This case analysis is written by Sneha singhal BALLB(H.) 4th year student during her internship under LeDroit India.
Introduction
A pivotal judgement in Indian patent law is the Novartis AG v Union of India case, decided by a two-judge bench of the hon’ble supreme court of india. In this landmark ruling, Novartis challenged the intellectual property appellate boards rejection of its patent application for the beta crystalline form of “Imatinib Mesylate”. The supreme court upheld the rejection, finding that the drug did not demonstrate an enhanced or superior therapeutic “efficacy” compared to the already “Imatinib Mesylate”. Essentially, the court determined that the new form lacked an inventive step.
This case is crucial for understanding section 3(d) of the patent act, 1970, as it clarifies the requirements for patentability, particularly emphasizing the need for an invention to exhibit both novelty and non-obviousness.
Facts of the case
This case revolves around “Glivec”, a drug derived from the original compound imatinib. Let’s break down its patent history and the legal battles that ensured
In 1992, Novartis secured a patent from the US Patent and Trademark Office (USPTO) for imatinib, a patent that also encompassed its pharmaceutically acceptable salt forms. By 2001, the US Food and Drug Administration (FDA) approved one such salt form, “Imatinib Mesylate”. Unlike the original free base imatinib, the mesylate salt is water-soluble, making it suitable for use in the human body.
Later, in 1997, novates pursued another US patent, this time for a specific variation of “Imatinib Mesylate”. Its beta crystalline form. The USPTO eventually granted this patent, as the beta crystalline form notably enabled the oral administration of “Imatinib Mesylate”.
However, novates faced a different challenge in india. In 1998, they sought product patent protection in India for the same beta crystalline form, the india patent office rejected their application in 2006. A key reason for this rejection was Novartis failure to demonstrate significantly enhanced “efficacy” of the beta crystalline form compared to the original “Imatinib Mesylate”, requirement stipulated under section 2 d of the patent act. This decision was upheld by the IPAB on June 26, 2009, prompting novates to appeal to the supreme court.
To address the enhanced “efficacy” requirement of section 3(d), Novartis conducted studies in 2005. These studies aimed to show, among other hirings, a 30% increase in the bioavailability of the beta crystalline “Imatinib Mesylate” over the original imatinib.
Issues Involved
- Whether the invention Beta crystalline form of “Imatinib Mesylate” claimed by Novartis is more efficacious than the substance that it was derived from i.e. “Imatinib Mesylate”?
- What is the test of “efficacy” in the context of Section 3(d) of the Patent Act, 1970?
Supreme court ruling
In April 2013, the supreme court of india delivered a pivotal judgement, rejecting Novartis appeal and affirming the earlier decisions regarding the patent for the beta crystalline form of “Imatinib Mesylate”. The two-judge bench unequivocally stated that this new form was merely a variation of the already known substance, “Imatinib Mesylate”, whose “efficacy” was well established.
The court provide crucial clarity on the interpretation of “efficacy” within section 3(d) of the patent act, 1970, especially concerning medicines. It ruled that “efficacy” in the context exclusively refers to therapeutic “efficacy”. This means that not all properties of a drug are relevant only those directly linked to its therapeutic benefit are considered.
Addressing a key point, the supreme court stated that a roughly 30% increase in bioavailability could qualify as an increase in therapeutic “efficacy” under section 3(d), provided sufficient support such as claim. However, when comparing the beta crystalline form of “Imatinib Mesylate”, the court scrutinized properties like flow characteristics, improved thermodynamic stability, and reduced hygroscopes. It concluded that none of these properties contributed to an increase in therapeutic “efficacy” as per section 3(d). furthermore, Novartis failed to provided any documentation demonstrating that the beta crystalline form offered superior “efficacy” compared to the original “Imatinib Mesylate”.
This ruling significantly reinforced India’s stance on preventing the ever-greening of the patents and emphasized the strict requirements for demonstrating genuine therapeutic advancement for new drug forms.
Analysis
The Novartis case centered on the appellate attempt to patent “Imatinib Mesylate”. Under the Indian patent’s amendment act, 2005, a new invention must not have been previously published or used anywhere globally before the patent applications filing date, and it must not include a complete specification. This means that a new invention cannot be part of the state of the art as defined by section 2(1)(I) or be in the public domain. Consequently, anything already existing or easily learned cannot be patented.
