The Indian Patent Office released the ‘Revised Draft Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals’ on 12th August, 2014. Comments and suggestions can be sent before 2nd September, 2014. The draft guidelines discuss the approach to determine ‘invention’, ‘inventive step’ and ‘industrial application’ besides Section 3 on non-patentable inventions and sufficiency of disclosure and support of claims.
Illustrative examples are provided at various points to better explain the conclusions drawn. The guidelines state that combination or composition claims should be dealt under novelty also since a combination may already be in public domain and cite the example of a corneal healing aid comprising Vitamin A and a sterile buffer administered to the eye which may be found in a prior art disclosing the use of the eye-drops to rewet contact lenses, wherein said eye-drops comprise of Vitamin A, the sterile buffer and other excipients. For product by process claims, the product must qualify for novelty and inventive step irrespective of the novelty or inventive step of the process.
The guidelines for examination of biotechnology applications and guidelines for processing of patent applications relating to traditional knowledge and biological material released earlier are to be incorporated appropriately while processing patent applications.