Case of Novartis

Introduction

IP is an immaterial type of ownership, while "parent" is an intrinsic subset of IP. The state grants a patent a constitutional right to exclude anyone from making, using, or selling its invention for a maximum period of 20 years. One of India's main judgments in the Novartis AG V. Unión was the judgment of the two-judge bench of the Hon'ble Supreme Court of India. In this case, Novartis challenged the rejection by IPAB of its patent application on the beta-critical form "Imatinib mesylate" which the Supreme Court of India rejected because the drug did not produce an improved or higher therapeutic efficacy than the substance known, i.e. "Imatinib mesylate" which means the drug does not involve an inventive step. One of the key reasons why Novartis' patents were rejected was that already patented products could be prevented evergreening by making small changes.

Facts of the Case

1. In 1998 one of the world's largest drug companies was named. In 1998. The application for a patent for the treatment of Chronic Myeloid Leukemy (CM L) and Gastrointestinal Stromal Tumors (GIST), invented from Beta crystalline form of "Imatinib mesylate" was rendered by Novartis International AG before the Chennai Patent Office in compliance with TRIPS Agreement. This medication is known for its use in cancer care, and in more than 35 countries, the same drug is patented.

2. The grant was restricted to methods, processes, and not products in India, as specified in Article-5 of the 1970 Patent Act when Novartis filed its own patent application. Following the abolition of Section 5 of the Patent (Amendment) Act in 2005, patents were issued for processes and methods, but also for goods.

3. It is considered that Novartis patent applications for drug Glivec were taken in 2005 and Madras Patent Office denied them because the drug was anticipated to be published beforehand and failed to fulfill the novelty and non-obvious requirement; further, the alleged invention was declared as unpatentable under Section 3(d) of the Patent Act of 1970 as such. Patent for Zimmermann.

4. Subsequently, in 2006, Novartis submitted two written petitions under Art. 226 of the Constitution of India to the Madras High Court. Section-3(d) of the Patent Act, 1970 was subsequently ruled unconstitutional because the TRIPS Agreement was not complied with and therefore in violation of Article-14 of the Constitution of India and Article-14 of the other against the order passed by the Madras Patent Office. The High Court of Madras transferred the matter in 2007 to the IPAB (Tribunal of Appeals for Intellectual Property). Finally, this recourse was heard and rejected by IPAB that it met novelty and non-obvious tests, but Section-3(d) of the Patent Law 1970 affected the patentability of the device. IPAB is confident that the already patented product will not be ever greened by making slight improvements and providing Indians with convenient access to life-saving medicaments.

Issue of the Case

1. What is a recognized material under the terms of paragraph 3(d) of the Patent Act of 1970?

2. What does the sense of efficacy mean under Section-3(d) of the Patent Act 1970?

3. Under Section 3(d) of the Patent Act of 1970, is it deemed to be an improvement of therapeutic effectiveness in bio-availability??

4. Whether the Novartis claimed invention "Beta crystalline form of imatinib mesylate" is more powerful than the substance derived from "Imatinib mesylate"?

The judgment of the Case

In April 2013, the Supreme Court's two judge-bank of India dismissed Novartis's appeal and maintained that Imatinib Mesylate's beta crystalline form is a new form of the known material, i.e. Imatinib Mesylate, which is well known to have been successful. The Supreme Court has made it crystal clear that in section 3(d) of the medicine "Efficacy means "Therapeutic Efficacy" The Supreme Court claimed that all the properties of the medicine do not apply. In the third question, the Supreme Court ruled that an improvement of around 30% in bioavailability would be deemed to be an increase in therapeutic effectiveness pursuant to Section 3(d) of the Patent Act of 1970. The Supreme Court compared the efficacy of the ' Beta crystalline imatinib mesylate' and its flow characteristics, better thermodynamic stability, and lower hybricity with that of the 'Imathinib mesylate.' The Supreme Court found that none of these properties contributes to increasing therapeutic efficiency under Section-3(d).

Analysis of the Case

• In a study of Zimmerman's patent and associated scholarly publications, the court first analyzed the issue of the prior art. The Zimmerman Patent revealed that imatinib mesylate was not new itself, and did not qualify for the testing of the invention under paragraph 2(1)(j) and paragraph 2(1)(ja) of the Patents Act (1970). The court then analyzed the beta crystalline form of imatinib mesylate, and wrote: "For the sake of arguments it is acceptable to be considered new in the sense that the Zimmermann patent is unknown. (It is another matter whether or not it requires an 'inventive phase' and now there is no need to deal with this point of view.)

• The Court took pain to point out that during the era of change, the patent application in question was filed under Indian patent law, in particular with regard to the striking provisions of Section 5, which had barred product patents, and the extension of Section 3(d), for which there was no case law yet.

Conclusion

The Hon'ble Supreme Court judgment seeks to prohibit proprietary drugs from being ever greened and reliefs those not able to afford to sell the lifesaving medications, for these pharmaceutical firms are not, therefore, available to everyone. In its judgment, the Supreme Court claimed that India is a developed country and that it is important for the lives of one billion people to have access to drugs cheaper than ever. Section 3(d) of the Patent Act 1970 forbids secondary patents from being secured by these major pharmaceutical firms by making slight improvements in established technology. Novati has failed to show that "Beta Crystalline form of Imatinib Mesylate" therapeutic effectiveness is more compared with the "Imatinib Mesylate" therapeutic efficacy. So the Supreme Court dismissed the patent application of Novartis.

BY-

Ankita Rathi