[Ip-health] Patent office eases rule for pharma companies
claire.cassedy at keionline.org
Wed Oct 29 13:32:00 PDT 2014
Patent office eases rule for pharma companies
Wed, Oct 29, 2014 11:51pm
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
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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