Patent amendment rules 2019

The Patents (Amendment) Rules, 2019 have now come into effect through a notification by the Central Government on the 18th of September 2019 in its official gazette. A major change brought about by the new rules is that now in addition to startups and applicants designating India as ISA or electing India as IPEA in their corresponding PCT applications, the option of seeking expedited examination is now available to a wide category of applicants. According to the Patents (Amendment) Rules, 2019 rule 24 C is substituted to read as follows:

“…(b) that the applicant is a startup; or

(c) that the applicant is a small entity; or

(d) that if the applicant is a natural person or in the case of joint applicants, all the applicants are natural persons, then the applicant or at least one of the applicants is a female; or

(e) that the applicant is a department of the Government; or

(f) that the applicant is an institution established by a Central, Provincial or State Act, which is owned or controlled by the Government; or

(g) that the applicant is a Government company as defined in clause (45) of section 2 of the Companies Act, 2013 (18 of 2013); or

(h) that the applicant is an institution wholly or substantially financed by the Government;

Explanation:- For the purpose of this clause, the term ‘substantially financed’ shall have the same meaning as in the Explanation to sub-section (1) of section 14 of the Comptroller and Auditor General’s (Duties, Powers and Conditions of Service) Act, 1971(56 of 1971); or

(i) that the application pertains to a sector which is notified by the Central Government on the basis of a request from the head of a department of the Central Government.:

Provided that public comments are invited before any such notification; or

(j) that the applicant is eligible under an arrangement for processing a patent application pursuant to an agreement between Indian Patent Office and a foreign Patent Office.

Explanation:- The patentability of patent applications filed under clause (j) above will be in accordance with the relevant provisions of the Act.”

Source: banana IP

Demand side innovation policy

Demand side innovation policy is now considered imperative for nations economic growth. It needs to be coupled with more traditional supply side innovation policies. While , supply side is taken care in most developed nations, catching up economies still struggle for want of knowledge capabilities and funds. Demand side is more tricky and less articulated. Compatibility with WTO, multilateral, bilateral agreements is one issue. More daunting is the systems and mindset that comes in the way of picking winners. Training public procurers needs long term commitment of policy makers, bureaucrats and other stake holders of a National Innovation System.

This compendium addresses this new topic listing several best practices.
Available at:
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Notion Press
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Indian Pharma- export thrust leads to import dependence.

In the post-2000s period, India’s policymakers went on to promote an imbalanced growth of sales revenue in the case of large domestic pharmaceutical firms in an accelerated and highly skewed way. Large firms were allowed to grow by increasing their sales revenue through the expansion of pathways of low road to industrial development.  They were were allowed to produce and sell branded generics and combination products in the domestic market. Second, large firms were allowed to outsource production to small-scale firms for sale in the domestic market. Third, domestic firms supplied contract manufacturing and research services to foreign firms. Fourth, large firms were allowed to build strategic alliances and collaborations with other large firms of domestic and foreign origin. Fifth, trade was liberalised with a view to encourage exports embedded in imported active pharmaceutical ingredients. Consequently, there has been a rise in the number of large firms who do not undertake in-house manufacture of the core ingredient of the pharmaceutical formulations, or APIs, by themselves. That has made India dependent on China for key starting materials (KSMs), intermediates and APIs . 

The “success story” of the Indian pharmaceutical industry will be over when China enters the finished products market globally, which it is starting to. 

The Drug Discovery and Development Industry in India— Two Decades of Proprietary Small-Molecule R&D

Initially, post the 2000s, drug discovery research drove innovation activity by stressing on in-house R&D capabilities for close to 30 domestic pharmaceutical firms . However, the engagement of domestic pharmaceutical firms with drug discovery for new drug development has been on the decline from 2012. The number of patents filed on new chemical entities (NCEs)  by the domestic pharmaceutical firms is small . Presently, there are only three firms pursuing some activity in drug discovery and new drug development .
Read the paper.