Google penalized by Delhi High Court for misrepresenting disclosures
In a notable judgment in early April, the IP Division of Delhi High Court dismissed Google LLC’s (Google) appeal against the rejection of its patent application by the Assistant Controller of Patents and Designs (Controller), and imposed a fine of Rs 1 lakh (~USD 1,200) on the tech giant for presenting incorrect information and failing to disclose critical details about its corresponding applications in Europe.
In 2007, Google filed a patent application before the Indian Patent Office (IPO) for its technology that enables users to manage seamless instant messaging across different smart devices like desktops and PDAs, irrespective of the device. The application was rejected by the Controller based on lack of novelty and inventive step in view of prior art.
Aggrieved by the impugned order, Google appealed before the erstwhile Intellectual Property Appellate Board (IPAB). After the dissolution of IPAB in 2021, the case was transferred to the Delhi High Court where it was eventually heard in December 2023. During the proceedings involving detailed arguments on novelty and inventive step by both sides, the Court inquired about the status of the corresponding patent applications in other countries. Google responded by stating that the US and Canadian patent applications were granted, while the European patent (EP) application was abandoned. The IPO’s Counsel refuted this by pointing out that the EP application had in fact been rejected on the basis of lack of novelty and inventive step and not abandoned. Court also found that a divisional application with the identical title as that of the rejected EP application had also been filed and its status was also disclosed as “abandoned”, when in fact it was also rejected on the same grounds.
Taking serious note of Google’s conduct in the proceedings, the Court noted that Google had misrepresented facts to the IPO as well as the Court which also breached its duty of disclosure under the Patents Act, 1970 (Act).
The Court finally dismissed the appeal on merits for not meeting the novelty and inventive step requirement. Additionally, the Court ordered Google to pay costs of INR 1 Lakh (~USD 1,200) for presenting wrong facts to the Court and not meeting the disclosure requirements under the Act.
This judgment re-emphasizes the necessity for applicants to provide complete and accurate information throughout the application process, especially concerning information related to corresponding foreign patent applications, which may be material to the grant.
Asserting Patent Infringement with the help of Doctrine of Equivalence
The overarching issue in SNPC Machines Private Limited & Ors. v. Mr. Vishal Choudhary revolves around the application of the doctrine of equivalents to determine patent infringement, focusing on whether functional similarities between two competing brick-making machines constitute a violation of patent rights, despite differences in their physical designs and mechanisms.
In April 2024, the plaintiff, SNPC Machines Private Limited & Ors. (SNPC), filed an infringement suit related to brick-making machines against defendant, Vishal Choudhary (Vishal Choudhary), sold under name of Padma Brick Making Machine in the Delhi High Court. The suit sought “permanent injunction” restraining Vishal from using, making, manufacturing, offering for sale or selling or importing impugned brick-making machines.
The suit patent in question is SNPC’s mobile brick-making machine that molds and lays bricks as it moves, controlled by an operator from a cabin. SNPC claimed that Vishal’s machine is doing the same work, in almost the same manner to accomplish the same results as SNPC’s brick-making machine.
However, Vishal contented that there were distinct differences between the two – Vishal’s machine lacked a cabin and steering mechanism, was designed to be towed by a tractor instead of an integrated mobility system like SNPC’s machine and utilized kinetic energy for operation, in contrast to the electrical energy powering SNPC’s machine.
Vishal argued that since their machine did not include every element specified in the patent claims, they did not infringe on the suit patent, invoking the ‘all elements rule’ as a defense. Furthermore, they raised the issue of prosecution history estoppel, stating that SNPC has previously focused only on roller and die assembly matters, which helps in shaping and forming the bricks, whereas now it was also emphasizing the machine’s integrated mobility.
SNPC countered stating that such differences were “trifling and insignificant” and that Vishal’s machine performed absolutely no function while it was stationery, and therefore included wheels to ensure mobility. They invoked ‘the pith and marrow of the invention’ principle and urged the Delhi High Court to not focus only on the “literal infringement”. Furthermore, they urged the Court to apply the “Doctrine of Equivalents”, to check whether the substituted element in the infringing product does “the same function” in substantially “the same way” to accomplish substantially “the same result” (triple identity test). In other words, SNPC claimed that Vishal had merely replaced the integrated mobility of SNPC’s machine with the tractor, to achieve exactly the same result.
