[Ip-health] Press Coverage on Mashelkar Committee in India
Gopa Kumar
kumargopakm@gmail.com
Wed Jan 17 04:46:17 2007
--
[ Picked text/plain from multipart/alternative ]
Mashelkar blow to generics firms
Reghu Balakrishnan
MUMBAI: The recommendations of the Mashelkar Committee report on
patent issues is likely to have a negative impact on pharmaceutical firms
that thrive by manufacturing copycat versions of off-patent drugs.
A 5-member committee, headed by R A Mashelkar, former Director-Genera=
l
of the Council of Scientific and Industrial Research, in its report release=
d
on Friday, has recommended against settting a limit on the grant of patents
to new chemical entities (NCEs) or new molecular entities (NMEs).
The US Food and Drugs Administration defines NCEs or NMEs as drugs
that contain no active molecule or ion - or 'moiety' =97 that been already
approved by it earlier. An active 'moiety' is the molecule or ion
responsible for the physiological or pharmacological action of a drug.
The Mashelkar panel said limiting the grant of patents would not be
TRIPS-compliant.
What will the suggestion, if implemented, mean?
Experts say it could be financially harmful to the Indian population,
which depends on cheap versions of off-patent drugs, they say.
Because the multinationals can keep patenting drugs going off-patent
by tweaking a molecule or two - or, in pharma parlance, by 'evergreening'
their patents.
Says a patent expert: "The biggest beneficiaries of patenting of
incremental modifications are the multinationals. There is ample evidence o=
f
this. The Mashelkar Committee recommendation is totally in line with the
MNCs' skewed argument =97 that patenting of incremental modifications helps
Indian companies and not the MNCs. The ground reality is the other way
around."
The report said it was important to distinguish between evergreening
and incremental innovations, which are sequential developments that build o=
n
the original patented product and may be of tremendous value.
But Swati Piramal, director, Nicholas Piramal, one of India's largest
pharma firms, said the recommendations will be helpful to Indian companies
who are more into research & development.
"Evergreening of drug patents with trivial changes would be
eliminated," she said.
But extending the patent period of the drugs based on the innovative
changes may curb the scope for manufacturing the copycat versions, says the
official of a pharma firm.
"This can make the drug unaffordable to the common man."
Gopakumar Nair, another patent expert, said the recommendations have
adopted a middle-of-the-road approach, avoiding controversies.
"The panel insisted on avoiding the circumstances for evergreening of
patents. There should be stringent rules against this as well as frivolous
patents," he said.
The committee, called the 'Technical Expert Group on Patent Law
Issues,' set up to study the patentability of micro-organisms and the
definition of 'pharmaceutical substance' to mean an NCE or NME, however,
said every effort must be made to provide drugs at affordable prices to the
people of India.
"Detailed guidelines should be formulated and rigorously used by the
Indian Patent Office for examining the patent applications in the
pharmaceutical sector so that the remotest possibility of granting frivolou=
s
patents is eliminated," the report said.
http://www.dnaindia.com/report.asp?NewsID=3D1074345
Leg-up for MNC pharma cos as panel faults patents law
GIREESH CHANDRA PRASAD
TIMES NEWS NETWORK[ MONDAY, JANUARY 15, 2007 03:33:25 AM]
Mumbai: A high-level panel headed by Council of Scientifi=
c
and Industrial Research (CSIR) director-general RA Mashelkar has told the
government that the Patents Act amendment of 2005, which made it difficult
for companies to get patent protection for minor modifications to older
drugs, is not in tune with India's international obligations.
The recommendation has tremendous implications for the
generics pharma industry, which believes the copies of MNC drugs they could
introduce would significantly reduce if the threshold for patenting a drug
is lowered. As per the existing law, new forms and uses of an older (or
off-patent) drug would be considered worthy of patent protection only if
they are significantly different in their properties that decide their
efficacy.
The panel, which submitted its report recently, has argue=
d
that denying patent protection to new forms and uses of older drugs is not
in line with the WTO's Trade Related Intellectual Property Rights (Trips)
agreement. The government had appointed the committee after bringing this
safeguard in the law while introducing product patents in early 2005. If
this view gets political acceptance, the government may amend the patent la=
w
further.
The recommendation is likely to draw sharp reactions from
a majority of domestic pharmaceutical companies, which believe the existing
patentability criteria and safeguards help in preventing possible abuse of
monopoly by MNCs.
Mr Mashelkar has argued that many of Indian companies,
including Ranbaxy, Dr Reddy's and Cipla, are filing patent applications
abroad for incremental innovations. Restricting patent protection only to
totally new molecules (new chemical entities) would deprive them of the
chance to create intellectual property.
