Case Analysis
APPELLANT…NOVARTIS AG Vs. RESPONDENT…UNION OF INDIA & OTHERS Bench: Aftab Alam, Ranjana Prakash Desai DATE OF JUDGMENT: 1/4/2013 Facts:In,1998 Novartis a pharmaceutical company, filed an application of patent for specific variation of the Imatinib Mesylate salt in its beta crystalline form. Imatinib Mesylate is used to treat Chronic Myeloid Leukemia and marketed by Novartis as “Gleevec”In 2005, as part of a series of amendments to the Indian Patent Act that took effect on January 1, 2005 the Indian Parliament adopted section 3(d) which do not allow a patent to be granted to inventions involving new forms of a known substance unless it differs insignificantly in properties with regard to its ability to produce the intended result that is its efficacy. Novartis had challenged the constitutional validity of Section 3(d) saying that it was incompatible with the worldwide intellectual property standards decided the WTO TRIPS Agreement, in the Madras High Court in 2007 which was subsequently rejected. In 2013, Novartis by a way of Special Leave Petition (SLP) approached the Supreme Court against the rejection by the Indian Patent based on the Madras High Court. The new phase of litigation started in Intellectual Property Appellate Board (IPAB) which is an appellate body of patent controller IPAB considered the beta crystalline form of Imatinib Mesylate as new and inventive step but refused to grant a patent to the drug of Novartis since it was hit by Section 3(d). In May 2006, Novartis filed petitions under Article 226 of the Indian Constitution of India before Madras high Court of Madras and violative of Article 14 of the constitution.
Question of Law?
So, the question in the given case was regarding the scope of Section 3(d) of the Indian Patent’s Act (Amendment) Act 2005 whether the invention was inconsistent with its provisions and if it did fall within its ambit, whether it qualified the test of novelty and innovation as provided for in Act?
So, following are the main issues that came in front of Supreme Court are:
- `Interpretation of Section 3(d) of the patent act?
- Whether the invention qualifies for the test of novelty and inventive for the alleged product?
Held by Supreme Court:
The court held that the beta crystalline form of Imatinib Mesylate, failed the test of Section 3(d), of the Indian Patent Act. On the question of whether the product at hand came within section 3(d), the court said that since the product is simply a new form of a known substance section 3(d) is attracted and that the provisions therein ought to be satisfied. The court affirmed that India had adopted a standard of pharmaceutical patenting stricter than that followed by the US or the EU. In India a patent applicant must not only show that a new form of a known compound is different form an old form (physical efficacy). But that the modification will result in an improvement in the treatment pf the patient (therapeutic efficacy) which the court held Novartis had been unsuccessful in doing. Basically, the court said that the therapeutic efficacy of a medicine must be judged strictly and narrowly.
Analysis:
So, in this case SC help those people who can’t afford lifesaving drugs manufact5ured by certain pharma giants these companies who have made billion dollars are required to provide these drugs at lower prices this will generally help the poor. As the life of the patent can’t be denied to prevent new inventions but the purpose of these drugs is for the people and to help them at the time need. Basically, if we look at the company like Novartis, they are generally trying to earn the money by keeping life of the poor at stake and keeping monopoly over drugs. So, by the analysis it is true that the supreme court has been justified by its decision thereby prohibiting the liberal approach in granted patents as these can be termed as frivolous inventions.
Case Analysis
APPELLANT…NOVARTIS AG Vs. RESPONDENT…UNION OF INDIA & OTHERS Bench: Aftab Alam, Ranjana Prakash Desai DATE OF JUDGMENT: 1/4/2013 Facts:In,1998 Novartis a pharmaceutical company, filed an application of patent for specific variation of the Imatinib Mesylate salt in its beta crystalline form. Imatinib Mesylate is used to treat Chronic Myeloid Leukemia and marketed by Novartis as “Gleevec”In 2005, as part of a series of amendments to the Indian Patent Act that took effect on January 1, 2005 the Indian Parliament adopted section 3(d) which do not allow a patent to be granted to inventions involving new forms of a known substance unless it differs insignificantly in properties with regard to its ability to produce the intended result that is its efficacy. Novartis had challenged the constitutional validity of Section 3(d) saying that it was incompatible with the worldwide intellectual property standards decided the WTO TRIPS Agreement, in the Madras High Court in 2007 which was subsequently rejected. In 2013, Novartis by a way of Special Leave Petition (SLP) approached the Supreme Court against the rejection by the Indian Patent based on the Madras High Court. The new phase of litigation started in Intellectual Property Appellate Board (IPAB) which is an appellate body of patent controller IPAB considered the beta crystalline form of Imatinib Mesylate as new and inventive step but refused to grant a patent to the drug of Novartis since it was hit by Section 3(d). In May 2006, Novartis filed petitions under Article 226 of the Indian Constitution of India before Madras high Court of Madras and violative of Article 14 of the constitution.
Question of Law?
