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KIND OF PATENTS

Covering Main Invention Patent: Requiring Novel and Inventive Technical Advancements:

• Basic Filings : Direct India Filings
• Convention Filings: Claiming Paris Convention/WTO Priority
• National Phase: Based on PCT International Application

Covering any Improvement or Modification of a Main Invention Patent on Record:

Patent of Addition : Protect novel aspects vis-a-vis a prior dated main invention Patent

ALLOWABLE AMENDMENTS POST FILING

In Text : Only by way of Disclaimer, Correction or Explanation;

In Claims: Should not extend beyond the scope of originally filed claims.

Publication and Provisional Rights on Pending Applications:

• All applications for patent are published after 18 months from Priority/date of filing whichever is earlier.
• Publication of application entails Provisional Rights-Patentee can claim damages from date of publication of pending application in e-Journal but infringement suit allowed after grant.
• Patent Searches through published Indian Patent Applications possible for pre-grant opposition.

Request for Examination:

Anytime within 48 months from priority date.

Examination taken up only after six months from publication of application in Official Journal

Patentable Claims/ Pharmaceutical Products:

• 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 reword to new product or process 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.

Critical Issues Under Consideration in case of advancements relating to inventions involving “Biological Resources”

Developments Leading to Statutory Provisions and Patentability Issues:
Doha Ministerial Declaration, 2001: Consequences and Historical facts

• 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;
• Relevant Guidelines prescribed by the Indian Patent Office on patentability of advancements involving bio-resources sourced from India or abroad:
• For PLANT BASED APPLICATIONS fulfilling patentability criteria by considering any prior Traditional knowledge in indigenous community and folklore documented under India’s own TKDL (Traditional Knowledge Digital Library) and the relevant sections of 3(b), 3(c), 3(d),3 (h), 3(i), 3(j), 3(p) of the Indian Patents Act, 1973 elaborated hereunder;

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;
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(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;
3(h) A method of agriculture or horticulture is not an invention;
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;
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;
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.
For BIOTECHNOLOGY BASED APPLICATIONS fulfilling patentability criteria by considering the relevant sections of 3(b), 3(c), 3(d), 3(f), (h), (i), (j), (p) of the Indian Patents Act, 1973; 3(f) elaborated hereunder:
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.
THUS IN BIORESOURCE BASED ADVANCEMENTS, WHEREIN THE BIORESOURCE IS SOURCED FROM INDIA, PATENTS IN MAY BE SECURED ONLY AFTER FULFILLMENT OF PATENTABILITY CRITERIA AND THE DUE PERMISSION FROM NATIONAL BIODIVERSITY AUTHORITY (NBA), INDIA:

INSIGHTS ON PATENTABILITY CRITERIA - PLANT BASED PATENT APPLICATIONS

• 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).

EXTENSION OF PATENTABILITY CRITERIA - BIOTECHNOLOGY BASED PATENT APPLICATIONS

• 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.

Disclosure Requirements Questioning Validity :

After the date of publication of application and before the date of grant preferably within 6 months from publication anyone can oppose the grant relying inter alia on:

• a. Documents which could reveal prior publication or lack of inventive merit or lack of patentability;
• b. Complete specification failing to describe the invention or manner in which the invention is performed;
• c. Complete Specification does not disclose or wrongfully disclose the source or geographical origin of biological material used

DEADLINES

• Convention Filings : Within 12 months
• PCT National Phase : Within 31 months :

National Phase Entry should be made with specification and claims of international phase and with fees based thereon. Further amendments only by special request for voluntary amendment after the national phase is filed.

Patent of Addition : After filing main invention and within the term of the main invention.

Extensions : None

FEES

Basic fees vary when Applicant is an Individual and when it is a legal entity such as a Company Excess Fees :

• Payable for more than 30 Sheets & For more than 10 Claims;

For multiple priorities beyond 1 priority