In June 2013, Lundbeck received the European
Commission’s decision that agreements concluded
with four generic competitors concerning citalopram
violated competition law. The decision included fining
Lundbeck EUR 93.8 million (approximately DKK 700
million). Lundbeck paid and expensed the fine in the
third quarter of 2013. In March 2021, the European
Court of Justice rejected Lundbeck’s final appeal of the
European Commission’s decision. So-called “follow-
on claims” for reimbursement of alleged losses,
resulting from violation of competition law, often arise
when decisions and fines issued by the European
Commission are upheld by the European Court of
Justice. The below mentioned “follow-on claims” are
ongoing or threatened. Lundbeck disagrees with all
claims and intends to defend itself against them.
At the end of first quarter 2023, the UK health
authorities served their claim form on Lundbeck and
several generic companies, and Lundbeck filed its
defense in the third quarter of 2023. The hearing on
whether the claim is time-barred was held in the
second quarter of 2024 and the Competition Appeal
Tribunal has subsequently issued a decision in favor of
the UK health authorities. Lundbeck has been granted
permission to appeal the decision to the Court of
Appeal.
In late October 2021, Lundbeck received a writ of
summons from a German health care company
claiming compensation for an alleged loss of profit
plus interest payments, allegedly resulting from
Lundbeck’s conclusion of agreements with two of the
four generic competitors, which were comprised by
the EU Court of Justice ruling. Lundbeck filed its first
defense in May 2022 and the parties have
subsequently exchanged additional pleadings. The
first instance court hearing was held in the second
quarter of 2024, and Lundbeck currently expects that
additional procedural steps will be taken before a first
instance court ruling, currently expected in first half of
2025. The first instance court ruling may be appealed,
and it may take several years before a final conclusion
is reached by the German courts.
Lundbeck has been informed about potential claims in
several other European countries, however, it is still
uncertain whether the potential claims will be actively
pursued.
In Canada, Lundbeck is involved in three product
liability class-action lawsuits relating to
Cipralex
®
/Celexa
®
(two cases alleging various Celexa-
induced birth defects and one case against several
SSRI manufacturers (incl. Lundbeck) alleging that SSRI
(Celexa
®
/Lexapro
®
) induces autism birth defect), three
relating to Abilify Maintena
®
(alleging i.a. failure to warn
about compulsive behavior side effects) and one
relating to Rexulti
®
(also alleging i.a. failure to warn
about compulsive behavior side effects). The cases
are in the preliminary stages and as such there is
significant uncertainty as to how these lawsuits will be
resolved. Lundbeck strongly disagrees with the claims.
In 2018, Lundbeck entered into settlements with three
of four generic companies involved in an Australian
federal court case, in which Lundbeck was pursuing
patent infringement and damages claims over the sale
of escitalopram products in Australia. Lundbeck’s
case against the last of the four generic companies,
Sandoz Pty Ltd, went up to the High Court of Australia,
who has decided that Sandoz Pty Ltd infringed
Lundbeck’s escitalopram patent between 2009 and
2012. The High Court has sent the case back to the first
instance court for recalculation of the damages
awarded to Lundbeck in first instance which amounted
to AUD 26.3 million. In the meantime, Lundbeck’s
appeal of the Australian Patent Office’s decision to
grant Sandoz a license will be heard on August 24,
2024.
Lundbeck received a Civil Investigative Demand
(“CID”) from the U.S. Department of Justice (“DOJ”) in
March 2020. The CID seeks information regarding the
sales, marketing, and promotion (including the
promotional speaker program) of Trintellix
®
. Lundbeck
is cooperating with the DOJ. Otsuka and Lundbeck
have resolved the patent infringement litigation case
with Mylan and Viatris with respect to certain of the
patent listed for Abilify Maintena
®
in the U.S.
Otsuka and Lundbeck have received Paragraph IV
certification from Sun Pharma with respect to certain
of the patents listed for Abilify Maintena
®
in the U.S.
and commenced patent infringement proceedings
against Sun Pharma. The FDA will stay approval to Sun
until 30 months from receipt of the paragraph IV
certification or a court decision in Sun’s favor.
In June 2022 in the U.S., several entities created for the
purpose of receiving assignment of claims from payors
providing health insurance coverage pursuant to
Medicare Parts C and D and Medicaid filed a complaint
against Lundbeck and others. The complaint alleges
that Lundbeck and the other defendants conspired to
increase the unit price and quantity dispensed of