[Ip-health] Comments on Mashelkar Committee
Gopa Kumar
kumargopakm@gmail.com
Thu Jan 18 15:35:17 2007
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[ Picked text/plain from multipart/alternative ]
*Technical Expert Group on Patent Law Issues (Mashelkar Committee): A
Critique*
The report of the Technical Expert Group on Patent Law Issues (Committee)
has submitted its Report to Ministry of Commerce and Industry, Government o=
f
India on 29th December 2006. The Report is made available to the public on
12th January 2007.This Committee was established with the following terms o=
f
reference.
a) whether it would be TRIPS compatible to limit the grant of patent
for pharmaceutical substance to new chemical entity or to new medical entit=
y
involving one or more inventive steps; and
b) whether it would be TRIPS compatible to exclude micro-organisms fro=
m
patenting
The Committee has made the following recommendation to the government with
regard to the scope of patent protection to new chemical entities.
*"In the light of the above discussion, it would not be TRIPS compliant to
limit granting of patents for pharmaceutical substance to New Chemical
Entities only. However, every effort must be made to provide drugs at
affordable prices to the people of India. Further, every effort should be
made to prevent the grant of frivolous patents and 'ever-greening'. Detaile=
d
Guidelines should be formulated and rigorously used by the Indian Patent Of=
f
ice for examining the patent applications in the pharmaceutical sector so
that the remotest possibility of granting frivolous patents is eliminated"*=
*
.*
The following paragraphs offer a critique on the major findings of the
Committee with regard to the above recommendation and major findings of the
Committee, which lead to the above recommendation.
1. The terms of reference clearly mentions that task was to find it *whe=
ther
it would be TRIPS compatible to limit the grant of patent for
pharmaceutical substance to new chemical entity or to new medical entity
involving one or more inventive steps*. However, the Committee does
not answer this question and also cites the so called national interest =
to
make its recommendation. The reasons cited in the Report for making the
national interest argument are based on certain assumptions which are ei=
ther
irrational or highly contested ones. According to the Committee "*
Granting** patents only to NCEs or NMEs and thereby excluding other
categories of pharmaceutical inventions is likely to contravene the mand=
ate
under Article 27 to grant patents to all 'inventions'. Neither Articles =
7
and 8 of the TRIPS Agreement nor the Doha Declaration on TRIPS Agreement=
and
Public Health can be used to derogate from this specific mandate under
Article 27".* With these two lines the Committee concludes that
limiting the scope of patenability to new chemical entities would violat=
e
the TRIPS obligation under Article 27. In other words the Committee brus=
hes
aside their mandate i.e. to examine the above legal question and
indulges in rhetoric. The Committee is expected to give its reasons
whatsoever they may be to make the above assertions. A quick analysis is
attempted in the following paragraphs to show the merits of the Committe=
e's
view i.e. *it would not be TRIPS compliant to limit granting of
patents for pharmaceutical substance to New Chemical Entities only. *
1. Firstly, the Committee fears that limiting the scope of
patentability to NME /NCE is likely to contravene the mandate of TRIPS.
Further the Committee states that Articles 7 and 8 as well as Doha
Declaration on TRIPS Agreement and public health cannot be used to derog=
ate
the mandate under Article 27. This conclusion of the Committee is based =
on
superficial analyses. (The Committee does not give any reason for even t=
his
conclusion). Article 27 creates two obligations which are relevant our
discussion. Firstly, both products and process patents should be
available to inventions in all fields of technology provided they are ne=
w,
involve inventive step and capable of industrial application. Secondly,
availability and enjoyment of rights should not be discriminated on the
basis of place of invention, field of technology or place of manufacture=
.
1. The first obligation is that product and process patents should be
made available to inventions. However, availability does not mean grant =
of
patents to all patent applications. Grant of patent is based on applican=
t's
ability to satisfy patentability criteria and any other relevant
requirements. According to Article 27 patents are granted to an inventio=
n.