The Court concurred with SNPC that the Doctrine of Equivalents should be applied, using the triple identity test, to determine if Vishal’s machine performs the same function in the same way to achieve the same result as SNPC’s product. The doctrine suggests that an invention can infringe on a patented invention if it functions almost the same way and produces a similar result as the patented invention, even if there may be minor differences between the elements or features of the two products. In other words, if the infringing product is equivalent to the patented invention in terms of its functionality, it may still be considered infringing.
Further the Court noted that while there were differences between SNPC and Vishal’s machine, these differences did not detract from the fundamental aspect of the invention – i.e., the mobility to ensure mobility of the assembly, albeit through different mechanisms. The Court concluded that these differences, according to the doctrine of “the pith and marrow”, were integral to the core functionality of the invention. The Court further interpreted that, without “mobility” the Vishal’s machine would serve no purpose considering it had a roller and die mechanism as well, therefore did not absolve them of infringement.
The Court considering all the facts and evidence, submitted granted a interim injunction in favor of SNPC, restraining Vishal from manufacturing and selling brick-making machines similar to the Plaintiffs’ patented brick-making machines. By focusing on the essential functionality of the patented invention, the Court helped protect SNPC against infringement, promoting innovation and fair competition in the market.
This judgment highlights the importance of the doctrine of equivalence in patent infringement cases, where there are two similar products and the question is whether one product performs the same function in the same way to achieve the same result as the patented invention, despite minor differences in their elements.
New Indian Patents (Amendment) Rules 2024: What You Need to Know
Significant changes to benefit patent applicants and owners
The Indian Patent (Amendment) Rules, 2024 (Rules) have been notified and made effective by the Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry, Government of India on March 15, 2024, with an intent to:
- Expedite and streamline the prosecution of patent applications;
- Allow flexibility on certain previously non-extendible deadlines through extension fees;
- Simplify the requirements for corresponding foreign filing particulars as well as working statements; and
- Curb the filing of frivolous pre-grant oppositions.
India: the rising sun of Standard Essential Patent (SEP) enforcement in 2024
India’s market size – for telecoms and beyond – and increasingly mature Standard Essential Patent (SEP) licensing environment
have brought high-profile conflicts between patent holders and implementers to the fore.
This article aims to provide a snapshot of the current landscape, delve into the anticipated developments in 2024, and shed light on why India is emerging as a desirable location for resolving SEP licensing disputes.
IPO ends decade-long pre-grant opposition to Gilead’s Sofosbuvir prodrug
In a landmark case, Gilead Pharmasset, LLC v Sankalp Rehabilitation Trust and Ors., the Indian Patent Office (IPO) in Kolkata granted a patent to Gilead Pharmasset, LLC (Gilead), covering the prodrug molecule of anti-HCV drug Sofosbuvir. The IPO rejected all the 13 pre-grant oppositions, filed by various opponents including pharma companies, advocacy groups, and individuals against the patent application. The case spanned a decade.
The patent application was opposed primarily on the grounds of lack of novelty, lack of inventive step, non-patentability under section 3(d), and insufficiency of disclosure and failure to disclose information under section 8 of the Indian Patent Act, 1970. Since these multiple oppositions were filed at varying intervals, the grant proceedings were substantially delayed.
After considering all the materials on record, the Controller of Patents (Controller), held as follows: made the following key findings:
- Validity of priority date of the application: The Opponents challenged the priority application dated March 30, 2007, based on the patent application US 60/309,915 and argued that submitted documents D23 and D24 should be considered valid prior art for assessing the novelty of the claims. However, the IPO found these arguments unpersuasive, noting that the priority document was valid and adequately disclosed the claimed compound’s components and stereochemical configurations.
- Lack of Novelty: The IPO concluded that the claimed compounds were novel due to their structural differences and lack of explicit disclosures in the cited documents, strengthening the novelty of the claimed compound and its process of preparation.
- Lack of inventive step: The IPO acknowledged the uniqueness of the claimed compound comprising specific moieties and substituents, which were not obvious compared to the cited prior art. The IPO also rejected the opponents’ arguments suggesting the compound was obvious in view of prior art disclosing HIV or cancer treatments, emphasizing that applying these teachings to HCV treatments without considering structural and stereochemical aspects would be implausible.
