The Patent Act 1970

The Indian Patents Act, 1970 was established on 20th April, 1972. This
act has replaced the Indian Patents and Designs Act, 1911. The Ayyangar
Committee Report headed by Justice N. Rajagopala Ayyangar
recommended the establishment of the said act. There were many major
changes that were recommended. One of the major changes was the
introduction of process patents with regard to medicines, drugs etc. But
section 3(d) is considered as the most criticized part of this act. Moreover,
this section is the tyranny for many pharmaceutical industries. Many of
the drug patents are rejected on the ground that it lacks novelty or it
does not result in enhanced efficacyIt also mentions the conditions that a
person needs to know before filing the patent in any field and these are
Novelty, Utility and Non-obviousness (NUN test).

The invention needs to pass the desired test only then such invention can
be patented.
Patent act, 1970 also restrict the monopoly rights of the patent owner
over the patented drug or medicine.
There are numerous historical judgments that deal with the patents in
pharmaceutical sector and the complications they face in the grant of
patents.The article deals with the case law “Novartis AG. V. Union of
India” is one of the landmark judgments in the Indian Patent regime. This
was the long run battle fought by Novartis for the grant of patent for the
invention of a drug that he discovered for the treatment of leukemia.

Section 3(D) of Patents Act 1970

Section 3 of the Patents Act 1970 says about the inventions which are not
patentable. Under section 3(d) of the act says that the mere discovery of
a new form of a known substance which does not result in the
enhancement of the known efficacy of that substance or the mere
discovery of any new property or new use for a known substance or of the
mere use of a known process, machine or apparatus unless such known
process results in a new product or employs at least one new reactant.
Explanation -For the purposes of this clause, salts, esters, ethers,
polymorphs, metabolites, pure form, particle size, isomers, mixtures of
isomers, complexes, combinations and other derivatives of known
substance shall be considered to be the same substance, unless they
differ significantly in properties with regard to efficacy.

NOVARTIS AG v. UNION OF INDIA

Novartis v. U.O.I. is one of the landmark cases in Intellectual Property
Law. The case brought into the question, the interpretation of section 3(d)
of Indian Patent Act, 1970. The battle started in the year 1980 by the
International Pharmaceutical Company, Novartis International AG which
invented a drug named “Gleevic” which was an anti-cancer drug. It was
used for the treatment of Chronic Myeloid Leukemia (CML) and
Gastrointestinal Stromal Tumours (GIST) but the major thing was it was a
beta crystalline form of Imatinib mesylate.
The patent application filed by Novartis was rejected by Madras Parent
Office on the ground of anticipation by previous publication. Also it was
said that it lacks the requirement of novelty and non-obviousness
therefore, it is not capable of patented.
After that, Novartis filed two writ petitions in 2006 in Madras High Court
under Article 226 of the Constitution of India. it was being also contended
that section 3(d) of Patent Act, 1970 was held unconstitutional on the
ground that it is not in consonance with the TRIPS agreement.
Then the case was transferred to IPAB (Intellectual Property Appellant
Tribunal) in 2007 which was dismissed by IPAB
Finally in the year 2013, this battle came to an end. The Supreme Court
rejected the appeal filed by Novartis. It was held by the court that the
beta crystalline form of Imatinib Mesylate is only a new and modification
of the substance Imatinib Mesylate.