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

Silverman, Ed Ed.Silverman at wsj.com
Fri Aug 22 07:19:44 PDT 2014

Yes, I'm also curious to understand the potential impact. 

Ed S

Sent from my iPhone

> On Aug 22, 2014, at 10:13 AM, "Matthew Kavanagh" <matthew at healthgap.org> wrote:
> 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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