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

[Mike Palmedo]

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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 hav=
e 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 deliver=
y systems of existing molecules, for which they will seek patent protection=
 in India. Also, as Indian companies bid aggressively for overseas assets a=
nd tie-up with global pharma companies for manufacture and research, there =
is a pressing need for them to change their image of =91copycat manufacture=
rs=92.

Under pressure from domestic companies, the government in 1970 had abandone=
d the idea of a product patent regime, allowing only process patents. There=
 are globally three types of patents: patents on the molecule, on the proce=
ss of manufacturing or on the drug delivery system. Today these same compan=
ies are encouraging the grant of patent not only for new molecules, but als=
o 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 s=
tep and have commercial utility," said Ranbaxy Labs in an annex to Dr RA Ma=
shelkar's report on the patent bill. "This will provide the necessary filli=
p to development of novel drug delivery system (NDDS) in our laboratories."=
 The company continues to maintain its stance though the Mashelkar report h=
as now been withdrawn.

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

Nicholas Piramal is working on a new version of Novartis' cancer drug Gleev=
ec (known in India as Glivec). "We are shooting ourselves in the foot. Incr=
emental 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 wi=
ll be much more affordable than Novartis' for cancer patients," she explain=
ed.

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

In order to prevent pharma companies to unfairly extend their product's pat=
ent life, the Indian government has introduced in the Indian patent law a l=
egal provision -section 3 (d)- that stipulates that modifications of alread=
y-known medicines cannot be patented, unless they make the drugs significan=
tly more effective. "Section 3(d) of the Indian patent law goes further tha=
n what is TRIPS-compatible," feels Dr Swati Piramal, Director, Strategic Al=
liances and Communications, Nicholas Piramal.

However most domestic companies still feel that section 3(d) is necessary t=
o prevent any abuses. "Patents should not be given to cosmetic modification=
s 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. Ever=
y 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 dir=
ector, corporate affairs and global corporate communications, Ranbaxy Labs,=
 "There is a need to define and provide guidelines for understanding the te=
rm '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 allo=
wing 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 Phar=
ma Alliance (IPA), one of the industry's largest trade bodies, has taken th=
e 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