1. 1 4 TH REGIONAL PLANT BIOTECHNOLOGY FORUM INTELLECTUAL PROPERTY PROTECTION OF GENETICALLY MODIFIED PLANTS

2. www.dmkisch.com 2 DEFINITION OF GENETICALLY MODIFIED PLANT (GMP) IN TERMS OF THE GENETICALLY MODIFIED ORGANISMS ACT NO. 15 OF 1997 “genetically modified organism” means an organism the genes or genetic material of which has been modified in a way that does not occur naturally through mating or natural recombination or both, and “genetic modification” shall have a corresponding meaning;

3. www.dmkisch.com 3 WHAT IS INTELLECTUAL PROPERTY? (ACCORDING TO WIPO) Intellectual property (IP) refers to creations of the mind: inventions, literary and artistic works, symbols, names, images, and designs used in commerce. IP is divided into two categories: Industrial property, which includes inventions (patents), trademarks, industrial designs, and geographic indications of source; and Copyright. I wish to add animal and plant varieties under the category “inventions”.

4. www.dmkisch.com INTELLECTUAL PROPERTY RIGHTS: These include:  Patents  Trade marks  Registered designs  Copyright  Plant breeders’ rights  Other exclusive rights  Other statutory rights 4 Are the statutory and common law rights available for the protection of IP and specifically for GMP.

5. www.dmkisch.com PATENT PROTECTION FOR GMP:  New  Inventive  Industrially applicable  Not excluded as a reward to the inventor or successor in title in return for a full disclosure of the invention in a patent specification.as a reward to the inventor or successor in title in return for a full disclosure of the invention in a patent specification. 5 Territorially and time limited negative right granted for an invention that is:

6. www.dmkisch.com FOLLOWING ARE EXCLUDED (AMONGST OTHERS):  Discoveries (non-isolated gene or microorganism in its natural environment without asserted utility?);  An invention the publication or exploitation of which would be generally expected to encourage offensive or immoral behaviour (biopharmacy?): 6 “ Researchers from the John Innes Centre in Norwich, Great Britain have obtained genetically modified tomatoes rich in anthocyanins, a category of antioxidants belonging to the class of flavonoids. These tomatoes, added to the diet of cancer-prone mice, showed a significant protective effect by extending the mice lifespan. ”

7. www.dmkisch.com FOLLOWING ARE EXCLUDED (AMONGST OTHERS):  Any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a micro-biological process or the product of such a process (plant variety produced by cross pollination?). 7

8. www.dmkisch.com 8 PATENTING LIFE Entered into force on 30 July 1998. The EU member states implemented the Directive into their national law by 30 July 2000. Application by Kingdom of the Netherlands and others v European Parliament, and others for the annulment of Directive 98/44/EC was rejected on 9 October 2001 (1) THE EUROPEAN DIRECTIVE FOR THE LEGAL PROTECTION OF BIOTECHNOLOGICAL INVENTIONS (DIRECTIVE 98/44/EC):

9. www.dmkisch.com 9 “Biotechnological inventions” are inventions which concern a product consisting of, or containing, biological material or a process by means of which biological matter is produced, processed or used. “Biological Material” means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system. PATENTING LIFE DEFINITIONS IN DIRECTIVE:

10. www.dmkisch.com A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection. “Microbiological process” means any process involving or performed upon or resulting in microbiological material. 10 PATENTING LIFE DEFINITIONS IN DIRECTIVE:

11. www.dmkisch.com “Plant variety” means any plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a plant variety right are fully met, can be: Defined by the expression of the characteristics that results from a given genotype or combination of genotypes; Distinguished from any other plant grouping by the expression of at least one of the said characteristics; and Considered as a unit with regard to its suitability for being propagated unchanged. 11 PATENTING LIFE DEFINITIONS IN DIRECTIVE:

12. www.dmkisch.com 12 Biotechnological inventions shall also be patentable if they concern: Biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature; Plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety; and A microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety. PATENTING LIFE PATENTABLE BIOTECHNOLOGICAL INVENTIONS IN TERMS OF DIRECTIVE:

13. www.dmkisch.com 13 CRITICISM OF DNA PATENTS: a DNA sequence essentially constitutes a discovery or information and are therefore not patentable. RESPONSE TO CRITICISM: distinguish between: information discovered i.r.o. natural phenomenon (scientific information) = mere discovery – not patentable; and a natural or artificial phenomenon that constitutes information (genetic information) - could be patentable. PATENTING LIFE

14. www.dmkisch.com 14 A mere DNA fragment without indication of a function or specific asserted utility is not a patentable invention. A DNA fragment, of which specific utility, e.g. use as a probe to diagnose a specific disease, is disclosed, is a patentable invention as long as there is no other reasons for rejection. PATENTING LIFE The Trilateral Project B3b sets the following guidelines for the USPTO, EPO, JPO in considering patentability of DNA fragments:

