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India – Patent Office Issues Revised Draft Guidelines For Examination Of Patent Applications In The Pharmaceutical Sector.

8 October, 2014

 

Legal News & Analysis – Asia Pacific  India – Intellectual Property 

 

To streamline examination processes in relation to applications pertaining to pharmaceuticals, the Indian Patent Office has released draft guidelines with an objective that the same serve as guidance to examiners with a hope that these would assist examiners and the industry

 

Some key elements:


1. No Requirement To Disclose The INN Name 


An INN is the generic name of a pharmaceutical drug assigned to it by the WHO. If the INN name is mentioned in the patent specification then non practitioners can easily identify and file oppositions against patents. 


2. Novelty 


Claimed subject matter lacks novelty if the prior art document implicitly discloses or inherently anticipates the subject matter of the invention.


3. Inventive Step 


The guidelines, in illustrative examples referred to the PEGylated interferon (Pegasys) case wherein invalidation on the grounds of obviousness was declared. The judgement as passed in the matter talked about the test for Obviousness as under:
The classical touchstone for obviousness is the technician skilled in the art but having no scintilla of inventiveness or imagination; a paragon of deduction and dexterity, wholly devoid of intuition; a triumph of the left hemisphere over the right. The question to be asked is whether this mythical creature (the man in the Clapham omnibus of patent law) would, in the light of the state of the art and of common general knowledge as at the claimed date of invention, have come directly and without difficulty to the solution taught by the patent. It is a very difficult test to satisfy.


However, the above judgement has since been stayed and therefore the revised guidelines do not find mention of the same as a guiding principle. 


4. Industrial Applicability/Utility 


The patent specification must disclose a practical application and industrial use for the claimed invention wherein a concrete benefit must be derivable directly from the description coupled with common general knowledge. Mere speculative use or vague and speculative indication of possible objective will not suffice.


This has been objected to by the industry given that the guidelines do not provide any case law on the point of “merely speculative” us and moreover the the Act only requires to have an “industrial application” and does not require require commercial viability.


5. Enablement/Insufficiency Of Disclosure

The draft guidelines stipulate that only representative compounds mentioned in the embodiments claimed on the Markush Structure (Markush structures are chemical symbols used to indicate a collection of chemicals with similar structures and allow the patent-holder to be deliberately vague as to the most active/effective structural formula while concealing relevant information from competitors) need to be tested.
The draft guidelines are still under review by the Patent Office

 

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