Page 191 - DMGT401Business Environment

Business Environment

Notes Indian behemoth Ranbaxy and Dr. Reddy's Lab bagged the largest number of US FDA approvals
for generic drugs ahead of other global generic majors like Teva, Sandoz, Mayne and Bedford.
Ranbaxy has already obtained the approvals for Clarithromycin along with Andrx and Roxane.
It is also the only generic company till now to have received tentative approvals for Simvastatin
and Pravastatin, whose patent expired in 2006. On the other hand, DRL has already secured the
EMR for Ondansetron. The company has already secured tentative approvals for Finasteride
along with Teva. (The Economic Times 18 December 2004.)
After the implementation of WIPO agreement, widespread changes are taking place in the
industry. In accordance with WIPO agreement, India also promulgated the Patent (Amendment)
Ordinance 2004. India has complied with the WTO negotiations by amending its Patent Act, 1970
in 1999 and also through Patents (Amendment) Act, 2002. The Patent (Amendment) ordinance
was a further step in this direction.
Some of the important provisions and their legal implications in respect of product patents are
as follows:

1. Patentable Subject Matter: According to the new ordinance, whatever falls within the
purview of the definition of 'invention' will be patentable in India. The amendment to the
Act in 2002 defines invention as "A new product or process involving an inventive step
and capable of industrial application".

Thus, if a product satisfies the tests of patentability, viz., novelty, inventive step (non-
obviousness) and industrial application (utility) it can be patented in India.
The second requirement of a patentable invention is that of novelty, which requires that
the invention should not have been known to the public before the patent application was
lodged. The novelty of an invention is determined by the patent examiner conducting a
search of literature in the relevant field to determine what the state of the art was at the
time of the patent application being filed.
The novelty requirement also necessitates that the invention should not have disclosed
publicly by the person applying for the patent. An example of the application of that rule
is that the application must not have offered the product for sale before applying for a
patent. The requirement of novelty is not actually as strict a limitation as one might
suppose. If the invention simply combines two well known pre-existing products of
techniques – say a method of encryption and a method of compression the combined
invention is still likely to be considered as novel.
Such an invention may however be found to lack an 'inventive step, which is the third and
final requirement that a patentable invention has to fulfil. An invention that lacks a
sufficient inventive step is one that would be obvious to a suitably skilled person, such as
another programmer who had access to technical literature in the field.

This comes with a certain exception. As under Section 3(j), "Plants and animals in whole or
any part thereof (other than micro organism) including seeds, varieties and species and
essentially biological process for the production of plants and animals – cannot be patented".
This is in line with Article 27.3 of TRIPS. Under Section 3(d) of the Act, the mere discovery
of any new property or new use for a known substance is not patentable.
(a) Farm Sector: The new amendment has not categorically excluded seeds developed by
novel means. The third amendment has extended the product patent regime, which
includes seeds developed by novel means, particularly transgenic seeds.

184 LOVELY PROFESSIONAL UNIVERSITY