NOVARTIS GLIVEC CASE STUDY
ASSIGNMENT ON NOVARTIS GLIVEC CASE STUDY
SUBMITTED BY: ANU KHARE BATCH: WEEKEND
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NOVARTIS GLIVEC CASE STUDY
ACKNOWLEDGEMENT
It is an honor for me to express my deep gratitude for those people involved in this endeavor. I take this privilege to express my deep sense of gratitude and heartfelt gratefulness to Miss. Richa Khullar. And Ms. Shruti for their support and guidance. I would also like to thank Bimla and Kuldeep, my batchmates for their support. At last I am also grateful to IIPTA for providing me knowledge, guidance and study material.
Anu Khare
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NOVARTIS GLIVEC CASE STUDY
ABSTRACT: Novartis , a Swiss based pharmaceutical company has filed two cases both on Indian Patent Office on rejection of patent application for the cancer drug Imatinib Mesylate ( Brand name Glivec) and the sec 3 d of the new Indian Patent lawcthat form base of opposition.
INTRODUCTION: Imatinib Mesylate is (Glievac) is a cancer drug used in the treatment of Myeloid Leukemia (cancer of blood). It is produced and marketed internationally by swiss pharmaceutical Novartis and various Indian Pharma companies such as Cipla,Hetero, Natco and Ranbaxy. Novartis sell gleivac at rate of 1,20,000 per patient per month in India. However generic version of drugs costs at about 8000 per patient per month in India. Novartis filed the application for patent in Chennai High Court in 1998 ,at that time India did not grant patents on medicine ,so they are given EMR (Exclusive Marketing rights) , which excludes others from production and sales of generic version in the market . After 2005 as India starts reviewing product patent applications application of Novartis has been rejected on basis of sec 3d and pre grant opposition. Novartis has filed two cases against Indian patent office’s rejection of patent application for the cancer drug Imatinib Mesylate (Glivec) and the section of the new Indian patent law which formed the basis of the patent office decision.
HISTORY OF CASE: Filing of patent by Novartis: Novartis filed an application at Chennai patent office in 1998 to grant a patent on Imatinib mesylate (glivec). At that time India did not yet grant patents on medicines but in Nov., 2003 Novartis able to get EMR (Exclusive Marketing Rights) for a period of 5 years based on previous provision of Indian patent act. Granting EMR was a TRIPS obligation for countries like India which do not give patent on pharmaceutical products. After 2005 , Indian Patent Office began to review pharma product patent applications EMR are either given patent or are rejected .If rejected EMR rights also ends. EMR works like a patent monopoly which prevents other pharma companies to manufacture of sell generic products of Imatinib Mesylate.
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NOVARTIS GLIVEC CASE STUDY
PRE GRANT OPPOSITION OF PATENT:
Cancer patient aid association has filed an opposition on behalf of cancer patients in the Chennai patent office, as it is allowed to oppose a patent before it is granted by a person or group. Pre grant oppositionof Glivec is made on five points: 1) There is prior publication of the invention through patent applications filed in many countries, including Canada and the US, in 1993, by taking priority from the Swiss application filed in 1992. Claims show that patent is granted not on the compound in its free form but also for the salt form of Imatinib Mesylate. 2) There is no inventive step , specifications do not show any inventive step in making salt from the free base of Imatinib Mesylate.and the process described is too obvious for the person skilled in art. 3) Crystal salt form does not allow to invention. 4) Patent application does not claim any therapeutic efficacy. Rejection ground of sec 3(d) 5) At the time of filing the patent application in 1998 Switzerland is not recognized as convention country in India .Therefore the patent application from Switzerland is not eligible for the one year priority available to applications from convention countries. Moreover to these grounds Glivec costs Rs.1,20,000 per patient per month which is not affordable in comparison to cost of generic medicines which is Rs. 8000 per month per person. This is beneficial for public health in developing countries like India. Also India is the main market of medicine for developing countries. So low cost medicines are needed . Issuing of patent will effect such requirements. REJECTION OF PATENT APPLICATION BY CHENNAI PATENT OFFICE:
Chennai Patent Office in January, 2006 rejected the patent application on the ground that the application claimed ‘only a new form of a known substance’. This ground of rejection on the basis of sec 3 d. As per chapter II of Indian Patent Act, 2002, some inventions are not patentable, these are – Sec 3: What are not inventions Sec 4: Inventions relating to atomic energy are not patentable
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NOVARTIS GLIVEC CASE STUDY
Sec 5: Inventions where only methods or processes of manufacture are patentable. As per Sec 3(d) of Indian Patents (amendment) act, 2005 “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs atleast one new reactant.” Indian Patent Office rejected Novartis patent application for “Glivec” on the basis of this sec3 (d), which states polymers, isomers metabolites etc are considered to be same substance unless they show difference in properties in regard of efficacy. This rejection of patent application also ends EMR on glivec upto 2018. NOVARTIS CHALLENGES PATENT ORDER AND INDIAN PATENT LAW:
On 17, May 2006 Novartis filed two cases in Chennai Patent Office – 1) First case challenges the order of the Chennai Patent office, which rejected patent application of Novartis for Glivec on the ground of pre grant opposition by the Cancer patient aid association. 2) The second case filed by Novartis challenges the constitutionality of Sec 3(d) of Indian patent act, 2005. This sec was introduced to prevent the misuse of the product patent regime. Novartis claims that sec is not in compliance with TRIPS. This sc prevents pharma companies to obtain patent on trivial improvements or new medical uses of known molecule. Indian patent law ,when become fully compliant with TRIPS Agreement and introduced a product patent Regime in 2005, it safeguard the law using condition that patent is not given on mere discoveries of new forms or new medical uses of known substance until an enhancement in efficacy is proven. This is as per TRIPS agreement. TRIPS do not define what invention is and what is the measure of efficacy, which allows WTO countries to use the provision as per their understanding. NOVARTIS PERSPECTIVE:
As per Novartis “Our case in India is solely about safeguarding intellectual property, not about patient access”
As stated, Novartis is not trying to change any provision that support access, they are only challenging parts of Indian law that rejects Glivec. They do not challenge provisions that provide for access under International trade agreements, specifically the WTO’s Agreement on TRIPS and the Doha Declaration. They are only trying to protect the Intellectual Property rights on www.iipta.com
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NOVARTIS GLIVEC CASE STUDY
Glivec, by contesting the rejection of Glivec. Novartis supports TRIPS condition that promotes access for developing countries. They are challenging to additional hurdles to patentability in India that discourage both breakthrough and incremental innovation. If the patent law is effective, with the help of this companies like Novartis can continue to bring improvements and innovations to patients and societies. Moreover Glivec , a life saving drug of cancer is a true innovation . Rejection of its patent application shows the deficiencies in Indian Patent system.
COURT’S DECISION:
Court rejected patent application of Novartis on ‘Glivec’ as it is not able to prove therapeutic efficacy. Therefore the court held that sec 3(d) is not violative of article 14 of the Constitution of India.
Court also rejected the argument of petitioner that sec 3(d) is not compliant to TRIPS agreement.
CONCLUSION: The judgement is welcomed globally by treatment activists and public interest groups. Novartis disagree with the judgement and warned that court ruling will discourage much required investment in drug innovation. As per judgement efficacy is judged on the basis of therapeutic efficacy of the drug. Judgment is in favour of patients and developing countries.
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REFERENCES:
novartis glivc study/Ipr-Case-Study.htm
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