As pharmaceutical industry is adopting digital technologies to improve growth and profitability, protection of intellectual property rights (IPR) has become a challenging task for the industry.
There are several cases of IP cyber theft reported in the country. To remain competitive and profitable, the pharmaceutical companies are adopting digitisation as well as making huge investments on research and development of new/improvised drugs and hence, it is imperative to protect the IP associated therein and earn revenue by its commercialisation.
Pharmaceutical industry currently has an evolving IPR strategy requiring a better approach in the internet era.
Pharmaceutical firms are making a significant investment in adoption of technological innovations such as industrial robots, artificial intelligence, and machine learning etc. Use of these technologies in automation of patented process and formulation has some serious consequences as these technological advancements are not fully secure. Their security can be compromised. Hackers can access them and tweak the patented process/formulation causing product defect that could result in financial loss, erosion of brand value of the manufacturers and loss of lives, said Prashant Mali, cyber law & cyber security expert and a High Court lawyer.
If any error occurs in manufacturing of products because of robots, they can be confiscated by law enforcement agency.
Talking about measures to protect IPR in today's time, Mali said “Most of the companies hardly pay attention to revisit their agreement with CROs, distribution channels which were signed years back. This often relaxes manufactures' control over CROs, distribution networks posing risk to them. In the internet era, the firms need to protect their brand value on online platforms because it may get tarnished by rouge elements. For this, the companies need to closely monitor their brand equity over social media. Social media can be exploited by former and disgruntled employees of the company to tarnish image of the company. To protect this, the companies need to get social media guidelines signed by the employees. It can curb rougue practices of employees damaging image of the company on online platform.”
To protect data from employees getting it out of network, the companies need to have interface monitoring BYOD devices to keep track on employees' internet usage. The companies need to have cyber security culture in internet era to protect IPR. The development of cyber security culture should be initiated by top management of the company. Tools put in place to protect IPR can be circumvented but employees trained in cyber security play a crucial role in protecting IPR, he said.
Sharing best practices in protecting R&D data in internet era, Mali said, “To secure R&D data, pharma companies need to isolate R&D department from internet and other connectivities. There is no guarantee of security of R&D data stored on cloud or third party network. The companies should have their own infrastructure to protect their data.”