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

Nehaa Chaudhari nehaa at cis-india.org
Fri Aug 22 09:52:10 PDT 2014

Not binding law. For the purposes of achieving uniformity and 
standardization across patent offices in the country. Internal guide for 
patent examiners more than anything else, and therefore a guide to those 
who file patent claims on what the patent examiners are going by. 
Possibly also to explain some terms.

Sometime last year, the Indian Patent Office (IPO) also released 
Guidelines to determine the patentability of Computer Related Inventions 
and had consultations around this issues, that were attended by the 
Controller as well as Deputy Controllers of Patents in India.

Similar questions were raised on the validity and the impact of these 
guidelines.  In response, the IPO said that these guidelines were just 
guidelines and not binding law. They said that examination of patents 
would be done on the basis of these guidelines, and this was something 
that parties could bear in mind while drafting and filing their claims. 
The guidelines were also intended to achieve uniformity in the process 
of adjudication across the patent offices in the country. It was felt 
after some observation that different patent offices in the country 
adopted differential standards while granting/rejecting patent claims 
and the IPO wanted to bring about some uniformity and standardization.  
They made it very clear that no one could challenge a decision of the 
IPO on the basis of something mentioned in the guidelines. The 
guidelines were also aimed at bringing about some clarity on some of the 
technical aspects of patenting computer related inventions- some terms 
were sought to be explained/defined.

As far as I know, the situation will be similar in the case of the 
present guidelines.

On 8/22/2014 7:49 PM, Silverman, Ed wrote:
> Yes, I'm also curious to understand the potential impact.
> Ed S
> Pharmalot/WSJ
> 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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Nehaa Chaudhari
The Centre for Internet and Society
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