[Ip-health] Econ Times: Copycat drug cos convert, back MNCs on patents

[Mira Shiva]

Dear Mike ,
This article first tries to degrade  production of Generic equivalents as
"copycat" drugs .Even when patent for process existed legally in India as in
several other countries prior to that ,terms like" pirates " etc were used
,miscommunicating to the medical community & the public
making generic equivalents sound illigel ( & also as substandard & spurious.
The companies mentioned  returning to support MNC's , had publically stated
their appreciation of the Mashelkar Committee when it was announced .a large
number of pharmaceutical companies do not share this position .
.
Most of the public health organizations do not share this
& are outraged at the blatantincorporation of the several paragraphs from
Interpat financed IPI U.K Report . The objection is not merely of the"
verbatim copying "but more so it is with the  content & the conclusion of
the mashelkar Committee Report .
 There are several organizations deeply concerned about the Public Health
implications of this report's conclusion  on Access & affordibility of
medicines to people within India & to other developing countries ,specially
the poor .

The need to find a different R& D framework is highlighted yet again  where
incentives are not tied  to to IPR & monopoly control . making the results
out of reach of people ,who need them the most .
  A  statement was released at a press coference on 22nd in Delhi expressing
deep concern about the content & conclusion of the Mahelkar committee Report
Dr Mira Shiva
A 60 Hauz Khas
New Delhi
110016
 All India Drug Action Network ,
 Medico Friends Circle
 Jan Swasthya Abhiyan
Inititiative for Health Equity & Society
National Working Group on Patent Laws
Centad
Intenational People,s health Council (South Asia )
Health Action International Asia Pacific
Lawyers Collective
Cancer patienta Association
Peoples Health movement
Navdanya
Research Foundation for Science technology & Ecology
& many others .
The issue is not of plagarism alone but the interpretation & conclusion .
Modification of the sentences which communicate the same conclusion is not
acceptable as the implications for public health are too serious .


----- Original Message -----
From: "Mike Palmedo" <mike_palmedo@yahoo.com>
To: <ip-health@lists.essential.org>
Sent: Friday, February 23, 2007 9:28 PM
Subject: [Ip-health] Econ Times: Copycat drug cos convert, back MNCs on
patents


--
[ Picked text/plain from multipart/alternative ]
http://economictimes.indiatimes.com/News/News_By_Industry/Healthcare__Biotec
h/Copycat_drug_cos_convert_back_MNCs_on_patents/articleshow/1662515.cms

Copycat drug cos convert, back MNCs on patents

NOEMIE BISSERBE
Economic Times
February 23, 2007

MUMBAI: Once known for trashing patents and denouncing prohibitive pricing
by big pharma, Indian generic companies have changed their stance. Many have
now begun siding with the multinationals to support the grant of patents for
incremental inventions in India.

The main reason behind the change is that companies are themselves working
on incremental innovations like new forms, derivatives and new drug delivery
systems of existing molecules, for which they will seek patent protection in
India. Also, as Indian companies bid aggressively for overseas assets and
tie-up with global pharma companies for manufacture and research, there is a
pressing need for them to change their image of 'copycat manufacturers'.

Under pressure from domestic companies, the government in 1970 had abandoned
the idea of a product patent regime, allowing only process patents. There
are globally three types of patents: patents on the molecule, on the process
of manufacturing or on the drug delivery system. Today these same companies
are encouraging the grant of patent not only for new molecules, but also for
incremental inventions -- molecules which have been slightly modified from
their original form, or to which a new substance has been added.

"We are of the opinion that incremental innovations in terms of developing
new forms, new derivatives and new delivery systems of existing drug should
be granted patent protection provided they are new, involve an inventive
step and have commercial utility," said Ranbaxy Labs in an annex to Dr RA
Mashelkar's report on the patent bill. "This will provide the necessary
fillip to development of novel drug delivery system (NDDS) in our
laboratories." The company continues to maintain its stance though the
Mashelkar report has now been withdrawn.

After the amendment was introduced in Parliament in March 2005, the commerce
and industry minister referred it to an expert committee, headed by Dr. RA
Mashelkar, for detailed examination. Says a DRL official: "It cannot be
argued that incremental innovation is not innovation and is therefore not
patentable." Wockhardt MD Habil Khorakiwala adds: "Restricting patents only
to new chemical entities could hurt both MNCs and Indian companies."

Nicholas Piramal is working on a new version of Novartis' cancer drug
Gleevec (known in India as Glivec). "We are shooting ourselves in the foot.
Incremental inventions should be patented in India. If not, we will not be
able to patent and launch in India our version of Gleevec, although our drug
will be much more affordable than Novartis' for cancer patients," she
explained.

The grant of patents has however opened the door in the West to a phenomenon
referred to as 'evergreening', whereby the patent holder files a fresh
patent on trivial modifications made on the molecule to extend its monopoly
beyond the 20-year period granted for the original patent.

In order to prevent pharma companies to unfairly extend their product's
patent life, the Indian government has introduced in the Indian patent law a
legal provision -section 3 (d)- that stipulates that modifications of
already-known medicines cannot be patented, unless they make the drugs
significantly more effective. "Section 3(d) of the Indian patent law goes
further than what is TRIPS-compatible," feels Dr Swati Piramal, Director,
Strategic Alliances and Communications, Nicholas Piramal.

However most domestic companies still feel that section 3(d) is necessary to
prevent any abuses. "Patents should not be given to cosmetic modifications
and improvements that do not fundamentally alter the clinical profile and
therapeutic value of the drug. Seeking patents for such modifications aims
at evergreening," said Mr. Khorakiwala. "Section 3(d) is no different from
the varying standards of patentability that operate around the world. Every
country can follow its own norms and determine whether such norms should
appear in the statute, or rules or regulations," adds a DRL official.

However, section 3(d) has many gray areas. Says Ramesh Adige, executive
director, corporate affairs and global corporate communications, Ranbaxy
Labs, "There is a need to define and provide guidelines for understanding
the term 'efficacy' in the rules so that frivolous inventions do not get
patents. Examination will have to be rigorous and follow the guidelines to
be given in the rules."

A large section of the domestic pharma industry also still claims that
allowing patents for incremental innovations, regardless of efficacy, will
have a negative impact on access to healthcare in India, analysts feel.
"Given the poverty in India, granting patents to incremental innovations
might not be in the interest of the country," says Glenn Saldanha, managing
director, told ET.

In an annex to Dr RA Mashelkar's report on the patent bill, the Indian
Pharma Alliance (IPA), one of the industry's largest trade bodies, has taken
the position that patents should be granted exclusively to new molecules.

Mike Palmedo
Research Coordinator
Program on Information Justice & Intellectual Property
American University, Washington College of Law
T - 202-274-4442 | F - 202-274-4226 | mpalmedo@wcl.american.edu
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