NOVARTIS A.G V UNION OF INDIA

FACTS AND BACKGROUND OF THE CASE

The Appellant filed the patent application in the Madras patent office for a beta crystalline form of imatinib, but the Madras patent office on July 17 1998 rejected it. The appellant filed the case in Madras High Court and the Court kept the case in the mailbox as there was no law was enacted for this subject matter. Indian Patent Act 1970 was in the transitional stage. TRIPS agreement which was enacted in 1995 and India was also a Member of TRIPS. The appellant was granted Exclusive market rights under the Patent Act 1970. But there was no amendment made so the case was kept in the mailbox. India amended the provision to comply with the TRIPS agreement as there was the threat of trade sanctions on India by other Member Countries. As India was a member country but did not make any amendments this was the reason for the threat. Then in 2005, India amended the patent act and then the court handled the case. The court transferred the case to the Assistant Controller of Patents and Designs. Assistant Controller of Patents and Designs rejected the application as it violated the provisions of Section 3(d) of The Patent Act 1970. Then the Appellant filed the writ petitions challenging the validity of the Provision and the Appellant claims that it is violating fundamental rights particularly Article 14. So when the constitutional validity of the act will be tested by checking the intention of the act. Later the there was Intellectual Property Appellate Board was established. Then this case was transferred there. Intellectual Property Appellate Board handled the writ petitions and dismissed the decision made by the Assistant Controller of Patents and Designs as the invention passed the tests of novelty and non-obviousness and dismissed the writ petitions in challenging the validity of the Provision as it is not compliance with Section 3(d) of the Patent act,1970. Then the Appellant challenged the decision of the Appellate Board in the Supreme Court through a Special Leave Petition (Article 136). This was not encouraged by the Supreme Court as an appeal should be first filed in the high court and then the final appeal should be made in the Supreme Court. [1]

ISSUES

Whether the patent be given for the Imaitinib under the Indian Patent Act,1970?

Whether the Section 3(d) of the Indian Patent Act is valid Constitutionally?

ARGUMENTS

By Appellant’s Counsel

1. Section 3(d) of the Patent Act 1970 was not valid under the constitutional law as it is violating Article 14- Right to equality.
2. The Invention made by the Appellant involved the inventive step under section 2(1)(j) of the Patent Act.
3. Section 3(d) was not in compliance with the TRIPS agreement as India was a member country in this so it needed to amend the laws which are in compliance with the TRIPS Agreement.
4. section 3(d) of the Patent Act can’t be applicable in this as the granting a patent based on these provisions is unsupportable.
5. The Beta crystalline form of Imatinib is not a known substance it is a conceivable substance and this beta form has new properties compared to the base form and there is developed usage of than base form of Imatinib. [2]

 By Respondent’s Counsel

1. The patent application filed by the applicant did not follow the provisions of Section 3(d) of the Patent Act,1970.
2. There cannot be a Patent produced for the substance which is already existing.
3. The Patent Office and Intellectual Property Appellate Board rejected the patent application as not involving the inventive step.
4. Zimmermann patent got patent in the US office. TRIPS agreement protects the patent over the member countries. India was a member country of TRIPS. India needs to protect the patent as an obligation of the member country. The invention was inspired by Zimmermann’s patent. There are many similar statements to the Zimmermann patent. There is much material evidence to show that this Beta form of imatinib was consumed by this patient. The process of invention is very similar between these two. So this can be taken as a known substance and known efficacy under 3(d) of the patent act so this cannot be granted a Patent. [3]

