Patenting aspects of traditional knowledge and natural products

For B.Pharm, 6th Sem

1. Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma & Neem

2. INTRODUCTION Traditional Knowledge: It may be considered as knowledge, know how, skills, innovations or practices; that are passed through generations within your communities, and thereby form part and parcel of your community. For examples, your knowledge About traditional medicines Traditional hunting or fishing techniques Animal migration patterns Water management, etc. These are precious assets, which are required to be protected.

3. Why it is important to protect? Traditional knowledge is integral to the identity of most local communities. It plays an important role in your health care, food security, culture, religious identity, environment, trade and development. If somebody tries to exploit your traditional knowledge for industrial or commercial benefits, it can affect your interests.

4. Intellectual P roperty Right (IPR) Defined as the Legitimate rights of the inventor for protection of his intellectual property thus excluding others from making, copying, using or selling his proprietary subject matter. IPR provides such protection. The Head Office of the Patent office is at  Kolkata  and its Branch offices are located at Chennai, New Delhi and Mumbai.

5. Types of IPR

6. PATENT Patent is A grant of exclusive right/type of IPR For an invention By the Government To the inventor F or limited period (20 years) In exchange for full disclosure of invention To prevent others from selling, making or using the invention. A patent is  an exclusive right granted for an invention , which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem. To get a patent, technical information about the invention must be disclosed to the public in a patent application .

7. OBJECTIVES OF PATENT 1.Giving a legal monopoly to the patentee to reap the economic benefits from his invention. 2.Facilitating the improvements or providing the alternative approaches to develop the new ideas or and products. 3. Invention of new drugs.

8. THE PATENT ACT 1970 According to the act: 1. A new invention 2. It should be new and non-obvious with respect to prior art 3. It must useful (Utility) 4. Not previously in use Invention, as per the act may be defined as any new and useful.

9. PATENTABLE: (From pharmacy) New process of manufacture NCE (New chemical entities, after 2005) New formulation processes New composition of matter

10. NON-PATENTABLE 1. Well established natural laws 2.Methods of detection, diagnosis or treatment of diseases 3 . Analytical methods 4.Methods of agriculture/cultivation 5 . The products made by Chemical synthesis 6.Animal,plant and biological methods for growing and rearing them. 7. Scientific methods 8. Mathematical/business methods 9. Literacy, drama, Music,. 10. Arrangement and re-arrangement/duplication

11. PROCEDURE FOR PATENTING: STEPS Step 1 – Check if your invention is patentable Step 2 – Draft the patent application Step 3 – Filing the patent application : Form 1  – Application for patent grant Form 2  – Patent specification form (provisional or complete) Form 3  – Undertaking and statement with regards to foreign applications under section 8 ( mandatory only in case a corresponding application for patent is filed in a foreign country) Form 5  – Declaration of invention to be filed with complete application Form 26  – Form authorizing patent agent (applicable only if you opt for an agent to help file the patent) Form 28  – Mandatory only if applicant is claiming small entity or start-up status Priority Documents  – You need to provide priority documents only if priority is being claimed from a foreign patent claim or application. Step 4 – Publishing the patent application Step 5 – Examining the patent application The patent examiner is obligated to follow a few steps of his/her own while examining your application. They are as under When the application lands on the examiner’s desk, it is scrutinized according to the Patent Act and underlying rules. The patent examiner searches for similar technologies to ensure the invention satisfies patentability criteria. After reviewing the application, a first examination report (FER) is submitted in which, grounds for objections, if any, are also stated. The examiner lists his objections in detail. This can further extend the application process by another 6- 9 months. Note that examiner objections are quite common in case of patents. If the inventor needs to make changes to his/her objection, he/she can file a request for time extension by submitting Form 4.

12. Step 6 – Decision to grant patent Once the examiner finds no objections in the patent application, he grants the patent. The patent is then published in the official patent gazette . https://ipindia.gov.in/ Step 7 – Renewing the Patent The patent holder also needs to renew his patent by paying an annual renewal fee. In India, it is possible to renew your patent for a period of 20 years at maximum , from the date the patent was first filed.

13. FILLING AN APPLICATION A. Name, address and nationality of the applicant B. Title, Name, address and nationality of the inventor, if he is not the applicant or co-applicant C. Specifications (provisional and complete) giving the details of the invention D. Claims, definition and scope of the invention

14. EXAMINATION OF THE APPLICATION A. Prior approved patents or applications filed B. Novelty C. Usefulness D. Nature of claims

15. Opposition: A three month time period is given for any opposition. Contrary claims can be filed and contested Granting & sealing of patent : In case of no opposition or clearing satisfactorily all the objections by the applicant, patent is granted and sealed by the patent office by publishing in the official gazette. https://ipindia.gov.in/

16. Revocation : The validity of the patent can be challenged in High court under specified grounds. The patent will be revoked if the court upholds the challenge. Validity of a patent: Patent for food and medicines and drugs produced by chemical processes 5 Years period from the date of Granting the patent OR 7 Years period from the date of filing application OR whichever is earlier. The term of every patent granted is  20 years from the date of filing of application .

