Traditional knowledge, Biopiracy, Cases of collision between TK and Patent system & Bioprospecting

Traditional Knowledge (TK):

Traditional knowledge (Indigenous knowledge or Local knowledge) means knowledge that acquired over years and transferred from generation to generation within indigenous community. It is a living body of knowledge. It generally forms part of a people’s cultural and spiritual identity. Here traditional means not old or untechnical in nature. It reflects traditions of communities. It does not reflect nature of knowledge itself, but reflects the way in which that knowledge is created, preserved or disseminated.

“I had seen in childhood that my grandfather stored wheat grains, pulses in packet with neem twigs and neem seeds to avoid spoilage of grains during storage. Although, he had not a good scientific knowledge on neem. He learned this practice from his grandpa and he learnt from his grandpa and so on. This knowledge they adopted not from any book or document or institute, because 50-70 years ago nobody else was even educated in my village. They had verbally acquired this knowledge from their predecessor.”

Biopiracy:

Day by day our genetic research becomes more advance, So, does our ability to use plants and animal to develop new drugs or modify crops to get maximum benefits. Biopiracy happens when researchers or research organization take biological resources without official sanction, largely from affluent countries or marginalized people. Biopiracy is not limited to drug development, it also occurs in agricultural and industrial contexts. Indian products such as the neem tree, tamarind, turmeric, and Darjeeling tea have all been patented by foreign firms for different lucrative purposes. Although, some of the patents have been revoked or got claims amendment. Biopiracy creates a situation of ugly collision between TK and the present patent system.

Several cases of biopiracy are present which itself explain actual problems in the interaction between Traditional Knowledge and Patent system. Here, we can read about three cases of bad collision between traditional knowledge and Patent system.

Cases of collision between TK and Patent system:

1.      The Turmeric case [Turmeric, Curcuma longa Linn.]

The rhizomes of turmeric are used as a spice in Indian cooking and it has been traditionally used for centuries to heal wound and rashes. In 1995, two Indian origin scientists,  at the university of Mississippi Medical Centre were granted a patent 5,401,504 on use of turmeric in wound healing. 

This Patent claimed the administration of effective amount of turmeric through oral or local route to enhance wound healing process, as a novelty finding. To get a patent, Patentee has to fulfill the basic requirements of novelty, non-obviousness and utility. Thus, if the claims covered by relevant published art, then the patent becomes invalid. The CSIR argued that medicinal use of turmeric is not a novel invention, it is known and has been used in India from thousands of years. CSIR presented 32 references, some of them over hundred years old. The formal request for re-examination of the patent was filed by Council of scientific & Industrial Research (CSIR) at USPTO on 28^th October 1996. Challenging the patent on the ground of existing prior-art. The first office action in the re-examination was issued by USPTO on 28^th March 1997, which rejected all six claims based on the references submitted by CSIR as being anticipated by submitted references and therefore, considered invalid under 35 U.S.C. 102 and 103. After the first office action, the university of Mississippi Medical Centre, decided not to pursue the case and transfer the rights to inventors, who decided to file a response. The inventors chose to pursue the case further on the grounds that powder and paste had different physical properties i.e. bioavailability and absorbability. The inventors further mention that oral administration was available only with honey and honey itself has wound healing properties. In the second office action, Examiner rejected all the claims once again and made his action final. He made it clear that, powder and paste forms are equivalent in view of the cited art. After the second rejection, inventors had interview with examiners and deleted claims 5-6 and also restricted invention to a “non-healing surgical wound” and requested the examiner to allow the amended claims. On, 20^th November 1997, the examiner rejected all the claims once again as being anticipated and obvious and in 1998 the re-examination certificate was issued that signified the end of the case.

1.      The Basmati Rice case [Rice, Oryza sativa Linn.]

The rice is an important aspect of life in the southeast and other part of Asia. For centuries, it has been the main pillar of their food and culture. During this period, indigenous farming communities developed, nurtured and conserved over a thousand distinct species of rice. This is the main reason, that patenting of Basmati by RiceTec Inc. is not recognize as only Intellectual property and cultural theft, but it also warns farm communities of southeast Asia. RiceTech Inc. a Texas based company, in 1997, patented a rice type called “American Basmati”. RiceTech Inc. had been trying to enter into international Basmati market with brands like “Kasmati” and “Texmati”.  Finally, the company claimed that they developed a new variety of rice by interbreeding basmati with other variety and they proudly called it Texmati or American Basmati. RiceTec Inc, was issued the Patent number 5663484 on Basmati rice lines and grains on September 2, 1997. 

