NON PATENTABLE INVENTIONS B) Primary or intended use or commercial exploitation of which could be contrary to Public order or morality or which

causes serious prejudice to human, animal or

plant life or health or to the environment . For example: o o o o Gambling machine, device for house-breaking, Biological warfare material or a device, WMD Onco-mouse case, embryonic stem cell Terminator gene technology,

C ) Mere Discovery of a Scientific Principle or Formulation of an Abstract Theory or discovery of any living thing or discovery of nonliving substance occurring in nature -Discovery adds to the human knowledge by disclosing something ,not seen before, whereas, - Invention adds to human knowledge by suggesting an act to do which results in a new product or new process

Archimedes Principle, Superconducting Phenomenon etc as such not patentable.

However, An apparatus/method for technological application may be patentable. Discovery of a substance, freely occurring in nature is not patentable.

- However, if that substance is first to be isolated from its surrounding and a process for obtaining it is developed , the process may be patentable.

d) 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.

3 d : Explanation :
For the purposes of this clause,

salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixture of isomers, complexes, combinations, and other derivatives of known substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.
eg. New use of Aspirin in heart ailments, Mere new uses of Neem

Novartis Case

In 1997, Novartis AG, filed a patent application in the Chennai Patent Controllers office for the beta-crystalline of imatinib mesylate, brand name Glivec (Gleevec) on the ground that it invented the beta crystalline salt form (imatinib mesylate) of the free base, imatinib.

Novartis patent application was kept in the mail-box and not opened until 2005 .

In the meantime, Novartis had obtained Exclusive Marketing Rights (EMR) for marketing Gleevec in India.
In 2005, India amended its patent law to comply with its obligations under the TRIPS Agreement to provide process and product patent.

Novartis Case
Many Generic Companies filed pre-grant oppositions against Novartis patent application for imatinib mesylate, on the ground;

that Novartis alleged invention lacked novelty,

was obvious to a person skilled in the art, and that it was merely a new form of a known substance that did not enhance the substances efficacy, and was thus not patentable under section 3(d). Generic companies contended that the 1993 patent effectively disclosed both the free base, imatinib, and the acid-addition salt, imatinib mesylate. They further contended that different crystalline forms of imatinib mesylate didnt differ in properties with respect to efficacy, and thus the various forms of imatinib mesylate must be considered the same substance under section 3(d).

Novartis Case
Novartis filed writ petition (2007) 4 MLJ 1153) and in its
challenge to the constitutional validity of section 3(d) was that the use of the term efficacy in section 3(d) is vague and ambiguous, and therefore violates the equality provision (Article 14) of the Indian Constitution. Madras High Court issued its decision rejecting Novartis writ petitions challenging the validity of section 3(d).

It held that the term efficacy was known in the pharmaceutical field to mean therapeutic efficacy.

Novartis Case
Appeal on merits before IPAB
IPAB overturned the Patent Controllers findings on novelty and inventive step and held that the beta-crystalline form of imatinib mesylate was new and involved an inventive step. However, the IPAB held that Novartis alleged invention did not satisfy the test of section 3(d); It further held that Novartis did not provide data to show that the beta-crystalline form of imatinib mesylate exhibited significantly enhanced therapeutic efficacy over imatinib mesylate, the known substance.

E) A substance obtained by mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance For example: Not patentable1) Paracetamol + Certizin = A drug 2) A mixture of sugar and some colorants in water to produce a soft drink is mere admixture But, a mixture resulting into synergistic properties of mixture of ingredients however, may be patentable e.g Soap, Detergents,lubricants etc

i) Any process for medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or a similar treatment of animals to render them free of disease or to increase their economic value or that of their products. For example: o Removal of cancer tumor o Surgical processes o Method of vaccination

However , Method performed on tissues or fluids permanently removed from the body Surgical,therapeutic or diagnostic Apparatus or instrument are not excluded from patentability

j) Plants & animals in whole or any part thereof other than micro- organisms, but including seeds, varieties and species and essentially biological process for production or propagation of plants & animals For example:Clones and new varieties of plants: Not patentable; Microorganisms, per se: Not patentable, If human intervention in the process plays a significant role- not an essentially biological process A process for the production of plants or animals if it consists entirely of natural phenomena such as crossing or selection- essentially biological

Thank You