NEW YORK, April 25 (Reuters) - Mallinckrodt's ( MCKPF ) bankruptcy
permitted the drug company to end a perpetual royalty agreement
with Sanofi-Aventis involving the best-selling medication
Acthar, the 3rd U.S. Circuit Court of Appeals ruled on
Wednesday.
Affirming a lower court decision, the 3rd Circuit found that
Mallinckrodt's ( MCKPF ) termination of royalty payments after it filed
for bankruptcy in 2020 created, at best, a claim by
Sanofi-Aventis for damages under the sales contract.
Mallinckrodt ( MCKPF ) acquired Acthar, a gel medication used to treat
multiple sclerosis and infantile spasms, from Sanofi-Aventis in
2001, agreeing to make a one-time payment of $100,000 plus a 1%
royalty on future sales of the drug. After Mallinckrodt ( MCKPF ) ended
royalty payments, Sanofi had argued that Mallinckrodt ( MCKPF ) had no
right to continue selling the drug without making further
royalty payments.
The three-judge panel ruled that Sanofi-Aventis' claim, like
other pre-petition debts, was eligible to be wiped out so that
Mallinckrodt ( MCKPF ) could exit bankruptcy with a "fresh start."
"Bankruptcy frees debtors from lingering claims like this
one," Judge Stephanos Bibas wrote.
Mallinckrodt ( MCKPF ) declined to comment, and Sanofi did not
immediately respond to a request for comment.
Sanofi had argued that royalty payments were essential to
the overall sale agreement. But the 3rd Circuit disagreed,
saying that the agreement transferred the drug to Mallinckrodt ( MCKPF )
outright, without protecting Sanofi from the risk of future
non-payment.
"To protect itself, Sanofi could have structured the deal
differently," Bibas wrote. "It could have licensed the rights to
the drug, kept a security interest in the intellectual property,
or set up a joint venture to keep part ownership. But it chose
not to do so."
Acthar has been a blockbuster drug for Mallinckrodt ( MCKPF ), with
sales reaching nearly $1 billion in 2019, according to the 3rd
Circuit opinion.
But increased competition has caused Acthar sales to decline
in recent years, eventually pushing Mallinckrodt ( MCKPF ) into a second
bankruptcy in 2023. Acthar generated $516 million in net sales
in 2022, but sales declined by 20% for the first six months of
2023, according to Mallinckrodt's ( MCKPF ) bankruptcy court filings.
The case is In re Mallinckrodt Plc ( MCKPF ), U.S. Court of Appeals
for the Third Circuit, No. 23-1111.
For Sanofi: Stuart Brown, Craig Martin and Ilana Eisenstein
of DLA Piper
For Mallinckrodt ( MCKPF ): Melissa Arbus Sherry of Latham & Watkins;
Michael Merchant and Amanda Steele of Richards, Layton & Finger
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