Traditional Medicine and its intellectual property Right in

IndiaBhushan Patwardhan

CCTM CME Dharamshala

17 March 2017

Traditional Medicine: Modern Approach For Affordable Global Health

WHO CIPIH Workshop, GenevaMay 30,31& June 1, 2005

Bhushan Patwardhan, PhDInterdisciplinary School of Health Sciences

University of Pune

Pune, India

bhushan@unipune.ernet.in

With Avinash Patwardhan, MD

WHO CIPIH: Research question

Traditional Medicine: Could more effective use be made of them in providing affordable treatments ?

March 17, 2017 Patwardhan- CIPIH Workshop 4

TM Best practices: Home remedies

• Turmeric in wound healing

• Tinospora in sepsis

• Asparagus as galactogogue

• Long pepper as bioenhancer

• Neem for oral hygiene

• Ashwagandha for growing children

• Oil massage for babies

• Yoga for CVDs

TM Best Practices: Drug Discovery

CSIR: NMITLI and Network Projects

March 17, 2017 Patwardhan- CIPIH Workshop 6

March 17, 2017 Patwardhan- CIPIH Workshop 7

NMITLI Herbal Drug Development3 Years Outcome

• Rheumatic and Musculoskeletal Disorders• Osteoarthritis, Rheumatoid arthritis

• Stage I RCT indicated one formulation significantly better than Glucosamine

• Hepatic Disorders• Pre-clinical suggest better activity than sylimarine

• Diabetes• Pre-clinical suggest better insulin sensitizing activity

Leads from Ayurveda

Curcumin, Gingerol, Gugullosterones, Eugenol, catechins, Anethol, Piperine, Apocynin, Genestein,

polysaccaharides from TC, biflavanoids from Semecarpus, Gallates, Bacosides, Boswellic acid,

Glycrrhizin, Allicin...

March 17, 2017 Patwardhan- CIPIH Workshop 9

Curcuma longa

• Ayurvedic description

• Lead molecule: Curcumin

• Biological targets: Aryl hydrocarbon receptor, Cytochrome P450 enzymes, Glutathione S-transferase, kinases, COX, iNOS, MMP

• Therapeutic class: Cancer, Inflammation, Diabetes and Chemo prevention

Chen HW.Anti-invasive gene expression profile of curcumin in lung adenocarcinoma based on a high throughput microarray analysis. Mol Pharmacol. 2004 Jan; 65(1): 99-110.

Limtrakul P, Modulation of human multidrug-resistance MDR-1 gene by natural curcuminoids.BMC Cancer. 2004 Apr 17; 4(1): 13.

March 17, 2017 Patwardhan- CIPIH Workshop 10

Zingiber officinale

• Ayurvedic description

• Lead molecule: Gingerols

• Biological targets: Vannolloid receptors

• Therapeutic class: Antipyretic, analgesic, antitussive, cardiotonic, and sedative

Dedov VN. Gingerols: a novel class of vanilloid receptor (VR1) agonists. Br J Pharmacol. 2002 Nov; 137(6): 793-8.

Ohizumi et al. Stimulation of sarcoplasmic reticulum Ca (2+)-ATPase by gingerol analogues. Biol Pharm Bull. 1996 Oct; 19(10): 1377-9.

Our ancient knowledge both from codified and non codified sources is our Intellectual

Property – We must protect it!

Intellectual Property

• Creation

• Innovation

• Commercialization

• Protection

• Enforcement

• Copyright

• Industrial Property• Trademarks

• Patent

• Industrial designs

• Confidential information

• Geographical Indications

Novelty, Non obviousness, Application

Why IP protection is given• Capital expenditure for new

products

• R & D

• Marketing and advertisement

• Maintaining loyal followers

• profit

• Can be sold

• Can be bought

• Can be lease or rent

• Can pass under a will

• Can be assigned

IP: International Conventions & Indian Act• Paris Convention for Protection of Industrial Property 1967 ( 1989)

• Berne Convention for the Protection of Literary and Artistic Works 1971 ( 1990)

• Trade-related aspects of Intellectual Property Agreement 1994 ( 1995)

• Patent Cooperation Treaty (PCT) 2004

• UN Convention on Biodiversity

• National Biodiversity Authority India

Protection for Copyright • Protection given by law for a term of years to the composer, author

etc… to make copies of their work..

• Work include literary, artistic, musical,films, sound recordings,broadcasts.

• Commercial and moral rights.

• No registration provision.

Protection for trade marks• Commercial exploitation of a product

• To identify the product, giving it a name

• “mark” includes a device, brand, heading, label, ticket, name, signature, word, letter, numeral or any combination.

• Does not include sound or smell

• Can either be registered or not registered

• Advantages of registered trade marks

• Application can be made for goods and services

• Perform certain function such as indication of quality,identifying a trade connection

Protection for patent• Basic idea of granting a patent

• “ the applicant applied to the government for the right of patent and in return for the monopoly given he must disclose everything about the invention in the patent document” ( the description)

• Duration 20 years.

