I have prepared a PowerPoint presentation on how Intellectual Property Rights (IPR) impact public health and how IPR law governs pharmaceutical companies.

1. ASSIGNMENT
ON
PUBLIC HEALTH AND INTELLECTUAL PROPERTY
RIGHTS: NOVARTIS, BAYER CASE STUDY

2. Public health is the science and art of preventing disease,
prolonging life and promoting health through the organized
efforts . Public health is a fundamental human right and a key
indicator of social and economic development. It is also a vital
component of national security and global stability.
Intellectual property rights are the legal rights that protect the
creations of the human mind, essential for fostering
innovation, creativity and competitiveness in the knowledge-
based economy. They also provide incentives for research and
development, especially in the fields of science, technology
and medicine.

3. There is often a perceived conflict between public health and intellectual property rights,
especially in the context of access to medicines and vaccines. On one hand, there is a need to
ensure that the fruits of innovation are affordable and accessible to all, especially the poor and
marginalized sections of the society. On the other hand, there is a need to respect and reward
the intellectual property rights of the innovators, who invest time, money and resources in
developing new and improved products and processes.
India is fully committed to the protection and promotion of
intellectual property rights, as well as the right to health. India has
enacted and revised its intellectual property laws in compliance with
the international standards and obligations, such as the TRIPS
Agreement. India has also taken measures to safeguard public health
and prioritize access to essential medicines and vaccines, as affirmed
by the Doha Declaration on TRIPS and Public Health

4. India has adopted a National Intellectual Property Rights Policy in 2016, which aims to foster a
dynamic, vibrant and balanced intellectual property system in the country, that will catalyze the
socio-economic development and enhance the welfare of the people. The policy has seven
objectives, which are:
IPR Awareness: Outreach and Promotion
Generation of IPRs
Legal and Legislative Framework
Administration and Management
Commercialization of IPRs
Enforcement and Adjudication
Human Capital Development
The policy also recognizes the importance of public health and states that India shall continue to
utilize the legislative space and flexibilities available in international treaties and the TRIPS
Agreement. It further states that India shall examine the patentability criteria to ensure that
frivolous patents and ever-greening are not granted, and that the patent system is not abused
by those who may unreasonably resort to rights conferred by such patents.

5. India has also implemented various mechanisms and initiatives to facilitate access to medicines
and vaccines, such as:
COMPULSORY LICENSING
PATENT POOL
VACCINE BOND
These are some of the examples of how India is trying to balance public health
and intellectual property rights in a progressive manner. However, there are still
many challenges and opportunities that need to be addressed and explored.

6. The Novartis case1: Novartis, a Swiss pharmaceutical company, applied
for a patent in India for a cancer drug called Glivec, which is a beta
crystalline form of imatinib mesylate. The Indian patent office
rejected the application, citing that the drug was not a new invention,
but a modified form of a known substance, and that it did not show
any enhanced therapeutic efficacy, as required by section 3(d) of the
Indian Patent Act. Novartis challenged the rejection in the courts,
arguing that section 3(d) was unconstitutional and violated the TRIPS
agreement. The case reached the Supreme Court of India, which
upheld the patent office’s decision and dismissed Novartis’ appeal in
2013. The court ruled that section 3(d) was valid and consistent with
TRIPS, and that Glivec did not meet the criteria of patentability under
Indian law. The court also stated that the patent law was designed to
prevent ever-greening of patents, which is a practice of extending the
patent term by making minor changes to existing products.

7. Bayer, a German pharmaceutical company, held a patent in India for a cancer
drug called Nexavar, which is sorafenib tosylate. The drug was priced at Rs. 2.8
lakh per month, which was unaffordable for most patients. Natco, an Indian
generic drug manufacturer, applied for a compulsory license to produce and
sell a cheaper version of the drug, which would cost Rs. 8,800 per month. A
compulsory license is a legal provision that allows a third party to use a
patented invention without the consent of the patent holder, subject to
certain conditions and payment of adequate compensation. The patent office
granted the compulsory license to Natco in 2012, citing that Bayer had failed
to meet the reasonable requirements of the public, that the drug was not
available at an affordable price, and that the patent was not worked in India.
Bayer appealed against the patent office’s order to the Intellectual Property
Appellate Board (IPAB), which upheld the grant of the compulsory license in
2013. Bayer then appealed to the Bombay High Court, which also affirmed the
IPAB’s decision in 2014. The court held that the patent office and the IPAB had
followed the law and the guidelines in granting the compulsory license, and
that the public interest and the right to health outweighed the patent rights of
Bayer.

8. THANK YOU