India Patent Law Case Study

The efficacy provision in the Patents Act of 2005 for India was necessary because it prevented other medications that were a new form of an existing drug from being patented. Any company trying to introduce a new medication was required to show proof that the medication had more effectiveness than an existing drug. In regards to the patent provisions in India, the provisions were put in place for many different reasons. In 1970, India Parliament adopted a new Patent Law that prohibited foods or medications from being patented. Due to India patients being poor and the country being undeveloped, these laws were created. Studies showed during this time, that patients in India were paying more for medications than patients in the United States and European countries. Due to these findings, the …show more content…
When India joined they had to amend their patent law to allow patents for medications and as a result, they passed the Patents Act of 2005, which gave regulations and restrictions for patents being approved for pharmaceuticals. This new law was that any medication that was created as a new form from an existing drug could not be patented unless the company could provide proof that the new medication was more effective than the existing medication. Novartis created Glivec as a new medication, but it had imatinib in it which was a drug that had been previously used. Novartis AG, a Swiss pharmaceutical company was seeking a patent in India for an anti-leukemia medication that was advertised in North America as Gleevec and in the rest of the world as Glivec. India ruled that Novartis did not meet the requirements for Glivec. Novartis did not meet the requirements because they were not able to prove effectiveness of the new medication they were trying to have patented. Instead, they were only able to show that the medication Glivec had 30% higher bioavailability. Bioavailability is the portion