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INTELLECTUAL PROPERTY AND ANTITRUST LAW

permitted by the IP Statute, preventing IP holders from AFTER A CONFIDENTIAL
extending the duration or expanding the scope of their INQUIRY, THE FORMER SDE
IPRs. While decided by a single vote margin, this landmark (SECRETARY OF ECONOMIC
case serves as a testament to CADE’s ability to deal with LAW, LATER REPLACED BY
complex matters and appropriately balance the advantages CADE’S SUPERINTENDENCE)
of static competition with a well-defined IP policy able ORDERED THE INITIATION OF A
to foster innovation. FULL-BLOWN INVESTIGATION
(THIS ORDER IS EQUIVALENT
TO A STATEMENT OF
Lundbeck: Sham litigation and OBJECTIONS, SO WE WILL
“data package” protection REFER TO IT AS THE “SO”).
THE SO ESTABLISHED
In 2010, the Brazilian Association THAT LUNDBECK’S LAWSUITS
of Generic Drug Companies (Pró Genéricos) submitted TO ENFORCE ITS DATA
a complaint alleging that Lundbeck harmed competition PACKAGE EXCLUSIVITY WERE
by filing lawsuits that required the Brazilian food and A SHAM BECAUSE THEY
drug administration agency (ANVISA) to cease relying SOUGHT A PROTECTION
on the company’s data package to issue authorizations NOT CONFERRED UNDER
for generic drugs of an antidepressant named Lexapro . BRAZILIAN LAW AND
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Pró-Genéricos argued that Lundbeck’s lawsuits were a MISREPRESENTED LEGAL AND
sham because the Brazilian Intellectual Property Act does FACTUAL ASPECTS.
not award data package protection, so Lundbeck’s had
filed a baseless suit and misrepresented facts and claims to obtain an exclusionary injunction.
After a confidential inquiry, the former SDE (Secretary of Economic Law,
later replaced by CADE’s Superintendence) ordered the initiation of a full-blown investigation
(this order is equivalent to a statement of objections, so we will refer to it as the “SO”). The
SO established that Lundbeck’s lawsuits to enforce its data package exclusivity were a sham
because they sought a protection not conferred under Brazilian Law and misrepresented legal
and factual aspects. To the SO, the Brazilian Law did not confer data exclusivity rights, so
Lundbeck was improperly seeking an injunctive relief with the sole goal of harming rivals. The
SO also contended that even if Lundbeck had the exclusivity right, antitrust law would provide
a mandate for enforcers to determine whether the enforcement of such right was beneficial
under the rule of reason. These very broad investigative powers that the SDE was seeking to
retain generated significant concerns among market players. The pharma industry was carefully
observing this case, especially after CADE fined Eli Lilly in roughly BRL 36 million for alleged
sham litigation practices .
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9 See Administrative Process No.
08012.006377/2010-25. We represented
Lundbeck in this case. Any opinions and
views expressed here are our own and do not
represent our client’s position in the case.