By Renu Bala Rampal and Rashmi
INTRODUCTION
In this article, the Hon’ble Madras High Court interprets the term “Diagnostic” in light of section 3(i) of the Indian Patents Act. This judgment clarifies the most perplexing questions such as whether the term “Diagnostic” should be limited to “in-vivo” or “in-vitro” diagnostic method, whether the term “Diagnostis” should be construed as a form of treatment, and whether the term screening would be qualified as diagnostic in the purview of section 3(i). This judgment outlines the steps to recognize and distinguish patentable from non-patentable matter, aiding both inventors and the Indian Patent Office in identifying patentable subject matter under section 3(i) of the Indian Patents Act.
BRIEF OVERVIEW OF THE MATTER
The Chinese University of Hong Kong and SEQUENOM, INC (herein referred to as Appellants) filed a patent application bearing application no. 4812/CHENP/2012, titled “Fetal Genomic Analysis from a Maternal Biological Sample”. The patent application was filed with 44 claims on June 01, 2012, with the Indian Patent Office (IPO), claiming priority from five U.S. applications with the earliest priority date of the application as November 05, 2009, and the application was published in patent journal dated March 21, 2014. Subsequently, a First Examination Report (FER) was issued by the Indian Patent Office on November 29, 2017, citing multiple objections under sections 2(1)(j), 3(i) and 10(5) of the Indian Patents Act, 1970. The Appellants filed the response to the FER along with an amended set of claims 1-12 on May 28, 2018. Thereafter, a hearing notice was issued in the matter on April 24, 2019, wherein the objection under section 2(1) (j) and “non-patentability” u/s 3(i) was again cited by the Assistant Controller.
After considering the written submissions filed by the applicant on June 26, 2019, the Assistant Controller passed an order dated March 31, 2021, wherein it was held that as the subject matter of claims 1-12 relates to “diagnostic method”, the claims are non-patentable under Section 3(i) of the Act. Therefore, the application was refused under Section 15 of the Act.
The Assistant Controller cited the following reasons for refusing the patent application.
- The invention of the subject patent application is a process for diagnosing the genetic or non-genetic diseases of the foetus according to paragraph [0007].
- The method claimed in the subject patent application discloses the maternal sample for determining the haplotype and/or genotype of the foetus and parental allele inherited by the foetus, which is non-patentable under section 3(i) of the Patents Act, 1970.
APPEAL FILED BY THE APPELLANTS
An appeal under the provision of Section 117A of the Patents Act was filed by the Appellants before the Hon’ble Madras High Court against the order passed by the Assistant Controller (hereinafter referred to as Respondent).
SUBMISSIONS MADE BY THE LEARNED COUNSEL OF THE APPELLANTS DURING THE COURT’S PROCEEDING
- The Section 3(i) bars grant of patents related to methods of diagnosis performed by a healthcare professional on patients thereby ensuring that the healthcare professional can adopt best methods for disease diagnosis and treatment without infringing any patent.
- By referring to the communication from the Indian Permanent Mission and the 2010 Manual of Patent Office Practice and Procedure (the 2010 Manual), the 2011 Manual of Patent Office Practice and Procedure, and the 2013 Guidelines for Examination of Biotechnology Applications for Patents, the learned counsel stated that the expression diagnostic in section 3(i) of the Indian Patents Act should be limited to in-vivo diagnostic methods only.
- The Learned Counsel submitted that the claimed method determining foetal fraction from biological sample is a non-invasive prenatal screening test, which requires further testing for revealing the pathology of patients.
- The Learned Counsel further stated that the expressions of section 3(i) clearly demonstrate that a method should be considered as diagnostic if it is used for the treating human beings for making them free of disease.
- The Learned Counsel relied upon the order of the EBoA (Enlarged Board of Appeal), case No. G 0001/04 and stated that the method is considered to be diagnostic if it consists the following four steps: (i) the examination phase involving the collection of data, (ii) the comparison of such data with standard/reference values, (iii) the finding of any significant deviation, i.e. a symptom, during the comparison, and (iv) the attribution of the deviation to a particular clinical picture, i.e. the deductive medical or veterinary decision phase. Since, the method claimed in subject patent application does not include clinical diagnosis, i.e. the fourth method step, the claimed invention is not a diagnostic method under section 3(i) of the Indian Patents Act. The counsel further added that the impugned order also referred to these four method steps.
SUBMISSIONS MADE BY THE AMICUS CURIAE DURING THE COURT’S PROCEEDING
The Amicus Curiae was appointed by the Hon’ble High Court for assisting the Court in this matter. The Amicus Curiae submitted following points before the Hon’ble High Court.
