LIFE FORMS, HERBAL DRUGS AND PATENT REGIMES

1. LIFE FORMS, HERBAL DRUGS AND PATENT REGIMES M.P.NAYAR Consultant ENVIRONMENTAL RESOURCES RESEARCH CENTRE, TRIVANDRUM.

2. INTELLUCTUAL PROPERTY RIGHTS • PATENTS • PLANT BREEDERS RIGHTS • COPY RIGHT • TRADE MARK • INTERNATIONAL CONVENTIONS • TRADE RELATED INTELLUCTUAL PROPERTY (TRIPS) • CONVENTION ON BIOLOGICAL DIVERSITY • UNION FOR PROTECTION OF PLANT VARIETIES(UPOV)

3. TRADE RELATED INTELLUCTUAL PROPERTY RIGHTS (TRIPS)- ISSUES • PRODUCT INSTEAD OF PROCESS PATENTS SHOULD BE ACCEPTED FOR CHEMICALS AND PHARMACEUTICALS • LIVING ORGANISMS LIKE MICROORGANISMS HAVE TO BE PROTECTED BY PATENTS OR SIMILAR LAWS.

4. ACTION TAKEN ON THEISSUES-TRIPS BY PARLIAMENT. PATENT AMENDMENT ACT OF 1999. APPLICATIONS FOR PRODUCT PATENTS IN AGRO CHEMICALS AND PHARMACEUTICALS WOULD BE EXAMINED IN 2004 AND GRANTED IF IT MEETS THE STIPULATIONS IN 2005. PATENT 2ND AMENDMENT BILL: INTRODUCED IN THE PARLIAMENT - NOT YET PASSED. • ACCEPTING PRODUCT PATENT REGIMES AS PER TRIPS • RAISING THE TERM OF PATENT TO 20 YEARS • NARROWING THE FRAMEWORK FOR COMPULSORY LICENSING. • ALLOWING PATENTING OF MICROORGANISMS • THE BILL PROVIDES STRONGER PROTECTION TO PATENT HOLDERS.

5. SYNOPTIC VIEW OF IPR ON LIFE FORMS • IPR REFERS TO ALL FORMS OF PROPERTY THAT ORIGINATE FROM A CONCEPT OR PRODUCT OF INTELLIGENCE. • PATENTS ARE RIGHTS GRANTED BY GOVERNMENTS FOR A CERTAIN PERIOD OF TIME ( TYPICALLY 17 OR 20 YEARS). • ELIGIBILITY: NOVEL; MUST NOT BE OBVIOUS; MUST NOT BE “ DISCOVERY” BUT “INVENTION”; must have industrial application. • “Discovery” means acquiring knowledge ie. Protein synthesis in Nature. “ Invention” means cloning or transferring of genes.

6. ELIGIBILITY OF PATENTS IN LIFE FORMS OR HERBAL DRUGS • PRODUCTS: NEW MOLECULES OR NEW ORGANISMS (MICROORGANISMS ISOLATED OR MODIFIED.) • COMPOSITIONS: FORMULATIONS OF PRODUCTS FOR SPECIFIC USES. • NEW USES: PRODUCTS OR MICROORGANISMS FOR NEW USES.

7. MICRO-ORGANISMS FOR PATENTING? • Diamond versus Chakrabarty case in 1980. Man- made micro-organsims granted patents by USPTO. • The USPTO under class 435 defines microorganisms as ‘bacteria, actinomycetes, cyanobacteria unicellular algae, fungi, protozoa, animal cells or plant cells or virus.”

8. MICRO-ORGANISMS , BASIS OF LIFE AS PER ENDOSYMBIOSIS A PRIMITIVE PLANT CELL HAS SYMBIOTIC ASSOCIATION OF UNICELLULAR CYANOBACTERIA FUNCTIONING AS PHTOSYNTHETIC PLASTID AND BACTERIA FUNCTIONING AS MITOCHONDRIA. American lawmakers in 1987 (USPTO) ISSUED AN ORDER THAT EXTENDED PATENT PROTECTION TO ALL”MULTICELLULAR LIVING ORGANISMS, INCLUDING ANIMALS, EXCLUDING HUMAN BEINGS.

9. All GENES ARE NATURAL AND OBVIOUS • ALL GENES OCCURRING IN BACTERIA, FUNGI OR MICROORGANISMS ARE NATURAL AND OBVIOUS. • HOW SUCH NATURAL GENES PASS THE YARDSTICK OF NOVELTY OR INVENTIVENESS? • ARRANGEMENTS OR INSERTION OF SUCH NATURAL • GENES THROUGH BIOTECHNOLOGICAL INTERVENTIONS (TRANSGENICS) WHICH ARE OBVIOUS SHOULD NOT BECOME ELIGIBLE CRITERIA FOR PATENT REGIMES. • IN THE INDIA PATENT SECOND AMENDMENT RULES 2002, INCLUSION OF MICROORGANISMS FOR PATENTING IS HIGHYLY UNETHICAL AND OPEN FLOOD GATES OF FOREIGN PATENT NORMS AND HENCE SHOULD BE REJECTED.

