Medium and small scale pharma units in India need to update themselves to survive in changing regulatory and intellectual property environment. The government through the new IPR policy and amendment to the Rules (2016) is sending out clear signals that patents will be enforced in India to protect the patentee's rights, according to Dr. Gopakumar G Nair, CEO, Gopakumar Nair Associates.

Unlike in the past, no section of Indian pharmaceutical industry can hope to survive without keeping pace with changing regulatory and intellectual property regimes. Every single pharma player needs to do their homework well and try to steer clear of IP/patent/trademark infringements as well as serious adverse FDA inspection remarks in reports, noted patent expert said.

India’s patent litigation scenario had become hectic and hot after amended Patent Act was notified in 2005. Many infringement suits have been filed by MNCs against large Indian pharma companies, like Ranbaxy, Dr Reddy’s, Cipla, Natco, Glenmark and many others. However, by 2016, there is a relative calm in the court cases, because voluntary licensing options seem to have replaced infringement suits. Lately, larger Indian companies are opting out of patent litigations. Cipla, Natco, BDR are frontline examples.

In this scenario, MNCs as well as their Indian licensing pharma partners are increasingly looking at IP/patent/trademark/passing off infringement activities of smaller pharma companies and even trading and purely exporting firms. Websites of smaller Indian companies need to be cleaned up to avoid false claims and infringing product offers. Plagiarism in product inserts and descriptions need to be avoided. Proper patent infringement status checks need to be done by MSMEs before declaring data on the internet, he said.

While the Indian government appears bound and committed to retain the balance of “rights and obligations” and while the Indian government appears keen to retain the delicate balance between affordability and accessibility, the government through the IPR policy and amendment to the Rules (2016) is making it clear that IPs/patents will be implemented in the country to protect the patentees rights. The option for compulsory licence is being less favoured by larger Indian pharma who prefer the voluntary route. These developments could leave Indian pharma MSMEs more and more vulnerable.

Talking about the positive side of IPR/patents in MSMEs, he said “Indians are emerging as the most enterprising community in pharma. Innovation and creativity and is finding expression increasingly through “Jugads” in India, so much so, the world has started accepting “Jugad” culture and philosophy. Without installing self-imposed limitations, Indian pharma MSMEs need to start participating through Jugad-based or innovation-based IP creation of their own as a culture in their organisational environs. MSMEs in pharma has a major role and promising future in India provided they are compliant to regulatory regimes. India and Indian patients will continue to look forward to pharma MSMEs to keep up their contributions to “affordable access” for quality medicines.”