Page 196 - DMGT401Business Environment

Unit 8: Legal Environment

5. Addition to a new provision to circumscribe rights in respect of mailbox applications, so Notes
that patent rights in respect of the mailbox shall be available only from the date of grant
of patent and not retrospectively from the date of publication.
6. Strengthening the provisions relating to national security to guard against patenting
abroad of dual use technologies.
7. Clarification of the provision relating to patenting of software related inventions when
they have technical application to industry or are in combination with hardware.

8. Rationalisation of provision relating to time-lines with a view to introducing flexibility
and reducing the processing time for patent application and simplifying and rationalising
procedures.
9. The government has the power to acquire a patent for national requirement.
10. Polymorphs new forms of older drugs are patentable.

11. Parallel imports are allowed.
12. Local production is mandatory.

13. The earlier provision of 'new use' criteria is modified to 'mere new use'.
14. Transfer of cases from High Courts to the Appellate Board (S.117G.)

8.2.3 Issues of Concern

Incrementally Modified Drugs (Ever Greening): Incrementally Modified Drugs (IMDs) include
new formulations, new combinations of active ingredients or new salts or esters of approved
compound. In the US brand manufacturers have flooded the market with IMDs, which "in 85% of
the cases, do not provide significant improvement over currently marketed therapies" (National
Institute for Health Care Management, Changing Patterns of Pharmaceutical innovation:
A Research Report, May 2002, p5).
In the pharmaceutical sector it is very common to file a patent application for already known
molecules by claiming trivial improvements. This naturally extends their monopoly even after
the expiry of the original patent. This process is often referred to as ever greening. Ever greening
of pharmaceuticals patents is a problem that India would have to grapple with in the near future,
when the product applications that are currently in 'mailbox' are examined.

Example: In the mailbox there are nearly 12,000 product patent applications, which
would have to be examined according to the provision of the recently amended act. It is to be
noted that between 1995 and 2003, only 274 new chemicals entities were granted marketing
approvals by the US Federal Drug Administration (FDA).
This implies that an overwhelming majority of the applications in the 'mailbox' cover IMDs.
According to a report of the US National Institute of Healthcare and Medicines (NHCM), drug
manufacturers patent a wide range of inventions connected with incremental modifications of
their products, including minor features such as inert ingredients and the form, colour and
scoring of tables. In some cases, these patents may discourage generic companies from trying to
develop a competitive product. In others, the generic company may be able to design around the
new features.

In such conditions, it is necessary for developing countries like India to limit the scope of
patentability only to new chemical entities so as to ensure accessibility, availability and
affordability of medicines.

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