A representative of the domestic pharma industry told ET
that they do so in other countries as the laws there provide for it, but do
not want Indian law to allow protection for minor modifications. If allowed=
,
many pre-1995 molecules, which are not eligible for patents now, may get
protection here and it would restrict Indian companies' ability to launch
their copies here and abroad.
Mr Mashelkar, however, has tried to distinguish between
the advantages of incremental innovation and abuse of patent rights.
"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 incremental developments ought to be
encouraged by the Indian patent regime. However, any effort to extend a
patent monopoly by making trivial changes to an already existing patented
product (ever-greening) should be prevented," the report says.
It has also recommended that excluding micro-organisms pe=
r
se from patent protection would be violative of Trips agreement and there
should be guidelines to ensure that only micro-organisms modified by
substantial human intervention are patented.
http://economictimes.indiatimes.com/articleshow/msid-1188089,prtpage-1.cms
Economy
Drug discovery yet to gain ground in India, says report
Alok Sharma
New Delhi, Jan 14 The technical expert group headed by R A
Mashelkar, in its recent report, has suggested that limiting the grant of
patents to only new chemical entities would not be TRIPS compliant, while
exclusion of micro-organisms per se from patent protection could be
"violative" of the international charter.
The group, in the report made public on Friday, said granting
patents to only new chemical entities (NCEs) or new medical entities (NMEs)
and excluding other categories of pharmaceutical inventions, was likely to
contravene the mandate of the international charter to grant patents to all
"inventions".
It said drug discovery research was still finding its feet in
India. Though many companies were investing, it would be at least a decade
before a critical mass was in place and results started accruing. Thus,
restricting patentability to just NCEs would mean that most of the
pharmaceutical product patents would be owned by MNCs and not by domestic
pharma companies.
There was a need to form strict guidelines for examination of
the applications involving micro-organisms from the point of view of
substantial human intervention and utility. Its excluion from patent
protection is not in sync with TRIPS, the report said.
The experts have suggested that the India Patent Office make an
effort to prevent grant of frivolous patents and their 'ever-greening' by
preparing strict guidelines.
The committee was set up in April 2005 and expected to submit
the report within three months. It, however, took one year and nine months
to do the job. When contacted, an industry analyst said: "product
development still remains a key area as many companies in the country do no=
t
have money. The current position of big companies ruling the roost is likel=
y
to continue.?"
These recommendations are, however, not legally binding on the
government. Whether to include the suggestions in the policy solely depends
on the government, added the analysis.
http://www.financialexpress.com/fe_full_story.php?content_id=3D151739
Panel against curb on drug patenting
Special Correspondent
Opposes New Chemical Entity criterion
CHENNAI: A five-member expert committee headed by
R.A.Mashelkar, the immediate past Director-General of the Council of
Scientific and Industrial Research (CSIR), has recommended to the governmen=
t
against limiting the grant of patents for pharmaceutical substances to "new
chemical entities" (NCEs) or "new medical entities" (NMEs) involving one or
more inventive steps.
National interest
In its recommendation submitted last month, the committee
has said that not only the requirement of compliance with the TRIPS (trade
related aspects of intellectual property rights) agreement of the World
Trade Organisation (WTO) but also "national interest perspective" would
warrant imposing any such restriction in India's Patents Act 1970 - an issu=
e
that had been raised in Parliament, following which the committee was set
up.
The committee similarly advised against excluding
microorganism per se from patent protection from the point of view of both
the TRIPS agreement and national interest.
Incremental invention
The report said it was important to distinguish
"ever-greening" (attempts by patentees to get extension of a patent monopol=
y
by executing trivial and insignificant changes to an already existing
patented product) and "incremental innovations" which are "sequential
developments that build on the original patented product and may be of
tremendous value in a country like India". "Therefore such incremental
developments ought to be encouraged by the Indian patent regime", it said.
Referring to the opinion of a section of stakeholders tha=
t
even the current provisions in the Patents Act could be held to be TRIPS
non-complaint, it pointed out that drug discovery research was "still
finding its feet" in India. "Though many companies are investing [in R and
D], it will be a decade before a critical mass is in place and results star=
t
accruing. Thus restricting patentability to just NCEs would mean that most
of the pharmaceutical product patents would be owned by MNCs".
It pointed out that most of the international patents hel=
d
by Indian industry were based on incremental inventions.
