[Ip-health] India may patent small changes

[Prabhu Ram]

Govt may patent small changes

NEW DELHI: Even as the government waits for Dr RA Mashelkar committee
to correct 'technical inaccuracies' in its report on patent issues, it
seems to have accepted the panel's key recommendation to encourage
incremental innovation.

Government officials say they are convinced that encouraging
incremental innovation will benefit Indian pharma companies as well as
patients.

"It may not be prudent to award patent only for a new molecule
discovery, something which requires billion dollars of R&D investment.
No Indian companies can afford it. So we are looking for ways to award
patent for discovery of a new form of a known substance which results
in the enhancement of the known efficacy of that substance," says a
senior government official.

The government is also working to evolve norms, which may guide patent
examiners understand what constitutes 'enhancement of the known
efficacy' of a substance. Currently, with no such guideline in place,
most 'incremental innovations' are unlikely to be accepted for patents
by the patent office.

A wider consultation involving the industry and intellectual property
experts is being held and norms could be ready by the end of the next
month, said the official. "A new form of drug, which involved no new
molecule, but brought a significantly faster recovery to a patient
could be considered for patent," says the official explaining what
'enhancement of efficacy' may possibly mean.

With the 'enhancement of efficacy' guideline in place, the examiners
can easily distinguish between 'incremental innovation' and what is
commonly referred to as 'evergreening'.

Distinguishing the two, Mashelkar report says, "While evergreening
refers to extension of 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."

Recently, Swiss drug maker Novartis' attempt to obtain patent for its
anti-cancer drug Glivec failed after the Indian patent office rejected
its plea citing Section 3(d) of the Indian patent law, which does not
allow patent for incremental improvement on the existing product.

Once the norms are in place, an order to grant or reject a patent
would be more convincing to all parties concerned. Besides, it would
make it difficult for applicants such as Novartis to challenge patent
office orders, as there would be much more clarity over what makes the
grade for patent.

Following the Madras High Court's rejection of Novartis' challenge of
the law, Dr Mashelkar had said on Monday that disputes like Novartis'
can be avoided if a clear guideline distinguishing 'incremental
innovation' from 'evergreening' was in place.

Dr Mashelkar panel had submitted its report last December but withdrew
its report two months later citing 'technical inaccuracies' following
allegations of plagiarism.


Source: http://economictimes.indiatimes.com/News/News_By_Industry/Healthcare__Biotech/Pharmaceuticals/Govt_may_patent_small_changes/articleshow/2266811.cms