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TMI Blog2023 (10) TMI 1453X X X X Extracts X X X X X X X X Extracts X X X X ..... invention per se points to a diagnosis for treatment. If such process does not uncover pathology for any reason, it would not be diagnostic for purposes of Section 3(i). What is determinative, therefore, of whether a process is diagnostic is to ask the question whether the process is inherently and per se capable of identifying the disease, disorder or condition for treatment of the person. It bears repetition that such capability of the process should, in turn, be determined by assuming that a person(s) skilled in the art, including a medical doctor, examines the results. If the person(s) skilled in the art would not be in a position to diagnose the disease, disorder or condition, as the case may be, on the basis of the process because the process is not designed to diagnose diseases, disorders or conditions, such process, whether labelled as screening or anything else, would not qualify as diagnostic for purposes of Section 3(i) - The corollary would be that the Controller would be required to make this determination on a case- by-case basis. Into which category, the claimed invention falls remains to be considered. It cannot be concluded that the process described by the claimed ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e biological sample: measuring a size of the nucleic acid molecule; identifying which nucleic acid sequence the nucleic acid molecule is derived; a computer system determining a size distribution of the nucleic acid molecules corresponding to a first sequence of the identified nucleic acid sequences; and based on the determined size distribution, determining a classification of whether a sequence imbalance exists for the first sequence. 5. At the hearing before the authority, the appellant contended that the detection of a sequence imbalance does not ipso facto lead to the conclusion that there is foetal chromosomal aneuploidy and, therefore, it cannot be concluded on the basis of paragraph [0006] or the other paragraphs of the complete specification that the claimed invention is a diagnostic method for detection of foetal chromosomal aneuploidy. By the impugned order, except amended claims 23, 34 and 46, the amendments relating to the other claims were held to be permissible under Section 59 of the Patents Act. It was concluded, however, that amended claims 1 to 46 lack an inventive step in view of prior art documents, D1 and D2. 6. The Assistant Controller of Patents examined the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... laims 01-43 filed on 07/05/2019 are not patentable as per the provisions of Section 3(i) of Patents Act 1970. Therefore, it is hereby decided that the patent application 4863/CHENP/2012 is refused under section 15 of the Act. Counsel and contentions 7. Oral arguments were advanced by Ms.Archana Shanker, learned counsel for the appellant; and by Mr.AR.L.Sundaresan, learned Additional Solicitor General of India (ASGI), assisted by Mr.Rajesh Vivekanandan, Deputy Solicitor General, on behalf of the respondent. Mr. Calab Gabriel, learned counsel, who has had considerable experience in patent law, made submissions at the hearing on 05.10.2023 to assist the Court. 8. Ms.Archana Shanker submitted that the method envisages carrying out in vitro analysis of fragments of nucleic acid molecules taken from a biological sample containing both foetal and maternal DNA. She further submitted that sequence imbalances are identified by examining the size distribution of such nucleic acid molecules, including by using a computer programme. Upon receipt of objections, she submitted that two express disclaimers were introduced by the appellant to the effect that the method is non- diagnostic and perform ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... o in this regard. 11. The next contention of learned counsel was that only diagnostic methods for the treatment of human beings with a view to render such human beings free of disease fall within the scope of Section 3(i). In order to substantiate this contention, learned counsel referred to the language of Section 3(i) and contended that the expression to render them free of disease also applies to and qualifies treatment of human beings, including by use of diagnostic processes. 12. By relying upon principles of interpretation, such as ejusdem generis and noscitur a sociis, she contended that the word 'diagnostic' should be interpreted by taking into account the words with which it is associated in Section 3(i). Since Section 3(i) also uses expressions such as other treatment of human beings and to render them free of disease , she contended that a method would qualify as diagnostic only if it is intended for the treatment of human beings for purposes of rendering them free of disease. 