   Jazz Pharmaceuticals has acquired UK medicinal cannabis company GW Pharmaceuticals in a takeover worth $7.2 billion.
Big Pharma
28 February 2023   Court finds no method-of-use in patent claims | Judgment is a win for rival firm Avadel.