Significantly TRIPS does not offer any definition for invention and only
mentions the basic requirements of an invention to become eligible for
patent protection. This gives a lot of freedom to member states to deter=
mine
the meaning of invention as well as to exclude applications for secondar=
y
patents from patent protection. Patents for new drug use or a new
combination of drugs can be excluded from patent protection by defining
invention in that manner. Further all inventions become eligible for pat=
ents
only when they satisfy the all three criteria viz. novelty, inventive st=
ep
and industrial application. Since TRIPS leaves it to member countries to
define these three criteria, this gives an opportunity to the implementi=
ng
country to determine the scope of patentability i.e. will it be
limited to new chemical entities or will it also include incremental
innovations (not inventions). Since most of the incremental modification=
s
/innovations fails to satisfy the high threshold level of patentable
criteria, they would not be eligible for patent protection.
1. According to the second obligation under Article 27 what is
prohibited is the discrimination of availability and enjoyment of patent
rights on the ground of place of invention, field of technology, place o=
f
manufacture. This means that discrimination on other grounds is
permitted. Further, the prohibition is only against discrimination and n=
ot
on the differentiation. In other words differentiation is still permissi=
ble.
The WTO Disputes Panel also recognized this reasoning in the *EC =96
Canada Case (WT/DS 114)*. Therefore limiting the scope of
patentability to new chemical entities does not violate the obligation o=
f
non-discrimination as to the field of technology under Article 27(1). Th=
us
it cannot be argued that limiting patentability to new chemical entities
would be discriminatory as the limitation would only be with respect to =
the
pharmaceutical sector. While upholding the Bolar provision the Panel hel=
d
that: *"Article 27 prohibits only discrimination as to the place of
invention, the field of technology and whether products are imported or
produced locally. Article 27 does not prohibit bona fide exceptions to d=
eal
with problems that may exist only in certain product areas". *
1. Again as stated earlier, the word *availability* does not mean the
grant of patent in all circumstances. The non=96discriminatory provision=
does
not prevent member countries to fix the threshold of patentability crite=
ria.
The patentable criteria are applicable to all fields of technology and d=
o
not discriminate against any technology. Therefore every country has a
freedom to fix a high level of threshold for patentable criteria and the
exclusion of discoveries from patentability would not be incompatible wi=
th
TRIPS obligation. Therefore TRIPS leaves it to member countries of the W=
TO
to define certain key provisions that determine the scope of patentabili=
ty.
The Agreement permits States to *"determine the appropriate method*"
to implement the provisions of the TRIPS Agreement within their legal
system. There is a legislative flexibility within the TRIPS framework to
determine the scope of patentability by providing suitable definitions t=
o
the three basic criteria of viz. novelty, inventive step and industrial
applications. The Committee has not either examined or stated reasons in=
its
report on these methods of restricting the scope of patent protection.
1. The objective of TRIPS is mentioned in Article 7 which states *"the
protection and enforcement of intellectual property rights should
contribute=85 to the mutual advantage of producers and users of technolo=
gical
knowledge and in a manner conducive to social and economic welfare=85" *=
On
the objectives of TRIPS, India's submission states: " *=85patent rights
should be exercised coherently with the objectives of mutual advantage o=
f
patent holders and the users of patented medicines, in a manner conduciv=
e to
social and economic welfare and to balance of rights and obligations. Wh=
ere
confronted with specific situations where the patent rights over medicin=
es
are not exercised in a way that meets the objectives of Article 7, Membe=
rs
may take measures to ensure that they will be achieved=85" *India's
socio-economic context, where millions are unable to access the public
healthcare system requires that it balance the right of access to afford=
able
medicines with patent rights. While the introduction of product patents =
is
of great advantage to pharmaceutical companies who hold patents, restric=
ting
patent protection to new chemical entities will provide relief to Indian
patients who will be able to access affordable pre-1995 drugs produced
generically. **
* *
1. Further, principles of implementation under Article 8 states "*member=
s
may, in formulating or amending their national laws and regulations, ado=
pt
measures necessary to protect public health and nutrition, and to promot=
e
the public interest in sectors of vital importance to their socio econom=
ic
and technological development=85" *According to India's submission *"any
interpretation of the provisions of the Agreement should take into accou=
nt
the principles set forth in Article 8. The reading of such provision sho=
uld
confirm that nothing in the TRIPS Agreements will prevent Members from
adopting measurers to protect public health, as well as from pursuing th=
e
overarching policies defined in Article 8". *Hence, India is free to
limit the scope of patentability to new chemical entities in its Patents=
Act
to protect public health.
