Patent Overview in Novartis Case ppt
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The document discusses the significance of patents in protecting inventions, focusing on the Novartis AG v. UOI case regarding the cancer drug Glivec. The Indian Supreme Court rejected Novartis's patent application for a modified version of Glivec, determining it did not offer novelty and could fall under 'evergreening,' facilitating access to more affordable generic alternatives for patients. The ruling emphasizes the right to health and highlights the importance of affordable medicines, as generic versions of drugs are accessible to a larger population.
Patent Overview in Novartis Case ppt
- 1. Anu.B Intern at Biz & Legis www.bizandlegis.com
- 2. Patent is an intellectual property tool that safe guards the invention of an inventor. The validity of patent is for 20 years from the date of filing of patent application Pharmaceutical derivatives are granted patent if it possess the character novelty. Pharmaceutical means of or relating to pharmacy As like other products, for obtaining patent the molecule structure, function properties etc have to be specified in detail www.bizandlegis.com
- 3. WHY PATENTS? 1. Prevent others from commercially utilize that invention 2. Encourage financial risk and long term research 3. Patents guarantee dissemination of information www.bizandlegis.com
- 4. Novartis AG v. UOI decided on 1st April 2013 Facts of the case Novartis is the world’s leading pharmaceutical company filed patent application for its new version of cancer drug. The drug is called glivec and is very expensive. Glivec was already in the market, however they decided to seek a patent on a slightly altered version potentially giving it longer period of market exclusivity. www.bizandlegis.com
- 5. The case hinged on s.3(d) of the Indian Patents Act which does not allow patents of new version of known drug molecules if they make it more effective than before. In the mean time many Indian companies produced generic drugs at very cheap rate which was consumed by 300000 people . Whereas 16000 people use glivec. Generic versions can be manufactured when the product expires the patent. www.bizandlegis.com
- 6. ISSUES INVOLVED 1. whether glivec is a patentable product? 2. Whether it involves ever greening? JUDGEMENT With the majority under the presence of Aftab Alam .J. and Ranjana Prakash Desai .J. the court held that the patent application is rejected on the grounds that : www.bizandlegis.com
- 7. 1. Mere modification does not give novelty to the product and the applied product has no better effect than the already existing drug. 2. If the application is allowed to grant patent for glivec it becomes re-patenting and lie within the purview of ever greening which is prohibited under the Indian Patent Law. 3. Since the patent for the already existing drug has expired manufacturing and selling of generic versions within the country at cheap rate. www.bizandlegis.com
- 8. A majority of indian population uses generic version of glivec at cheap rate and enjoy the easy accessibility of medicine. The judgment has paved a clear path to establish and secure human rights by complying right to health through this judgment. It can be proudly concluded that Human rights win as giant pharma Novartis loses the case. www.bizandlegis.com
- 9. Inalienable fundamental rights to which a person is inherently entitled simply because he/she is a human being. UDHR 1948 Substantive rights- 1. Right to life 2. Freedom from torture 3. Freedom from slavery 4. Right to fair trial 5. Freedom of speech 6. Freedom of thought, conscience and religion 7. Freedom of movement 8. Rights debates ( Right to keep and bear arms, future generations, sexual orientation and gender identity, trade, water, reproductive rights and information and communication technologies ) ICCPR 1966 ICESCR 1966 www.bizandlegis.com
- 10. RIGHT TO HEALTH Recognized in the UDHR, ICESCR and Convention on the Rights of Persons with Disabilities. Art.25 of UDHR- Everyone has the right to a standard of living and well being of himself and his family. Preamble of WHO declares it to be a fundamental right of every human being to enjoy the highest attainable standards. www.bizandlegis.com
- 11. Defined u/art. 12 of ICESCR Impliedly involves right to access medicine, right to treatment and precautionary measures. Accessibility increases when the price of medicine is cheap, nation based production, availability of alternative at cheap rates etc. Accessibility decreases when price in high, imported medicine and rules regarding the exporting countries etc. www.bizandlegis.com
- 12. GLIVEC GENERIC VERSION OF GLIVEC Manufactured and distributed by Novartis, a foreign company. Expensive in nature. Pack of 30 tablets costs $ 1,100. Accessibility is low. 16000 people in India preferred glivec Manufactured and distributed by approved local companies such as NATCO. Least expensive Nexavar- generic version- pack of 120 tablets costs $ 1000. Accessibility is high. 300000 people prefer generic version
- 13. WHO WILL MEET THE HUMAN RIGHTS EFFECTIVELY???? GLIVEC OR ITS GENERIC VERSION!!!!! www.bizandlegis.com
- 14. The judgment is nothing but the rejection of patent application of glivec filed by Novartis. As the application is very related to ever greening which is barred by Indian Patent law, no injustice has been done to Novartis by the judgment. Since patent period has been expired, encouragement of manufacturing of generic version of the same is permissible and do not amount to violation of law. www.bizandlegis.com
- 15. Government shall take quick steps to increase accessibility of these generic version and the cheap rate of medicine enhance the mobility and accessibility. Cancer is a serious disease that may cause death. Right to health being a human right is clearly violated on death of people due to this reason. www.bizandlegis.com
- 16. Judgment makes it easier to extend the accessibility of the generic drugs through its extensible manufacturing and distribution. Governmental steps can be smoothly adopted and implemented for making the drug to reach the nook and corner of the country. It can be noted that the compulsory licensing of the same drug would not increase its accessibility . www.bizandlegis.com
- 18. The judgment of Novartis case can be regarded as the most fruitful, viable and traceable decision that meet the human rights to the highest ends. Other Judgments favorable of generic drug manufacturers Roche Pegasys case- November 2012 Januvia patent case- 2nd April 2013 www.bizandlegis.com