Tiêu đề Session 5: Mr. AR.pdf ✅

Not an invention and not patentable (3) Section 3(h): Methods of Agriculture Introduction: Section 3(j) Bibliography N.R.D.C’sApplication (Australia High Court), reproduced as an Appendix in [1961] R.P.C. at 134 N.V. Philips'Gloeilampenfabrieken'sApplication (1954) 71 R.P.C. 192 Exclusion added in Section 3 and not Section 5 Thus, Parliament considered that these items carried an inherent vice - not worthy of being called inventions In the matter of C. & W.’sApplication for a Patent, (1914) 39 R.P.C. 235 Schering A.G.’sApplication, [1971] R.P.C. 337 In the Matter of an Application by the Canterbury Agricultural College for L.P. 36327/54, (1958) 75 R.P.C. 86 plants and animals in whole or any part thereof other than micro organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals; processes that are not "essentially biological processesfor production or propagation of plants and animals" are not hit micro ogranisms are not hit Recollect Provision added only in 2002 But Section 3(j) insertion in 2002 was along with Section 5 amendment first part: plants and animals in whole or any part thereof including seeds, varieties and species second part excludes: essentially biological processes for production or propagation of plants and animals legislative history confirms that it corresponds toArticle 27.3(b),TRIPS Members may also exclude from patentability: ... (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Membersshall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.The provisions of this subparagraph shall be reviewed four years after the date of entry into force of theWTOAgreement. 5. In the case of inventions— (a) claiming substancesintended for use, or capable of being used, asfood or as medicine or drug, or (b) relating to substances prepared or produced by chemical processes(including alloys, optical glass,semi- conductors and inter-metallic compounds), no patent shall be granted in respect of claimsfor the substancesthemselves, but claimsfor the methods or processes of manufacture shall be patentable. Explanation.-For the purposes of thissection, "chemical processes" includes biochemical, biotechnological and microbiological processes. "biochemical, biotechnological and microbiological processes" = TRIPS "non-biological and microbiological" Ergo, after 2002 amendment: "biochemical, biotechnological and microbiological processes" were allowed products obtained from "biochemical, biotechnological and microbiological processes" were hit Deletion of Section 5 in 2005Amendment with no change in Section 3(j) Ergo, after 2005 amendment: products prepared or produced by "biochemical, biotechnological and microbiological processes" dont stand excluded anymore but 'why'? Is IndiaTRIPs compliant? Addition of "parts thereof"in Section 3(j) exclusion Absence of express provision allowing "non-biological and microbiological processes". But this not a violation: One view: limb, organ, leaf, flower, cells, genetic material are all "parts" But, consider because Section 3(c) already excludes naturally existing items if a word in a statute is "reasonably capable" of being interpreted in more than one way, use that interpretation that conforms to TRIPS but principle of effectiveness in treaty interpretation suggests thatTRIPS impliedly also excludes certain "parts" to prevent circumvention, it is logical to interpret theTRIPS provision as excluding plants and animals directly as well as indirectly. E.g. seeds, grafts, fruits etc can be used to grow entire plant E.g. totipotent cells can be used to regenerate the whole organism (b) context suggests provision is dealing with organisms/living systems - e.g. "plants", "animals", micro organisms" (a) it is logical to differentiate between what exists naturally and what is artificial (c) DuringTRIPS negotiation, a proposal considered but not ultimately accepted was to allow members to exclude "parts thereof" Ergo, those "parts" capable of regeneration into a whole plant or animal are also covered under the "plants and animals" Ergo, "plants and animals in whole or parts thereof"in Section 3(j) = whole plant, whole animal, and parts capable of regeneration into a whole plant or animal second part of Section 3(j) only excludes: essentially biological processes for production or propagation of plants and animals processes that are not "essentially biological processesfor production or propagation of plants and animals" are not hit = "non-biological and microbiological processes" = "biochemical, biotechnological and microbiological processes" that were deemed the same as chemical processes in Section 5 (which ultimately got deleted) Caution: EPC has a different provision Article 53(b) since 2000 (exceptions to patentability as opposed to inherent unpatentability) plant or animal varieties or essentially biological processesfor the production of plants or animals; this provision does not apply to microbiological processes or the productsthereof. EPC legislative history confirms that "varieties" were excluded to avoid dual protection under both Patent law and PlantVariety law does not really apply in India because the exclusion is beyond just varieties This distinction is irrelevant in India No clear explanation behind excluding essentially biological processes in EPC legislative history no wonder evenTRIPS does not have clarity in this respect only varieties excluded Nevertheless, the concept of "essentially biological processes"in TRIPS and Indian law was simply lifted from EPC (i) Essentially biological: (ii) Not Essentially biological: a. a process of sexual crossing and selection that includes within it an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing. b. Such additional step must be performed within the claimed process itself and cannot be upstream (dealing with the preparation of the plant(s) to be crossed) or downstream (steps dealing with the further treatment of the plant resulting from such crossing and selection process). (iii) However, such additional technical steps performed either before or after the process of crossing and selection