9911796707
TMI Blog2023 (10) TMI 1453X X X X Extracts X X X X X X X X Extracts X X X X ..... ant. 2. The appellant originally filed Application No. PCT/EP2010/066935 under the Patent Co-operation Treaty (PCT). IN 4863 is the national phase application derived from the said PCT application. 3. In relation to IN 4863, the appellant received the First Examination Report (FER) on 17.11.2017 raising multiple objections, including objections under Section 3(i) and (k) of the Patents Act, 1970 (the Patents Act). The appellant responded thereto on 14.05.2018 and submitted revised claims. The claims were further revised, pursuant to receipt of the notice of hearing on 07.05.2019, by introducing disclaimers stating that the invention involved a non- diagnostic method and was carried out in vitro on a biological sample. 4. The amended claim 1, as of 07.05.2019, of the appellant is as under: "1. A non-diagnostic in vitro 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: for each of a plurality of the nucleic acid molecules in the biol ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... (containing mother and fetal DNA), where the imbalance is relative to a genotype, mutation status, or haplotype of the mother. Such an imbalance can be determined via a size distribution of fragments and a ranking of a size distribution (e.g. a statistical value representing a size distribution) of fragments from respective chromosomes relative to each other are used to determine an imbalance. For instance, a ranking of the size of fragments of the at-risk chromosome in the test sample can be compared to the ranking for the at-risk chromosome that was obtained from a reference biological sample. Thus a diagnosis can be performed based on the comparison. As an example, if the ranking changes (e.g. indicating a reduction in size of the nucleic acid fragments) by a specified amount then a diagnosis that a fetal chromosomal aneuploidy exists in the at-risk chromosome may be made. Here the amended claims 01-43 include all the above mentioned steps and thereby it makes possible to decide the general physical state of an individual and it clearly constitutes a method of diagnosis. In view of the above, the requirements of objection no 2 communicated in the hearing notice is not met as t ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nuals of patent practice and procedure issued periodically by the Controller of Patents. By way of illustration, learned counsel pointed out that the Draft Manual of Patent Office Practice and Procedure published in 2005 (the Draft Manual of 2005) referred expressly to methods of treatment of human beings practised on the human body. In fact, she pointed out that it was stated expressly therein that methods of diagnosis performed on tissues or fluids, which have been permanently removed from the body, were excluded. She also referred to paragraph 4.9.14 of the Manual of Patent Office Practice and Procedure 2008 and contended that it contains identical language. reference to paragraph 08.03.06.08 of the Manual of Patent Practice and Procedure 2010 (the 2010 Manual), she submitted that it states that "methods of diagnosis practised on the human and animal body is not patentable", thereby indicating that diagnosis undertaken in vitro is patent eligible. Clause 9.03.05.08 of the Manual of Patent Office Practice and Procedure, published on 26.11.2019 (the 2019 Manual) and the Guidelines for Examination of Biotechnology Applications for Patents, published in March 2013 (the 2013 Guidelin ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Europe SA v. Anand Mahajan and Others, 2009 SCC OnLine Del 2826 on the significance of disclaimers in delimiting and curtailing the scope of the monopoly claim, and in order to substantiate the contention that the impugned order did not take into account the disclaimers of the appellant. 15. Learned counsel also submitted that amended claims can be filed at the appellate stage because an appeal is an extension of the original proceeding. In support of this contention, she placed reliance on the judgment of the Delhi High Court in Societe Des Produits Nestle SA v. The Controller of Patents and Design and Another, 2023/DHC/000774, where the Delhi High Court concluded that it is permissible for parties to amend their claims in proceedings before the Court. In line with the above contention, the following revised claim 1 (as on 2.08.2023) was submitted for consideration: "1. A computer implemented non- diagnostic in vitro 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 femal ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... relied on the judgment of the Division Bench of the Bombay High Court in Merind Ltd. v. State of Maharashtra 2004 SCC OnLine Bom 1269. He further submitted that the golden rule is to interpret a statutory provision literally unless literal interpretation would result in manifest absurdity. In this case, he submitted that construing the expression 'diagnostic' literally does not render it absurd. By relying on paragraphs 10 to 10.2 of the judgment of the Supreme Court in Hira Singh & Anr. v. Union of India & Anr.,(2020) 20 SCC 272, where the Supreme Court held that the quantity of neutral substances should also be reckoned while determining commercial quantity under the Narcotic Drugs and Psychotropic Substances Act, 1985, he submitted that the word "diagnostic" should be construed broadly and not narrowly. 