NEEM and HOODIA. Two European Patent Applications involving Traditional Knowledge

Transcription

1 NEEM and HOODIA Two European Patent Applications involving Traditional Knowledge 1

2 Neem Tree Scientific Name: Azadirachta indica A.Juss. Synonym: Melia azadirachta, Antelaea azadirachta Family: Meliaceae Origin: Southern Asia, India The Neem Tree Growth Habits: Large evergreen tree, up to 100 feet tall (30 m), trunk up to 8 feet in diameter (2.5 m) Used traditionally as a safe pesticide and insecticide Neem Seed Activity attributed to the key ingredient azadirachtin 2

3 EP Claim 1 as originally filed (1990) An insecticide and foliar fungicide comprising neem oil which is substantially free of azadirachtin and salannin, said neem oil prepared by: a) extracting dried, coarsely ground neem seeds with a non-polar, hydrophobic solvent to obtain a neem oil extract, b) removing the solvent to obtain the neem oil product 3

4 Neem Case Examination Phase Objections by Examining Division Claim 1 to be construed as directed to neem oil as such Neem seed extracts with hexane known, as well as their insecticidal properties Antifungal effects of neem seed also known However: Antifungal effects of azadirachtin-free extract of neem seed neither known nor suggested from any document retrieved during search 4

5 Neem Case Claim 1 as granted (1994) A method of controlling fungi on plants comprising contacting the fungi with a neem oil formulation containing 0.1 to 10 % of a hydrophobic extracted neem oil which is substantially free of azadirachtin, to 5.0% of emulsifying surfactant and 0 to 99% water. 5

6 Neem Case Opposition (1995) Common opposition filed by Magda Aelvoet, at that time President of the Greens in the European Parliament, together with the Indian Research Foundation led by Vandana Shiva and the International Federation of Organic Agriculture Movements (IFOAM), supported by several other organizations 6

7 Neem Case Grounds for opposition Exceptions to Patentability Art. 53(a) EPC: exploitation of invention contrary to morality: Neem tree has been used in India for millenia, patent would threaten livelyhood of gatherers of neem tree Art. 53(b) EPC: Patent claims plant variety: By using seed from one plant variety, the patent indirectly claims the variety as such 7

8 Neem Case Grounds for Opposition Art. 54 EPC: Novelty Novelty and Prior Use Antifungal effects of neem oil and neem leaves known for centuries Affidavit Mr. Phadke (India): Public field trials took place in 1985/1986 involving treatment of plants with hexane extracts of neem seed, antifungal effect observed 8

9 Neem Case Oral Proceedings (2000) Morality Plant variety Decisions by Opposition Division: Morality: No direct link between endangering of livelyhood of people in India and claimed method of controlling fungi, European Patent gives no rights in India Traditional uses known for centuries are related to novelty/prior use issues and have to be documented Plant variety: Azadirachta Indica is not a variety, but species, a higher taxonomic unit Claim to method of controlling fungi cannot be construed as relating to the plant as such 9

10 Neem Case Oral Proceedings Novelty criteria Art. 54 EPC (1) An invention shall be considered to be new if it does not form part of the state of the art. (2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application. 10

11 Neem Case Oral Proceedings Novelty criteria Prior Use / Oral Disclosure Date of oral disclosure applicable if confirmed by later written confirmation Burden of proof on behalf of opponent Public prior use: When, What, How, Where and by Whom has to be proven by opponent up to the hilt 11

12 Neem Case Oral Proceedings Novelty Witness Hearing- Decision Oral testimony of Mr. Phadke credible to Opposition Division Established that hexane neem seed extract containing a surfactant used in public to treat plants against fungi Decision Main request lacks novelty and (restricted) auxiliary request inventive step Patent revoked 12

13 Neem Case Appeal (2005) T 416/01 The Technical Board of Appeal dismissed the appeal of the Patent Proprietor against the decision of the Opposition Division. 13

14 Hoodia Case Hoodia gordonii Scientific Name: Hoodia gordonii Sweet Family: Asclepiadaceae Origin: Southwestern Africa Growth Habits: Succulent, forming clumps of 12 inches tall, 12 inches wide (30 by 30 cm) 14

15 Hoodia Case EP The patent application (Council for Scientific and Industrial Research, ZA) claims the use of an extract obtained from a plant of the genus Trichocaulon or Hoodia, and of certain compounds isolated from these plants, as an appetite suppressant, for preventing, treating and combating obesity. 15

16 Hoodia Case Prior Art Bot. Jahrb. Syst. (1993) refers to Hoodia and mentions that : "The edible species have a peculiar pervasively spreading sweet taste which is remarkably persistent and is said to quench thirst and hunger for extended periods". White & Sloane, The Stapelieae (1937) reports an effect as described by a person having eaten the plant upon advice of a native guide and who is quoted with the words: "... it saved further suffering from the pangs of hunger so efficiently that I could not eat anything for a day after having reached the camp." 16

17 Hoodia Case Examination / Appeal The Examining Division refused the application in 2003 for lack of novelty and inventive step. The Board of Appeal came in 2005 to a different conclusion (based on a more restricted claim including also the feature of the active steroidal glycoside named PYM 50057) 17

18 Hoodia Case Appeal Based on comparative data of the applicant comparing the effect of intake of the active agent and the eating of a certain quantity of Hoodia plant the Board came to the conclusion that the effects disclosed by the prior art can be explained by the "stomach-filling properties" of the plant but did not lead obviously to the conclusion that an extract of the plant could be used as an appetite-suppressant, antiobesity medicament. The Board referred the case back to the Examining Division with the order to grant a patent. This was done in March

19 Hoodia Case Appeal Traditional Knowledge In his decision the Board stated also: "The Board is aware that the traditional knowledge of the original inhabitants of the Kalahari desert, like the San people, is the subject of a large number of publications. Many thereof have been published on the Internet. However, most of these documents have been published after the filing date of the present patent application and there is no convincing evidence on file that this post-published information, about what was known before the filing date, reflects reality. Therefore, the Board will not take into account post-published documents relating to traditional knowledge allegedly available to the public before the filing date, and consider only those documents which have been published before said date and which refer to different uses of plants of the genera Trichocaulon and Hoodia." 19

20 Hoodia Case Royalty agreement The CSIR have entered a benefit sharing agreement with an organisation representing the San people, to ensure that any financial benefit flowing from the commercialisation of the patented Hoodia gordonii extract is shared with people whose traditional knowledge first led to the investigation of the plant. 20

21 Thank you for your attention! A n y Q u e s t i o n s? 21