Last 20 July 2016 the Barcelona Court of Appeal issued a judgment confirming the
dismissal of a patent infringement action filed by Pfizer against sildenafil
generic competitors in Spain. Pursuant to its decision of October 2014 in the
escitalopram case (Lundbeck &
Almirall vs. generics), the Barcelona Court of Appeal has confirmed its new
case law regarding the TRIPs Agreement and pharmaceutical patents filed before
8 October 1992.

Background

Pfizer was the holder of European patent EP 0 463 756 (EP’756), which
was filed in June 1991 and granted in April 1995 with three different sets of
claims, one of them special for Spain with process claims only. The Spanish
translation of the patent was published in July 1995.

In 2002 Pfizer obtained an SPC, which entered into force when the patent expired in
June 2011 and lasted until June 2013.

In March 2006 Pfizer filed a “revised translation” of the EP'756 patent with the
SPTO, which included product claims. The SPTO refused to publish the revised
translation and Pfizer brought the case to the contentious-administrative
courts. Finally, in November 2010 the Contentious Administrative Chamber of the
Supreme Court annulled the SPTO’s decision and ordered the publication of the revised
translation of the patent, which was made in August 2011, i.e. after the patent
had expired and the SPC had entered into force.

In October 2011 Pfizer sued all the companies that were marketing sildenafil
generics in Spain arguing infringement of the patent and of the SPC based on
the product claims of the revised translation. Some of these generics had been
on the market since late 2009 and early 2010.

By judgment of 28 October 2014, the Commercial Court No. 7 of Barcelona dismissed
the infringement action following a decision issued by the Barcelona Court of
Appeal in the escitalopram case just some days earlier, which, based on the
case law from the CJEU of July 2013 and January 2014 on the interpretation of
TRIPs (Article 70), had acknowledged that former Spanish jurisprudence had to
be reviewed and corrected.

Pfizer appealed this first instance judgment.

The judgment of the Barcelona Court of Appeal

With its judgment of 20 July 2016, the Barcelona Court of Appeal has dismissed Pfizer’s
appeal.

Basically, the Court of Appeal has ratified the doctrine of its decision of October
2014 in the escitalopram case, which was analogous to the sildenafil case.
Thus, after reviewing the case law from the Spanish Supreme Court and its own
previous decisions regarding the interpretation of Articles 27 and 70 of TRIPs,
in relation to the prohibition to patent pharmaceutical products as such in
Spain before 8 October 1992, the Barcelona Court of Appeal has concluded as
follows:

  • The CJEU decisions on the interpretation of Articles
    27 and 70 TRIPs are binding and their doctrine is to be applied to all cases,
    and not just to future cases.

  • The CJEU decisions supersede former Spanish case law
    regarding the interpretation of these TRIPs provisions because, according to
    the CJEU, they cannot be construed so broadly. Therefore, Articles 27 and 70
    TRIPs do not contradict former Article 167.5 EPC, which continues to apply.     

  • The above applies to all European patents filed before
    8 October 1992, regardless of whether they were granted before or after the
    entry into force of TRIPs in Spain (1995) and regardless of whether they were
    granted with or without product claims for Spain. So, these patents cannot
    effectively claim pharmaceutical products as such in Spain.

The Barcelona Court of Appeal has also rejected the additional arguments raised by
Pfizer regarding the alleged binding nature of the decision of the Contentious
Administrative Chamber of the Supreme Court of November 2010, which
acknowledged Pfizer’s right to the publication of the revised translation of
the patent.

In summary, this judgment confirms and consolidates the new doctrine of the
Barcelona Court of Appeal as initiated with its decision in the escitalopram
case, which is currently still pending at the Supreme Court.

Pfizer has filed an extraordinary appeal with the Supreme Court.