17. As regards the contention that the process of diagnosis should include all four method steps, he contended that the EBoA opinion is not binding on this Court. By laying emphasis on the use of the word 'process' in Section 3(i), learned ASGI further contended that every method step involved in the process of diagnosis qualifies as a diagnostic method under Sec ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... aimed invention does not partake of the essential feature of diagnosis, namely, clinical deduction. As regards the embodiments described in the complete specification, she submitted that they are no more than examples of potential industrial application. She also submitted that the claimed invention merely identifies one property, size distribution, of nucleic acid molecules. By once again referring to the manuals of practice and procedure published by the Patent Office, she reiterated in conclusion that the Patent Office's understanding of Section 3(i) is that it applies only to in vivo and not in vitro testing. Such understanding is further reflected, according to learned counsel, in the grant of patents to several applications in respect of in vitro diagnosis. Discussion, analysis and conclusions Construction of Section 3(i) 21. The construction of Section 3(i) of the Patents Act is at the heart of this dispute. Section 3(i) is set out below: "3.What are not inventions - The following are not inventions within the meaning of this Act,- .... (i) any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human bein ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... f treatment. When viewed in isolation, the first purpose "to render them free of disease" could apply to human beings. However, keeping in mind that the first and the second limbs deal with distinct subjects; they are separated by the disjunctive "or"; and the pronoun "them" is used after the antecedent "animals", I conclude that said pronoun is referable only to the last antecedent "animals" and not to human beings. Apart from the above reasons, it bears mention that treatment is provided not only to free/cure a person of disease but also for prophylactic purposes, to alleviate pain, prevent aggravation of or to better manage a condition or disorder. Hence, I reject the contention that the word "diagnostic" in Section 3(i) should be confined to treatment of human beings to render them free from disease. 23. Proceeding further with the analysis of Section 3(i), it opens with the phrase "any process for the" and the following express terms are set out: medicinal, surgical, curative, prophylactic, diagnostic and therapeutic. When read with any of the above express terms, the opening phrase remains incomplete and does not make complete sense. For example, "any process for the medicin ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... o such option because "any process for the ... diagnostic ... or other method for treatment of human beings" is not syntactically correct because the word "process" at the beginning of the provision is incompatible with the proposed word "method", both being analogous. More importantly, it does not resolve the fundamental problem of diagnosis or the diagnostic method not being a form of treatment. Hence, I propose to make sense of the expression "any process for the diagnostic...or other treatment of human beings" with reference to both text and immediate context. 25. Diagnosis - whether by physical examination and/or an analysis of symptoms or by use of diagnostic devices or running laboratory tests - is an essential pre-requisite for rational treatment. Sometimes the link between diagnosis and treatment is close and immediate, such as, typically, in the case of coronary angiography and angioplasty; whereas, at other times, there could be a long interval between diagnosis and, for example, treatment by surgery. Whether the interval is short or long, diagnosis and treatment are understood as distinct processes. Because the word "diagnostic" is juxtaposed in Section 3(i) with words ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... in that Section 3 of the Patents Act was amended to include exclusions from patent eligibility as permitted under the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement). TRIPS Agreement 27. Article 27 of the TRIPS Agreement, which deals with patentable subject matter, is set out below: Article 27 Patentable Subject Matter 1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced. 2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environmen ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ice, as exemplified by its manuals, I find that both the Draft and Final Manual of 2005 clearly exclude patent eligibility only in respect of in vivo diagnostic methods. Likewise, paragraph 4.9.14 of the 2008 Manual and paragraph 08.03.06.08 of the 2010 Manual also contain substantially similar language. Such language is, however, not present in the 2019 Manual, which defines diagnostic methods as under: "(e) Diagnostic methods: Diagnosis is the identification of the nature of a medical illness, usually by investigating its history and symptoms and by applying tests. Determination of the general physical state of an individual (e.g. a fitness test) is considered to be diagnostic." After defining diagnostic methods in the above manner, the 2019 Manual provides several examples of subject matter excluded under Section 3(i). Among such further examples is diagnosis practised on the human or animal body. The 2013 Guidelines are in identical language. Thus, while earlier versions of the patent manuals of practice and procedure limit patent ineligibility to in vivo diagnosis, there is nothing in the presently applicable final manual or guidelines which supports the construction that i ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... to a particular clinical picture, i.e. the deductive medical or veterinary decision phase. 33. Thereafter, the EBoA recognised that there are two possible constructions of Article 52(4): a narrow construction that excludes diagnostic methods practised on the human or animal body only if all the above mentioned four method steps are involved or a broad interpretation excluding all method steps relating to diagnosis or of value for the purpose of diagnosis. By adopting the narrow interpretation, the EBoA reasoned that "intermediate findings of diagnostic relevance must not be confounded with diagnosis for curative purposes stricto sensu ... which consists in attributing the detected deviation to a particular clinical picture" and concluded that all the four method steps outlined above should be involved in the diagnostic method for it to be excluded from patent protection. The operative portion of the order is set out below: "1. In order that the subject-matter of a claim relating to a diagnostic method practised on the human or animal body falls under the prohibition of Article 52(4) EPC, the claim is to include the features relating to: (i) the diagnosis for curative purposes ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... s, such as by use of ultrasound devices, endoscopy, computer tomography (CT) scans, magnetic resonance imaging (MRI) and coronary angiography, the processes of diagnosis are ordinarily performed by or under the supervision of medical doctors. Even if performed by a technician under supervision, the results are generally provided along with the clinical diagnosis. Therefore, it is probable, albeit not certain, that in such processes all the four method steps specified by the EBoA would be involved. 