Novartis v. Natco Pharma involves opponents of patent examination

A careful balance between encouraging innovation and making sure that patents are awarded based on merit characterizes patent law. Pre-grant opposition is a process that is essential to maintaining this balance since it makes it easier to thoroughly review patent applications. This article explores the complex legal rules that the regulation process and outlines its constraints. 

Novartis AG v. Natco Pharma Limited

The court critically examined the order issued by the Controller of Patents on December 14, 2022, permitting certain modifications that ultimately led to the issuance of Indian Patent No. IN414518. There was later legal action against this patent grant to Novartis. e pre-grant opposition, highlighting its role as a facilitator in the examination.

A careful balance between encouraging innovation and making sure that patents are awarded based on merit characterizes patent law. Pre-grant opposition is a process that is essential to maintaining this balance since it makes it easier to thoroughly review patent applications. This article explores the complex legal rules that the regulation process and outlines its constraints. 

The Division Bench of the High Court of Delhi on January 9, 2024. The court critically examined the order issued by the Controller of Patents on December 14, 2022, permitting certain modifications that ultimately led to the issuance of Indian Patent No. IN414518. 

There was later legal action against this patent grant to Novartis. The Hon’ble Division Bench of the High Court of Delhi dismissed the pre-grant opponents’ claims that they had a right to be heard during the patent examination process when it rendered its subject matter judgment. Consequently, the subject matter patent is granted and the Controller of Patents’ order is upheld. 

The subject matter patent IN’518 was applied for by Novartis AG. It was derived from PCT application no. PCT/US2006/043710 dated 8 November 2006, which was submitted to the Controller of Patents on June 8, 2007, as an Indian national phase application with no. 4412/DELNP/2007. Pre-grant opponents included Natco Pharma Limited and a few other organizations.

Pre-grant opponents argued that they were not given a fair hearing before the decision allowing changes to the patent application being granted. In particular, on November 3, 2022, all five pre-grant objection hearings were concluded. Despite this, the applicant was instructed by the Commissioner of Patents to make revisions, which were ultimately approved on December 14, 2022. 

If pre-grant opponents have an interest in the patent examination process and should be required to participate, particularly when the patent application is being reviewed for changes, is the central question at hand. 

The Honorable Division noted that the right of hearing is principally connected to the resolution and handling of the representation for opposition before the grant of the patent as per Rule 55(5) of the Patent Rules, 2003. The court held that granting the pre-grant opponent a hearing opportunity during the representation phase does not inevitably convey an inalienable right to take part in the patent examination procedure. 

This view balances the interests of applicants and opponents of the grant while maintaining the procedural autonomy of the Controller’s office in conducting exams.  It is critical to realize that pre-grant opposition representation is not a hostile or contentious process. Rather, its main goal is to support and ease the process of reviewing the patent application. 

The constructive objective of pre-grant opposition, which seeks to guarantee that patents are issued based on legitimate and meritorious grounds, is highlighted by this facilitative role. 

Under Section 25(1) of the Patent Act of 1970, pre-grant opposition is limited in its scope. This clause limits the scope of the opposition to statutory limitations by outlining the grounds on which it may be raised. 

The location of a pre-grant patent opposition within the framework of the patent examination is made clear by the Division Bench’s interpretation. The court guarantees an equitable and effective patent examination process by differentiating between phases where competitors have a right to be heard, including pre-grant opposition, and phases where their involvement is not required. 

Pre-grant opposition plays a crucial but limited part in the process of examining patent applications. Its facilitative character intends to support the Controller in carrying out a comprehensive review of patent applications, guaranteeing compliance with legal requirements and natural justice principles. 

The court’s remarks, which highlight the pre-grant opponent’s limited ability to interfere in the patent grant process through pre-grant opposition alone, demonstrate that this function is not without restrictions. 

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