1. It is a well known rule that any treaty obligations should be
interpreted in the light of its objectives and principles. This was furt=
her
stated in the Doha Declaration on the TRIPS Agreement and Public Health
which states that "each provision of the TRIPS Agreement shall be read
in the light of the object and purpose of the Agreement as expressed, in
particular, in its objectives and principles". Hence, every member
country has the freedom to limit the scope of patentability.
1. On the question of whether Doha Declaration on the TRIPS Agreement
and Public Health supports the limitation on scope of patentability the
answer is a big "Yes". According to the Doha Declaration "*We agree
that the TRIPS Agreement does not and should not prevent members from ta=
king
measures to protect public health. Accordingly, while reiterating our
commitment to the TRIPS Agreement, we affirm that the Agreement can and
should be interpreted and implemented in a manner supportive of WTO memb=
ers'
right to protect public health and, in particular, to promote access to
medicines for all".( Para 4)* There is no doubt that measures like
limiting the scope of patentability to new chemical entities is to prote=
ct
public health by reducing the number of monopolies in the pharmaceutical
markets. A lesser number of patents would provide space for generic
companies and promotes access to medicines. Thus any measures on restric=
tion
of scope of patentability should be interpreted in the light of Para 4
of the Declaration and the WTO Dispute Body is to give due consideration=
to
such measures if it is for protecting the public health. The Committee
totally ignores these facts while making its assertion that "*Neither
Articles 7 and 8 of the TRIPS Agreement nor the Doha Declaration on TRIP=
S
Agreement and Public Health can be used to derogate from this specific
mandate under Article 27**".***
1. The demand for restriction of scope of patentability for the
pharmaceutical inventions came up in India for two reasons. Firstly,
on public health grounds and secondly on adverse effects of misuse of
patents on the generic industry. Unfortunately, the Committee has not
addressed the implications of extending patent protection to ever greeni=
ng
and incremental modifications of a known chemical substance on access to
medicines and public health. The Committee sets three arguments under th=
e
heading "National interest perspective" to support its view on patent
protection for incremental modifications/innovations. The so called nati=
onal
interest perspective considers only the interest a few big Indian
pharmaceutical companies. (The merits of the argument are discussed
subsequent paragraphs.). There is no reference to public health concerns=
in
the report. This forces one to wonder that whether public health is not =
a
factor while considering national interest.**
1. However, the Committee has of the opinion that "*It is important to
distinguish 'ever-greening' from what is commonly referred to as
'incremental innovation'. While 'ever-greening' refers to an extension o=
f a
patent monopoly, achieved by executing trivial and insignificant changes=
to
an already existing patented product, 'incremental innovations' are
sequential developments that build on the original patented product and =
may
be of tremendous value in a country like India. Therefore, such incremen=
tal
developments ought to be encouraged by the Indian patent regime".* Henc=
e
the Committee attempts to make a distinction between ever greening and
incremental innovation. However, the Committee ignores the fact that bot=
h
having the same effect in practice especially considering its implicatio=
ns
for access to medicines. It is also to be noted that according to Indian
Patents Act a patent is granted for inventions and innovations. The same
view is reflected in its recommendation. It is a well known fact that
detailed guidelines alone of little help in preventing ever greening and
frivolous patents without statutory support. Further, the present
infrastructure of Indian patent office does not support this view. **
1. According to the Committee "*Restricting patentability just to NCEs
or NMEs could have both legal and scientific ramifications. There is a
perception that even the current provisions in the Patents Act could be =
held
to be TRIPS non-compliant. Drug discovery research is still finding its =
feet
in India. Though many companies are investing, it will at least be a
decade before a critical mass is in place and results start accruing. Th=
us,
restricting patentability to just NCEs would mean that most of the