36. By contrast, while carrying out in vitro diagnosis, the first three method steps may be carried out by persons other than medical doctors, even without supervision by medical doctors, whereas the fourth method step may only be carried out by a medical doctor. Consequently, more often than not, the first three method steps would be undertaken separately by persons qualified in allied sciences or by qualified technicians who would provide such data to the medical doctor. On such basis, the medical doctor would make the clinical diagnosis (i.e. the non-patentable fourth step). Therefore, in the context of in vitro diagnosis, if the approach of the EBoA were to be adopted, the Section 3( ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... that the inevitable results of the tests would lead to a particular diagnosis; the reliability thereof being of limited significance. In effect, while interpreting Article 52(4) and 53(c) of the EPC, it was recognised that the requirement that all four method steps be involved could lead to clever patent claims drafting to circumvent patent ineligibility, and the "inevitable results of the test" was evolved as a filter to weed out patent ineligible claims camouflaged by clever claims drafting. 41. As discussed earlier, Section 3(i) uses the word "diagnostic" in juxtaposition with forms of treatment, such as medicinal, surgical and therapeutic, and in association with the words "other treatment of human beings". By taking note of the above and recognising that Section 3(i) differs materially from Articles 52(4) and 53(c) of the EPC inasmuch as Section 3(i) excludes from patent eligibility any process for the diagnostic treatment of human beings, whereas Article 52(4) and 53(c) exclude only diagnostic methods practised on the human body, I conclude that the word "diagnostic" should receive a construction which is in consonance with text and context. Such construction does not call f ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... y also be undertaken, for instance, of skin type to decide on the use of cosmetic processes or products. The methods or processes adopted in the above three illustrations may potentially also be used in relation to medical treatment. Therefore, from the perspective of deciding a patent application, use cases are relevant only for the limited purpose of ascertaining whether the claimed invention can per se uncover pathology and form the basis of treatment. Screening and Diagnosis 44. In medical literature, a distinction is often drawn between screening and diagnosis. Such distinction is typically made on the basis that asymptomatic persons are screened, persons at risk of any disease, disorder or condition are put through preliminary tests for early diagnosis and symptomatic persons are put through diagnostic tests. This raises the question whether such screening of asymptomatic persons would qualify as diagnostic for purposes of Section 3(i). In my view, if a screening test is capable of identifying the existence or non-existence of a disease, disorder or condition and/or the site, extent, severity or other aspects thereof for treatment of human beings, irrespective of whether th ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... y not always be bright and could blur on occasion; even so, there is sufficient support both in the text and immediate context of the expression "diagnostic" in Section 3(i) to reach the above conclusion. 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. Claimed invention: diagnostic? 47. The appellant contended that the claimed invention cannot be construed as a diagnostic process for treatment of human beings because the appellant does not diagnose the medical condition and merely provides data in relation to sequence imbalance by a size distribution analysis of DNA fragments taken from a biological sample, including by using a computer programme. The appellant also contended that the patent eligibility of the claimed invention cannot be tested by examining one of the use cases or embodiments of the claimed invention and should be tested on the basis of the amended claims which delimit and fix the boundaries of the claimed invention. 48. In order to decide whether the contention of the appellant is correct, it is necessary to set out the ba ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e under Section 3(i). Paragraphs [0006] and [0008] are as under: "[0006] Certain embodiments of the present invention can provide systems, methods, and apparatus can use a size-based analysis to perform a prenatal diagnosis of a sequence imbalance (e.g. a fetal chromosomal aneuploidy) in a biological sample obtained from a pregnant female subject. For example, a size distribution of fragments of nucleic acid molecules for an at-risk chromosome can be used to determine a fetal chromosomal aneuploidy. Some embodiments can also detect other sequence imbalances, such as a sequence imbalance in the biological sample (containing mother and fetal DNA), where the imbalance is relative to a genotype, mutation status, or haplotype of the mother. Such an imbalance can be determined via a size distribution of fragments (nucleic acid molecules) corresponding to a particular sequence relative to a size distribution to be expected if the sample were purely from the mother, and not from the fetus and mother. A shift (e.g. to a smaller size distribution) can signify an imbalance in certain circumstances." "[0008] In another embodiment, a difference between a size (e.g. A statistical value repre ..... X X X X Extracts X X X X X X X X Extracts X X X X
|