- Non-patentability under section 3(d): The IPO rejected the argument that the claimed invention was a mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of the substance. It held that the opponents’ reliance on prior art failed to establish the existence of any known substance with similar structure and efficacy to the claimed compound, or that the claimed invention lacked novelty and efficacy.
- Sufficiency of disclosure: The IPO found that the invention’s description in the application extensively covers the structure, stereochemistry, and preparation methods of the claimed compounds. Furthermore, examples and procedures outlined in the description provide adequate guidance and the claimed compound’s process, enabling skilled practitioners to understand and implement them effectively.
K&S Partners’ team comprising Litigation Practice Chair, Sanjeev Kumar Tiwari, Practice Lead (Life Sciences, Chemistry & Pharma, Amrish Tiwari and Partner and Chem-Pharma Patent Expert, Dr Jyoti Choithani Ramani, successfully represented Gilead Pharmasset, LLC in this important case.
Court Rules Data Privacy Prevails Over Business Methods in E-Commerce
In a pivotal decision, in the case Priya Randolph v the Deputy Controller of Patents and Designs, the Madras High Court has significantly impacted the criterion of patentable inventions in India, safeguarding a privacy-focused technology amidst e-commerce giants.
Priya Randolph and Rohit Chaturvedi (inventors) sought patent protection for their system that selectively conceals user data, specifically physical addresses, during e-commerce transactions. However, after their application was dismissed as a non-patentable “business method” under Section 3(k) of the Indian Patents Act, 1970 (the Act), the inventors approached the Court.
The inventors primarily contended that the claimed invention, encompassing hardware, software and firmware, was a technological advancement that furthers privacy and data protection, not business method, as asserted by the Deputy Controller of Patents and Designs (Deputy Controller).
The Deputy Controller argued that since the invention has involvement in e-commerce, it naturally fell under business methods and Section 3(k) automatically applied, rendering it ineligible for patent protection.
The Court, guided by para 4.5.2 of the Guidelines for Examination of Computer Related Inventions of 2017 (CRI Guidelines), clarified that merely touching upon e-commerce doesn’t automatically classify an invention as a business method. It emphasized the importance of the invention’s substance, specifically in this case, the invention’s distinct technological contribution to data privacy beyond routine business processes.
Consequently, the initial rejection was set aside, and the matter remanded for reconsideration by a different officer. The inventors were granted a reasonable opportunity to further present their case, with a reasoned decision expected within four months.
This order re-emphasizes the important markers made in the CRI guidelines for business method that the substance of claims matter, not the form in which they are presented.
Patentability of Synergistic Combinations Yielding New and Improved Results
In a notable ruling in the case, Biomoneta Research Pvt ltd. v Controller General of Patents Designs, the Delhi High Court (Court) resolved an appeal by Biomoneta Research Pvt. Ltd. (Biomoenta) against the Controller General of Patents and Designs’ (Controller) rejection of their 2017 patent application for an ‘Air Decontamination Assembly.’
The case is significant for its detailed analysis of inventive step in patent law and the Court’s consideration of European patent guidelines.
Biomoneta contended the rejection of its patent application, which was previously followed by a PCT Application and subsequent national phase applications in the US Patent and Trademark Office and European Patent Office (EPO). The Indian Patent Office (IPO) had objected to the application, citing a lack of inventive step under Section 2(1)(ja) of the Indian Patents Act, 1970, (the Act) and referenced three prior art documents (D1 to D3).
In its defense, Biomoneta emphasized the uniqueness of its air decontamination technology, which utilized a low voltage electric field and conducting plates with 3D material, arguing its effectiveness against viruses like COVID-19 and features like filter-less operation and reduced power consumption.
The Court first referred to the judgement in F. Hoffmann-La Roche Ltd. v Cipla Ltd, for the “test to be followed for determining inventive step and lack of obviousness,” and Documents D1-D3. The Court noted that Biomoneta’s invention shared some features with existing technologies, such as the use of conducting plates and electric fields. However, Biomoneta’s unique combination of these elements with low voltage electric fields and 3D material-coated plates demonstrated an inventive step. This combination led to advancements like filter-free operation, reduced power consumption, and effective pathogen elimination, setting it apart from prior art and justifying the patent grant.