The patent covered 20 claims covering not only a novel rice plant but also various rice lines; resulting plants and grains, breeding and propagation. Its claims 15-17 were for a rice grain having characteristics similar to the traditional Indian Basmati rice lines. The said claims 15-17 would have come in the way of Indian exports to US, if legally enforced. Evidence from the IARI Bulletin was used against claims 15-17. The evidence was backed up by the germplasm collection of the Directorate of Rice Research, Hyderabad. The patent was challenged on the fact that the plant varieties and grains already exist as a staple in India. 75 percent of U.S. rice imports are from Thailand and that the remainder is from India and Pakistan and both varieties are rice that cannot be grown in the United States. The legal theory is that the patent is not novel and for an invention that is obvious, being based on rice that is already being imported in the United States. This was objected to by two Indian nongovernmental organizations (NGOs) — Centre for Food Safety, an international NGO that campaigns against biopiracy, and the Research Foundation for Science, Technology and Ecology, an Indian environmental NGO who filed legal petitions in the United States. The Centre for Scientific and Industrial Research also objected to it. The Indian government, after putting together the evidence, officially challenged the patent in June 2000. Soon after filing the re-examination request, RiceTech chose to withdraw claims 15-17 along with claim 4. Based on the exhaustive office action, RiceTech has now surrendered the claims 1 to 3, 5 to 7, 10, 14 and 18 to 20. This means that as against the Indian attack on 3 claims, RiceTech is withdrawing 15 claims. 

In Summary, RiceTech having withdrawn claims 15-17. The threat of infringement by export of Basmati grains to US has been averted. Also, with the surrender of all other broad claims, the alleged threat to export of grains of insensitive rice lines from India has been averted. USPTO has ordered that the title of the patent be changed from ‘Basmati Rice Lines and Grains’ to ‘Rice Lines Bas867, RT1117 and RT1121’. 

1.      The Neem case [Neem, Azadirachta Indica]

Neem tree is known to Indian people for thousands of years. In the annals of the ancient Siddha system of medicine, the first medicinal plant mentioned as well as found a place, in ancient Tamil literature is neem or margosa. Neem has been used by humankind from time immemorial as a deterrent for smallpox and other infectious diseases and is also considered to possess powers to ward off evil spirits. The earliest mention about the uses of medicinal plants were found in Thirumular Thirumantiram-Ennayiram, Tholkappiam and the ancient Tamil works of Sangam literature, which were believed to have been written thousands of years ago. Siddha medicine is one of the oldest medical systems known to mankind. Its origin goes back to 10 000 B.C to 4 000 B.C. The Siddha system of medicine (traditional Tamil system of medicine), which has been prevalent in the ancient Tamil land, is the foremost of all other medical systems in the world.

Indian scientists have been researching the neem tree as a natural pesticide since 1920 but Western awareness of its qualities wasn’t raised until 1959 when German entomologist Heinrich Schmutterer witnessed a locust plague in the Sudan and noticed that the Neem trees were the only ones that had withstood the onslaught. He immediately started studying the Neem tree and his work in turn generated a great deal of western scientific interest in its pesticidal qualities. 

The first U.S. patent on a storage stable composition for Neem seed extract was issued in 1985 to inventor Robert O. Larsson. The patent was improved upon by The U.S. company W.R. Grace who built upon this knowledge and developed a storage stable azadirachtin formulation which increased the shelf-life of the pesticide to up to two years. For this they were granted two co-dependent US patents in 1991 and 1992 respectively. W.R. Grace in partnership with The United States of America as represented by The Secretary of Agriculture jointly filed a Patent Application for the formulation with the EPO, who after a long drawn out examination process granted the applicants the patent in 1994. 

The patents granted to W.R. Grace in Europe and the U.S. stirred up a lot of feelings in India and amongst many CSOs who felt that W.R. Grace had claimed for their own, knowledge, which belonged to the people of India. The US based Foundation on Economic Trends organized and filed a petition for re-examination on the grounds that the invention lacked non-obviousness in the light of prior art which was represented by the prior use in India. 