- The Amicus Curiae submitted that there is a drafting error in the nature of casus omissus in Section 3(i) of the Indian Patents Act, as amended by Act 38 of 2002. The Amicus Curiae relied upon the judgments of the Supreme Court in Union of India & Anr. v. Hansoli Devi & Ors.,(2002) 7 SCC 273 and Padma Sundara Rao & Anr. v. State of T.N. & Ors., (2002) 3 SCC 533, for his statement of casus omissus. The Amicus Curiae further stated that Section 3(i) should be read as “any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other methods for treatment of human beings”.
- The Amicus Curiae further submitted that the Technical Board of Appeal and EPO guidelines only allow those inventions, which do not claim a clinical diagnosis.
SUBMISSIONS MADE BY THE LEARNED COUNSEL OF THE RESPONDENT DURING THE COURT’S PROCEEDING
- The Learned SPC of the Respondent submitted that para 0007 of the complete specification discloses the diagnosis of genetic diseases such as chromosomal aberrations, which implies that the claimed method is diagnostic in nature. In response to the contention of the appellants that Section 3(i) should be limited to in-vivo diagnosis, the learned SPC submitted that there is no indication in Section 3(i) which implies that section 3(i) excludes in-vitro diagnosis and should be only limited to in vivo diagnosis.
- In response to the contention of the appellants that the diagnostic process should include all four method steps, the learned SPC submitted that the EBoA opinion is not binding on this Court. The learned SPC referred to the Pre-Conception and Pre-Natal Diagnostic Techniques Act, 1994 and submitted that the process claimed in the subject invention makes sex determination feasible, therefore, the subject patent application is non-patentable.
JUDGMENT PASSED BY THE HON’BLE MADRAS HIGH COURT
Interpretation of section 3(i)
Upon considering the contentions of the Appellant, Respondent, and Amicus Curiae, the Hon’ble High Court determined that section 3(i) of the Patents Act contains two limbs:
- any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings; or
- any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products.
The Hon’ble High Court stated that two limbs of Section 3(i) is self-sufficient and distinct in nature. The first limb of section 3(i) deals with human beings whereas the second limb deals with animals; and the two limbs are separated by disjunctive ‘or’. The expressions “increase their economic value or that of their products” in second limb of section 3(i) is non-applicable to human beings. Although, it is clearly depicted that two limbs of section 3(i) are distinct in nature, they are separated by disjunctive ‘or’ and pronoun “them” is used after the antecedent “animals” therefore, pronoun ‘them” is referred to the antecedent “animals” only and not to human beings. The expression “treatment” in section 3(i) deals with curing or making a person free from diseases, alleviating pain, prophylactic, preventing aggravation or managing a condition or disorder in a better manner. Hence, the “diagnostic” word in section 3(i) is not confined to treating human being for rendering them free of disease.
The Hon’ble High Court determined that the opening phrase of section 3(i) “any process for the” read with the followed terms “medicinal, surgical, curative, prophylactic, diagnostic and therapeutic” is not complete. Hence, the opening phrase of section 3(i) is complete when read as “any process for the medicinal treatment of human beings” and so on. However, it does not work for the term “diagnostic” i.e., “any process for diagnostic treatment of human beings” does not make complete sense unlike in the case of the forms of treatment dealt with in. The expression “or other treatment of human beings” in first limb of section 3(i) indicates that the word “treatment” can be interpreted widely.
Interpretation of the terms “Diagnosis” & “Treatment”
The Hon’ble High Court stated that diagnosis “is a method for identifying the existence or non-existence of a disease or disorder or condition and/or the site, extent, severity or other aspects thereof”, which per se does not considered as a form of treatment. The Hon’ble Court did not concur with the suggestions made by the Amicus Curiae, which proposed considering the issue as a ‘casus omissus’ and adding the expression ‘methods for’ after ‘other treatment of human beings’ in the first limb of Section 3(i), to be read as: “any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other methods for treatment of human beings”. The Hon’ble High Court found this suggestion unhelpful, as it did not address the issue of excluding ‘diagnostic methods’ from being considered as a form of treatment. The Hon’ble High Court further stated that diagnosis is an essential requirement for the rational treatment and both the processes of “diagnosis” and “treatment” is entirely different. The Hon’ble High Court concurred with the argument of Learned Counsel of the Appellants that the expression ‘diagnostic’ should be read in conjunction with its associated terms in section 3(i). Therefore, when the word “diagnostic” is read alongside “forms of treatment”, it should be limited to the processes that reveal the pathology of the patient for the purpose of treatment.
