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

Baker, Brook b.baker at neu.edu
Fri Aug 22 09:41:34 PDT 2014

The new revised draft guidelines can be found at:  http://www.ipindia.nic.in/iponew/draft_Pharma_Guidelines_12August2014.pdf

They are a revision of an earlier 2014 draft found at:  http://ipindia.nic.in/iponew/Guidelines_Pharma_PatentApplication_28February2014.pdf

I haven't examined them closely to see what's changed, but I hope they are well designed to reduce the number of unwarranted secondary patents being granted by the India Patent Office.  Earlier studies have found that examiners are not routinely interpreting patentability criteria, including section 3(d), to weed out unworthy pharmaceutical patents, and the numbers of pharmaceutical product patents granted, as detailed in the article, are far in excess of the number of new chemical entity products introduced each year.

Argentina has issued stringent guidelines for examining pharmaceutical patents, which are reportedly presently being challenge by Big Pharma.  Hopefully, more and more countries will begin to enact and apply stringent standards to reduce barriers to generic versions of life-saving medicines.

Professor Brook K. Baker
Health GAP (Global Access Project) &
Northeastern U. School of Law, Program on Human Rights and the Global Economy
Honorary Research Fellow, Faculty of Law, Univ. of KwaZulu Natal, SA
400 Huntington Ave.
Boston, MA 02115 USA
(w) 617-373-3217
(c) 617-259-0760
(f) 617-373-5056
b.baker at neu.edu
From: Ip-health [ip-health-bounces at lists.keionline.org] on behalf of Matthew Kavanagh [matthew at healthgap.org]
Sent: Friday, August 22, 2014 10:09 AM
To: Thiru Balasubramaniam
Cc: ip-health at lists.keionline.org
Subject: Re: [Ip-health] Business Standard: Govt set to revise patent norms     for pharma

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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