NEW DELHI :
British drugmaker AstraZeneca Plc’s non-executive chairman Leif Johansson said while India’s tough intellectual property (IP) regime has improved over the last few years, further relaxations in regulations, especially on incremental innovations, are needed to put it on a par with developed nations.
Johansson sought easing of laws to allow patents for incremental innovation, which would help broaden application of a drug beyond its initial disease target. For example, a drug initially designed to treat cancer in one part of the body could be used for other target areas. “I wouldn’t really characterize IP in the pharmaceutical sector (in India), at least, as a problem. I’m not seeing anything that scores on my radar screen as a real problem," Johansson said in an interview.
Earlier, India’s patent regime was seen as one of the toughest in the world, and, at one point in 2014, the US government had classified India as a “priority watch list country". Over the last few years, however, the government has increasingly benchmarked conditions for issuing patents to international standards and the timeline for patent approvals has also significantly reduced. This has led Johansson to believe that the Indian patent regime has considerably eased.
AstraZeneca’s Indian subsidiary is now also growing faster than the global pace. Global sales are growing by 19%, while India is growing by 30% and will continue to do so, he said.
The company plans to soon file for regulatory approval for its innovator drug Lokelma, used to treat elevated potassium levels in the blood, AstraZeneca Pharma’s India managing director Gagandeep Singh Bedi said.
AstraZeneca is awaiting the Drug Controller General of India’s approval for wider applications for three novel drugs and plans to launch its anti-diabetic medicine Qtern and oncology drug Calquence.
In the past two years, the company has introduced five novel medicines through its Indian arm, including oncology drugs Imfinzi and Tagrisso, and anti-diabetic drug Xigduo XR.
One can always discuss incremental innovation, if one wants to call it that, or finding further indications for an approved molecule, but the best thing for India in the long-term would be to come very close to the international standards, such as in Germany and the US, Johansson said.
Under Section 3(D) of India’s Patent Act, mere discovery of a new derivative form, property or use of a known substance does not allow a company to claim patent for the product. Bedi said AstraZeneca, along with other firms, has urged the Centre to resolve problems with regard to this section.
The US and other developed countries issue patents for incremental innovations. However, this has attracted criticism for alleged misuse by companies. Some firms have allegedly extended validity of patents to avoid entry of generic drugs, in effect “evergreening" the patent.
Johansson disagreed: “Your picture that we are just ever-greening everything by ticking the box (for patents), that is not the way everything happens. Is there a debate about this? Yes, but it is not a trivial debate."
A lot of research and, with it, a lot of funding goes into finding other indications for novel drugs and companies should be reimbursed for that, said Johansson.