Professor Kamal Puri Director, WIPO-QUT Master of Intellectual Property Law Program

1. How to reconcile indigenous rights with IPRs? AIPPI Forum 14 October 2011 Workshop IV Professor Kamal Puri Director, WIPO-QUT Master of Intellectual Property Law Program QUT, Brisbane, Australia Patentability of Traditional Knowledge

2. Abstract Many patent applications cover inventions that consist directly of existing TK, or are obvious adaptations or applications of it.  By strict interpretation of the patent law, such applications should be rejected outright because they do not meet the novelty and non-obviousness requirements. Clearly, the patent applicant has not derived the right to apply from the true inventor.  Further, the TK pertaining to the alleged invention constitutes as relevant prior art under the patent law.  However, because TK is often orally transmitted, evidentiary and other issues including the date of the disclosure and whether the disclosure was sufficient to enable the recipient to put the new technology into effect, crop up.  From the Patent Office’s perspective, the practical issue is: what should constitute the relevant prior art? Is it possible to halt or minimise the cultural and financial harm to indigenous owners by commercialization of TK through the vehicle of patent protection?  Before attempting to change the patent law and practice, it is important to become aware of the serious harm that the unrestrained usurpation of TK is causing to the indigenous communities who are collectively holding vast TK through a form of custodianship with responsibilities for maintaining and passing on knowledge according to customary laws and practices.

3. Entitlement to a patent • Exclusive rights for 20 years for new, non-obvious and industrially applicable ideas. • “Actual inventor” to be stated – the person who made the discovery, i.e., the idea for it originated in his or her mind. • Person entitled to apply: inventor, person entitled to have the patent assigned upon grant, assignee or legal representative. • Actual inventor to be identified in the Notice of entitlement - identification of the inventor is fundamental as the patent right is derived, directly or indirectly, from the act of invention.

4. Inventions based on TK - queries • How is novelty assessed against the prior art base? • Has the applicant declared all relevant known prior art? • Does TK constitute prior art? • Do patent search authorities take account of TK in the course of assessing the validity of patent applications? • Is TK-related prior art accessible to patent authorities? • Is TRIPS compatible with TK? • Should TRIPS require mandatory disclosure of origin by patent applicants for avoiding the patenting of inventions that are based on TK or derived from or guided or made use of TK?

5. Unique characteristics of TK Tradition-based know-how and information on the management of natural resources, traditional medicine, crafts and artistic designs. • Originates in a wide range of social, cultural, environmental and technological contexts. • Dynamic, not static or antique. • Often not recorded in writing - orally transmitted knowledge. • Passed down from generation to generation. • Collectively held by communities. • Use and dissemination often governed by long-standing customary law and practice. • Innovative and has scientific or technological components • Often associated with genetic resources.

6. Patent protection under TRIPS • Article 27(1) obliges governments to make inventions eligible for patenting that are new, involve an inventive step (or be non-obvious) and capable of industrial application (or be useful). • TK will normally not be eligible for patentability because of lack of novelty. • Further, TK usually created by a community and not on an individual basis will not fall within the definition of patentability. • Lack of protection of TK under TRIPS has raised an assumption that TK is freely accessible.

7. Recap on TRIPS • Came into effect on 1 January 1995. • To date, the most comprehensive multilateral agreement on IP. • Triggered globalisation of IP by providing for globalminimum standards concerning the availability, scope and use of IPRs. • Overall objectives: advancement of global free trade; reduction of distortions and impediments to international trade and development of trade-friendly measures and procedures to enforce IPRs . • Governments allowed to reduce any short term costs through various exceptions, e.g., to tackle public health problems. • Trade disputes over IPRs to be resolved under the WTO’s dispute settlement system. • WTO chosen as a forum for TRIPS because it has greater enforcement power through international trade mechanisms than WIPO.

8. Relationship between TRIPS & CBD • Report by WTO’s DG, Pascal Lamy (21 April 2011). • Purpose: to reduce the risk of patents being incorrectly granted over genetic resources and associated TK. • Options: disclosure requirement, database system, national-based approaches to enforcing PIC and equitable benefit sharing, or the use of contracts. • Queries: Whether a mandatory disclosure requirement would • really bolster the capacity of patent law to reward innovation; • be unreasonably burdensome for patent applicants and/or IP offices; • result in uncertainty and deter investment in innovation, thus undermining the role of the patent system; and • be workable without more precise definitions for "genetic resources" and "traditional knowledge“.

9. Nagoya, Japan 29 October 2010 - Divided world! • Disclosure as a TRIPS obligation: Brazil, India Bolivia, Colombia, Cuba, Dominican Republic, Ecuador, Peru, Thailand, and supported by the African group and some other developing countries: amend TRIPS so that patent applicants required to disclose the country of origin of genetic resources and TK used in the inventions, evidence that they received PIC and evidence of “fair and equitable” benefit sharing. • Disclosure through WIPO: Switzerland: amend the regulations of WIPO’s PCT (and, by reference, WIPO’s Patent Law Treaty) so that domestic laws may ask inventors to disclose the source of genetic resources and TK when they apply for patents. Failure to meet the requirement could hold up a patent being granted or, when done with fraudulent intent, could entail a granted patent being invalidated. • Disclosure, but outside patent law: EU’s position includes a proposal to examine a requirement that all patent applicants disclose the source or origin of genetic material, with legal consequences of not meeting this requirement lying outside the scope of patent law. • Use of national legislation, including contracts rather than a disclosure obligation: US - CBD’s objectives could be best achieved through national legislation and contractual arrangements based on the legislation, which could include commitments on disclosing of any commercial application of genetic resources or TK.