13. In support of the contention that the expression diagnostic method should be confined to in vivo diagnosis, the opinion of the Enlarged Board of Appeal (the EBoA) in case No.G 0001/04 ( ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... plurality of the nucleic acid molecules in the biological sample; measuring a size of the nucleic acid molecule; identifying which nucleic acid sequence the nucleic acid molecule is derived; a computer system determining a size distribution of the nucleic acid molecules corresponding to a first sequence of the identified nucleic acid sequences; and based on the determined size distribution, determining a classification of whether a sequence imbalance exists for the first sequence. Later, on 5.10.2023, another set of amended claims 1-43 was filed before this Court. The last amended claim 1 (current claim 1) is as under: 1. A computer implemented method for measuring a sequence imbalance in a biological sample from a pregnant female subject, wherein the biological sample includes nucleic acid molecules that are part of nucleic acid sequences, the nucleic acid molecules from the fetus and the pregnant female subject, the method comprising: measuring a size of the nucleic acid molecule for each of a plurality of the nucleic acid molecules in the biological sample; identifying which nucleic acid sequence the nucleic acid molecule is derived; determining a size distribution of the nucle ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... on interpretation of Section 3(d) in Novartis AG v. Union of India Ors., (2013) 6 SCC 1, he concluded that the impugned order is in conformity with the requirements of the Patents Act and that no interference is warranted. 18. After orders were originally reserved in this matter, arguments were heard in The Chinese University of Hong Kong v. The Assistant Controller of Patents and Designs, CMA (PT) No.14 of 2023, which also involves interpretation of Section 3(i) of the Patents Act. In that case, apart from the submissions of learned counsel for the respective parties, I had the benefit of the submissions of Mr. Adarsh Ramanujan, learned counsel, who appeared as amicus curiae. After observing arguments in that case, learned counsel for the appellant requested that permission be granted to provide clarifications. By acceding to that request, the matter was listed on 05.10.2023 and, on that date, both Ms. Archana Shanker and Mr. Rajesh Vivekanandan made brief submissions. In addition, Mr. Calab Gabriel, learned counsel and patent law expert, made brief submissions to assist the Court. 19. Mr. Calab Gabriel submitted that only testing carried out to uncover pathology should be constr ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... economic value or that of their products. Before delving deeper, a minor argument is dealt with. Because the text of Section 3(i) does not contain a comma between prophylactic and diagnostic, a tentative argument was made by the appellant that it should be confined to prophylactic or preventive diagnosis. Aside from the fact that punctuation is not determinative, this contention is liable to be rejected because the Patents (Amendment) Act, 2002 (Act 38 of 2002) contains a comma after the word prophylactic but the comma was not placed within the quotation marks as is evident from the following relevant provision thereof: 4. In Section 3 of the principal Act,- (d) in clause (i),- (i) after the word prophylactic , the words diagnostic, therapeutic shall be inserted; Therefore, the missing comma is no more than printer's devil. Besides, such contention is wholly incompatible with one of the principal contentions of learned counsel for the appellant that the diagnostic method should be adopted for the treatment of human beings so as to render them free of disease. 22. Section 3(i) contains the following two limbs: (a) any process for the medicinal, surgical, curative, prophylactic ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ve express terms becomes meaningful only if read along with the succeeding words as: any process for the medicinal treatment of human beings and so on. This construction works perfectly if each express term describes a form of treatment and such is the case with all express terms except diagnostic , and this statement calls for explanation. A human being may be treated for a disease or disorder or condition by administering medicines, performing surgery or by administering therapy involving medicines or other forms of treatment such as radiation or a combination thereof. If such treatment is administered in order to cure the human being of a disease, it is curative. On the other hand, if medicine or vaccination is administered to prevent a human being from developing a disease or to prevent a more severe manifestation of such disease, it is prophylactic. The common thread running through the following categories - medicinal, surgical, curative, prophylactic and therapeutic - is that they are clearly methods of treatment of human beings. Apart from the above mentioned specific processes, Section 3(i) contains the generic expression or other treatment of human beings . The use of the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... onstrued in isolation but should be understood noscitur a sociis, i.e. in association with the accompanying words of Section 3(i) read as a whole. In principle, I concur. When viewed in context, i.e. in association with forms of treatment , I conclude that the word diagnostic should be limited to diagnostic processes that disclose pathology for