10. PATENT ACT 2ND AMENDMENT- IS NOT CONSUMER FRIENDLY • SCOPE FOR SUITABLE DEFINITIONS FOR MICROROGANISMS AND GENES WHICH INDIA COULD TAKE ADVANTAGE OF. • CLAIMS FOR USES OF COMPOUNDS COULD BE INCLUDED. • DISCOVERY OF A NEW USE OF A COMPOUND OR MOLECULE SHOULD HAVE BEEN INCLUDED. ( Swiss-type”) - UTILITY PATENTS • ARTICLE 31 OF TRIPS DOES NOT PLACE ANY RESTRICTION UNDER WICH COMPULSORY LICENSING CAN BE GIVEN. IT IS NECESSRY TO HAVE EASY TO ADMINISTER CL SYSTEM. • The entire amendment is made mechanically: reapeating the Trips clauses and mechanically following the same.

11. PATENT ACT 2ND AMENDMENT : IS NOT CONSUMER FRIENDLY • ARTICLE 30 OF TRIPS PROVIDES LIMITED EXCEPTIONS FOR PATENT RIGHTS. • PERMISSION OF NON –PATENTEES IN INDIA TO PRODUCE AND EXPORT PATENTED MEDICINES TO LEAST DEVELOPED COUNTRIES SHOULD BE INCLUDED

12. OTHER LAWS ENACTED BY PARLIAMENT: DIRECT BEARING ON HERBAL INDUSTRY • THE BIOLOGICAL DIVERSITY BILL:2000 conservation of biological diversity and sustainable utilisation; regulates access to biological reources through National Biodiversity Authority and through State Biodiversity Boards. Allows free access to biological resources to citizens of india for research; use of bioresources for traditional systems of medicine (Vaids & Hakims); Protection of Indigenous knowledge. THE FEAR OF BIOPIRACY LED TO BUREUCRATISATION OF PERMIT SYSTEMS WHICH WOULD AFFECT COLLABORATIVE SCIENTIFIC RESEARCH ON BIODIVERSITY

13. OTHER LAWS ENCACTED BY PARLIAMENT:DIRECT BEARING ON HERBAL INDUSTRY • THE PLANT VARIETY PROTECTION AND FARMER’s RIGHTS BILL 1999. Includes transgenics in the definition of “Variety”. The bill provides for a protection of 15-18 years. Researchers are given excemption for use of the protected variety. The registration of essentially derived varieties shall requisre authorisation by the breeder of the initial variety. • Farmers have been given the right to resuse the farm-saved seeds. Protection is prohibited to environmentally harmful transgenics or those have “Terminator technology”

14. Other laws enacted by Parliament: a Direct bearing on herbal industry • Geographical Indications of Goods (Registration and Protection) Act, 1999. Intends to register and protect Geographical Indications. A statement of how geographical indication of goods originating from the concerned territory is known in respect of quality, reputation or other characteristics which are exclusively or essentially to the geographical environment.

15. India losing on Herbal Patents? • India is losing the patents of various herbal medicines and formulations to foreigners. eg. Basmati, cumin , gooseberry, blackberru, pepper, soap nut, bitter gourd, brinjal etc. • USPTO patented eight ginger formulations which is used to treat gastroesophagal reflux.(Seshadri,2001). • Article 7 & 8 of TRIPS are used to reject patent applications that try to patent the herbs used in Ayurveda with trivial modifications. • Endemic Plants of India comprising 33% of Indian flora are only truly indigenous to India. (Nayar,1996)

16. India losing the race for herbal patents? Of the 416 herbal patents filed in the US Patent office (1996- 2001), only 18 belonged to India, while US has 134 patents and Canada has 66 herbal patents. There are 174 processes patents for Castor, used for industrial and non-food products. The companies which have developed several Castor processes could form a cartel, trying to get the raw materials from India at a low price. The above principle holds good for several herbal products unless we move faster in developing high quality scientific work on “Utility Patents”. Madan Diwan, Coordinator, World Agricultural Forum (2001). rediff.com.

17. Chinese herbal patents:Scientifc Methodologies followed: • : Quality Assurance of Herbs: • Identification (TLC finger print) • Validation ( Species and plant parts) • Efficacy ( Phytochemical profile ( HPLC , Thin Layer Chromatography, Mass Spectrocopy, Gas Chromatography) • Quality Extraction (Cold percolation)

18. CHINESE HERBAL PATENTS: SCIENTIFIC METHODOLOGIES • QUANTIFIED ACTIVITY AND STANDARDISATION Liquid Extract, Low Temperature Vaccum concentrater, Liquid concentrate, Granulatioin, Low Temperature Vacum Oven, Milled to tiny granulation, Tablet punch. Enteric coat, Finished tablets ( Tested for Friability, disintegration, physical properties, active compounds).

19. Chinese herbal patents: Quality assurance processes: • Tested for aroma, Colour, Texture, Content of specified activities, Thin layer chromatography finger printing, Microbial levels, Amount of extraneous matter, Pesticides and herbicides, Heavy metals, Afflatoxins and Radiation levels. • Adulteration testing. • Substitution of species. • Poor quality of herbs.