Interpretation of the terms “In-vivo” and In-vitro”
The Hon’ble High Court stated that the amendment of section 3(i) was done by Act 38 of 2002 by adding words like “diagnostic” and “therapeutic”. The Hon’ble Court further stated that the language of section 3(i) does not indicate that the word “diagnostic” should be confined only to in vivo diagnosis nor does it exclude in vitro diagnosis. The amendment of section 3(i) to include exclusions of patentable matter is permitted under the TRIPS Agreement.
The Hon’ble High Court stated that the draft and final manuals of 2005, paragraph 4.9.14 of 2008 manual and paragraph 08.03.06.08 of 2010 manual clearly mention the exclusion of in-vivo diagnostic method from patent eligibility. However, the final manuals of 2013 and 2019 does not mention in-vivo diagnostic method as patent ineligible. Instead, they define diagnosis as “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”. Therefore, the language of latest guidelines of the final manuals do not indicate the exclusion of in-vivo diagnostic methods from patentability.
The Hon’ble High Court analysed the EBoA opinion and Article 52(4) of the EPC and noted that while Article 52(4) of the EPC includes the phrase “diagnostic methods practised on the human or animal body”, section 3(i) of the Indian Patents Act does not include such a reference. This suggested that the term ‘diagnostic’ in section 3(i) applies to both in-vitro as well as in-vivo diagnostic methods. Furthermore, Section 3(i) excludes any process for the diagnostic treatment of human beings from patent eligibility, the term “diagnostic” should be interpreted in light of both its textual meaning and its context. The claims should be examined within the context of the complete specification, to determine whether they describe a process for making a diagnosis for treatment. This assessment should assume that a person skilled in the field, including a medical doctor, is reviewing the claims and specification. If the process allows for making a diagnosis for treatment—regardless of whether it is definitive—the method would be considered patent-ineligible. Conversely, if the process does not allow for diagnosis for treatment, it would be patent-eligible. Thus, the Hon’ble High Court concluded that the final step of the diagnostic method in the EBoA opinion, which requires the intellect of a healthcare professional to diagnose the disease, cannot be patented unless it is performed by a device.
Interpretation of the terms “Screening” and “Diagnosis”
The Hon’ble High Court further stated that if a screening test is able to identify the existence or non-existence of any disease or disorder for the treatment of human being, such test would be considered as diagnostic under the purview of section 3(i). Furthermore, if such screening test identifies the disease or disorder but requires a confirmatory test, such screening test would also be considered as diagnostic under section 3(i) of the Indian Patents Act.
The Hon’ble High Court concluded that the diagnosis claim should be examined by a person(s) skilled in the art within the context of the embodiments of complete specification to determine whether the process is intended for diagnosis in the context of treatment. If the process is for diagnosis related to the treatment, then the process is considered non-patentable, on the contrary, if the process for diagnosis is not intended for the treatment, and, if such a process is incapable of uncovering pathology, or, if the person(s) skilled in the art cannot diagnose any disease or disorder based on the claimed process, as the process per se is not meant to diagnose the disease, such process would not qualify as diagnostic for purposes of Section 3(i) of the Indian Patents Act, and therefore, is patent eligible.
Judgement
The Hon’ble High Court thus determined that claimed method of the subject patent application per se was not able to identify any disease or disorder and a further testing was required to identify such disease or disorder. The subject patent application claimed an indicator, foetal fraction, which was required for further testing to diagnose the disease. The Hon’ble High Court was of the view that “determining foetal fraction is related to diagnosis but itself is not “diagnostic”. Further, the Hon’ble High Court did not concur with the contention of learned SPC that the test of subject patent application may be used for sex determination. For the reasons set out above, the Hon’ble High Court allowed the Appellant’s appeal and set aside the order issued by the Respondent, allowing the patent application for grant with amended claims 1-12.
Conclusion
The Hon’ble Madras High Court’s judgment in the case of Chinese University of Hong Kong and SEQUENOM, INC. vs The Assistant Controller of Patents & Designs provides much needed clarity on section 3(i) of the Indian Patents Act, which has previously raised several challenges regarding the interpretation of the term “diagnostic”. The Court concluded that the term “diagnostic” under section 3(i) applies to both in-vivo as well as in-vitro processes, but is limited to those processes that reveal the pathology of the patient. If a process requires further testing to identify any disease or condition, it does not fall under the purview of section 3(i) of the Indian Patents Act. This judgment establishes a new precedent, and will assist the Indian Patent Office in distinguishing between diagnostic and non-diagnostic tests, a determination that must be made on a case-by-case basis.
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