New Delhi: Today's judgement by a division bench of the Supreme Court of India, dismissing drug major Novartis' appeal for a patent for its anti-cancer medicine imatinib mesylate or Glivec, was heartily welcomed by the Medecins Sans Frontieres (MSF) and the Cancer Patients' Aid Association (CPAA).
"This verdict means that generic drug companies can produce quality drugs at low prices -- a breather for generic drug manufacturing companies and a boon to the numerous poor in developing countries who cannot afford the high-priced original patent drug," said Anand Grover, senior counsel and director of Lawyers Collective HIV/AIDS Unit who represented CPAA in this matter at a press conference in Delhi today. You can listen to what he has to say below:
The CPAA along with many other generic drug manufacturing companies had opposed Novartis' patent application for Glivec and the verdict is important because it strengthens the case against ever-greening — a practice where drug companies retain their patents by making minor changes (oftentimes a change in its form) of a drug patented by them to establish or extend their monopoly over it.
Under the Indian Patents Act 1970, Section 3(d) of the Act, which was introduced by the Parliament in 2005 as a public health safeguard to prevent ever-greening, disallows patenting of new forms of known substances, unless the new form exhibits a significant enhancement in efficacy.
After the verdict YK Sapru of CPAA said, " We are very happy that the Apex Court recognized the rights of patients to access affordable medicines over profits for big pharmaceutical companies through patents. Our access to affordable treatment will not be possible if the medicines are patented. It is a huge victory for human rights."
Recognising the impact of patents on access to medicine, the Supreme Court called for a strict implementation of Section 3(d) and stated that patent applicants had to meet the standard of Section 3(d) before they could get patents in India.
Grover, the counsel for CPAA said that the impact of the SC judgement will have a positive and far reaching effect across the world. "The Supreme Court's interpretation of Section 3(d) gives life to Parliment's intent of facilitating access to medicine and of incenvitising only genuine research. By refusing patent monopolies on minor changes to known molecules, this judgement will facilitate early entry of generic medicines into the market for other medicines and diseases too," Grover said.
Leena Menghaney of Medecins Sans Frontieres, which relies on Indian manufactured generic drugs to treat diseases in Africa and other poor countries around the world, said that the judgement will most benefit patients in developing countries. "Novartis' attacks on the elements of India's patent law that protect public health have failed. The Supreme Court's decision prevents companies from abusing the patent system to get secondary patents on existing medicines to block price-busting generic competition, " Menghaney said.
Novartis had argued that Section 3(d) only applies to new forms of already approved medicines. It also argued that better physiochemical qualities such as shape of the molecule, stability, hygroscopicity and solubility, would satisfy the test of enhanced efficacy.
The Supreme Court, however, held that the physiochemical properties of the beta crystalline form of imantinib mesylate may be beneficial for patients in some manner but they do not meet the standard of efficacy required by Section 3(d).