[Ip-health] Business Standard: Govt set to revise patent norms for pharma

Thiru Balasubramaniam thiru at keionline.org
Fri Aug 22 06:48:37 PDT 2014

Govt set to revise patent norms for pharma

*Guidelines won't replace present structure, but will let examiners adopt
standard procedure in evaluating complex applications*
*Sushmi Dey  |  New Delhi *
*August 19, 2014* Last Updated at 00:47 IST

The government is set to revise the guidelines for evaluating applications
seeking intellectual property rights (IPR) for pharmaceuticals.

This follows an increasing number of drug patent
<http://www.business-standard.com/search?type=news&q=Patent>filings, along
with litigation between innovator companies and generic drug producers.

The controller general of patents, designs and trademarks, under the
department of industrial policy and promotion, issued draft guidelines last
Tuesday in this regard. “The (aim is) to help examiners and controllers of
the patent office consistently achieve uniform standards while examining
and granting patents,” a senior official said.

The proposed guidelines, he said, would complement the existing norms and
procedures. Detailed guidelines on certain provisions of patent law will
enable a standard procedure while evaluating and deciding on complex
applications. The government feels pharma products require separate
guidelines due to the intricacies involved and the implications in the case
of medicines.

Uniform evaluation standards are also expected to reduce and bring clarity
on patent challenges.

According to an intellectual property right
lawyer, India granted as many as 970 pharmaceutical product patents between
2007 and 2011, whereas the number has increased to around 1300 between 2011
and 2013.

In 2005, when India changed its patent law and started granting patents in
medicines, only three pharma patents were granted. The number rose to 113
in 2006 and 772 in 2007. The trend continued with as many as 1,369 patents
being approved in pharma in 2008 and 1,046 in 2009, as per the Indian
patent office.

While patent approvals have increased, patent challenges and litigations
are also on a rise in the country. Various domestic firms including Natco,
Cipla  <http://www.business-standard.com/search?type=news&q=Cipla>and
Glenmark  <http://www.business-standard.com/search?type=news&q=Glenmark>have
locked horns with multinationals such as Novartis, Merck and others over
patent infringement etc. In some cases, domestic firms have also approached
the government and the regulator to issue compulsory license against
patented medicines.

According to the official, the draft guidelines aims at bringing in clarity
and uniformity in various provisions of the patent law such as section 3(d)
which does not allow incremental innovation to be patented.

The proposed guidelines also define words such as "invention" and
"inventive step" and explains how they need to be interpreted while
examination of applications seeking IPR
<http://www.business-standard.com/search?type=news&q=Ipr>on pharmaceuticals.

The draft guidelines, however, clarifies that applications should be
examined on a case -to - case basis, without being prejudiced.

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