the treatment of human beings. After dealing with other contentions of the appellant, I propose to examine the different purposes for which testing of human beings may be carried out a little further down the road. 26. I now turn to the contention that such diagnostic processes should be confined to in vivo diagnosis. The text of Section 3(i) was amended by Act 38 of 2002 by including the words diagnostic, therapeutic . As is evident from the language of Section 3(i), there is no indication therein that the word diagnostic should be confined to in vivo diagnosis. Even if the net were to be cast wider, I find nothing in the language of Section 3 or in any other provisions of the Patents Act that lead to the inference that the expression 'diagnostic' should be confined to in vivo diagnosis. Although text and statutory context do not su ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... r the treatment of humans or animals; (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, Members shall 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 the WTO Agreement. 28. Clause 3(a) of Article 27 enables members to exclude from patent eligibility the following: 'diagnostic, therapeutic and surgical methods for the treatment of humans or animals'. Article 27(3)(a), thus, indicates clearly that the diagnostic method should be for the treatment of humans or animals, but no other limitation or restriction on the scope of the expression diagnostic methods is discernible from Article 27(3)(a). The travaux pr paratoires or preparatory materials leading to the conclusion of an international treaty is a recognised source for the construction of such international treaty both under the Vienna Convention on the Law of Treaties, 1969, and customary intern ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... understood the provision. The EBoA opinion 30. The appellant relied upon the EBoA opinion for two purposes: (i) to contend that the word diagnostic should be confined to in vivo diagnosis; and (ii) to contend that a process would not qualify as diagnostic unless all four method steps in diagnosis are involved. Before turning to the EBoA opinion, it is instructive to set out Article 52(4) of the Convention on the Grant of European Patents, 1973 (European Patents Convention/EPC) which is as under: 52(4) Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application within the meaning of paragraph 1. This provision shall not apply to products, in particular substance or compositions, for use in any of these methods . (emphasis added) 31. The EBoA noticed the language of Article 52(4) of the EPC and, in particular, the expression diagnostic methods practised on the human or animal body , and, on that basis, in paragraph 6.1 of the opinion, concluded that the text of the provision itself gives an indication favouring a narrow interpre ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... cur when carrying those out among these preceding steps which are of a technical nature. 2. Whether or not a method is a diagnostic method within the meaning of Article 52(4) EPC may neither depend on the participation of a medical or veterinary practitioner, by being present or by bearing the responsibility, nor on the fact that all method steps can also, or only, be practised by medical or technical support staff, the patient himself or herself or an automated system. Moreover, no distinction is to be made in this context between essential method steps having diagnostic character and non-essential method steps lacking it. 3. In a diagnostic method under Article 52(4) EPC, the method steps of a technical nature belonging to the preceding steps which are constitutive for making the diagnosis for curative purposes stricto sensu must satisfy the criterion practised on the human or animal body . 4. Article 52(4) EPC does not require a specific type and intensity of interaction with the human or animal body; a preceding step of a technical nature thus satisfies the criterion practised on the human or animal body if its performance implies any interaction with the human or animal body, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nciples were formulated and measures taken to preclude circumvention by clever patent claims drafting. The EPO Guidelines (March 2023) contain inter alia the following guidance: The requirement that the final decision phase be included in the independent claim as an essential feature is to be applied only if it is clear from the application/patent as a whole that the inevitable result of the findings leads unambiguously to a particular diagnosis : this will have to be decided by the division on a case-by-case basis. In Case Number T 0125/02 dated 23 May 2006, the Board of Appeal of the EPO dealt with claims relating to a method of ascertaining the 38/54 current lung function of a human subject, which included a claim for interpreting a deviation between the recorded values of the subject and reference values, and concluded that the method, be it positive or negative, is sufficient to decide upon the therapeutic action to be taken in response to the diagnosis . On such basis, the patent application was rejected. 