could be separately protectable. E.g. genetic engineering methods to purposefully insert and/or modify one or more genes in a plant. a process for the production of plants which is based on the sexual crossing of whole genomes and on the subsequent selection of plants, in which human intervention, including the provision of a technical means, serves to enable or assist the performance of the process steps (aka "conventional breeding") Europe Enlarged Board ofAppeals, NovartisII & Essentially biological processes Thus, plants perse (claims that do not cover"plant varieties") can be patented under the EPC Later clarification that plants produced through "essentially biological processes" are not patentable because of the second part ofArticle 53(b) Some conclusions: micro organisms ordinary technical meaning non-cellular or unicellular organisms that require use of microscope, such as bacteria, viruses etc. Under EPC, even a plant cell or animal cell is considered micro organism but this may not apply in India because if the plant cell or animal cell is capable of regenerating into the whole plant or animal, it would hit as a "part" of plant/animal (i) Section 3(j). In its first part, it excludes "plants, animals and parts thereof...". In its second part, it excludes "essentially biological processes for the production or propagation of plants and animals. (ii) Section 3(j) to be read with the now-repealed Section 5. Biochemical, biotechnological and microbiological processes, or substances prepared or produced by biochemical, biotechnological and microbiological processes are not excluded under Section 3(j) (iii)The exclusion of "parts" of plants and animals must be interpreted to only cover those parts that are capable of regenerating into a whole plant or animal. (iv) Section 3(j) expressly considers microorganisms to be patentable subject matter, but in combination with Section 3(c), only considers genetically engineered or artificially created microorganisms to be patentable subject matter. (v)Under Section 3(j), the term 'microorganism' refers only to non-cellular or unicellular organisms that cannot be observed by the human eye without any aid, such as viruses, bacteria, fungi et cetera excluding 'parts' of plants and animals. Position different under the EPC where microorganisms can include plant and animal cells. (vi) Consequently, artificially constructed protein sequences, genetic material, gene cassettes, vectors, hybridomas etc., which are all substances prepared by biotechnological and microbiological processes, are not hit by Section 3(j).These would anyway not constitute 'parts' of plants or animals because such products are not capable of regenerating into a whole plant or animal. (vii)As regards the second part of Section 3(j), viz. "essentially biological processes...", it declares as inherently unpatentable, breeding methods where the traits or characteristics of the plant or animal is a result of natural biological processes.This would be the case even if the breeding was undertaken with the assistance of technology, so long as no artificial traits or characteristics were introduced into the bred plant or animal by way of said technology. In contrast, a claimed process where one of the process steps by itself introduces a trait into the genome or modifies a trait in the genome of the plant, would not be hit by Section 3(j) (ix) Section 3(j) operates without prejudice to the exclusion under Section 3(c). CaseT-0356/93, Plant Cells/PLANTGENETIC SYSTEMS (Technical Board of Appeals) CaseG-0001/98,Transgenic Plant/NOVARTIS II (Enlarged Board of Appeals) CaseG-001/08, Essentially biological processes (Enlarged Board of Appeals) But why make this distinction between plants/animals on the one hand and micro organisms on the other? Harvard College v. Canada (Commissioner of Patents), [2002] 4 SCR 45 Monsanto Canada Inc. v. Schmeiser, [2004] 1 SCR 902 Consider the Canadian SC judgments in HarvardOnco-mouse and Monsanto cases PPVFRA (PPV) Variety - Section 2(za) Types Extant New Farmers Common knowledge Examination system Filing Scrutiny (Section 20) TRIPSArticle 27.3(b) Advertisement (Section 21(1)) Opposition (Section 21(2) Grant Benefit sharing (Section 26) Infringement Revocation Compulsory license Continued: Section 3(j) "'variety', means a plant grouping except micro-organism within a single botanical taxon of the lowest known rank, which can be— (i) defined by the expression of the characteristicsresulting from a given genotype of that plant grouping; (ii) distinguished from any other plant grouping by expression of at least one of the said characteristics; and (iii) considered as a unit with regard to itssuitability for being propagated, which remains unchanged aftersuch propagation, and includes propagating material ofsuch variety, extant variety, transgenic variety, farmers’ variety and essentially derived variety." "Plant" v/s "PlantVariety" EDV Hybrid? Are weTRIPs compliant? UPOV "3. Members may also exclude from patentability: .... (b) plants and animals other than micro-organisms, and essentially biological processesfor the production of plants or animals other than non-biological and microbiological processes. However, Membersshall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.The provisions of thissubparagraph shall be reviewed four years after the date of entry into force of theWTO Agreement." Distinction with PatentsAct Subject Matter Qualification Criteria Protection even for OldTechnology Tenure Rights Conferred Exceptions/Limitations Description/Specification? PPV has research exemption that is broader than PatentsAct research exemption PPVAct has farmers exemption which does not apply to Patents Act PatentsAct has other exemptions which do not apply to PPV act Source: https://worldcoffeeresearch.org/work/next-generation- f1-hybrids/f1-hybrids-explainer/ Implication Qua Parental Line (viii) Claims for 'transgenic' plants and animal as a whole are not permissible under 3(j) as they are not considered 'substances prepared or produced by biochemical or biotechnological or microbiological process'