
Financial statements Consolidated financial statements Notes Parent financial statements Reports
Lundbeck Foundation Annual Report 2023 Page 108
Contractual obligations, contingent assets
and liabilities, and collaterals - continued
Lundbeck has been informed about potential claims in a
number of 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 received
AUD 51.7m(DKK 242m) 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
26.3m (DKK 121m). In the meantime, Lundbeck’s appeal
of the Australian Patent Office’s decision to grant
Sandoz a license will be heard on 24 August 2024, 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 USA. Two opponents have since withdrawn and
Lundbeck has settled with eight opponents. As
communicated by Lundbeck in company release no. 706
dated 1 October 2021, the cases against the six
remaining opponents (the “ANDA Filers”) have been
decided by the US District Court for the District of
Delaware (the ‘Court’). The Court found that Lundbeck’s
compound patent (US Patent No. 7,144,884) is valid. The
compound patent expires 17 December 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 was infringed by the relevant ANDA
Filers, except that Lupin was found to infringe a patent
covering Lundbeck’s process for manufacturing
Trintellix. 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 US Court of Appeals for the Federal
Circuit has affirmed the District Court decision on 7
December 2023, which is now final.
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 USA, and Lundbeck and Otsuka have instituted
patent infringement proceedings against Mylan and
Viatris Inc. The FDA cannot grant marketing
authorisation in the USA to Mylan or Viatris Inc. before
the patents expire unless they receive a decision in their
favor. The trial has been re-scheduled to start on 17 June
2024 and a District Court decision is currently expected
by October 2024. Abilify Maintena® is covered by several
US 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 US being in
2034.
Lundbeck received a Civil Investigative Demand (“CID”)
from the US 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.
In June 2022 in the USA, 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 and is currently under appeal.
In June 2023 in the USA, Humana Inc., an insurer, filed a
complaint against Lundbeck US 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 alleges that
Lundbeck’s activities targeted Humana Inc. and other
private Medicare insurers who were forced to bear the
costs of the alleged illegally subsidised drug sales.
Lundbeck denies the allegations in the complaint and
intends to defend itself.
Product return obligations
The Group has product return obligations that are
normal for the industry. Management does not expect
any major losses from these obligations apart from the
amount already recognised.
Usual representations and warranties are made in
connection with the divestment of enterprises and
operations. There are no significant outstanding claims
that are not sufficiently recognised in the balance sheet.
Research and development milestones and collaborations
The Group has entered into a number of agreements
relating to research and development of new products
and intellectual property rights from acquisitions, as
well as other collaborations. According to these
agreements, the Group is committed to pay certain
milestones.
At 31 December 2023, potential future milestone
payments amounted to DKK 1,106m (DKK 1,095m at 31
December 2022).
Sales milestones, royalties and other payments
The Group is committed to paying certain commercial
sales milestones, royalties or other payments based on a
percentage of sales generated from the sale of goods