So, the question in the given case was regarding the scope of Section 3(d) of the Indian Patent’s Act (Amendment) Act 2005 whether the invention was inconsistent with its provisions and if it did fall within its ambit, whether it qualified the test of novelty and innovation as provided for in Act?
So, following are the main issues that came in front of Supreme Court are:
- `Interpretation of Section 3(d) of the patent act?
- Whether the invention qualifies for the test of novelty and inventive for the alleged product?
Held by Supreme Court:
The court held that the beta crystalline form of Imatinib Mesylate, failed the test of Section 3(d), of the Indian Patent Act. On the question of whether the product at hand came within section 3(d), the court said that since the product is simply a new form of a known substance section 3(d) is attracted and that the provisions therein ought to be satisfied. The court affirmed that India had adopted a standard of pharmaceutical patenting stricter than that followed by the US or the EU. In India a patent applicant must not only show that a new form of a known compound is different form an old form (physical efficacy). But that the modification will result in an improvement in the treatment pf the patient (therapeutic efficacy) which the court held Novartis had been unsuccessful in doing. Basically, the court said that the therapeutic efficacy of a medicine must be judged strictly and narrowly.
Analysis:
So, in this case SC help those people who can’t afford lifesaving drugs manufact5ured by certain pharma giants these companies who have made billion dollars are required to provide these drugs at lower prices this will generally help the poor. As the life of the patent can’t be denied to prevent new inventions but the purpose of these drugs is for the people and to help them at the time need. Basically, if we look at the company like Novartis, they are generally trying to earn the money by keeping life of the poor at stake and keeping monopoly over drugs. So, by the analysis it is true that the supreme court has been justified by its decision thereby prohibiting the liberal approach in granted patents as these can be termed as frivolous inventions.
Case Analysis
APPELLANT…NOVARTIS AG Vs. RESPONDENT…UNION OF INDIA & OTHERS Bench: Aftab Alam, Ranjana Prakash Desai DATE OF JUDGMENT: 1/4/2013 Facts:In,1998 Novartis a pharmaceutical company, filed an application of patent for specific variation of the Imatinib Mesylate salt in its beta crystalline form. Imatinib Mesylate is used to treat Chronic Myeloid Leukemia and marketed by Novartis as “Gleevec”In 2005, as part of a series of amendments to the Indian Patent Act that took effect on January 1, 2005 the Indian Parliament adopted section 3(d) which do not allow a patent to be granted to inventions involving new forms of a known substance unless it differs insignificantly in properties with regard to its ability to produce the intended result that is its efficacy. Novartis had challenged the constitutional validity of Section 3(d) saying that it was incompatible with the worldwide intellectual property standards decided the WTO TRIPS Agreement, in the Madras High Court in 2007 which was subsequently rejected. In 2013, Novartis by a way of Special Leave Petition (SLP) approached the Supreme Court against the rejection by the Indian Patent based on the Madras High Court. The new phase of litigation started in Intellectual Property Appellate Board (IPAB) which is an appellate body of patent controller IPAB considered the beta crystalline form of Imatinib Mesylate as new and inventive step but refused to grant a patent to the drug of Novartis since it was hit by Section 3(d). In May 2006, Novartis filed petitions under Article 226 of the Indian Constitution of India before Madras high Court of Madras and violative of Article 14 of the constitution.
Question of Law?
So, the question in the given case was regarding the scope of Section 3(d) of the Indian Patent’s Act (Amendment) Act 2005 whether the invention was inconsistent with its provisions and if it did fall within its ambit, whether it qualified the test of novelty and innovation as provided for in Act?
So, following are the main issues that came in front of Supreme Court are:
- `Interpretation of Section 3(d) of the patent act?
- Whether the invention qualifies for the test of novelty and inventive for the alleged product?
Held by Supreme Court:
The court held that the beta crystalline form of Imatinib Mesylate, failed the test of Section 3(d), of the Indian Patent Act. On the question of whether the product at hand came within section 3(d), the court said that since the product is simply a new form of a known substance section 3(d) is attracted and that the provisions therein ought to be satisfied. The court affirmed that India had adopted a standard of pharmaceutical patenting stricter than that followed by the US or the EU. In India a patent applicant must not only show that a new form of a known compound is different form an old form (physical efficacy). But that the modification will result in an improvement in the treatment pf the patient (therapeutic efficacy) which the court held Novartis had been unsuccessful in doing. Basically, the court said that the therapeutic efficacy of a medicine must be judged strictly and narrowly.
Analysis:
So, in this case SC help those people who can’t afford lifesaving drugs manufact5ured by certain pharma giants these companies who have made billion dollars are required to provide these drugs at lower prices this will generally help the poor. As the life of the patent can’t be denied to prevent new inventions but the purpose of these drugs is for the people and to help them at the time need. Basically, if we look at the company like Novartis, they are generally trying to earn the money by keeping life of the poor at stake and keeping monopoly over drugs. So, by the analysis it is true that the supreme court has been justified by its decision thereby prohibiting the liberal approach in granted patents as these can be termed as frivolous inventions.
by deepankar chugh