• Patent for invention

• Patent can be applied for a product or a process.

• Patentable invention must be new, involves an inventive step and industrially applicable

• Priority date- first to file

Protection for geographical indication

• Meaning “ an indication which identifies any goods as originating in a country or territory, or a region or locality where a given quality, reputation or other characteristic of the goods is essentially attributable to their geographical origin”

• Product must come from a particular geographical territory

• Uses a name link to the particular geographical nature of the territory

• Such as labu sayung from the sayung Perak,

• Batik Trengganu, batik Kelantan etc.

• To stop others from using

Commercialization

• Assignment

• Licenses

• - exclusive

• - non-exclusive

Traditional Knowledge and Intellectual Property

What is Traditional Knowledge (TK) ?

Customary Protection of TK

Problems Confronting TK Holders

Why is Protection of TK Important ?

Intellectual Property and TK - WIPO’s Response

What is Traditional Knowledge?

Collective responsibility & ownership

Transmitted orally across generations

Medicinal, Agricultural

& Ecological Knowledge

Music & Dance,

Stories & Poetry

Spiritual ExpressionArtesanat

(Handicrafts)

Constantly evolving

TK: A Multi-Faceted Concept

Tradition-basedCreations

Spiritual & Religious Beliefs

Aesthetics (Art,

Entertainment)

Educationhistory, traditions, ethicsCultural Identity

Practical Knowledge

Oral Tradition

Emphasis on Community

Protecting TK: What are the Benefits

Increases opportunities for socio-economic development

Provides rights for TK holders

Preserves knowledge base of communities

Creates added value for humankind

Provides opportunities for sharing benefits of TK

Enables participation in global markets

Customary Protection of TK

Monitored & enforced by elders, spiritual and religious leaders

Informal regimes govern the use & transmission of TK at community level through rules, rights & obligations

Customary law results from repeated practices

Problems Confronting TK Holders

Rejection of tradition by new generation and encroachment of modern lifestyles

“Modern” science may deem traditional knowledge inferior

Dilution of traditional knowledge and practices through acculturation and diffusion

Commercial exploitation by “others”, e.g. bioprospecting, use of indigenous designs

Value of TK

• Affordable health care has been appreciated globally and endorsed by the WHO.

• Expediting discovery through innovations has been recognized• The World Intellectual Property Organization (WIPO) recognizes that the

TK, genetic resources (GRs) and traditional cultural expressions (TCEs), or expressions of folklore are economic and cultural assets of indigenous and local communities and their countries.

• Other intergovernmental agencies such as the United Nations Development Program are promoting inclusive innovation policies where no one is left behind- participation with access and building alternative sustainable incentive mechanisms that benefits all.

• These are especially critical in achieving human development goals in sectors such as health, agriculture and environment.

How a country or a community can protect its traditional knowledge from piracy? • The Indian national initiative of Traditional Knowledge Digital Library

(TKDL) is one of the most sophisticated protective responses to the concerns of bio-piracy.

• Some countries in South America have developed sui-generis systems for protection of traditional knowledge and are struggling to harmonize national legislations with CBD, TRIPS, WIPO and other related international provisions.

Access and Benefit Sharing (ABS) system

• This requires convenient access to traditional knowledge

• In return, a fair sharing of benefits arising from the modified use of mainly traditional knowledge products.

• The ABS norms, due to the demands of social activists, have also been applied to domestic use of traditional knowledge of local communities by national companies or research establishments.

• The case of Kani Tribals and an Indian Ayurvedic Company has become an international case study in the domestic context.

• The ABS norms have been applied mainly to traditional knowledge related to biological or geological resources.

• However, commercial health interventions which use traditional knowledge like Yoga, Ayurveda, lifestyle modifications and therapeutic diets have largely remained out of ABS debates.

• Still, several sui-generis systems and ABS are awaiting humane and just resolution.

ABS for Spa industry

• For integrated knowledge systems to work, they will also have to include the full range of traditional medicine, including yoga, detoxification therapies and therapeutic diets.

• These have largely been excluded from existing ABS debates, yet they play an increasing role in global public health.

• Global economy of the spa industry and estimated the global wellness industries at a total value in 2007 of $1.2 trillion,

• If the spa industry is profiting from indigenous traditions, it is reasonable to ask what the industry is returning to these cultures.

• Corporate social responsibility programs can support the revival of local traditions, development of micro-enterprises related to traditional knowledge, and fair trade practices for the purchase and export of traditional health products and ingredients.

