Home >Companies >Patent office eases rule for pharma companies

Mumbai: India’s patent office has conceded a key demand of the pharmaceutical industry, dropping a proposed clause that would have enforced a more stringent examination of patent applications.

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.

Before any patent is granted, the examiner must search and establish that the claimed invention is unknown and no patents existed for this prior to 1995. To eliminate patent applications for pre-1995 molecules, the draft guidelines released in August had sought to rely on the drug’s so-called international non-proprietary name (INN), which is the generic name of a drug given by the World Health Organization (WHO) to identify the unique nature of the drug’s ingredients as the key words for online search.

Foreign drug makers, industry lobbies and other stakeholders had criticized the clause, saying it was difficult to use generic names to describe new inventions and that it would not generate accurate search results.

The change in rules followed recent changes in intellectual property regulations and verdicts by Indian courts on cases involving pharmaceutical patent claims in the last several years.

The INN search was proposed as there were several instances of patent applications filed for similar or same drugs using different names or descriptions.

The patent office has now made it an optional clause as the examiner can decide what is appropriate for a perfect search on a case-to-case basis.

“While conducting a prior art search, the examiner should design/frame a comprehensive search strategy by combining various search parameters including key words, compound searches, molecular formula, INN or generic name or international patent classifications, etc.," according to the final guidelines.

“It is to be noted that quite often the claims of the pharmaceutical compounds involve derivatives of known compounds having established pharmaceutical activities. Also, it has been observed that such pharmaceutical substances have already been assigned generic names. When the patent specification under examination discloses such INNs, the examiner should search the prior art on the basis of such INNs as well," the new rules say.

According to the new norms, in case it is found that the applicant claims the second use/indication in the form of a product claim of an already known pharmaceutical compound/new form of a known substance or compound, the examiner should follow the same methodology and ask the applicant to inform the INN of the pharmaceutical substance. And, if the applicant does not inform the INN even on the request, the examiner should try to find out the INN and use it in the search strategy.

But this relaxed norm can be misused, says an industry expert. “At a time when pharma companies find it hard to come out with new inventions, they often try finding modifications and incremental changes on existing drugs, to come out in the market, using misguiding descriptions," said a senior executive from the industry, who doesn’t want to be identified.

Not-for-profit patient care groups, including Médecins Sans Frontières, had welcomed INN, Mint reported in September.

The Indian patent office’s new patent rules have, however, retained most of its draft rules, including enhanced therapeutic efficacy as a key criterion for patent grant for modified forms of already known drugs, among others, in the final document.

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