Further, the Court referenced the EPO guideline on combining features versus mere juxtaposition in patent claims; these guidelines emphasized that an invention should be assessed as a whole and not merely upon the combinations. Further, if the combination of features yields a new and improved result, it merits patentability. The Court found that Biomoneta’s device, addressing several disadvantages of existing technologies, wasn’t just a simple combination of known features but involved an inventive step. The Court also stated that while secondary considerations alone don’t make an invention patentable, combining existing results in a novel, beneficial way can justify a patent grant.
The Court’s decision was further influenced by the grant of a corresponding US patent, viewing it as corroborative of the invention’s novelty and inventiveness. As a result, the Court overturned the previous rejection, directing the patent application to proceed for grant.
This decision stands out for its detailed examination of inventive step, considering both Indian and European patent law principles. It emphasizes the importance of a holistic and comprehensive approach in patent adjudication, especially in complex technological fields, setting a valuable precedent for future patent assessments.
Inventiveness Test Should Be Applied to Entire Invention, Not Parts
In the matter of Groz-Beckert Kg v Union of India & Ors, the Calcutta High Court heard the appeal of Groz-Beckert KG (GBKG) against the rejection of their patent application by the Controller of Patents and Designs (Controller).
The case dealt with the issue of whether, can an invention be assessed on its constituent parts, while evaluating its patentability.
GBKG’s patent application was for a method and apparatus for processing textile materials, designed to improve the efficiency and functionality in the textile industry, granted in over 11 jurisdictions worldwide. However, the Controller rejected it stating it lacked an inventive step under Section 2(1)(ja) of the Indian Patents Act, 1970 (Act) and also formality issues concerning the submission of the Proof of Right.
GBKG argued that the Controller’s finding was based on an incorrect assessment of the invention by dividing it into two parts, rather than viewing it as an integrated invention comprising of multiple interlinked features.
The Court, referring to the guidance on this aspect provided by the Indian Manual of Patent Office Practice and Procedure (the Manual), agreed with GBKG’s contentions. Citing the precedent set in Bishwanath Prasad Radhey Shyam v Hindustan Metal Industries, the Court emphasized the necessity of strictly and objectively judging the “obviousness” of an invention and considering it in entirety, rather than as isolated parts. The Court also observed that the Controller had overlooked the technical advancements claimed by GBKG. Drawing from the principles outlined in State Bank of India v Ajay Kumar Sood, the Court noted that the rejection was based on incomplete facts and lacked reasoning.
Consequently, the Court overturned the Controller’s decision and directed a fresh evaluation of the patent application within three months, ensuring GBKG’s right to a hearing.
High Court Affirms Scotch Whisky Association’s GI Infringement Lawsuit Right
The Scotch Whisky Association (SWA), a company incorporated in the UK won an appeal (Scotch Whisky Association v J.K. Enterprises & Ors) before an Appellate Bench of the High Court of Madhya Pradesh in Indore.
The appeal arose from an order passed by the Commercial Court in District Indore. The Commercial Court held that SWA’s suit for infringement of its geographical indication (GI) Scotch Whisky, against the defendant JK Enterprises (JKE), was maintainable only if it impleaded an ‘authorised user’ of the GI as a necessary party.
The concept of ‘authorised user’ is unique to the Indian GI law. It essentially refers to any person claiming to be the producer of the goods in respect of which a GI has been registered. The Geographical Indications of Goods (Registration & Protection) Act, 1999 (the GI Act) permits authorized users to register themselves with the GI Registry. They can even sue for infringement, among other rights.
JKE defended the appeal and argued that SWA was not entitled to sue independently for infringement under Section 21(1) of the GI Act without impleading an authorized user as a necessary party. Section 21 (1) reads as follows:
21. Rights conferred by registration.
(1) Subject to the other provisions of this Act, the registration of a geographical indication shall, if valid, give,-
(a) to the registered proprietor of the geographical indication and the authorised user or users thereof the right to obtain relief in respect of infringement of the geographical indication in the manner provided by this Act;
(b) to the authorised user thereof the exclusive right to the use of the geographical indication in relation to the goods in respect of which the geographical indication is registered.
It was JKE’s argument that the ‘and’ in Section 21(1)(a) of the GI Act must be read conjunctively and not disjunctively. When done so, JKE argued, there would be a requirement to implead the authorized user along with the registered proprietor in a suit for infringement.