(c) Copyright 2000 - 2006 The Hindu
http://www.hindu.com/2007/01/13/stories/2007011304831700.htm
Mashelkar panel`s view on wider patentability flayed
Joe C Mathew / New Delhi January 16, 2007
The Mashelkar panel's recommendation to consider all modifications an=
d
variants of new chemical entities (NCEs) as patentable has invited criticis=
m
from sections of Indian pharmaceutical industry and public interest
organisations, saying the group had failed to back its case.
Mashelkar could not be contacted for comment.
The Technical Expert Group on Patent Law Issues, in its
recommendations submitted on December 29, 2006, had noted that granting
patents only to NCEs or new molecular entities (NMEs), thereby excluding
modifications and variants of NCEs, would contravene the TRIPS provisions o=
f
the World Trade Organisation (WTO). It had also stated that excluding
micro-organisms per se from patent protection would be violative of the
TRIPS Agreement.
Critics of the panel's views feel the "arguments are based on certain
assumptions that are either irrational or highly contestable."
D G Shah, secretary general, Indian Pharmaceutical Alliance (IPA),
told Business Standard: "As the title suggests, the reference to the group
was on 'patent law,' but there is hardly any evidence in the report to
support its interpretation. Most parts of the report are devoted to
narrating the positions of various interest groups, but very little is
devoted to what made the Technical Group take the view that to limit
patentability to NCEs is not compatible with the TRIPS Agreement."
CENTAD, an NGO that deals with international trade policies, was more
critical in its response.
"The terms of reference clearly mention that the task was to find
whether it would be TRIPS compatible to limit the grant of patent for a
pharmaceutical substance to a new chemical entity or to a new medical entit=
y
involving one or more inventive steps. However, the committee does not
answer this question and also cites so-called national interest to make its
recommendation. The national interest argument is based on certain
assumptions which are either irrational or highly contestable," K M
Gopakumar of CENTAD said.
According to him, the demand for restriction of scope of patentabilit=
y
for pharmaceutical inventions came up for two reasons: First on the grounds
of public health, and second due to the adverse effects of misuse of patent=
s
on the generic industry.
"The so-called national interest perspective considers only the
interests of a few big Indian pharmaceutical companies. There is no
reference to public health concerns in the report. This forces one to wonde=
r
whether public health is not a factor while considering national interest,"
he added.
Interestingly, Indian patent law, in its current form, is TRIPS
compliant and does not limit patents to NCEs or NMEs in a strict sense.
Neither does it call for a blanket ban on micro-organisms.
The Mashelkar panel's views were sought after the Left parties, which
favoured a stricter patent regime than the current one, wanted to explore
the possibility of limiting patentability only to NCEs or NMEs.
With the panel's view in place, there is no chance of the Left demand
being re-considered.
Patents
Mashelkar suggestion to grant patent for incremental modifications to
benefit only MNCs
Wednesday, January 17, 2007 08:00 IST
Our Bureau, New Delhi
The recommendation of Dr Mashelkar panel to encourage incremental
innovations by the patent regime assumed great relevance to India and it
would go a long way to make drugs available at affordable prices, according
to Ranjit Shahani, president of Organization of Pharmaceutical Producers of
India.
Reacting to the report, Dilip Shah, secretary general of Indian
Pharmaceutical Alliance said, ``As the title suggests, the reference to the
Group was on "patent law" but there is hardly any evidence in the report to
support its interpretation. Most part of the report is devoted to narrate
position of various interest groups, but very little is devoted to providin=
g
an insight into what made the Technical Group take the view that to limit
patent ability to NCEs is not compatible with the TRIPS agreement.''
Expressing sharp reservation on the recommendations of the panel,
public interest group, Centad said, that the report came as per the line of
the MNCs argument that patenting of incremental modifications helped Indian
companies not the MNCs.
``The biggest beneficiaries of patenting of incremental modifications
are multinational pharmaceutical corporations. There is ample evidence to
show the patent rights manipulation of MNCs,'' K M Gopakumar of the Centad
said.
The IPA functionary said that they engaged the services of Prof.
Abbott of Florida State University, who is being consulted by several
Governments including India often, to examine the issues referred to the
technical expert group. But his views did not get a mention in the report.
The panel has recommended that granting of patents only to new
chemical entities in pharmaceutical sector would not be TRIPS complaint,
among other suggestions.
``India's socio-economic context, where millions are unable to access
the public healthcare system requires that it balanced the right of access
to affordable medicines with patent rights. While the introduction of
product patents is of great advantage to pharmaceutical companies who hold
patents, restricting patent protection to new chemical entities will provid=
e
relief to Indian patients who will be able to access affordable pre-1995
drugs produced generically,'' Gopakumar said.
http://www.pharmabiz.com/article/detnews.asp?articleid=3D37129§ionid=3D=
&z=3Dy