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We can note for three of these holders:
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NOVARTIS
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Everolimus: 10 SPCs
in AT, BE, DK, FI, FR, GR, LU, NL, NO, PT, referring to 1993 Novartis patent and
to July 2003 Swedish MA, with an extension of about 4 years 10 months (SE
SPC filed in 2003).
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Eplerenone: 9 SPCs in
BE, DE, DK, GB, IE, IT, LU, NL, SE, referring to 1984 Novartis patent and
to Pfizer March 2004 Dutch MA
with an extension of 5 years.
It is important to note that, except for The Netherlands, these SPCs
were filed a few days before the patent expiry but before the issue of the
MA in the corresponding countries. Accordingly, the SPCs should not be
granted, and BE, LU, and SE granted SPCs could be invalidated.
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Mycophenolic acid: 8 SPCs in
AT, CH, GB, IE, LU, NL, PT, SE, referring to Novartis 1997
patent and to October 2002 Swiss MA or October 2003 French MA with an extension
of about 6 months or an extension of about 1 year and 6 months (FR SPC
filed in 2003).
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Other products:
pimecrolimus, zoledronic acid, bromocriptine: SPCs filed in a few
countries, particularly in new EU countries (corresponding SPCs formerly
filed in other countries).
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ASTRAZENECA
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Fulvestrant: 10 SPCs
in AT, BE, CH, DE, FR, GB, IT, LU, NL, SE, referring to Astrazeneca 1984
patent and to March 2004 EU or Swiss MA with an extension of 5 years.
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Melagatran: 8 SPCs in
AT, BE, DE, DK, IS, NO, PT, SE, referring to Astrazeneca 1994
patent and to December 2003 French MA with an extension of about 4 years 6
months (no published French SPC).
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Ximelagatran: 7 SPCs in
AT, BE, DE, DK, IS, PT, SE, referring to Astrazeneca 1996
patent and to December 2003 French MA with an extension of about 2 years
(no published French SPC).
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Other products:
esomeprazole, ertapenem, zolmitriptan, budesonide + formoterol, gefitinib:
SPCs filed in a few countries, particularly in new EU countries
(corresponding SPCs formerly filed in other countries).
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SANOFI-AVENTIS
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Cetuximab: 9 SPCs in
BE, CH, DE, FR, GB, GR, IT, NL, SE, referring to Aventis 1989
patent and to December 2003 Swiss MA or June 2004 EU MA with an extension
of 5 years.
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Cetuximab + irinotecan: 7 SPCs in
BE, DE, GB, GR, LU, NL, SE, referring to Aventis 1989
patent and to December 2003 Swiss MA or June 2004 EU MA with an extension
of 5 years.
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Other products: telithromycin,
rasburicase, dolasetron, felodipine + ramipril, insulin glargine, insulin
glulisine: SPCs filed in a few countries, particularly in new EU countries
(corresponding SPCs formerly filed in other countries).
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More than one SPC for one product
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According to Article 3 of the Medicinal Product Regulation, one of the
conditions for obtaining a certificate is that the product has not already
been the subject of a certificate. Article 3(2) of the Plant Protection
Product Regulation states: "The holder of more than one patent for the
same product shall not be granted more than one certificate for that
product. However, where two or more applications concerning the same
product and emanating from two or more holders of different patents are
pending, one certificate for this product may be issued to each of these
holders". This Article 3(2) should be taken into account when
interpreting Article 3 of the Medicinal Product Regulation.
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So,
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SPCs for
zoledronic acid were granted to:
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Roche Diagnostics referring to July 1987 patents (AT, BE, CH, DE,
ES, FR, GB, IE, IT, LU, NL, PT, SE, still pending in DK, FI)
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Novartis referring to November 1987 patents (AT, BE, CH, CY, DE, ES,
FR, GB, GR, IE, IT, LU, NL, NO, PT, SE, still pending in DK, FI).
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SPCs for
sibutramine were lodged by or transferred to Abbott
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Referring to 1982 patents: granted (AT); pending (IE)
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Referring to 1986 patents: granted (BE, GR, IT, LU, PT, SE), pending
(DK, ES, FI), refused (GB, NL)
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Referring to 1989 patents: granted (AT, BE, CH, DE, GB, IT, LU, NL,
SE), pending (IE).
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British and Dutch Patent Offices granted only one certificate to
Abbott, applying the "one product, one certificate" principle for
one holder. In Austria, Belgium,
Italy, Luxembourg,
and Sweden,
the Patent Offices granted two certificates to the same holder, one of
these certificates could be invalidated. We can note that in France,
there is no published SPC application (no application(s)? or application(s)
not yet published?), although a French MA was issued in 2001 for
sibutramine.
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