In 1995 the European Parliament member and representative of the Greens in the European Parliament, Magda Aelvoet, filed an opposition with the EPO with regard to the patent in cooperation with two CSOs.

The opponents filed for revocation of the patent in its entirety on the grounds that the patent lacked novelty in accordance with Article 54(1) and (2) EPC and lack of inventive step pursuant to Article 56 EPC. They also claimed that the patent was contrary to morality (Article 53(a) EPC) and pursuant to Article 100 (b) EPC that there was insufficiency of disclosure.

Ground for Opposition	EPO Statement
Morality (Article 53 (a) EPC)	The opposition division found the requirements for sufficiency of disclosure to have been met and that Article 53(a) EPC was not applicable to the present case.
Novelty (Article 54 (1) and (2) EPC)	The opposition division ruled in favor of the opponents. The opposition division found that alleged prior use as having taken place in 1985/1986 in the Pune and Sangli Districts of Maharashtra, Western India. The opposition division based this on the affidavit and testimony of Mr. A.D. Phadke.
Inventive Step (Article 56 EPC)	The Opposition division dismissed this auxiliary request nonetheless, because it lacked an inventive step in comparison to the prior art that was represented by the Indian TK.

Consequently, the EPO fully revoked the patent. The patentees appealed against this decision. The grounds for the appeal rested mainly on the assertion that Mr. Phadke’s affidavit and testimony were insufficient proof of prior use as their credibility could be put into doubt as they relied on precise testimonies of what had taken place between 10 and 14 years ago. There was no dispute between the parties concerning the existence of the prior art document (8) as a part of the state of the art within the meaning of Article 54(2) EPC. In the board’s view, document (8) is highly relevant for the ruling of the present case. Document (8), which the board refers to, is a scientific article published by H.B. Singh and U.P. Singh in Australian Plant Pathology in 1981. The board on the basis of document 8, found that the claims of the patent were to be regarded as novel over the contents of the article. The next step for the board was to review the inventive step. After examining the process outlined in the article and in the patent claim the board reached the conclusion that the patent should be revoked for lack of inventive step. The board of appeal also failed the auxiliary request because it did not meet the requirements of article 123 (2) EPC as the amendments extended beyond the content of the original application. Thus, the patent was finally revoked. In a press release on March 8th 2005 the Greens in the European Parliament cabled out to the world that the decision to uphold the revocation of a patent on the Indian Neem tree was “a killer blow to biopiracy in Europe and around the world”.

Possible Defensive Measures:

To avoid collision between Traditional knowledge & Patent system some defensive measure advised –

1.       Traditional Knowledge-Databases and Improved Prior Art Searches –

A)      On International level – First, in 2003 the International Patent Classification (IPC) was updated to include a new category which covers Traditional Knowledge, and thus will hopefully be an aid in discovering possible prior art in patent applications which relate to TK. Second, the Patent Co-Operation Treaty (PCT) enables filing for patent protection in a number of countries at the same time. The filing is subjected to an international search as regards prior art and a non-binding written opinion that judges the patentability. The minimum documentation that is required during a PCT search has been expanded to include eleven new TK-related databases.

B)      On National level - In India the Traditional Knowledge Digital Library project (TKDL) was created through a collaboration between several Indian Government agencies and aims to document disclosed traditional medicinal knowledge in the public domain, which relates to Ayurvedic, siddha and other traditional Indian medicine. The TKDL is digitalized and available in English, German, French, Japanese and Spanish. Access to the TKDL is however only granted to IPR-offices on the grounds that they sign an agreement of non-disclosure to any third party. The EPO have signed a non-disclosure agreement with India and the TKDL is therefore a part of available databases for prior art searches within the EPO.

2.       Disclosure –

Disclosure is part of the core rationale of patent law. Unless an invention is fully disclosed, a patent on that invention is invalid. It should be a mandatory requirement to disclose the origin of any genetic material or TK used in a patent. The intent is to support the rights and interests of states and indigenous people in relation to genetic resource and traditional knowledge. 

