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
received AUD 51.7 million (DKK 242 million) in 2018.
Lundbeck’s case against the last of the four generic
companies, Sandoz Pty Ltd, went up to the High
Court of Australia, who has now decided that Sandoz
Pty Ltd infringed Lundbeck’s escitalopram patent
between 2009 and 2012. The High Court has now
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 is
restarted and if a license is maintained in any form,
the first instance court will have to decide if such a
license can have impact on the damage awarded by
the High Court.
Together with Takeda, Lundbeck instituted patent
infringement proceedings against 16 generic
companies in response to their filing of Abbreviated
New Drug Applications (“ANDAs”) with the FDA
seeking to obtain marketing approval for generic
versions of Trintellix
®
in the U.S. Two opponents have
since withdrawn and Lundbeck has settled with eight
opponents. As communicated by Lundbeck in
company release no. 706 dated October 1, 2021, the
cases against the six remaining opponents (the
“ANDA Filers”) have been decided by the U.S. District
Court for the District of Delaware (the ‘Court’). The
Court found that Lundbeck’s compound patent (U.S.
Patent No. 7,144,884) is valid. The compound patent
expires December 17, 2026. Assuming the ruling is
confirmed at appeal, final approval will not be granted
to the relevant ANDA Filers until after expiration of the
compound patent, including any extension or
additional periods of exclusivity. A total of seven other
patents asserted at trial were found by the Court to
be valid or their validity was not challenged during the
trial. The Court decided that none of the seven other
patents were infringed by the relevant ANDA Filers,
except that Lupin was found to infringe a patent
covering Lundbeck’s process for manufacturing
Trintellix
®
. Unless and until the Court’s ruling is
reversed on appeal, the patents found not infringed
by a particular ANDA Filer will not prevent that ANDA
Filer from receiving final approval. For details on each
of the patents comprised by the case, please see
company release no. 706. The Court’s decision has
been appealed by Lundbeck to the U.S. Court of
Appeals for the Federal Circuit. Lupin has appealed
with respect to the process patent and the ANDA
Filers have cross appealed with respect to the validity
of two of the seven other patents. The validity of the
compound patent has not been challenged under the
appeal. The appeal hearing was held in September
2023 and a decision by the Court of Appeals is
expected late 2023 or early 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.
Lundbeck and Otsuka have received a Paragraph IV
certification from Mylan Pharmaceuticals with respect
to certain of the patent listed for Abilify Maintena
®
in
the U.S., and Lundbeck and Otsuka have instituted
patent infringement proceedings against Mylan and
Viatris Inc. The FDA cannot grant marketing
authorization in the U.S. to Mylan or Viatris Inc.
before the patents expire unless they receive a
decision in their favor. The trial has been scheduled
to start on April 1, 2024 and a District Court decision
is currently expected by August 2024. Abilify
Maintena
®
is covered by several U.S. patents relating
to specific forms of the active ingredient,
formulations, processes, devices, indications and
methods of use, which will expire in different years,
with the latest patent expiry date in the U.S. being in
2034.
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 Xenazine
®
. The case was
dismissed with prejudice earlier in 2023.
In June 2023 in the U.S., Humana Inc., an insurer,
filed a complaint against Lundbeck U.S. legal entities.
The complaint alleges that Lundbeck engaged in an
illegal kickback scheme to increase the sales and
sale price of Lundbeck’s Xenazine
®
. The complaint