In examining this issue, the Court looked at India’s obligations under the WTO’s TRIPs Agreement. It noted that the interpretation of the provisions of the GI Act, enacted in pursuance of the obligations under the TRIPs Agreement, must be in tune with such obligations and such interpretation must be purposive. Thereafter, the Court reviewed the provisions of the GI Act to understand the role of the registered proprietor and the authorised user. The Court’s review indicated that there are various provisions under the GI Act where the registered proprietor can act in its own right, without involving the authorized user. Two such provisions cited by the Court pertain to renewal of the GI and seeking additional protection. The Court also referred to Section 68 of the GI Act which specifically lists certain proceedings where the authorised user must be impleaded. Based on these provisions, the Court concluded that the registered proprietor has an independent legal status and entitlement to relate itself to the GI.
Citing the principle of “ubi jus ibi remedium,” (if there is a right, there is a remedy,) the Court pointed out that the legislature could not have been presumed to have conferred exclusive rights on the authorized user to the exclusion of the registered proprietor, who is the originator of the GI registration. The Court thus concluded that the word ‘and’ used in Section 21(1)(a) of the GI Act must be treated as ‘or’, else it would lead to a situation where the status of a registered proprietor of a GI would be pushed below that of the authorised user.
This is the first court order in India that discusses the rights of registered proprietors of GIs vis-à-vis authorized users. K&S Partners represented SWA in the action.
Court Rules on Determining Diagnostic Criteria in Patent Applications
The Madras High Court, this year, ruled on the much-awaited cases pertaining to interpretation of the scope of patentability of diagnostic methods patentability under the Indian Patents Act, 1970 (Act). Section 3(i) of the Act prohibits the patenting of diagnostic methods aimed at treating diseases in humans or animals to make them disease-free.
The two cases were appeals filed against rejection orders of the Controller of Patents (Controller) the matters of The Chinese University of Hong Kong v the Assistant Controller of Patents and Designs .
Case 1 – The Chinese University of Hong Kong vs. the Assistant Controller of Patents and Design (Indian patent application number 4863/CHENP/2012).
The University approached the Court against the Controller’s order rejecting their patent application for a method to detect foetal chromosomal abnormalities, deeming the method as a diagnostic one, and hence non-patentable under Section 3(i).
Section 3(i) specifically precludes from patentability:
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 University argued the following key arguments in support of their contention:
- In Vivo Application Requirement: The invention involved an in vitro (in the laboratory) analysis of fragments of nucleic acid molecules taken from a biological sample containing both foetal and maternal DNA. For a method to be classified as diagnostic in terms of Section 3(i), it should involve an in vivo application (within the living).
- Interpretation of Section 3(i): The lack of a comma between “prophylactic” and “diagnostic,” implies a restriction only to diagnostic methods used for disease prevention.
- Scope of Section 3(i): Only diagnostic methods for the treatment of human beings to make them “free of disease” fall within the scope of Section 3(i).
- Four-Step Diagnostic Method: A method is ‘diagnostic’ only if it includes four specific steps – data collection, comparison with standard values, identification of significant deviations, and linking these to a specific clinical condition (as recommended by the Enlarged Board of Appeal’s (EBoA) interpretation under the European Patent Convention (EPC)).
In response, the IPO presented the following arguments:
- The invention diagnosed foetal chromosomal abnormalities by identifying sequence imbalances in samples from the human body, making it diagnostic,
- Section 3(i) should be read broadly to include both in vitro (in the laboratory) and in vivo (within the living) diagnostic methods,
- The EboA’s opinion on the four-step diagnosis is not binding in Indian courts, and
- Any method involved in diagnosis qualifies as a diagnostic method under Section 3(i).
The Court analysed the interpretation of “diagnostic” within the context of Section 3(i), and passed judgement on the following:
- “Prophylactic Diagnostic”: The lack of a comma between “prophylactic” and “diagnostic” in Section 3(i) is a minor printing error and therefore, does not limit diagnostic methods to those treating humans to be disease-free.
- Diagnosis for Humans vs Animals: Section 3(i) has two distinct parts for human beings and animals. The animal-related provision mentions “any process for a similar treatment of animals” with three purposes of treatment: curing disease, increasing their economic value, or improving their products. However, the part applying to humans does not confine the word “diagnostic” to treatment of human beings to “render them free from disease”.
