• Should be worded as a new and inventive PRODUCT OR PROCESS.
• NEW FORMS/PROPERTY/USE OF KNOWN SUBSTANCE: Allowed only if specification demonstrates surprising and superior efficacy.
• NEW MIXTURES: Specification should demonstrate synergy/unexpected results in the mix. Therapeutic efficacy to be demonstrated for pharmaceutical/medicinal formulations.
• NEW COMBINATIONS: Combination should have working interaction towards a new technical advanced effect/article. Therapeutic efficacy to be demonstrated for pharmaceutical/medicinal formulations.
• Swiss Style Claims: Mere New Use of Known Substance as such not allowed. However if the compound is new it can be claimed as a new product or its involvement in a new process of manufacture.
• First Use Claims: Use claims as such are not allowed. You can try rewording to new product or processing claims involving such use.
• Dosage regime Claims: As method of treatment claims not allowed but technical advance of dosage in a product form such as a kit allowable.

• Software : Should be integrated with hardware and relate to some industrial application
• Business Methods : None

• A relationship was established between UN Convention on Biological Diversity (CBD) and TRIPS on the issue of access to Biological-resources & the fair and equitable sharing of the benefits arising from their utilization;
• India concluded TKDL Access (Non-Disclosure) Agreements with several International Patent Offices including USPTO, EPO, JPO etc; (link to the website may be given)
• India joined Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purposes of Patent Procedures on December, 2001;
• Section 10 (4) of the Indian Patents Act, 1970 amended in 2002 to include the mandate of disclosing the source and geographical origin of the biological material/ bioresource in the specification, and a declaration to that effect. If such biological material is not available to the public, the same has to be deposited to the International Depository Authority under the Budapest Treaty;
• Biodiversity Act 2002 was ratified.
• Section 2 (c) of Biodiversity Act, 2002 defines “Biological-resources”: means plants, animals and micro-organisms or parts thereof, their genetic material and by-products (excluding value added products) with actual or potential use or value, but does not include human genetic material;

1. 3(b) An invention, the primary or intended use or commercial exploitation of which would be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment is not an invention;
2. 3(c) The mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature is not an invention;
3. 3(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 new reactant is not an invention;
4. 3(h) A method of agriculture or horticulture is not an invention;
5. 3(i) Any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products is not an invention;
6. 3(j) Plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals are not inventions;
7. 3(p) An invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components is not an invention.

1. 3(f) The mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way is not an invention;

All applications for patents in India should be filed in prescribed Form 1 declaring involvement of biological resources, if any, from India and should also declare to obtain the necessary permission of the National Biodiversity Authority (NBA), India.

Also u/s 6(1) of the Biological Diversity Act, 2002 requires previous approval of the National Biodiversity Authority (NBA) on or after applying for patent and until grant of the Patent in India.

Patents may be obtained on a composition of combination of plants / extracts, alkaloids, ingredients isolated from plants, which when combined shows a special synergistic therapeutic effect , even if each of such plants / extracts, alkaloids, ingredients isolated from such plants are known to possess the same therapeutic effect for the treatment of a particular disease and documented under TKDL.

However, patents cannot be secured if the subject matter claimed relates to extracts/alkaloids and/ or isolation of active ingredients of plants which are naturally inherently present in the plants and if the use of such plants is pre-known as a part of the traditional knowledge documented under TKDL.

Patents are also obtained when a plant based ingredient as the active known to possess a therapeutic effect, when combined with other ingredients reveals a synergistic effect, when such other ingredients are not known to possess the same therapeutic effect.

Discovery of the Optimum or Workable range of traditionally known ingredients by routine experimentation is not inventive (in the absence of any synergy).

Products such as un-modified microorganisms, nucleic acid sequences, proteins, enzymes, compounds etc. which are directly isolated from nature are not patentable u/s 3(c) of the Indian Patents Act, 1973.

However, processes of isolation of unmodified microorganisms, nucleic acid sequences, proteins, enzymes, compounds etc. which are directly isolated from nature are patentable u/s 2(1)(j) of the Act.

Sequence claims of a polynucleotide/polypeptide are allowed if the sequences are new, have distinct/unexpected properties (e.g. known activity increases significantly) and is sufficiently enabled. Use of such sequence should not be merely speculative but specific, substantial and credible for establishing industrial applicability.

Fragments/ ESTs (Expression Sequence Tags) such as gene probe, chromosome marker should satisfy the question of usefulness and industrial applicability disclosing credible, specific, and substantial use such as a probe to diagnose a specific disease.

New form of a known substance/drug should have improved property (for known substance) / therapeutic efficacy (for drugs) to qualify u/s 3(d);

Method of treatment relating to application of substances to the body for purely cosmetic purposes is an allowable provision u/s 3(i); however, surgical, therapeutic or diagnostic instrument or apparatus are patentable, also manufacture of prostheses or artificial limbs and taking measurements thereof on human body are patentable.

Bioinformatics based invention not leading to any product is not allowed u/s 3 (k) of the Act.