Novartis Case Study Analysis
Novartis Case Study AnalysisNovartis: Facts
1. Jurg Zimmerman had invented a number of derivatives of N-Phenyl-2-pyrimidine-amine including Imatinab.
2. These derivatives had valuable anti-tumor properties and hence could be used in pharmaceutical compositions for the treatment of human beings against cancer.
3. These derivatives had been granted patent in both the US and Europe. Beginning with Imatinab in its base form.
4. Novartis claims to have developed Beta Crystalline form of Imatinab in a two-stage process and a direct process, with obtaining Imatinab Mesylate in amorphous form as an output in the stage one of the two-stage process.
5. An application was filed for the patent of the beta crystalline form of Imatinab Mesylate in India claiming that the newly invented form had more beneficial flow properties, thermodynamic stability and a lower hygroscopicity than the original Imatinab.
6. Further, they claimed it has better storage properties and that it was easier to process than the Imatinab in basic form.
7. However it was also claimed in the application for patent that all the inhibitory and pharmacological effects of the beta crystalline form of Imatinab Mesylate were also found in the base form of the compound.
Novartis: Law Points and Development of the Case
1. When the application was filed for patent in the year 1995,the patent laws in India were under transition phase and as a result the application held in a dormant mode.
2. Later in March 2002, the applicant makes another application for Exclusive Marketing Rights (EMR) of the product under the section 24A of Indian Patent Acts 1970, which now stands deleted following the amendments to the Indian Patent Act, and in the due course, the EMR for the product was granted to the applicant.
3. However during the period of EMR, the drugs sold by Novartis had base form of Imatinab in their composition of drug rather than the Beta Crystalline form of the Imatinab Mesylate for which the EMR was sanctioned.