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Double protection, article 3(c)
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Patent Office Comptroller
Decisions, O/138/05, 19/05/2005, Knoll AG
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Hearing of Knoll relating to
the plan to reject SPC GB/01/051 on the grounds that the product was
already the subject of SPC GB/01/053.
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The two SPCs were filed for
the same product: sibutramine hydrochloride monohydrate; they referred to
the same marketing authorisations (MA) and to two different patents
EP0230742 and EP0397831. SPC GB/01/053 had been granted.
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It was considered that article
3 of EEC regulation No 1768/92 must be interpreted in the light of article
3(2) of EC regulation 1610/96: the holder of more than one patent for the
same product shall not be granted more than one SPC for that product.
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The SPC application GB/01/051
was rejected.
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Swiss Marketing Authorisation, article 3(d)
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ECJ, C-207/03
and C-252/03, 21/04/2005
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Questions for a preliminary
ruling referred by the High Court of Justice (England and Wales), Chancery
Division (Patents Court) in the matter of Novartis, University College
London and Institute of Microbiology v Comptroller-General of The
Patent Office and by the Cour administrative du Luxembourg in the matter of
Ministre de l'Economie (Luxembourg) v Millenium Pharmaceuticals Inc.
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Novartis and Millenium had
applied for SPCs on the basis of a first MA issued by EMEA or by the
British authorities. The British and Luxembourg
offices considered that the first MA for these products within the meaning
of article 3(d) of the Regulation was the MA issued by the Swiss
authorities.
The tribunals before which
Novartis and Millenium appealed referred the following questions to the
ECJ:
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"1) Is the date of the granting
of a marketing authorisation in Switzerland, which is automatically
recognised in Liechtenstein, to be considered as the first authorisation to
place a medicinal product on the market, for the purpose of calculating the
duration of a supplementary protection certificate as provided in Article
13 of Regulation No 1768/92 (as amended by the EEA Agreement)?
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2) Is a competent authority
within the EEA obliged to rectify any existing supplementary protection
certificates, the duration of which has been erroneously calculated?"
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The ECJ ruled that:
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"In so far as an
authorisation to place a medicinal product on the market issued by the
Swiss authorities and automatically recognised by the Principality of Liechtenstein
under that State's legislation is the first authorisation to place that
product on the market in one of the States of the European Economic Area,
it constitutes the first authorisation to place the product on the market
within the meaning of Article 13 of Council Regulation …., as it is to be
read for the purposes of the application of the Agreement on the European
Economic Area".
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The Court considered there is
no need to reply to second question. It followed that there is no obligation
for the offices to rectify the expiry dates of SPCs.
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Product covered by the MA relied on not protected by
the patent, article 3(a)
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CA Paris, 4ème
Chambre, 19/01/2005, Abbott Laboratories v INPI
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Rejection of the appeal by
Abbott Laboratories against the decision of the director general of INPI to
reject SPC application 01C0039.
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The Court considered that the
composition of active principles Ritonavir and Lopinavir was not covered by
the basic patent and that Ritonavir protected by this basic patent was
already the subject of a 1996 MA issued before the MA relied on.
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Marketing Authorisation relied on found to be
invalid, articles 1(a), 2(b), 3(d)
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CA Paris, 4ème Chambre, 15/12/2004, Chiron
Corporation v INPI
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An appeal by Chiron
Corporation against the decision of the director general of INPI to reject
SPC application 01C0023 on the grounds that the MA (U96122) relied on was not
an MA for a medicinal product within the meaning of article 1(a) of EEC
Regulation No 1768/92.
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The Court considered that the
MA concerned diagnostic in vitro reagents for detecting the AIDS virus in
blood samples; these reagents have no "curative or therapeutic
property" and are not intended to be "administered to human
beings or animals with a view to making a medical diagnosis".
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The appeal was rejected.
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Bundesgerichtshof,
X ZB 5/03, 29/06/2004, MIT v DPMA
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An appeal by Massachusetts
Institute for Technology (MIT) against the decision of the Deutsche Patentamt
(BPatG, 25/11/2002) to reject SPC DE 19975057 for the product
"N,N'-Bis-(2-chlorethyl)-N-nitroharnstoff in Kombination mit
Polifeprosan" (carmustine combined with polifeprosan) on the grounds
that the MA relied on was not the first.
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MIT maintained that the
activity of Gliadel (an implant of carmustine in a matrix of polifeprosan)
is not solely determined by the active constituent carmustine but primarily
by its association with the excipient polifeprosan developed for this
special application. The German Patent office refused the SPC on the
grounds that the MA relied on was not the first for carmustine, an active
substance which had been long authorised (MA before 1998).
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Given that the French, British
and Dutch offices had granted SPCs for Gliadel, having interpreted
differently the expression "composition of active ingredients of a
medicinal product", the Bundesgerichtshof decided to stay the
proceedings and to refer two questions to the ECJ for a preliminary ruling
(C-431/04):
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a) Does the expression
"composition of active ingredients of a medicinal product" within
the meaning of article 1(b) of the Regulation presume that each of the
constituents of the composition is a substance having medicinal activity?
