Jazz Pharma ruling clears U.S. roadblock for rival narcolepsy drug
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[February 25, 2023]
By Blake Brittain
(Reuters) -A U.S. appeals court ordered Jazz Pharmaceuticals Inc on
Friday to de-list a patent related to its blockbuster narcolepsy drug
Xyrem from the U.S. Food and Drug Administration's register of approved
medications, in a win for rival drugmaker Avadel CNS Pharmaceuticals
Inc.
The decision by the U.S. Court of Appeals for the Federal Circuit
removes an obstacle for Avadel to sell its own narcolepsy drug Lumryz.
Avadel stock was up 4.2% Friday afternoon following the ruling, and Jazz
stock was down 1.4%.
The U.S. Federal Trade Commission had backed Avadel in the case, telling
the Federal Circuit that allowing the listing in the FDA's so-called
Orange Book would harm customers and stifle competition.
The Orange Book lists all patents that cover an approved drug and
methods for using it. Avadel argued successfully that Jazz's patent
should be de-listed because it relates to distributing Xyrem, not the
drug itself or how it is used.
The Federal Circuit said the inclusion of the patent was preventing the
FDA from approving Lumryz until June 2023.
Jazz said in a statement Friday that it still believes the patent was
properly listed in the Orange Book but intends to "fully comply" with
the order.
Avadel CEO Greg Divis said the company was pleased with the decision and
looks forward to "bringing Lumryz to the narcolepsy community, who have
been deprived of a treatment option that could dramatically improve
their quality of life."
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The United States Court of Appeals for
the Federal Circuit is seen in Washington, D.C., U.S., August 30,
2020. REUTERS/Andrew Kelly
The FTC declined to comment on the
decision.
Avadel said in a U.S. Securities and Exchange Commission filing on
Friday that it intends to seek final FDA approval for Lumryz after
Jazz complies with the order.
Jazz sold over $1.8 billion of Xyrem in 2021, according to a company
report. Both Lumryz and Xyrem use the same active ingredient, though
Lumryz is meant to be taken once per night, and Xyrem is taken twice
nightly.
The patent at the center of the case covers aspects of Jazz's
distribution system, which controls access to narcolepsy drugs with
a central pharmacy and computer database. It relates to a
risk-mitigation strategy that the FDA required before approving
Xyrem, whose active ingredient GHB can be misused as a date-rape
drug.
Jazz sued Avadel for infringing the patent and others in Delaware
federal court in 2021, in a lawsuit that is still ongoing.
The case is Jazz Pharmaceuticals Inc v. Avadel CNS Pharmaceuticals
LLC, U.S. Court of Appeals for the Federal Circuit, No. 23-1186.
(Reporting by Blake Brittain in Washington; Editing by Kim Coghill)
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