pharmaceutical product patents would be owned by MNCs".* Thus the
Committee states that Indian industry should be allowed to patent
incremental modifications/innovations in order to help them to graduate =
to
patent NCE. This is a baseless argument. Patenting and product developme=
nt
are different. There is ample evidence suggesting that Indian companies =
have
patented many new molecules in India and abroad. However, what they
are lacking are the resources for developing it as product. Hence, this =
view
of the Committee is contrary to reality. Further, there is no basis in t=
he
view that only through patenting of incremental modification will make o=
ne
capable to patent NCEs. Furthermore, the Committee totally ignores the f=
act
that limitation on patenting would help the generic manufacturers to use=
the
NCEs more quickly and benefit the Indian industry. Here the Committee we=
nt
out of its way to make a suggestion that Government should promote paten=
ting
of incremental modifications/innovations. Lastly, *the biggest
beneficiaries of patenting of incremental modification are multi nationa=
l
pharmaceuticals. There is ample evidence to show the patent rights
manipulation of MNCs. The Committee recommendations are totally in line =
with
MNCs argument that patenting of incremental modifications helps the Indi=
an
companies and not the MNCs. *
1. According to the Committee "*In case of patenting of drugs, the
protection to various forms of same substance (salts, esters, ethers,
polymorphs, metabolites, pure form, particle size, isomers, mixture,
etc.) is often seen as 'ever-greening' (extending incremental
protection to a subsisting patent) and hence such protection is
objected to. In most countries, patenting of an invention for
different forms of the same substance is subjected to the test of novelt=
y,
non-obviousness (unexpected effect) and utility before it is granted pat=
ent
protection. Such a protection in the form of incremental inventions in
respect of known and new molecules or a process potentially provides an
added advantage to an inventor or a firm to retain its market share or
capture a space in the established market. However, patenting an
invention does not imply that a person can practice the invention; he wo=
uld
have to exercise due diligence and ensure that the rights of others are =
not
infringed*." Here it is very clear that the Committee does not
consider the public health implications of extending patent protection t=
o
incremental modifications. It may give an advantage to a firm for captur=
ing
market or to retain a market share but there is also a fact that such
attempts would act as barrier to access to medicines. Further, too many
patents on a single substance in practice kills the theoretical rhetoric=
of
the Committee that patenting an invention does not imply that a person c=
an
practice the invention. Too many patents on the same substance would lea=
d to
a patent thicket and makes the due diligence practically impossible.
1. *According to the Committee "Many drug industry stakeholders feelthat=
the
use of the expression "new chemical entity" under the Patents Actwould
lead to many interpretations. While some Indian drug industry
representatives feel that limiting grant of patents to new chemical enti=
ties
will not be conducive to competitive growth, some others feel that paten=
t
protection should only be given based on the strict compliance of the
patentability criteria. Many Indian industry representatives are not in
favour of widening the scope of patentability. The group examined the
current level and type of R&D innovations that the Indian drugs and
Pharma industry was undertaking. Annexure IV and V provide some
representative samples of international patents filed by the Indian
industry. It is clearly seen that most of them are based on
incremental inventions". *Here the Committee tries to argue that since
Indian companies are patenting incremental modifications abroad
Indiashould reciprocate. However, we believe that patent policies are
determined
on the basis of developmental concerns including public health concerns.
Hence, patenting of incremental modifications elsewhere is should not be=
a
ground for to do the same in India. Lastly, such patenting is also
used by some companies as defensive mechanism to prevent others from
obtaining monopoly rights in such markets.
* *
( Paragraphs 3, 4, 5, 6 & 7 are from our submission to the Committee on
behalf of Affordable Medicines and Treatment Campaign ( AMTC) . Along with
me Anand Grover and Leena Menghaney drafted that submission).