- In vivo and in vitro diagnostic: Neither the language of Section 3(i) nor of Article 27(3) of TRIPS, an international agreement, restricts diagnostic methods to in-vivo; international agreements such as EPC also do not impose any limitation or restriction on the scope of the expression “diagnostic methods”. Besides, the Manual of Patent office Practice and Procedure 2019 also does not limit the word “diagnostic” to in-vitro.
- On the four-step method requirement: As regards the EBoA’s interpretation on applying the four-step method, the phrase “practised on human body” is key and is missing from Section 3(i). Thus, it cannot be applied to determine the scope of diagnostic method in Indian context.
- Determining “Diagnostic”: Patent eligibility for “diagnostic” processes requires assessment of the claims in the context of the specification. If a person skilled in the art, such as a medical doctor, concludes from this that the process leads to a diagnosis, it is non-patentable. Additionally, the test’s label alone doesn’t dictate patentability. If the test is used to diagnose a disease, disorder or condition for treatment of human beings, then it is diagnostic and patent ineligible, regardless of the patient’s symptoms. Conversely, if testing is for research or quality control, then the process is not diagnostic and patent eligible.
Therefore, the Court held that the University’s patent application claimed a diagnostic method, thus non-patentable under Section 3(i).
Case 2 – The Chinese University of Hong Kong vs. the Assistant Controller of Patents and Design (Indian patent application number 4863/CHENP/2012)
This case claimed a method for determining the foetal fraction in a maternal sample. Similar to Case 1, the University challenged the Controller’s refusal decision, deeming the method as a diagnostic one, and hence non-patentable under Section 3(i).
While making similar arguments as in Case 1, the University further emphasized that their method in this case was a preliminary step in prenatal testing, primarily focusing on the process of identifying foetal fraction, an indicator for further testing, rather than diagnosing a condition. Thus, the method, non-diagnostic in nature, should not be classified as non-patentable under the purview of Section 3(i).
The Controller held the same arguments as made in Case 1. Additionally, an independent lawyer appearing as amicus curiae (friend of the court) in the matter, also provided his expert views on Section 3(i), stating that:
- Section 3(i) contains a drafting error and the phrase “of treatment of human beings” should be read as “for treatment of human beings” for making sense of the provision,
- Based on legislative history of the provision, diagnostics are not limited to in vivo methods,
- The exclusions such as Section 3(i) were introduced as a matter of practicality and not as a matter of public policy, and
- That the Technical Board of Appeal at the European Patent Office follows the four-method requirement of EboA with caution and only grants patents if the claimed invention does not unambiguously point to a clinical diagnosis.
The Court applied the same principles as discussed in Case 1. Further the Court held that the method in Case 2 involved determining the foetal fraction in a biological sample, a process not inherently identifying a disease or condition, and further testing would be required for such purpose. Therefore, adopting the balanced approach of interpretation of the term “diagnostic”, the Court allowed the appeal.
Key takeaways:
- Broad Interpretation of “Diagnostic” in Section 3(i): The section does not exclude in vitro diagnostic methods. The definitive test is to see if the diagnosis discloses disease or pathology for the treatment of human beings.
- Distinct Treatment for Humans and Animals: The first part of Section 3(i) applies to human beings and the second part to animals exclusively.
- Non-restriction to Disease-free Diagnostic Methods: A diagnostic method need not render human beings free of disease to be non-patentable. If the method discloses disease or pathology for treatment, the bar of Section 3(i) shall apply.
- EboA’s Method Not Mandatory: The EboA’s four-step process for determining a diagnostic method is not universally applicable.
- Individual Assessment of “Diagnostic” Nature: Each patent application must be assessed individually to see if it leads to a diagnosis. If a skilled professional like a doctor determines it results in a diagnosis, it’s non-patentable. However, if it’s for research or quality control without leading to a diagnosis, it’s patent eligible
As a parting remark, the Court observed that given the recent patent approvals in favour of in vitro processes and technological advancements made in diagnosis, especially with genomic tools, the scope of the expression “diagnostic” in Section 3(i) might need to be restricted to in vivo processes. This change can be balanced by introducing compulsory licensing legislations.
The Court’s decisions in these cases set significant precedents for future patent applications in the biotechnology and biomedical diagnostics sectors. The rulings suggest that legislative amendments might be required to refine the scope of “diagnostic” in Section 3(i), potentially restricting its scope to in vivo processes.