Introduction
The concept of Intellectual Property Rights (IPR) in these modern times is progressing as people across the globe create more and more intangible assets with the use of their intellect and creativity. IPR protections various Intellectual Properties (IP) and fosters a sustainable mechanism to make it harmonious with growth. Patent is a subset of IPR, and it focuses on technical inventions, their application and process of manufacture. Patent grants exclusive right to prevent third parties from making, using, selling, offering for sale and importing the patented invention in the jurisdiction where patent is granted. But first, there are certain criteria laid out by the Indian Patents Act, 1970, which must be fulfilled for a product or a process to be considered as an invention; they are Novelty, Inventive Step and Industrial Application. In the case of Novartis AG vs. Union of India, we witness the standard requirements and importance of novelty and inventive steps in India. The Honourable Supreme Court of India clarified various terms stated under Section 3(d)[1] and applied the concept of Evergreening of Patents to solve the case effectively. The appeal was dismissed by the court on the basis that “Glivec” failed to show enhanced efficacy when compared to an already patented drug “Imatinib Mesylate”.
Facts
One of the largest multinational pharmaceutical corporations, Novartis AG, based in Switzerland, created a drug called “Imatinib Mesylate” and in 1992 filed it for a patent at the United States Patent and Trademark Office (USPTO), which was granted. In 1997, Novartis AG filed another patent application in the United States for a “Beta Crystalline” form of imatinib mesylate named “Glivec”, which was also granted a patent in the US. This same drug was also granted a patent in 35-plus countries[2]
Then, in 1998, Novartis AG filed a patent application for Glivec at the Madras Patent Office, India, which was facilitated via the TRIPS agreement. The application specified that it was a beta crystalline form of Imatinib mesylate and further illustrated that it helps to treat cancer, specifically Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumors (GIST). Novartis AG claimed the superiority of Glivec over previously patented imatinib mesylate, as it had improved flow properties, thermodynamic stability and lower hygroscopicity[3].
Prior to the Patent (Amendment) Act, 2005, India didn’t grant product patents but only process patents as per Section 5[4] of the Patents Act, 1970. Until the section was repealed, Novartis AG couldn’t pursue a product patent for Glivec.
In 2005, the Madras Patent Office considered and later (in 2006) rejected the product patent application filed by Novartis AG for Glivec on the basis that it was not novel, that is obvious to a person skilled in the art and was anticipated by the prior publication of Zimmermann patent; Novartis AG had also wrongly claimed date of filing of the application in Switzerland as the priority date in India. Further, Section 3(d)[5] of the Patents Act, 1970 was applied, “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.” and the patent office concluded that glivec was a new form of an already known substance which didn’t result in enhanced efficacy.
Aggrieved by the patent office’s rejection, Novartis AG filed multiple (one by the appellant and one by the Indian power of attorney holder) writ petitions in Madras High Court under Article 226[6] of the Constitution of India.
The appeals claimed Section 3(d)[7] of the Patents Act, 1970, to be unconstitutional, as it was alleged to be in contradiction to the TRIPS agreement and in violation of Article 14[8] of the Constitution.
In 2007, the Madras High Court transferred the case to the Intellectual Property Appellate Tribunal (IPAB) after its formation, along with the previous writ petitions challenging the order of the Assistant Controller. IPAB heard the appeal and reversed certain findings of the controller by approving Glivec’s novelty and nonobviousness but still rejected the application for a patent grant as the product was adequately being hit by Section 3(d)[9] of the Patents Act, 1970. As per IPAB reasoning, Section 3(d)[10] establishes high standards for patentability in India and stops the “evergreening of patents”, which is necessary for the benefit of the citizens of India, especially when it comes to life-saving drugs.
In 2009, Novartis AG filed a Special Leave Petition (SLP) under Article 136[11] of the Constitution before the Honourable Supreme Court of India, pleading against the order of IPAB.
Issues Raised
- To define “Known Substance”, stated in Section 3(d)[12] of the Patents Act 1970?
- To define “Efficacy”, as stated in Section 3(d)# of the Patents Act 1970,
- Whether Section 3(d)[13] of the Patents Act, 1970, allow a certain amount of increase in bioavailability to be qualified as increased efficacy?
- To compare the stated improvements of glivec with imatinib mesylate properties and judge the patentability?
Relevant Legal Provisions
- Section 3(d)[14] of the Patents Act, 1970: “the mere discovery of a new form of a known substance that does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy”.
Article 27(1)[15], TRIPS: “Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65[16], paragraph 8 of Article 70[17] and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced”.
Judgment
In 2013, the Hon’ble Supreme Court of India gave its final verdict, wherein the court rejected the patentability claim of Glivec, filed by Novartis AG. The court upheld previous verdicts of Glivec (a beta crystalline form of imatinib mesylate) as being a new form of an already-known substance with minor improvements. The court defined the word “Efficacy” as stated under Section 3(d)[18] of the Patents Act, 1970, apropos to “Therapeutic Efficacy” and “Known Substance” as something in public or traditional knowledge. Addressing the issue of a 30% increase in bioavailability, previously claimed by Novartis AG, the Honourable Supreme Court cleared that it would amount to an increase in efficacy, but Novartis AG failed to produce any proper evidence of the same (30% increase in bioavailability of Glivec when compared to imatinib mesylate). Further, the court tested all the other claims of improved flow properties, thermodynamic stability and lower hygroscopicity of Glivec with Imatinib Mesylate and found them to be of no value regarding enhanced therapeutic efficacy. No further documents were provided by Novartis AG, which claimed enhanced efficacy of Glivec over the previously patented drug imatinib mesylate. Lastly, no violation of the TRIPS agreement was found.
Conclusion
India is a developing country which is making a positive mark on geo-politics despite its demographic drawbacks. India upholds the responsibility of prioritising public health, and this judgment replicates the same. There was no violation of the TRIPS agreement because India successfully adopted Article 27[19] of TRIPS without contradicting it. Furthermore, the TRIPS agreement mandates countries to adopt the stated measures but gives member countries flexibility to adopt them at their convenience. The concept of Evergreening of Patents was used by the Honourable Supreme Court, especially in the context of the pharmaceutical industry, to stop big companies from exploiting public and welfare initiatives. Section 3(d)[20], among other areas, safeguards medicine availability to the public at large on a cheaper by price by stopping pharmaceutical companies from getting their inventions patented in perpetuity upon introducing minor changes; this means once the designated time of protection ends, those medicines will be available to the public for manufacture and trade at a cheaper price, without taking consent from the proprietor. Hence, the Honourable Supreme Court safeguarded all Indian citizens, especially the ones in need, from exploitation by the Pharmaceutical Industry. The high and fair criteria of patent protection in India promote fair competition and harmonise all industries. The court interpreted and defined the term “efficacy” as a tool to analyse the notion of invention and as a criterion to judge novelty and inventive steps. Ultimately, the Honourable Supreme Court gave clearance to Novartis AG to get patients over the drug Glivec, but the company failed to fulfill the established criteria.
Author: Hardik Manwani, UPES Dehradun
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