ICRIMINALLAW THE IMPACT OF THE BHARATIYA NYAYA SANHITA, 20 Home / Article / Natco Pharma v. Novartis AG: A Landmark Case on Patent Law and Public Health Natco Pharma v. Novartis AG: A Landmark Case on Patent Law and Public Health January 28,2025 @ Astha Srivastava Author: Dr. Teena Momsia, Dr BhimRao Ambedkar Law University, Jaipur, Rajasthan To the Point In the Novartis AG v. Natco Pharma Limited case, the Delhi High Court’s Division ch ruled that substantive examination and pre-grant opposition of a patent _ pplication are distinct and independent processes. Opponents cannot intervenein the substantive examination process. The Division Bench reversed the Single Bench’s interlocutory injunction against Natco, emphasizing that a granted patent does not carry a presumption of validity and can be contested at any stage. The court stressed the importance of “coverage” versus “disclosure” in patents, noting that patents must adequately disclose inventions to allow skilled individuals to utilize them as claimed. This ruling underscores the need for robust patents and has significant implications for the pharmaceutical industry. Abstract The landmark decision in Novartis AG & Ors. v. Natco Pharma Limited addresses important aspects of patent law, such as the standard for challenging patent validity, the interpretation of Section 3(d), and the necessity of adequate disclosure in patents. The ruling confirms that defendants can contest patent validity by raising substantial challenges that merit a trial and clarifies that enhanced bioavailability does not equate to higher therapeutic efficacy. Additionally, the decision underscores the need for patent holders to provide sufficient disclosure in specifications to enable others to utilize the invention. The implications for the pharmaceutical sector include heightened scrutiny of patents anda balanced approach to patent rights and public interest, ensuring access to essential medicines while fostering innovation. Use of Legal Jargon Interlocutory Injunction An interlocutory injunction is a temporary remedy granted by the court to restrain a party from committing a particular act until the final disposal of the suit. In the present case, the Single Bench initially granted an interlocutory injunction to Novartis, preventing Natco from manufacturing and selling Eltrombopag Olamine (ELT-O). However, the Division Bench later overturned this decision, acknowledging Natco’s credible challenge to the validity of Novartis’s patent. The court emphasized that a granted patent does not carry a presumption of validity and can be contested at any time. This case highlights the importance of interlocutory injunctions in balancing the interests of both parties, ensuring fairness and the enforceability of the final judgment. ‘tion 3(d) of the Patents Act, 1970 -ction 3(d), aims to prevent the ever-greening of patents by stoppingpharmaceutical companies from obtaining patents for minor modifications of known substances that do not significantly enhance their efficacy. It specifies that new forms of known substances, which do not result in enhanced efficacy, or discoveries of new properties or uses for known substances, are not patentable. This provision ensures that trivial modifications do not qualify for patent protection, promoting genuine innovation and ensuring accessibility to essential medicines. In present case, Natco challenged Novartis’s patent on Eltrombopag Olamine (ELT-O) under Section 3(d), arguing that it did not significantly enhance efficacy compared to Eltrombopag free acid. Section 3(d) states that new forms are not patentable unless they demonstrate substantial efficacy improvement. The Delhi High Court’s Division Bench agreed, ruling that the patent did not meet Section 3(d) criteria. The court emphasized that a granted patent does not carry a presumption of validity and can be contested at any stage, highlighting the need for robust and adequately disclosed patents. Prior Claiming Prior claiming, in patent law occurs when anew patent claim is challenged because the invention it describes has already been covered by an existing, earlier patent. If a new patent application includes an invention or aspect previously claimed, the new claim can be disputed based on prior claiming. Earlier Claim: The prior, or earlier, claim must be closely examined to determine what it covers. Subsequent Claim: The subsequent, or later, claim is then compared to the earlier claim. Overlap: If the invention described in the subsequent claim is already covered by the earlier claim, the subsequent claim may lack novelty and therefore, can be considered invalid. In the present case, Natco argued that Eltrombopag Olamine (ELT-O) was covered under an earlier patent, IN 213176 (IN’176), which had expired. They claimed that Novartis’s subsequent patent, IN 233161 (IN’161), was anticipated by the earlier patent, making it invalid under the principle of prior claiming. This argument was a significant aspect of Natco’s challenge to the validity of Novartis’s patent. _ck of Novelty and Inventive StepIn the present case, Natco challenged the validity of Novartis’s patent on Eltrombopag Olamine (ELT-O), arguing that it lacked both novelty and an inventive step. These criteria are essential for patentability, and Natco’s challenge aimed to show that Novartis’s patent did not meet these standards. Lack of Novelty means an invention is novel only if it hasn’t been disclosed in any prior art before the patent application date. Prior art includes previous