DECISION AND REASONING

The Supreme Court rejected the patent application made by the appellant. The invention made by the appellant was following the inventive step under Section 2(1)(j) of the Patent Act,1970 but it is not in compliance with the Section 3(d) provisions. Section 3(d) is valid under the constitution so when needed to check the provisions that are valid under the Constitution there is a need to find the intention for which the act or provisions are enacted these provisions are enacted for the purpose of not granting evergreen patent and patent should not be given to already existing thing. So any substance new form is produced then usage for the substance should not already exist there is no use in granting patents to these inventions. The efficacy should be new when the new form of the existing substance is produced. The finding of the new efficacy of the already existing substance is also not patentable. The appellant’s invention satisfies section 2(1)(j) and (j)(a) as a mere observation but it fails to satisfy b section 3(d) provision as there is medicine for treating cancer the appellant’s invention also produces the same usage and section 2(1)(j) and (j)(a) as there is no industrial application for it, the beta crystalline form of imatinib does not produce the new efficacy. The patent will be granted if it is satisfied with the test of efficacy which is the usage of things so when already there are drugs to treat cancer, the beta crystalline form of Imatinib is also used for treatment of the cancer. So it failed the test of efficacy. There should be new usage for the invention. There is no material evidence that the beta crystalline form of Imatinib is more efficient in treating cancer. So there is no additional usage produced by the invention so there is no use in granting the patent. Even though India is a part of the TRIPS agreement the patent invention should satisfy the Indian Patent Act,1970. If the provisions have the effect then only they can be registered in India. The Appellant was granted EMR for Imatininb so the Appellant was in the form of a tablet named Gleevec. This Gleevec contains the Imatinib only it does not contain the Beta crystalline form of Imatinib. The appellant claimed the patent for a new form of Imatinib but it appeared to getting the patent for the Imatinib original form only as the Appellant was making a sale on the Imatinib original form not the beta crystalline form of Imatinib. This was not allowed in India to get a patent for this invention. Imatinib was a known substance and the efficacy could also be inferred from the Zimmermann patent. [4]

LEGAL PROVISIONS

INDIAN PATENT ACT 1970

Section 2(j)– The term invention is defined under this provision. The invention involves a new process in the inventive method and there is an industrial application for it.

Section 2(j)(a)– The inventive step is defined in this provision. The invention step means advanced techniques when compared with existing knowledge having more knowledge of the economy or having both these skills. So these skills are not easily understood by the ordinary person who has skill in art. The inventive step is a feature of the Invention steps.

Section 3(d)– The simple discovery of the new form of the existing substance and the usage of the new form of substance also is not new, finding the new usage of the already existing substance and producing the product with the same known process and machine unless the new product is made these are things which cannot be patentable.

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 usage;

So when we apply this case imatinib is an already existing substance in which a new form that is beta form is produced but the usage is to treat the cancer. [5]

CONCLUSION

Any patent application which needs to be filed in India should satisfy the provisions of the Indian Patent Act,1970. Even foreigners can register patents in India as India was part of the TRIPS agreement. In the present case, The Appellant was a foreigner he was from Switzerland. India was part of the TRIPS Agreement so India has made amendments to comply with the international agreement. However, it should satisfy the provisions of the Patent Act for patent granting. The key fact in the case is that an appeal that is directly filed in the Supreme Court without filing it in the High Court is not encouraged by the Supreme Court. So this case cannot be used as a precedent for filing the appeal case directly in the Supreme Court. This was mentioned by the judge in the judgment. This case involves the new point of law for the patent. This was the first and landmark case in this subject matter. Patent laws are changing based on international agreements and treaties. The member country has to amend the laws to comply with the international agreement.

REFERENCES

[1]- Novartis case Judgement, Para 4,5,6,7,8,9,10,11,12 available at https.//main.sci.gov.in (last visited 18^th September 2024)

[2]- Novartis case Judgement, Para 136,165,166 available at https.//main.sci.gov.in (last visited 18^th September 2024)

[3]- Novartis case Judgement, Para 184,185,186 available at https.//main.sci.gov.in (last visited 18^th September 2024)

[4]- Novartis case Judgement, Para 190,191,192,193,194,195 available at https.//main.sci.gov.in (last visited 18^th September 2024)

[5]- Indian Patent Act,1970, available at https.//www.indiankanoon.org (last visited 17^th September 2024)