10. Reservations regarding Databases Despite agreeing on the general usefulness for patent examination of TK and genetic resources databases, members doubted whether: • databases could serve as the primary way to prevent erroneous patents; • fully exhaustive databases of TK were feasible, given the oral character of much TK; • recording TK in a database could itself lead to its misappropriation; • fully mapping out all the genetic resources potentially available in a mega-diverse country was possible; • a mandatory disclosure requirement would really bolster the capacity of patent law to reward innovation; • the requirement would help direct patent examiners towards the relevant databases; and • the additional costs and burden of incorporating the mandatory disclosure requirement as compared to existing obligations under Article 29.1 of the TRIPS Agreement would be justified.

11. Practical Challenges for the patent examiners • Unlike other areas of technology, prior art involving TK‑related patents rarely found in patent literature and often absent from the general scientific literature routinely searched by patent authorities. • Orally disclosed information can be treated as prior art, but lack of documentation raises evidentiary and other issues including the date of the public disclosure and whether the disclosure was sufficient to enable the recipients to put the new technology into effect. • TK must be part of the inventive process – a mere lead or a hint is not enough.

12. Assessment of prior art in Australia • Published information or public oral disclosures and actions anywhere in the world. • Universal novelty required for an invention to qualify for a patent. • Prior art includes: • Information published in written form locally or in foreign countries. • Information orally disclosed locally or in foreign countries. • Oral disclosure - “doing an act” • Disclosure must be public – disclosure to one other person enough if without an obligation of confidentiality. • Public working of an invention forms part of the prior art base.

13. Position under the Australian patent law • No examination guidelines specific to TK or genetic resources. • No judicial decisions relating to the relevance of TK or genetic resources as prior art. • No specific rules regarding the assessment of the person skilled in the art for the determination of inventive step when an element of TK is involved. • The only common general knowledge that can be used in objections of lack of inventive step is the common general knowledge in Australia. • If the knowledge is confidential to the community then it does not form part of the common general knowledge and so is not available to be used in any assessment of inventiveness.

14. TK as potential prior art • Two Patent Office decisions. • Vincent Joseph Collins and Maryann Collins v William Robert McGilvray[2002] APO 23 - a method for producing a blue colored oil from a mixture of the bark and wood from the Australian native Northern Cypress Pine. • Frank D’Amelio v Australian All Natural Pty Ltd[2003] APO 25 - a composition comprising an aqueous alcoholic extract from a plant commonly known as old man weed (Centipeda cunninghamii). • TK was clearly important background prior art. • However, both decisions relied on conventionally published documents for the purposes of novelty and inventive step. • In both, applications were found to be novel and inventive in light of the prior art provided at the hearing.

15. Painkiller bark – a happy experience • TK that helped an Aboriginal elder to get rid of severe pain by rubbing the bark of a tree to the top of his finger that had been bitten by a crocodile. • Collaboration with Prof Ron Quinn which has led to a patent by GU and the Jarlmadangah Burru Aboriginal Community. • Commercialisation licence granted to Avexis Pty Ltd, a Gold Coast biotech company. • The Aboriginal community has established its own company, JJ Lab Pty Ltd to supply the raw materials required for development and production of a product that could be sold over the counter.

16. Disclosure of source – Swiss proposal • TK and biodiversity were specifically mentioned in the Doha Ministerial Declaration (2001): “We instruct the Council for TRIPS, in pursuing its work programme including under the review of Article 27.3(b) … to examine, inter alia, the relationship between the TRIPS Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore. . . .” • Proposed by 77 developing countries in the Doha Round at the WTO to amend the TRIPS to require patent applicants to disclose the origin of biological resources and of TK used in inventions as well as evidence of prior informed consent and of fair and equitable benefit‑sharing. • Rationale: a mandatory requirement would establish a safeguard mechanism against the misappropriation of TK. • Swiss proposal regarding the mandatory declaration of the source of origin. • Swiss law now requires applicants to declare the source of genetic resources and TK in patent applications. • Fines of up to 100,000 Swiss Francs and the possibility for judges to make their rulings public. • Examples of countries such requirements have been introduced into their law are India, Andean Communities (Bolivia, Colombia, Ecuador and Peru) and Costa Rica (see also Recital 27 of European Directive 98/44, though voluntary).

17. Development of prior art national database • Establishment of a TK digital library in India with 150,000 medicinal categories of knowledge which it shares with the patent examiners on access basis. • Flip side – if included in a database, then the community from which it came no longer would be able to apply for patent on its own TK. • Broadening of the “minimum documentation” under the PCT to cover a wide array of TK‑related publications, e.g., Journal of Chinese Medicine; Indian Journal of Traditional Knowledge, Medicinal and Aromatic Plants Abstracts. • Development of a new main group for the International Patent Classification, with approximately 200 subgroups, in the field of medicinal preparations containing plants to assist the patent examiners to locate already published TK.

18. Conclusion • The essence of the patent system is transparency and disclosure. • Goal: To minimise the grant of patents that wrongly claim inventions that are based on, derived from, guided by or make use of TK. • Applicants for patents which consist of, or are developed from, TK or genetic resources should identify the source and provide proof that they were acquired with the prior informed consent of the country from which they were taken. • Digital Registers and Databases to assist patent examiners. • Experiences at the national level are mostly inconclusive. • Reopening the TRIPS Agreement is unlikely to be successful given that TRIPS is a compromise. • Collective/certification marks as well as geographical indications may be used. • Training of Patent office examiners on the context of TK and sensitivities about its use and handling.