Origiin IP Solutions views the move by the Indian Patent Office to simplify the method of analysing the patent applications of pharma companies a positive development. This would not just save time but also make the process of prior art search more efficient and accurate, Bindu Sharma (Patent Attorney) and chief executive officer, Origiin IP Solutions LLP, Bengaluru told Pharmabiz.

Recently, a clause in the draft rules, mandating the use of generic names of pharmaceutical substances to check whether discovery claims made in a drug patent application were already known or not, has been dropped in the final rules by Indian Patent Office. Though it is convenient to perform prior art search using generic name of the drug yet it leads to several discrepancies especially when the invention related to drug, which is derivative of a known compound, she added.  

Examination of a patent application is a process, where the claim made in a patent application is scrutinised by the examiner for novelty, non-obviousness and industrial use. As novelty is the first requirement for patentability, the examiner assesses the same by performing prior art search. Identification of prior art involves key word search, International classification search, assignees search etc. Such prior art is then compared with the claimed invention and novelty/patentability of the claimed invention is assessed.

Pharmaceutical patents have been always in news for one or the other reasons. Now for prior arts search, formulation of appropriate key words is needed, in order to search pharmaceutical patents, generic name of the drug, as given by World Health Organisation (WHO) is often used by the examiners as one of the key words, said Sharma.

The sole purpose of usage of generic name or International Nonproprietary Names (INN), as provided by WHO is to eliminate the usage of multiple names for the same drug. Hence INN acts as a standard generic name for the drug to describe unique nature of the drug’s ingredients to be used as key word for prior art search, she said.

The most critical issue related to usage of INN for prior art search is that if the patent application claims a drug, which is derivative of a known drug or compound, the search reveals all patents with the same INN as prior art. This makes the process of examination very complex and inaccurate. Once all such results have been obtained, comparison of the same with claimed invention is even more challenging, said the Origiin chief.

The good thing about the new rule is that if the patent application claims new use of the same substance or new form of the same substance, which is a non-patentable subject matter under Section 3 of the Indian Patents Act, 1970, examiner may ask applicant to disclose INN of the drug to the examiner. The prior art search in this case not just is directed towards INN but also takes into consideration the additional parameters, such as, key words, compound searches, molecular formula search or IPC or assignees based search etc which will generate accurate results, said Sharma.