Unit 5: Patenting and Regulatory Authorities of Natural Products

Definition and common terms

Patent

Patent: A legal right (a form of IPR) granted by a government to an inventor. It gives the inventor the exclusive right to make, use, or sell their invention for a limited period (usually 20 years), in exchange for a full and public disclosure of the invention.

To be patentable, an invention must be:

1. Novel (new)
2. Non-obvious (involve an inventive step)
3. Useful (have industrial applicability)

Crucially: A discovery of something that already exists in nature (like a plant or a gene) is not an invention and cannot be patented. However, a *new process* to extract a compound from that plant, or a *new use* for that compound, *can* be patented.

IPR (Intellectual Property Rights)

Intellectual Property (IP) refers to creations of the mind: inventions, literary and artistic works, designs, symbols, names, and images used in commerce. IPR are the legal rights that protect these creations, just as property rights protect physical land or goods.

Major types of IPR include:

• Patents (for inventions)
• Copyrights (for creative works like books, songs, software)
• Trademarks (for brand names and logos, e.g., "Coca-Cola")
• Geographical Indications (GI) (for products from a specific location, e.g., "Darjeeling Tea")

Traditional Knowledge (TK)

Traditional Knowledge (TK): Knowledge, innovations, and practices of indigenous and local communities around theworld.

It is developed over centuries, passed down from generation to generation, and is collectively owned by the community. The use of neem for antiseptic properties or turmeric for healing in India is perfect example of TK. Because TK is "prior art" (already known), it is not novel and cannot be patented.

Farmer's right & Breeder's right

• Breeder's Right: A form of IPR that gives a plant breeder the exclusive right to a new, distinct, uniform, and stable plant variety they have developed (e.g., a new type of hybrid rose or high-yield wheat). This is protected in India under the PPV&FR Act, 2001.
• Farmer's Right: A set of rights that balances the Breeder's Right. It recognizes that farmers are not just cultivators, but also conservers and breeders of traditional plant varieties. In India, this right gives farmers the freedom to save, use, sow, re-sow, exchange, or sell their farm produce, including seeds of a protected variety (except branded seed).

Bioprospecting & Biopiracy

• Bioprospecting: The legal and ethical exploration of natural biodiversity (plants, animals, microbes) to find new genetic resources and chemical compounds that have commercial value (e.g., for medicine, cosmetics). This is done with the permission of the host country and includes "benefit-sharing" agreements.
• Biopiracy: The illegal or unethical theft of these natural resources or the associated Traditional Knowledge. This typically involves a foreign corporation or institution patenting a resource or TK from a developing country without permission and without sharing any of the profits with the indigenous community that held the knowledge.

Case Studies: Turmeric patent and Neem patent

These are the two most famous examples of biopiracy against India, which India successfully fought and won.

Turmeric Patent (Haldi)

• What happened? In 1995, the US Patent and Trademark Office (USPTO) granted a patent (US Patent 5,401,504) to two researchers at the University of Mississippi Medical Center. The patent was for the "use of turmeric in healing wounds."
• India's Challenge: The Indian government (specifically, the CSIR) challenged this patent.
• India's Argument: This was not a new invention. It was a classic case of biopiracy. The use of turmeric (haldi) for healing wounds and as an antiseptic has been Traditional Knowledge (TK) in India for thousands of years.
• Evidence: CSIR provided ancient Sanskrit texts and other documents that clearly described the healing properties of turmeric.
• Outcome: In 1997, the USPTO agreed, revoked the patent, and accepted that the "invention" lacked novelty.

Neem Patent

• What happened? In 1994, the European Patent Office (EPO) granted a patent (EP 0436257 B1) to the US corporation W.R. Grace and the US Dept. of Agriculture for a "method of controlling fungi on plants using an extract from neem seeds."
• India's Challenge: The patent was challenged by a group of Indian and international NGOs, led by Dr. Vandana Shiva.
• India's Argument: This was also biopiracy. The fungicidal properties of neem oil and its extracts are well-known TK in India, where farmers have used it as a natural pesticide for centuries.
• Outcome: After a 10-year legal battle, the EPO revoked the patent in 2005, agreeing that the "invention" was not novel and was based on TK.

Drugs Technical Advisory Board (DTAB)

• What is it? The DTAB is a statutory body (established by law) under the Drugs and Cosmetics Act, 1940.
• Role: It is the highest technical advisory body in India on all matters related to the administration of the Act.
• Function: Its primary function is to advise the Central and State Governments on technical matters related to drugs and cosmetics. This includes:
  • Setting standards for drugs (including herbal drugs).
  • Advising on which drugs should be regulated.
  • Recommending amendments to the law to ensure drug safety, quality, and efficacy.
• Note: The DTAB is part of the CDSCO (Central Drugs Standard Control Organization), which is India's main regulatory body for pharmaceuticals, headed by the Drug Controller General of India (DCGI).

Plant based medicinal and aromatic industries and institutions in India

Industries (Companies)

India has a massive industry for Ayurvedic, Unani, and herbal products. Key players include:

• Dabur: One of the oldest and largest (e.g., Chyawanprash, Hajmola).
• Himalaya Wellness: Famous for herbal healthcare and personal care products (e.g., Liv.52).
• Baidyanath: A major traditional Ayurvedic company.
• Patanjali Ayurved: A large, newer company that has popularized herbal products.
• Zandu: Now part of Emami (e.g., Zandu Balm).

Institutions (Government & Research)

• Ministry of AYUSH: The government ministry responsible for promoting and regulating traditional systems of medicine (Ayurveda, Yoga, Unani, Siddha, Homoeopathy).
• CIMAP: (See Unit 2) Central Institute of Medicinal and Aromatic Plants (Lucknow). The premier CSIR lab for MAPs research.
• NBRI (National Botanical Research Institute): A CSIR lab in Lucknow that also works on plant-based drug development.
• ICFRE (Indian Council of Forestry Research and Education): Works on the conservation and cultivation of medicinal plants in forest areas.
• NIPER (National Institute of Pharmaceutical Education and Research): The top institute for pharmaceutical sciences, including pharmacognosy and natural product research.

Good Manufacturing Practice (GMP) of Indian system of medicine

GMP (Good Manufacturing Practice): A set of guidelines and quality standards for the manufacturing of drugs, cosmetics, and food. It ensures that products are consistently produced and controlled to the quality standards appropriate for their intended use.

The Ministry of AYUSH mandates GMP compliance for all Indian System of Medicine (ISM) manufacturing units to ensure safety and quality. Key components of GMP for herbal medicine include:

• Premises: The factory must be clean, hygienic, and well-designed to prevent cross-contamination.
• Raw Materials: Proper storage and testing of all incoming raw herbs to confirm identity (authentication) and purity (checking for adulteration, pesticides, heavy metals).
• Equipment: All machinery must be clean, calibrated, and properly maintained.
• Personnel: All workers must be trained in hygiene and proper manufacturing procedures.
• Quality Control: A separate quality control lab must test the raw materials and the final, finished products to ensure they meet the set standards (e.g., correct ingredients, correct weight, no microbial contamination).
• Documentation (The most important part): Every step must be documented. This includes batch manufacturing records (BMRs), standard operating procedures (SOPs), and quality test reports. This ensures traceability and accountability. If something goes wrong, the records can be checked to find the source of the problem.