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28 February 2023Big PharmaLiz Hockley

Jazz Pharma loses patent case over narcolepsy drug

Court finds no method-of-use in patent claims | Judgment is a win for rival firm Avadel.

A Delaware federal court has ordered Jazz Pharmaceuticals to delist a patent from the US Food and Drug Administration (FDA) as rival firm Avadel successfully proved a weakness in its claims construction.

The judgment, handed down on February 24, relates to a patent for Jazz Pharma's narcolepsy drug Xyrem, and enables Avadel to move a step closer to bringing its own narcolepsy medication Lumryz to the market.

The court found that the patent did not claim a method of use, but rather a system.

Jazz Pharma’s medication Xyrem has the active ingredient sodium gamma-hydroxybutyrate (GHB), which can be serious if misused by patients.

As such, the FDA’s approval of Jazz’s New Drug Application (NDA) for Xyrem depended on a Risk Evaluation and Mitigation Strategy (REMS) and had to include certain protocols that should be followed before prescribing or dispensing the drug.

It was Jazz’s REMS that formed the basis for its US patent number 8,731,963, which relates to a medicine distribution system.

These strategies ensure that access to abuse-prone drugs such as Xyrem is controlled through a central pharmacy and computer database that tracks prescriptions, patients and prescribers. In 2014, Jazz listed the patent in the Orange Book as covering a method of using Xyrem.

Claim construction

In December 2020, Dublin-headquartered Avadel submitted an NDA for its own GHB-based drug FT218 or Lumryz, but Jazz’s ‘963 patent prevented FDA approval until June 2023.

The ‘963 patent had been challenged in 2017 in a previous suit, Amneal Pharmaceuticals v Jazz Pharmaceuticals, in which three of its claims had been found unpatentable in an inter partes proceeding. The remaining claims expired in December 2022, but because Jazz had been granted exclusivity, the ‘963 patent prevented FDA approvals of follow-on products until June this year.

Unlike Xyrem, which requires the patient to take two doses at night, Lumryz is taken once a night.

However, Jazz sued Avadel for infringement, and Avadel responded with a counterclaim seeking to have the ‘963 patent delisted for failure to claim a drug or method of use. The court found in favour of Avadel, determining that as a matter of claim construction, the ‘963 claims a system and not a method of use.

The court stated that “each of the ‘963 patent’s three independent claims describes a ‘computer-implemented system’ that comprises ‘one or more computer memories’ and a ‘data processor […] The claims to a system comprising computer memories and a data processor are not claims to a method”.

Jazz has been ordered to delist the patent. Reuters reported that the firm said it believes the patent was listed properly in the Orange Book but intends to “fully comply” with the order.

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22 December 2022   Delisting affects a blockbuster narcolepsy drug | Orange book has specific listing criteria | Avadel.

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Generics
19 January 2023   UK-based cannabidiol lab sues firms behind proposed ANDA | Feud centres on a cannabis treatment for epilepsy.
Americas
22 December 2022   Delisting affects a blockbuster narcolepsy drug | Orange book has specific listing criteria | Avadel.

More on this story

Generics
19 January 2023   UK-based cannabidiol lab sues firms behind proposed ANDA | Feud centres on a cannabis treatment for epilepsy.
Americas
22 December 2022   Delisting affects a blockbuster narcolepsy drug | Orange book has specific listing criteria | Avadel.