Hridkamal Roy, Assistant Managing Editor, India Pharma Outlook
.jpg "Why Adapting Flexibility in IP Rights will Drive Generics Market")
In an effort to promote the generic medicines industry of the country, the government has taken positive steps regarding IPR issues related to the pharmaceutical sector of the country according to a report published by Global Trade Research Initiative (GTRI). A flexible interpretation of the Trade Related Aspects of Intellectual Property Rights (TRIPs) agreement that comes under the jurisdiction of the World Health Organization (WHO) has been done by authorities in India in response to the pressures levied down by developed countries on developing countries to take commitments on FTAs that relate to IPRs. By opposing to the “data exclusivity” and “patent linkage” issues in free trade agreements (FTAs), the government has opened up the doors for generics manufacturers to have greater market access and in the process significantly lower the cost of many life-saving drugs.
According to the paper published by GTRI, “India’s approach underscores a commitment to balancing innovation with public health needs, adopting a flexible interpretation of TRIPS to align with its developmental goals, and preventing the establishment of unfair monopolies, especially in the pharmaceutical sector,”.
The IPR issues or TRIPs-plus provisions go beyond the basic requirements in a TRIPs agreement and for over 100 bilateral investment treaties that have been sighed by the US until now, these provisions have been the cause for major problems all over the globe.
“India’s stance reflects its commitment to balancing these interests and fostering economic ties through trade agreements… India’s always stand against TRIPS-plus provisions. India has consistently safeguarded the interests of its domestic generic drug industry in FTAs,” GTRI Founder, Ajay Srivastava said to the media.
Even after the expiry of a patent, it is the issue of data exclusivity that can become a significant barrier and can delay the market entry for generic medicines. It is applicable for a specified period after expiration of a patent when the regulatory authorities are not in a position to rely on the clinical data of the primary manufacturer to provide approval for the generic version of any drug. It is because, after the expiry of a patent, the clinical data that was earlier submitted by the originator company regarding the safety and efficacy of a drug cannot be used as an immediate reference for approval of the generic versions of the same. This is why generic drugs manufacturers again have to wait for the expiry of data exclusivity and seek the regulatory approvals for the generic versions.
The Indian authorities has opposed this aspect mentioned in the TRIPs-plus provisions in order to ensure that generic medicines have can enter the market right after the expiry of a patent and not wait for more regulatory approvals.
To give an example, AstraZeneca obtained regulatory approval for its diabetes medicine saxagliptin in 2009, the patent for which expired in 2022. Added to this, the company benefitted from the data exclusivity provisions stated under the Drugs and Cosmetics Act, 1940. This prevented the usage of the related clinical data that was submitted for this medicine in order to provide the approvals for generic version of the drug. The data exclusivity period in India being five years for new drugs and three years for medicines that have been marketed elsewhere before, all generic manufacturers had to wait for approvals for generic saxagliptin until the data exclusivity expiry.
Litigation and legal challenges arise between branded and generics drugs producers regarding patent linkage on the grounds of infringement and validity of patents. There have been many instances where generic drugs manufacturers had to get involved in lengthy and expensive legal processes to challenge the patents listed by the branded medicine manufacturers. The process has resultantly delayed the approvals for the generic versions and restricted them to enter the market. In such cases where patent linkage has come into play, the regulatory authorities may hold the approvals for the generic versions of drugs if the corresponding branded drug company has listed a patent for the product. Here, the market entry of the generic versions is delayed until all the legal disputes between both manufacturers are solved.
Speaking against the patent linkage aspect will open huge opportunities for the already growing generics manufacturing sector of India. It will help the industry save a considerable amount of time and concentrate on production of generic versions of drugs faster without getting involved in legal hassles.
In this regard, Novartis obtained a patent for vildagliptin in 2007, which was set to expire in 2022. The company had secured regulatory exclusivity along with patent protection for this medicine that is used for diabetes. As a result, generic versions for vildagliptin were not approved even in case the listed patents were found to be invalid. This caused disputes between the generic and the branded manufacturers. This delay was particularly significant for India as vildagliptin was a popular drug used for the treatment of diabetes and the generics competition would not have only made the drug accessible to more people but also lower the price point for improved and affordable treatment for native patients.
The above steps taken by the government stand testimony to the fact that the country is thinking positively regarding the availability of essential medicines and making healthcare affordable for countrymen. It will provide immense opportunities for generics manufacturers in catering to the growing demand in the market and providing critical care drugs at subsidized rates.
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