When interpreting inventive step under section 2(1)(ja) of the act, an invention must demonstrate economic significance, a technological advancement over existing knowledge, or both. Crucially, it must not be obvious to a person skilled in the relevant field.
A key aspect f this case, and Indian patent law, is section 3(d). which prevents the patenting of derivatives of known substances unless they demonstrate enhanced “efficacy”. Following the 205 amendments, for a patent claim to be valid, the innovation must offer something more than just being a new form of a known substance
In this case, the appellant believed that imatinib free base (the known substance) would be easier to demonstrate as having a higher level of “efficacy” than “Imatinib Mesylate” the core issue as whether the claimed inventing (the beta crystalline form of “Imatinib Mesylate”) fell under the category of a known substance because it existed and was known before the claimed invention.
The supreme court explicitly clarifies that the term “efficacy” in this context refers exclusively to therapeutic “efficacy” they rejected Novartis broader interpretation, emphasizing that only qualities directly related to a drug therapeutic effect are relevant.
Regarding bioavailability (a medicine ability to dissolve in the bloodstream), the court acknowledges that protecting under section 3(d) could be granted if bioavailability increased by 30% and if it could be mentored that this increase boosted therapeutic effectiveness. However, after examining the claimed inventions “efficacy” against a recognized chemical, the court concluded that its qualities did not qualify under section 3(d) because they did not enhance therapeutic “efficacy”.
This ruling has been widely applauded for preventing the ever-greening of patented products, section 3(d) of the patent act 1970 effectively bars large pharmaceutical companies like Novartis in this instance, from securing subsequent patents imply by main minor modifications to existing knowledge or technology ultimately, Novartis failed to prove that the beta crystalline for of “Imatinib Mesylate” offered greater therapeutic effectiveness compared to “Imatinib Mesylate”.
Significance of the case
Section 3(d) of the Indian patent act serves as a vital instrument for judges, emphasizing them to prevent the patenting of minor, incremental changes to existing products. This provision is crucial in maintain a high bar for what constitutes a patentable invention.
- “efficacy” as a creation for patentability– The concept of “efficacy” can be employed in two ways evaluating patent application:
- “efficacy” can be a core criterion for determine whether something qualifies as a true invention worthy of patent protection.
- Alternatively, “efficacy” can be a factor in examining whether an invention is new or involves an inventive step beyond existing knowledge.
Even without a specific provision like section3(d), judges can still use the criterion of “efficacy”. For product derivatives- new versions of an existing product, especially with similar chemical structure- there’s often an initial assumption of obviousness. This presumption can only be overcome by demonstrating surprising effects of the derivative, such as enhanced “efficacy”.
- The decisive role of “efficacy” interpretation– How “efficacy” is defined is critical. The TRIPS agreement allows member countries the flexibility to interpret “efficacy” broadly or narrowly, as the Indian supreme court did by limiting it solely to therapeutic “efficacy”. Many drug derivatives might pass a broad test of physical “efficacy” but fail a stricter test of therapeutic “efficacy”. It is important to note that improved bioavailability doesn’t automatically translate to improved therapeutic “efficacy”.
- Patent scope and competition – Finally, if the claims of an existing patent are interpreted broadly-perhaps during infringement litigation to maximize its scope- competitors can then use wide scope to challenge the patentability of follow – on patents for derivatives of that already patented product. This creates a dynamic whereas patent holders aggressive enforcement strategies can paradoxically, open doors for challenges to their subsequent innovation.
Conclusion
The hon’ble supreme court judgement serves a dual purpose to curb the practice of evergreening patented products and to ensure access to affordable, life saving medications for the general populace. The court explicitly recognised India’s status as developing country, underscoring the vital need for medicines to be available at economical prices for its over one billion citizens.
This landmark decision, particularly its reliance on section 3(d) of the patent act, 1970, acts as crucial safeguard. It prevents large pharmaceutical companies from securing secondary patents by merely introducing minor alterations to existing technologies. In this specific case of Novartis, the supreme court rejected their patent application because they failed to demonstrate that the beta crystalline form of “Imatinib Mesylate” offered superior therapeutic “efficacy” compared to the original “Imatinib Mesylate”. This ruling reinforces India’s commitment to balancing intellectual property rights with public heath imperatives.
