Concept of Substantial Similarity In Pharmaceutical Patent Infringement Cases and the Implications of Section 3d of Indian Patent Act
Abstract
Dr. Shuchi Midha*1, Aditi Midha2
The research paper discusses the main aspects of Section 3(d) of
the Indian Patent Act 1970 with respect to the Indian
pharmaceutical industry. Three cases viz. the Novartis Glivec,
Pfizer’s Sutent and GSK’s Tykerb have been discussed that
explicitly demonstrate, pharmaceutical inventions rarely relate to
new chemical entities or novel active ingredients that have never
before been available for therapeutic use, thus encouraging
pharmaceutical companies to prolong patent protection by
obtaining separate patents on multiple attributes of a single
product. Section 3(d), whereby, regulates the granting of
pharmaceutical product patents by limiting the scope of
protection available for derivatives and new uses of a known
substance, thereby preventing patents on trivial modifications of
known substances. Thus, India’s Section 3(d) should be viewed as
a “public health safeguard” that aims to prevent “evergreening,”
and not a radical departure from international practices.
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