patent examination INDIA guidelines for pharmaceutical based inventions
Indian Patent Attorney, INTELLECTUAL PROPERTY STRATEGY, MARKET ENTRY strategy, medical device patents, Startup Lawyer India, venture capital financing

Overview of Pharmaceutical Patent Prosecution*Examination Guidelines IPO

  Pharmaceutical based Inventions Filed before the Indian Patent Office

The patent examination guidelines for pharmaceutical based inventions cover the following points: 

1. Patent Claims Of Pharmaceutical Inventions which includes Markush claims 

2. Comprehensive patent search strategy for conducting prior art search by the Patent Examiner 

3. Definition of “invention” under section 2(1)(j) of the Indian Patent Act 

4. Assessment of Novelty aspect of the invention 

5. Assessment of Inventive Step 

6. Industrial applicability of the technology 

7. Subject matter of Inventions which are not patentable 

8. Sufficiency of description, clarity and support of the patent claims in the specification 

9. Unity of invention

Patent Search Strategy for Pharmaceutical Inventions:

Comprehensive patent search strategy will be followed by the Indian Patent examiners. The patent search strings will include a combination of various search parameters.

The search parameters will be a combination of keywords, International Patent Classification (IPC), and compound searches. Thorough prior art search is expected to be carried out in patent as well as non-patent databases.

Pharmaceutical Compounds can be searched and identified from the various databases:

a) Molecular formula and structural formula searching; 

b) Name searching using IUPAC nomenclature; 

c) Compound searching using CAS Registry Numbers; 

d) Generic name searching (INN); and 

e) Search using International Patent Classification (IPC)

Many a times pharmaceutical compounds which are derivatives of known compounds having established pharmaceutical activities are claimed in the patent specification in the form of generic names (International Non-Proprietary Names, INN). In such cases, the patent examiner will search the prior art with INNs prior art search string. Moreover, in numerous pharmaceutical based inventions the patent applicant claims the second use or an indication in the form of a product claim of an already known pharmaceutical compound or a new form of a known pharmaceutical compound.

Even though, the patent examiner can seek information about the INN of the said pharmaceutical substance claimed in the patent application from the patent applicant there are chances that the conclusions drawn from the information provided may mislead the patent examiner. In my view, the Indian patent examiner can find out more information about the International Non-Proprietary Names by analysing data from the Electronic Orange Book.

Prior Art Search Strategy for Conducting Drug Patent Search in India

Search on Electronic Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Search String based on

Active Ingredient

Applicant Holder

Proprietary Name

Application Number

Patent

Therefore, prior art patentability search for patents covering (International Non proprietary Names – INN) as listed in the USFDA Electronic Orange Book should be taken into consideration. However, the Orange Book only provides US patent data. The patentability search can be extended and this information can be further used to conduct patent family searches on EPO website. Further, patentability search can be performed by analysing forward citation and backward citation of the identified patent specifications.

Biological Material and Micro-organism Deposit Details to be Disclosed in the Indian Patent Application

If the invention relates to a biological material which is not possible to be described in a sufficient manner and which is not available to the public, the application shall be completed by depositing the material to an International Depository Authority (IDA) under the Budapest Treaty. The deposit of the material shall be made not later than the date of filing of the application in India and a reference of the deposit shall be given in the specification within three months from the date of filing of the patent application in India. All the available characteristics of the material required for it to be correctly identified or indicated are to be included in the specification including the name, address of the depository institute and the date and number of the deposit.

 

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