patents, publications, or any publicly available information that describes the invention. Natco argued that Eltrombopag Olamine (ELT-O) was not novel because it was a new form of the known substance Eltrombopag free acid. They claimed ELT-O did not introduce significant changes and was covered under an earlier, expired patent (IN 213176), making Novartis’s subsequent patent (IN 233161) lack novelty. Lack of Inventive Step means an invention must not be obvious to a person skilled in the art. It should represent a significant technical advancement or possess economic significance. Natco argued that Eltrombopag Olamine (ELT-O) did not meet the inventive step requirement because it was an obvious modification of the known Eltrombopag free acid. They claimed that transforming Eltrombopag into its salt form (ELT-O) did not require inventive skill and was within the capabilities of a skilled person in the field. Therefore, Natco asserted that Novartis’s patent on ELT-O lacked the necessary inventiveness for patent protection. Section 10 of the Patents Act, 1970 The present section, specifies the contents of patent application specifications. Each specification, whether provisional or complete, must describe the invention and include a title indicating the subject matter. It must fully describe the invention, its operation or use, and the method by which it is performed. Additionally, the specification must disclose the best method known to the applicant for performing the invention and conclude with a claim or claims defining the scope of protection sought. In the Natco Pharma Limited v. Novartis AG case, the court assessed whether Novartis’s patent for Eltrombopag Olamine (ELT-O) complied with Section 10 of the Patents Act, 1970. This evaluation focused on the novelty and inventive step he invention. Natco Pharma contended that Novartis’s patent lacked both _velty and inventive step, arguing that ELT-O was simply an obviousmodification of existing knowledge and did not meet the required criteria for patentability. Markush Claims Atype of patent claim that lists multiple alternatives or options within a single claim. Named after Eugene Markush, who founded the Pharma Chemical Corporation in 1919 and filed a notable patent application in 1923, these claims use the phrase “selected from the group consisting of.” In the Natco Pharma Limited v. Novartis AG case, Markush claims were central. Novartis held a patent for a pyrimidine compound with various substitutions and modifications. Natco Pharma challenged its validity, arguing the compound was neither novel nor inventive. The court examined the Markush claim's validity and whether the invention was truly novel and non-obvious. Ultimately, the court ruled in favor of Natco Pharma, finding the patent did not meet the criteria for novelty and inventive step. The Proof Lack of Enhanced Therapeutic Efficacy: The Court noted that “The learned Single Judge has construed the above observations to hold that enhanced bioavailability is relevant while assessing enhanced therapeutic efficacy.” “73, The learned Single Judge has construed the above observations to hold that enhanced bioavailability is relevant while assessing enhanced therapeutic efficacy. We find ourselves unable to concur with the said view. The Court did not conclude that the property of enhanced bioavailability was a relevant factor in determining whether the invention had a higher therapeutic efficacy. On the contrary, the Court had emphasized the quote from a text - “However a determination that a drug product is bio-available is not in itself a determination of effectiveness”. 74. .... [tis also apparent that the Supreme Court did not accept that a demonstration of increase in bioavailability was a relevant factor in determining whether the invention had a higher therapeutic efficacy. On the contrary, the Court had emphasized the quote from a text - “However a determination that a drug product is bio-available is not in itself a determination of effectiveness.” Presumption of Validity: The Court emphasized that “At the outset, it is _.evant to note that there is no presumption of validity of a patent by virtue ofthe same being granted by the Patent Office.” “39, At the outset, it is relevant to note that there is no presumption of validity of a patent by virtue of the same being granted by the Patent Office. Thus, the fact that the examiners have conducted necessary investigations prior to the grant of patent does not render a patent immune from challenge to its validity. The contention that there was no pre-grant or post-grant opposition to IN’161 and therefore, Natco has to cross a very high threshold to assail the validity of the patent, is unmerited. The Act expressly enables a challenge to the validity of a patent at various stages.” Challenge to Validity: The Court observed that, given the Act’s framework allowing patent validity challenges at multiple stages, there is no statutory presumption of a patent’s validity, nor does it make the patent immune to validity challenges. “41, Absent any statutory presumption and given the scheme of the Act, which enables challenge to the validity of a patent at several stages, there is neither any presumption as to the validity of a patent nor renders the patent immune for challenge to its validity. 42. Thus, in an action for infringement of a patent, defence as to the invalidity of the patent on the grounds as provided in Section 64(1) of the Act, is available to the defendant. The court is required to examine the challenge with an open mindset and not from the standpoint of an assumption that the patent is validly granted. 