17. PATENTABLE NATURAL PRODUCTS I. Formulation of new composition or improved formulation is patented: Eg : Patented herbal anti-allergic composition which comprises a synergistic mixture of extracts from the fruits of Terminalia chebula , bark of Albizia lebbeck , Terminalia bellerica and Embblica officinalis and process of preparation of such composition . The present invention also contains the fruits of Piper longum , piper nigraum and rhizomes of Zinger officinalae and thoroughly mixed to get the final composition which has potent anti-allergic activity. The preparation is useful for the treatment of allergic conditions .

18. II. Patent for new use of the herbal constituents Eg : The weight loss properties of Forskohlin (obtained from the roots of Coleus forskohlli ) were discovered by the firm ( Sabinsa corporation), in humans, which is not a traditional use of the Coleus active. For this, the company was grantentd a patent for its use and composition in promotion of lean body mass, reduction of adipose tissue (fat) and weight loss.

19. III. Modification or Synthesis of the natural compounds: Eg : The novel steroidal glycosides compounds which are extracted and isolated from the extracts of plant of the genus Trichocaulon or Hoodia containing an appetite suppressant agent and the derivatives of such compounds are synthesized with the aim of increasing the activity of the active ingredient. Also, this invention provides novel intermediates for the synthesis of active compound. The active ingredient in the Hoodia gordonil plant is called P57 and is responsible for its appetite suppressant qualities . Phytopharm , a British pharmaceutical company, has the exclusive patent on P57.

20. IV. A Novel isolation process: Eg ; For the process of isolation of Azadirachtin (fungicidal activity) from the seeds of neem and also its storage . N.C.L, Pune, Indian patent V . A new application of an isolated compound: Eg ; For the use of turmeric as a stabilising agent for menadione , an antifungal agent. Japanesh patent . VI. The inventions with novelties: Eg ; Bio-pesticides VII. Biotechnology related products VIII. Purification of the natural products

21. Case Study Of Curcuma Turmeric is a tropical herb grown in east India. Turmeric powder has a deep distinct colour and bitter taste. It is used as dye, cooking ingredient, litmus in chemical tests and for medicinal purposes. A United States patent on turmeric was awarded to the university of Mississippi Medical centre in May 1995 , specifically for the use of turmeric in wound healing. Two years later, a complaint was filed by India’s council of scientific and industrial Research (CSIR). CSIR argued that turmeric has been used in India for thousands of years for healing wounds and rashes and therefore the patent on its medicinal use was not a novel invention . T he CSIR claim was supported by documentary evidence of traditional knowledge including ancient Sanskrit text and paper published in 1953 in the journals of Indian medical association. United States patent and trade mark office (USPTO) investigated the validity of the patent. In 1997 despite an appeal made by the patent holders, the USPTO upheld the CSIR objection and cancelled the patent due to lack of novelty.

22. Case Study Of Neem The Neem tree Azadirachta indica is a tropical evergreen tree native to India and is also found n other south east countries. The seeds, bark and leaves contain compounds with proven antiseptic, antiviral, antipyretic , anti-inflammatory, anti ulcer and antifungal properties. In 1971, US timber importer "Robert Larson " observed that the trees usefulness in India and began importing neem seeds to his company head quarters. He conducted safety and performance test of neem . Three years later he sold his invention to the US Department of agricultural and multinational chemical corporation WR Grace and co.

23. In 1992 the WR Grace and co secured its right to the formula that used the emulsion from the neem trees, seeds to make a powerful fungicide. In applying for the patent, the company had argued that it had used an extract of the trees, seed to make a new fungicide but the Indians claim that its patent was not sufficiently novel as Indian farmers have used this fungicide for decades. The Indians and members of the green party in the European union opposed the patent because they believed that the rights of the poor farmers in developing countries will be harmed. The Neem patent became the first to challenge European and US patents on grounds of biopiracy . The Indian scientists argued that the Indians have known the medicinal properties of neem long back. The European Patent O ffice (EPO) accepted the arguments offered by Indian scientist and rejected the order of the US patent office to award the patent to WR Grace and The victory is a result of four yearlong effort by the research foundation for science, technology and environment.

24. References 1.V.D.Rangari. Pharmacognosy & Phytochemistry . 2.Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian Medicine & Homeopathy).