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

Matthew Kavanagh matthew at healthgap.org
Fri Aug 22 07:09:13 PDT 2014

Anyone have an interpretation of what this is likely to mean?

Matthew Kavanagh
m: +1 202.486.2488

Sent from my mobile, please excuse typos and brevity...

> On Aug 22, 2014, at 9:48 AM, Thiru Balasubramaniam <thiru at keionline.org> wrote:
> http://www.business-standard.com/article/economy-policy/govt-set-to-revise-patent-norms-for-pharma-114081800840_1.html
> 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
> <http://www.business-standard.com/search?type=news&q=Intellectual+Property+Right>(IPR)
> 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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