43. .... The defendant is not required to establish that the patent is invalid, it has to merely show that the patent is vulnerable. If the challenge raised to the validity is substantial, the threshold standard for resisting an interim injunction in this regard - subject to other relevant considerations -would be met.” Disclosure vs Coverage: The Court explained that a broad claim, known asa Markush claim, which covers numerous compounds with a shared inventive concept, is acceptable as long as it is not overly broad or vague. “102. ...it is also necessary to clarify that a broad claim, which covers a large number of compounds with a common inventive concept at its core, also referred to as a Markush claim, is permissible, provided that the same is not overbroad or vacue. The disclosure made would require to be seen in the light of the invention ght to be patented and disclosed. Thus, in cases where an active therapeutic éredient, having therapeutic value is claimed and disclosed, the same may bepatentable. The protection in respect of the said claim would extend to substances disclosed as well as to those that are not specifically disclosed but are obvious toa person skilled in art and/or can be anticipated. The gap between coverage and disclosure would thus, necessarily have to be confined to only those substances which are otherwise anticipated or obvious to a person skilled in the art. It cannot extend to other substances or products that are neither disclosed nor are obvious to or anticipated by a person skilled in the art.” Prior Claiming: The Court ruled that if the complete specifications meet the requirements of Section 10 of the Act and the claim is valid, then any compound falling within that claim is also considered to be included in the complete specifications. “118. If the complete specifications furnished are compliant with Section 10 of the Act and the claim is valid, then it would follow that a compound, which is covered within the said claim is also included in the complete specifications. Thus, the second patent for such a compound that was fully covered would be vulnerable to challenge on the ground of prior claiming [under Section 64(1)(a) of the Act] and lack of novelty [Section 64(1)(e) of the Act] and lack of inventive steps [Section 64(1)(F) of the Act].” Conclusion The Natco Pharma Limited v. Novartis AG case is a landmark decision that underscores the delicate balance between patent law and public health. Natco challenged the validity of Novartis’s patent on Eltrombopag Olamine (ELT-O), arguing that the drug lacked novelty and inventive step, being an obvious modification of existing knowledge. The court concurred, highlighting that a granted patent does not carry an automatic presumption of validity and can be contested at any stage. This ruling facilitated greater access to affordable medicines by enabling Natco to produce and sell a generic version of the drug, thus increasing its availability to patients in need. The decision emphasized the importance of ensuring patents meet strict criteria for novelty and inventive step to prevent trivial modifications from being patented, thereby promoting genuine innovation and accessibility to essential medicines. This case serves as a reminder of how patent law can balance the interests of fostering innovation with the need affordable healthcare, ultimately benefiting public health.Citation: Natco Pharma Limited vs Novartis Ag and Anr, Delhi High Court, 24th April, 2024, FAO(OS) (COMM) 178/2021 FAQS QI: What was the main issue in the Novartis AG v. Natco Pharma Limited case? ‘Al: The main issue was whether pre-grant opponents have the right to intervene in the substantive examination process of a patent application. Q2: What was the court’s ruling? ‘A2: The court ruled in favor of Natco Pharma, invalidating the patent. Q3: What did the Division Bench of the Delhi High Court decide regarding the involvement of opponents in substantive examination? A3: The court decided that pre-grant opposition and substantive examination are separate and independent processes, and opponents do not have the right to intervene in the examination process. Q4: How does this decision impact the procedural autonomy of the Controller? AA4: The decision reinforces the procedural autonomy of the Controller in conducting examinations, ensuring that the examination process is not influenced by the involvement of opponents. Q5: What principles did the court emphasize in its ruling? ‘AS: The court emphasized the principles of natural justice and the need to balance the rights of applicants and opponents while maintaining the procedural integrity of the examination process.Lik ARTICLE _ Bachan Singh v. State of Punjab (1980): The Landmark Case That Navtej Singh Defined the ‘Rarest of Rare’ Doctrine in Indian Jurisprudence Johar v Union of > India Related Posts Child Labour MORAL POLICING IN Child Labour Child labourers. INDIA AND ITS LEGAL have totoillonghourstoeke REMEDIES out a living for themselves and support. MORAL POLICING IN INDIA AND ITS LEGAL REMEDIES -RoshniS , Sth year BA.LLB , Kerala Law Academy...Leave a Reply Balancing Act: A Critical Analysis of the Evolution of the Cinematograph Act and Its Amendments in India By- Saachi Singh Symbiosis Law School, Hyderabad Abstract: ‘The Cinematograph Act of 1952 has long been the cornerstone... Your email address will not be published. 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