TK knowledge scope

• traditional knowledge scope ranges from empirical knowledge about simple uses of natural resources to complex knowledge about sensory and non-sensory perceptions of nature,

• knowledge about the human phenome, classification of populations, theories of pathogenesis,

• novel drug discovery methods, metabolic potentials of food and drugs, understanding of mind and its dynamic states, schemes of systemic diagnosis of diseases,

• theory of homeostasis, multi-factorial etiologies and holistic approach.

TM role in universal healthcare

• Health care should be considered as a fundamental human right and under no circumstances people should be denied this for any reasons including scientific prejudice or commercial ambition.

• TM is medically, financially, socially beneficial

• WHO has recognized role of TM in affordable global health

Users responsibility

• The traditional, eastern, western, or any such divides can no longer remain barriers when the global understanding of this issue is enriching and widening.

• There are larger political questions related to hegemony of western knowledge systems over the knowledge systems or non-western cultures.

• The conflict may be based on a fundamental incompatibility between TK and western methods of science or theory

• The challenge lies in setting norms that allow sustainable exploitation of resources where benefits of TK can be explored, harnessed and integrated into global healthcare, coupled with a fair sharing of rewards.

• This is primarily the responsibility of users.

Domination of markets

• Market economies typically dominates such dynamics, the ethical and humanitarian approach should prevail

• Meeting grounds need to be created where the dignity and diversity of cultures are protected while the world continues to modernize.

• This will be the new meeting ground of IPR on the trans-disciplinary and cross-cultural knowledge highway.

Challenges for new norms

• The real challenge facing traditional knowledge and modern science seems to be to establish norms for cross-cultural transactions.

• It is of prime ethical and legal importance to practice a courtesy of informed consent – but what else?

• On what grounds should consent be denied to scientists by the custodians of traditional knowledge systems?

• These grounds may not be related to unfair commerce or trade but might also be based on epistemological incompatibility.

Ecological obligation

• The significance of this concern becomes evident in article 8(j) of the Convention on Biological Diversity 1992, where it is implied that medicinal plants, blood samples from indigenous people and research conducted by foreigners into indigenous ways of life, supported by indigenous possessors of traditional knowledge, have led to patentable discoveries of benefit solely to those foreign researchers, with no economic return to indigenous people themselves.

• The traditional medical knowledge of indigenous peoples throughout the world played an important role in identifying biological resources worthy of commercial exploitation.

• Knowledge about the way in which local people have used plants has always been important to collectors. Unfortunately, no international system has yet suc-cessfully designed and implemented a mechanism that provides for an effective legal protection to traditional knowledge holders’ rights at the international level.

Traditional and modern

• Despite the huge advances in modern medicine, most people in the developing world still rely on traditional — and effective — knowledge to treat illness and disease.

• Its value in providing affordable healthcare has been recognised by the WHO, and now national and international policymakers are calling for partnerships between modern and traditional medicine to help bridge the equity gap in global public health.

• But the two are fundamentally different: whereas traditional knowledge tends to be freely accessible (if culturally specific), modern knowledge is fiercely guarded by a rigid patent system, and dominates thinking in the developed world.

• In the face of these differences, how can, or should, we build partnerships?

Cross-cultural challenges

• We need a better way of balancing the interests of researchers wanting to develop traditional knowledge for modern medicine and the indigenous custodians of that knowledge, who are entitled to a fair share of any rewards.

• For example, it is ethically and legally important that scientists acquire informed consent from custodians of traditional knowledge — but what else? When is it appropriate for custodians to deny their consent? In some cases, denial may not be simply related to unfair commerce or trade but might also be based on epistemological incompatibility.

• For example, the case of Indian long pepper. It is used in several formulations in the Indian Ayurvedic tradition to enhance bioavailability and assimilation of another drug, and a commercial formulation of the plant's active ingredient, piperine, is now being used to reduce dosages of the drug rifampicin in tuberculosis treatments.

• According to traditional knowledge, to avoid side effects the plant should not be used for more than 40 consecutive days. But tuberculosis treatments must be taken for much longer than this. Should Ayurvedic physicians permit such misuse of their traditional knowledge?

Ending Western domination

• Creating an integrative knowledge system has the further challenge of the developed world's domination, especially over Asian knowledge bases. Why is modern biomedicine so frequently considered superior to traditional medicine?

• The Ayurvedic concept of 'prakriti' — seeing the individual as a whole — has greatly helped biomedical researchers understand new disciplines such as pharmacogenomics.

• There is greater appreciation now among scientists for the concept of traditional knowledge guiding biomedicine, rather than scientific methods being used as a tool to prove or disprove traditional concepts and practices.

• An integrative knowledge system that builds on such appreciation could drastically improve public health. It could even reverse the direction of knowledge flow in the world of modern science.

• Instead of science mining natural resources for new ingredients, traditional knowledge could reshape the scientific world by offering novel paradigms and solutions that will broaden outlooks and offer holistic solutions.

Biopiracy: IPR Wellknown Cases

• Turmeric

• Basmati

• Neem