3.       Moral Rights –

There is something beyond Novelty and Inventive step i.e. protection of religious-integrity of TK-Holders. Moral rights involve the right of attribution, the right to have a work published anonymously and the right to the integrity of the work. They are inalienable and cannot be transferred except through an agreement between the creator and a third party. Moral rights are in addition to standard copyright rights and are generally recognized in civil law jurisdictions. Distinct from any kind of economic right, moral rights directly address the relationship between the creator/artists/authors and their work. Thus, there have been suggestions that moral rights could offer an effective means for protecting indigenous people's rights in work that utilize or derived from indigenous knowledge.

Bioprospecting:

To Counter Biopiracy, Bioprospecting came into picture. Sadly, not many positive examples of bioprospecting exist. Ideally, it involves ethical considerations such as prior informed consent, access and benefit sharing agreements, and material transfer agreements before research commences. Earning from any commercial products should go towards local conservation efforts and the construction of infrastructure.

There are only a few bio-prospecting agreements throughout the world which are considered to be a success by all (both) of the involved stakeholders. The “Novartis-UZACHI BioLead Agreement” is one of them. In the agreement signed between the Union of Zapoteco Chinanteca Communities in Mexico and the Swiss firm, Novartis, Novartis agreed to pay between US$1 and US$2 million for each active compound.

GlaxoSmith Kline and the biotechnology company Extracta in Brazil made a transacted agreement worth US$ 3.2 million for the collection of 30,000 samples.

Bioprospecting is providing a good hope for benefits of TK holders and sets a benchmark for “Access and Benefit Sharing model”.

References:

1)      http://www.tkdl.res.in/tkdl/langdefault/common/Biopiracy.asp?GL=Eng

2)      https://biocultural.iied.org/convention-biological-diversity-and-its-working-group-article-8-j

3)   https://worldwide.espacenet.com/patent/search/family/022635898/publication/US5401504A?q=pn%3DUS5401504A

4)      http://lup.lub.lu.se/luur/download?func=downloadFile&recordOId=1555871&fileOId=1563800

5)      https://www.indiatoday.in/lifestyle/wellness/story/turmeric-is-a-miracle-spice-especially-when-used-as-an-effective-remedy-for-weight-loss-herbs-health-279399-2015-12-29

6)      https://www.nature.com/articles/37838

7)      http://www.mashelkar.com/

8)      https://csbweb01.uncw.edu/people/eversp/classes/BLA361/Intl%20Law/Cases/Study%20of%20Basmati%20Rice%20Intl%20Case.ssrn.pdf

9)      https://www.thehindubusinessline.com/economy/agri-business/indian-basmati-gets-geotag-of-authenticity/article8198619.ece

10)http://patft.uspto.gov/netacgi/nph-Parser Sect1=PTO1&Sect2=HITOFF&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&d=PALL&s1=5663484.PN.

11)   https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3695574/#b14

12)   https://europeangreens.eu/content/members-ep

13)   https://www.flickr.com/photos/ehktang/4137112757

14)   https://theconversation.com/biopiracy-when-indigenous-knowledge-is-patented-for-profit-55589

15)   https://www.sdfinance.undp.org/content/sdfinance/en/home/solutions/bioprospecting.html#mst-3

16)   https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.195.6114&rep=rep1&type=pdf

17)   http://nopr.niscair.res.in/bitstream/123456789/4927/1/JIPR%207%284%29%20308-323.pdf

18)   https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/who-to-set-up-centre-for-traditional-medicine-in-india/articleshow/79206378.cms

19)   https://commons.wikimedia.org/wiki/File:Tedros_Adhanom_Ghebreyesus_(44834995345).jpg

20)   https://www.uspto.gov/web/offices/pac/mpep/s2152.html

21) https://www.uspto.gov/web/offices/pac/mpep/s2158.html#:~:text=103(a).,then%20pre%2DAIA%2035%20U.S.C.

22)   http://sikkimnews.blogspot.com/2009/08/poor-monsoon-hits-sikkim-farmers-with.html

23) https://www.wipo.int/edocs/pubdocs/en/tk/786/wipo_pub_786.pdf

24) https://neemfoundation.org/about-neem/history-of-usage/

25) https://web.law.duke.edu/cspd/itkpaper4/