15. www.dmkisch.com 15 A DNA fragment showing no unexpected effect, obtained by conventional method, which is assumed to be part of a certain structural gene based on its high homology with known DNA encoding protein with a known function, is not a patentable invention. (EPO, JPO) The above-mentioned DNA fragment is unpatentable if the specification fails to indicate an asserted utility. (USPTO) The mere fact that DNA fragments are derived from the same source is not sufficient to meet the requirement for unity of invention. PATENTING LIFE The Trilateral Project B3b sets the following guidelines for the USPTO, EPO, JPO in considering patentability of DNA fragments:

16. www.dmkisch.com CASE STUDY GM SOY BEAN 16 Monsanto Technology LLC v Cefetra Article 9 of the Biotech Directive states that “the protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided in Article 5(1), in which the product is incorporated and in which the genetic information is contained and performs its function”.

17. www.dmkisch.com CASE STUDY GM SOY BEAN 17 European patent No. EP 0546090 of Monsanto Technology LLC’s, related to a gene in the soya plant which conferred herbicide resistance. The claim did not extend to soya meal containing this gene where the gene is no longer performing its herbicide resistance function. Article 9 of the EU Biotech Directive 98/44/EC therefore does not confer protection on a patented DNA sequence when it is contained in soya meal, where it does not perform the function for which it was patented.

18. www.dmkisch.com CASE STUDY TOMATO CASE 18 EP 1 211 926 was filed in 2000 by the Israeli Ministry of Agriculture for a: “method for breeding tomatoes having reduced water content and product of the method” Reduced water content in tomatoes would be more suitable for producing ketchup and other foodstuffs. This patent was granted in 2003 and was opposed on the basis that it involved a biological process.

19. www.dmkisch.com CASE STUDY TOMATO CASE 19 Article 53(b) of the European Patent Convention (the “EPC”) states that: “European patents shall not be granted in respect of plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof.” The South African Patents Act Section 25(4)(b) states that: “A patent shall not be granted for any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a microbiological process or the products of such a process.” The EPC Rule 26(5) defines an essentially biological process as a process which consists entirely of natural phenomenon such as crossing and selection.

20. www.dmkisch.com CASE STUDY TOMATO CASE 20 CLAIM 1 OF EP 1211926 “A method for breeding tomato plants that produce tomatoes with reduced fruit water content comprising the steps of: crossing at least one Lycopersicon esculentum plant with a Lycopersicon spp. to produce hybrid seed; collecting the first generation of hybrid seeds; rowing plants from the first generation of hybrid seeds; pollinating the plants of the most recent hybrid generation; collecting the seeds produced by the most recent hybrid generation; growing plants from the seeds of the most recent hybrid generation; allowing fruit to remain on the vine past the point of normal ripening; and screening for reduced fruit water content as indicated by extended preservation of the ripe fruit and wrinkling of the fruit skin.”

21. www.dmkisch.com CASE STUDY BROCCOLI CASE 21 In 1999, Plant Bioscience Ltd, filed a patent for a method of selectively increasing the anti-carcinogenic glucosinolates of Brassica (broccoli) with the European Patent Office The patent was granted in 2002 (EP 1 069 819) but was opposed, on the basis that the patent was for a biological process (finding and marking a particular gene and breeding plants showing the marked gene) which is excluded from patentability.

22. www.dmkisch.com CASE STUDY BROCCOLI CASE 22 CLAIM 1 OF EP 1069819 “1.A method for the production of Brassica oleracea with elevated levels of 4-methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both, which comprises: a)crossing wild Brassica oleracea species selected from the group consisting of Brassica villosa and Brassica drepanensis with broccoli double haploid breeding lines; b)selecting hybrids with levels of 4-methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both, elevated above that initially found in broccoli double haploid breeding lines; c)backcrossing and selecting plants with the genetic combination encoding the expression of elevated levels of 4-methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both; and d)selecting a broccoli line with elevated levels of 4-methylsulfinylbutyl glucosinolates, or 3- methylsulfinylpropyl glucosinlates [sic], or both, capable of causing a strong induction of phase II enzymes, wherein molecular markers are used in steps (b) and (c) to select hybrids with genetic combination encoding expression of elevated levels of 4-methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both, capable of causing a strong induction of phase II enzymes.”

