Violation of Drugs Patents: Boehringer Ingelheim demands authorities set mechanisms in place
A notification system would be helpful if any manufacturer files for approval with a state government and the DCGI and the patent holder is notified for the same, Manja stated.
New Delhi: Drug major Boehringer Ingelheim India has urged authorities to put in place a system that will inform patent holders whenever an application is filed by local brands for generic versions of patented molecules. The demand of the company, which is part of Germany's privately-held Boehringer Ingelheim, also comes at a time when there are rising concerns over patent infringements and copyright violations in various sectors, including the fast growing pharma space.
Boehringer Ingelheim India Managing Director Vani Manja noted that currently the burden is on the innovator to first get the patent then keep a check for any infringement.
"Patents are granted in India after intense scrutiny. Takes years to secure a patent/period of exclusivity. After the patent is granted, the period of exclusivity needs to be respected. However, patent linkage and notification is a must as in four years state governments can approve any local brand to produce and launch the generic versions of the molecule," she stated.
A notification system would be helpful if any manufacturer files for approval with a state government and the DCGI and the patent holder is notified for the same, Manja stated.
She also emphasised on the importance of having more investments lined up for enhancing R&D infrastructure.
"There are a lot of conversations to bring R&D competencies to India. If we have to build India into a pharma R&D capital, it is not only limited to manufacturing drugs. There is a need to also invest in R&D," Manja noted.
On pricing of innovator drugs, she stated: "Arguments around pricing need to be reformulated to be around value - it's not just a pill, it's a solution."
Manja noted that the company is having a conversation with Boehringer Ingelheim headquarters to do clinical trials of Indian patients locally.
In terms of focus areas in the country, she said the drug firm is focussed on providing solutions for non communicable diseases like diabetes and the connected issues related to the cardiovascular, renal and metabolic system.
"Sedentary lifestyle and dietary habits leading to increased NCD burden, even manifesting in the younger generation in their 20s. The risk of cardiovascular renal disease has also increased," Manja said.
Brain stroke is another huge unmet health need right from awareness to treatment and management as the disease isn't well understood, she noted.
"A lot of treatment options are not accessible to patients as they are unable to identify symptoms or reach the hospital on time, etc," she said.
Boehringer Ingelheim is also focussed on bringing solutions for various kinds of cancers and central nervous system disorders like schizophrenia, Manja stated.
Commenting on future product pipeline, she said that in about 1.5 to 2 years the company hopes to launch a speciality product in immunology dermatology indication for a rare disease called Generalised pustular psoriasis.
"It is a rare but largely unmet disease which can also be fatal, thus an important area to address," Manja said.
Boehringer Ingelheim India, which has already cracked the 100 million Euro revenue mark in 2019, also focuses on the animal health segment.
"COVID-19, Avian influenza are key examples of how human and animal health are interconnected," Manja noted.
Established in 2003, Boehringer Ingelheim India, manages the India and the neighboring markets' operations of the global enterprise. The company focuses on the key therapy areas of diabetes, cardiovascular and respiratory conditions
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