38. Similarly, in Case Number TT 0143/04, in the context of method claims relating to Alzheimer's disease, the Technical Board of Appeal of the EPO, by decision dated 12 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... determine whether it specifies a process for making a diagnosis for treatment. Such determination should be made by assuming that a person(s) skilled in the art, including a medical doctor, examines the claims and complete specification. If it is concluded that a diagnosis for treatment may be made, even if such diagnosis is not definitive, it would be patent ineligible, whereas, if diagnosis for treatment cannot be made, it would be patent eligible. As a corollary, one final issue falls for consideration: is there a case to exclude certain types of tests from the ambit of the expression diagnostic in Section 3(i) and I deal with this issue next. 42. The language of Section 3(i) uses the expression diagnostic...or other treatment of human beings and thereby appears to point in the direction of examining embodiments or use cases of processes to determine if they are diagnostic. Nonetheless, it should not be lost sight of that patent eligibility is decided at the threshold by examining claims that could have multiple use cases. Consequently, in the context of diagnostic processes, I am of the view that the embodiments of a claimed invention are relevant only for the purpose of ascert ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... agnostic tests are required to confirm the results of screening tests. Even in the specific context of non-invasive prenatal testing (NIPT), reference may be made to the publication by Medline Plus titled What is non- invasive prenatal testing (NIPT) and what disorders it can screen for and the publication by the American Clinical Laboratory Association Screening vs Diagnostic: Understanding Non-invasive Prenatal Screening . Adopting this approach, in my view, is also not in consonance with the meaning of diagnostic in Section 3(i), i.e. capable of uncovering the pathology. Put differently, if the screening test identifies the disease, disorder or condition albeit subject to confirmation by definitive tests, it would still qualify as diagnostic for purposes of Section 3(i) because the provision does not use the qualifier definitive . 46. What is determinative, therefore, of whether a process is diagnostic is to ask the question whether the process is inherently and per se capable of identifying the disease, disorder or condition for treatment of the person. It bears repetition that such capability of the process should, in turn, be determined by assuming that a person(s) skilled in ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... previously by adopting invasive methods such as chorionic villi sampling (CVS) or amniocentesis. Both these methods, therefore, involve some risk of foetal damage. Instead, recent advancements enable testing on a blood sample drawn from a pregnant female with a foetus of not less than a threshold gestational age (usually not less than 10 weeks). Such testing is done by using techniques that identify and work on cell-free DNA (cfDNA) fragments after identifying the foetal fraction in the biological sample. The proportion of cfDNA in maternal blood that comes from the placenta is the foetal fraction. DNA sequencing is undertaken by adopting methods such as massively parallel or high throughput sequencing and, on such basis, sequence imbalances, if any, are ascertained. By plotting the site and nature of imbalance, chromosomal aberrations, whether numerical or by way of mutations such as deletion, duplication and the like, may be identified. Chromosomal aneuploidy is a numerical aberration in which there is an extra chromosome (trisomy, three instead of two) or a missing chromosome (monosomy, one instead of two). By way of illustration, a trisomy of chromosome 21 is referred to as Do ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e. 50. The contention of learned counsel for the appellant that embodiments of the claimed invention should not be reckoned for determination of the claims cannot be accepted. Although the claims delimit the scope and ambit of the monopoly claim, the embodiments set out in the complete specification can and should be examined to assess whether the process is per se diagnostic. In my view, if the amended claim 1 or current claim 1 is examined in the context of the above and other paragraphs of the complete specification, it follows that person(s) skilled in the art would be able to arrive at a diagnosis as to whether a specific chromosomal aberration, such as an aneuploidy, exists by adopting this process. For some understanding of size distribution analysis, reference may be made to the article Size-based molecular diagnostics using plasma DNA for noninvasive prenatal testing by Stephanie C.Y. Yu et al, dated June 10, 2014, Proceedings of the National Academy of Sciences, Volume 111, No.23, pages 8583-8588. If a positive result for a chromosomal aneuploidy is returned, medical literature indicates that a medical doctor is likely to opt for definitive diagnosis by undertaking chorio ..... X X X X Extracts X X X X X X X X Extracts X X X X
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