23. www.dmkisch.com CASE STUDY TOMATO & BROCCOLI CASE 23 After thorough consideration of the context, objective, purpose and legislative history of the exclusion in Article 53(b) EPC, the Enlarged Board of Appeal of the EPO decided that:  A process for the production of plants involving sexually crossing whole plant genomes, and the subsequent selection of plants, is not patentable.  While technical devices or means, such as genetic markers, may themselves be patentable inventions, their use does not make an essentially biological process patentable. DECISION OF ENLARGED BOARD OF APPEAL OF THE EPO

24. www.dmkisch.com CASE STUDY TOMATO & BROCCOLI CASE 24  Merely including a technical step to enable or assist the performance of sexually crossing genomes of plants or of subsequently selecting plants does not override this exclusion from patentability.  Processes for producing plants by inserting or modifying a trait in the genome by using genetic engineering do not rely on sexual crossing of whole genomes and may therefore be patentable. However, in such a case sexual crossing and selection steps should not be in the claims, since adding further technical processing steps before or after the steps of sexual crossing and selection does not render such processes patentable either. DECISION OF ENLARGED BOARD OF APPEAL OF THE EPO

25. www.dmkisch.com 25 WHAT ARE PLANT BREEDERS’ RIGHTS (PBR)? Statutory right to exclude others from dealing (as defined in section 23) with plant material (propagating and harvested material) of a particular variety of plant without prior authorisation. PLANT BREEDERS’ RIGHTS

26. www.dmkisch.com 26 WHEN DOES A VARIETY QUALIFY FOR PBR PROTECTION? (GENERAL PROVISIONS OF THE ACT) IF IT IS: NEW DISTINCT UNIFORM STABLE PLANT BREEDERS’ RIGHTS

27. www.dmkisch.com 27 (a) NEW if propagating material or harvested material thereof has not been sold (or otherwise disposed of) by (or with consent of) the breeder: (i)in the Republic, not more than one year; and (ii)in a convention country, in the case of- (aa) vines and trees, not more than six years; or (bb) other varieties, not more than four years, prior to the date of the PBR application; PLANT BREEDERS’ RIGHTS WHEN DOES A VARIETY QUALIFY FOR PBR PROTECTION?

28. www.dmkisch.com 28 WHEN DOES A VARIETY QUALIFY FOR PBR PROTECTION? (b)DISTINCT – clearly distinguishable from common varieties; (c)UNIFORM – if, subject to expected variation, it is sufficiently uniform with regard to the characteristics of the variety in question; (d) STABLE – if the characteristics thereof remain unchanged after repeated propagation. PLANT BREEDERS’ RIGHTS

29. www.dmkisch.com 29 WHAT IS THE TERM OF A PBR REGISTRATION? 25 years –in the case of vines and trees 20 years –in all other cases Calculated from date registration certificate is issued PLANT BREEDERS’ RIGHTS

30. www.dmkisch.com 30 WHAT ARE THE RIGHTS OF THE PBR HOLDER? The exclusive right to undertake –the production or reproduction –conditioning for the purpose of propagation –sale or any other form of marketing –exporting –importing –stocking for any of these purposes, of propagating material or harvested material Legitimate procurement of material not infringement PLANT BREEDERS’ RIGHTS

31. www.dmkisch.com 31 WHEN DOES ONE INFRINGE A PBR? Undertaking any of the actions reserved exclusively for the breeder Failing to comply with any term or condition of a licence Using an approved denomination of a protected variety in relation to plants or propagating material of another variety PLANT BREEDERS’ RIGHTS

32. www.dmkisch.com TRADE MARKS 32

33. www.dmkisch.com NO DESIGN PROTECTION NO COPYRIGHT PROTECTION 33

34. www.dmkisch.com STATUTORY EXCLUSIVITY: CONDITIONAL GMO PERMITS 34

35. www.dmkisch.com CASE STUDY MON810 35 The patent containing the MON810 trait (ZA90/1417) lapsed in 2010. Technology fee charge for the use of the patented technology in seed. Should the technology fee still be charged in respect of the “post-patent” or “off-patent” use of the technology? Permit no 17/3(5/01/177) grants the exclusive rights to Monsanto to allow planting of seed containing the MON810 trait. Any seed company is free to apply for a permit now that the patent has expired. Technology and stewardship agreement - purchaser undertakes to pay a technology fee to Monsanto.

36. www.dmkisch.com CASE STUDY MON810 36 Over and above the charging of a technology fee, Monsanto should be justified in charging a fee for the administration involved in complying with the permit conditions. Heavy burden to ensure compliance with the permit conditions, including inspections of farms and monitoring of refuge areas and spraying practises. To the benefit of the agricultural sector to have access to the technology and to ensure that the technology remains effective and is used properly in accordance with the permit conditions to prevent insect and weed resistance from developing.

37. www.dmkisch.com CONCLUSION & QUESTIONS 37

38. www.dmkisch.com 38 At van Rooy Contact Details Patent Director Tel: 012 460 3203 Cell: 082 772 0952 Fax: 012 460 3270 atv@dmkisch.com www.dmkisch.com PO Box 3668 Pretoria 0001 Suite 3, Parkland Building 223 Bronkhorst Street Nieuw Muckleneuk Pretoria