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N. 35, September - October 2007
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 | Editorial
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Drug Patents in India and Spain
Prof. Dr. Pascual Segura
Patent Centre Director at the University of Barcelona
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On 6th August 2007, an
Indian Court dismissed a Novartis lawsuit stating that Section 3(d) of Patent
Law 2005 was unconstitutional. The Court did not rule on the incompatibility
between the section in question and the TRIPS Agreement, saying that this must
be decided at the WTO. The Court’s resolution has had a great impact in
the media, and some NGOs have interpreted it as a huge victory. The lawsuit was
brought after the rejection of a 1998 patent application on a crystalline form
of imatinib mesylate, which is the active ingredient of anti-cancer drug
Glivec. It is significant that this patent has been granted in other offices
after passing the patentability examination, including: the U.S. Patent Office,
the Japanese Patent Office and the European Patent Office (No. EP 998.473
B1).
Over last two years in Spain, much has been published about the two
(failed) attempts by Farmaindustria (which is made up of Spanish companies and
multinational corporations) to modify the patent regulations and about the
association’s complaints because of a supposed lack of harmonisation
with the TRIPS Agreement. That, the association says, has led to a
“judicial war” on patents of a dozen drugs, which have an annual
turnover of about 1,600 million euros. Starting in May 2007, Farmaindustria
asks the Spanish Government to effect this harmonisation using politics in
return for the association investing a large amount of money (300 million euros
in 5 years) in research into the treatment of rare diseases.
Therefore, there are people who think that the pharmaceutical patent
systems in India and Spain need to be harmonised with the TRIPS Agreement.
Below it is explained that there are two totally different situations, although
they influence each other.
It is common knowledge that, in the pharmaceutical field, the most
valuable claims are those of product on the active ingredient, and use or
therapeutic indications claims if the protected use is commercial and there is
no product protection. In Spain, the pharmaceutical product’s claims
started to be patentable for applications filed after 8th October 1992, by virtue of the reservations
provided by two laws that came into force in 1986: the European Patent
Convention (EPC) and the current Patent Law. Curiously, case law has not yet
decided whether or not these reservations affect the mentioned use claims.
First Glivec’s European Patent, No. EP 564.409 B1, was filed in 1993,
when there were no longer reservations. In this patent, free imatinib (not in
salt form) is described and imatinib and its pharmaceutically acceptable salts
are claimed.
When the TRIPS Agreement came into effect in Spain (probably on
25th January 1995), the reservations
were no longer applicable. However, Farmaindustria, considering a construction
of arts. 27(1), 70(2) y 70(7) of the TRIPS Agreement, which at the moment is
being studied by the Spanish Courts, claims that, on patents applied for before
8th October 1992, product claims
already included will be considered valid, or that previously nonexistent
product claims can also be added. Obviously, generic drug companies operating
in Spain, among which there are several from India, oppose this construction
since they consider the retroactive nature, which would be detrimental to them,
illegal. EPO has stated that art. 70(7) is only applicable to patents that were
pending on the date that the TRIPS came into force, regardless of whether
opposition has been filed. It also says that arts. 70(1) and (3) make clear
that there is no intention for the Agreement to have retroactive effect (cf.
Official Journal EPO, July 2007, pp. 439-441).
It is understandable that this controversy has arisen before Spanish
Courts since it concerns patents of a dozen active ingredients with great
commercial success which, if they didn’t have product or use protection,
would suffer from competition from generic drugs in Spain earlier than in the
biggest EU countries. However, it is incomprehensible to state that the Spanish
patent system is not harmonised with the EU, as it has been totally harmonised
since 1992. It is also incomprehensible that the Government is being asked for
a political solution since it lacks the competence, except in extraordinary
situations, such as wars or health emergencies.
The situation is completely different in India. It wasn’t
until its accession to the TRIPS Agreement at the beginning of 1995 that patent
applications including pharmaceutical product claims were accepted. Among the
referred applications was the previously mentioned 1998 patent application on
crystalline form of imatinib mesylate. According to art. 70(8) of the TRIPS
Agreement, these applications, called black
box applications, are being examined under the current Patent Law
2005. But Section 3(d) from this Law bans use claims and adds the extra
requirement of “enhanced efficacy” for the derivatives of a known
pharmaceutical product, such as salts, esters, ethers and crystalline forms.
Considering this section and the fact that imatinib was already described on
the 1993 application, all use and product claims included on the 1998 patent
application were rejected.
The desire to avoid that patents are granted for pharmaceutical
product derivatives without novelty or inventive step is understandable (though
it unfortunately happens sometimes, even at the biggest patent offices).
However, it is incomprehensible that this be prevented by introducing an
arbitrary new patentability requirement that is not provided for in the TRIPS
Agreement or the EPC. On the other hand, and contrary to Spain, there are many
practical difficulties in enforcing patent rights before Courts in India. This
fact helps powerful Indian companies devoted to fine chemistry (raw materials)
and to generic drugs, to the detriment of their competitors, including the
corresponding Spanish companies. These Indian companies, considered by some
NGOs as "the Pharmacy for the Third World”, do not give away their
products for free, but instead export them to the markets where the maximum
benefit can be obtained.
The 2001 Doha Declaration on the TRIPS Agreement and its further
implementations are meant to ensure that patents do not influence the
accessibility of drugs to poor countries or poor citizens in globally important
countries that have huge social differences, such as India. Spain ranks fifth
in the EU as regards economic importance, and its drugs are among the cheapest
from the EU. When a generic drug appears in Spain, the reference drug must
reduce its price even more, which favours parallel exportations. This is a
legal but unfair phenomenon. It is detrimental to innovative industry, although
it is not the Spanish patent system, which actually works reasonably well, that
is responsible for it.
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