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b) Does "composition of
active ingredients of a medicinal product" apply when one of the two
constituents is an active ingredient already known for a given condition
and the other constituent allows a pharmaceutical form to be obtained in
which the activity of the medicinal product for that condition is modified
(an implant with controlled release of the active ingredient to reduce its
toxicity)?
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In his opinion of 24/11/2005,
the advocate general suggests that the Court rules as follows:
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‘The concept of “combination
of active ingredients of a medicinal product” must be interpreted as
meaning that it does not preclude the grant of a supplementary protection
certificate to a combination of two substances, one of which is a known
substance with pharmacological properties of its own for a specific
therapeutic indication and the other is necessary for the therapeutic
efficacy of the first substance, for this indication.’
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This matter is to be compared
with that of Merck & Co v INPI in relation to a timolol
formulation.
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CA Paris, 4ème
Chambre, 6/11/2002, Merck & Co v INPI
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An appeal by Merck & Co
against the decision of the director general of INPI to reject SPC
application 94C0016 on the grounds that the MA relied on (NL19395 dated
12/04/1994) was not the first.
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Merck maintained that the
product, the subject of MA NL19395, was not a new presentation of the
proprietary medicine timolol, the subject of MA NL11439 dated 31/08/1978,
but a combination of timolol maleate and gellane gum.
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The Court considered that the
MA relied on concerned a new presentation of timolol and that gellane gum
was mentioned as excipient.
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The appeal was rejected.
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MA for human use and MA for veterinary use,
article 3 (d)
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ECJ, C-31/03, 19/10/2004
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Question for a preliminary
ruling referred by the Bundesgerichtshof following a decision of 17/12/2002
within the framework of an appeal by Pharmacia Italia against the rejection
of an SPC.
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The German Patent Office
rejected an SPC application for cabergoline on the grounds that the
relied-on MA of 13/03/1992 (first MA for human use) was not the first MA in
the Community within the meaning of article 19 of the Regulation (MA of
07/01/1987 for veterinary use, obtained before 1st January 1988,
the limiting date for obtaining an SPC in Germany).
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The Bundesgerichtshof referred
to the ECJ the question as to whether the first MA within the meaning of
article 19 must be an MA for a product for human use or whether it could
equally be an MA for a veterinary product.
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The ECJ ruled that:
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"The grant of a
supplementary protection certificate in a Member State of the Community on
the basis of a medicinal product for human use authorised in that Member
State is precluded by an authorisation to place the product on the market
as a veterinary medicinal product granted in another Member State of the
Community before the date specified in Article 19(1) of Council Regulation
..."
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On the basis of this decision
it is accepted that the first MA within the meaning of article 3(d) is the
first MA for either human or veterinary use.
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Product protected by the SPC not limited to the
product covered by the relied-on MA, article 3(a)
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CA Paris, 4ème Chambre, 10/09/2003, Bayer
Cropscience v INPI
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An appeal by Bayer Cropscience
against the decision of the director general of INPI to limit the product
protected by SPC 98C0021 to the combination of flufenacet (fluthiamide) +
metosulam, the subject of the MA relied on for the plant protection product
Diplome®, when Bayer Cropscience had applied for an SPC for flufenacet
alone.
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Bayer Cropscience maintained
that the SPC should be granted for flufenacet as protected by the claims of
European patent EP0348737.
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The Court considered it was not
within the competence of INPI to modify the terms of the application as
made by Bayer Cropscience and annulled the decision to grant the SPC for
the combination.
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More than one SPC on one patent for the same
product, article L. 611-3 CPI (French Law)
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CA Paris, 4ème
Chambre, 12/10/2005, G GAM SARL v PFIZER CORPORATION
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An appeal by G GAM
against the order of the tribunal de grande
instance de Paris prohibiting the continuation of the marketing of drugs named
"Fluconazole G GAM".
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The Court considered that SPC
92C0372 granted based on claims 1 and 6 to 8 of EP0069442 patent covering
the chemical compound fluconazole and corresponding pharmaceutical compositions
was not obtained unlawfully to the provisions of article L. 611-3 of the
Code de la
Propriété Intellectuelle (provisions in
force before 2 January 1993).
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SPC 92C0372 does not incur the
grievance of double protection with SPC 92C0371 granted based on claims 2
to 5 of EP0069442 patent covering the preparation of chemical compound
fluconazole, as a process claim does not give the same protection as a
product claim.
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Limitation of the duration of Italian SPCs,
article 3(8)
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Commissione dei
ricorsi contro i provvedimenti dell'Ufficio Italiano Brevetti e Marchi,
22/07/2003, 17/12/2003 and 20/01/2004
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Rejection of appeals against
law 112/2002 whose article 3(8) introduced a progressive reduction (6
months per year starting from 1st January 2004) of the duration
of those Italian SPCs subject to national law 349/1991. These appeals were
brought by, among others, Menarini, Pharmacia Italia, GSK, Biogen, Syntex,
Squibb, Merck & Co., Pfizer, Warner-Lambert.
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Note that the Corte
Costituzionale declared that it has no jurisdiction to rule on the validity
of article 3(8).
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