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Patent protection is one of the key aspects of intellectual property rights (IPR) in the pharmaceutical industry. It grants exclusive rights to pharmaceutical companies over their inventions, typically new drugs or innovative processes, for a limited period of time. Here are some important points regarding patent protection in the pharmaceutical sector:

Patent protection provides pharmaceutical companies with a significant competitive advantage by allowing them to recoup their investments in research and development. It incentivizes companies to invest in costly and risky drug discovery processes, as they can have a temporary monopoly on the market and charge higher prices to recover their expenses.

In exchange for patent protection, pharmaceutical companies are required to disclose detailed information about their inventions. This disclosure promotes knowledge sharing, scientific progress, and the development of new treatments by enabling other researchers to learn from the patented technology after the exclusivity period ends.  

INVENTION ELIGIBILITY

To qualify for patent protection, an invention in the pharmaceutical industry must meet certain criteria, such as being novel, non-obvious, and having industrial applicability. It should represent a new and inventive solution to a specific problem or offer a technical advancement.

There are generally three key criteria for patent eligibility: 

• Novelty: An invention must be new and not already known or disclosed to the public before the filing of the patent application. This means that the invention must not have been published, publicly demonstrated, or disclosed in any other way prior to the filing date.

• Inventive Step (Non-obviousness): The invention must involve an inventive step, meaning it should not be obvious to a person skilled in the relevant field of technology. In other words, the invention should demonstrate a level of creativity or ingenuity that goes beyond what would be considered straightforward or predictable by an expert in the field.

• Industrial Applicability: The invention must have practical utility and be capable of being made or used in an industrial or commercial setting. It should provide a specific and tangible benefit or solve a technical problem.

Once a patent is granted, the pharmaceutical company holds exclusive rights to the invention for a specified period, usually 20 years from the date of filing the patent application. During this time, other companies are generally prohibited from manufacturing, using, selling, or importing the patented invention without permission.

REGULATORY APPROVAL

Patents play a crucial role in the regulatory approval process for pharmaceutical products. New drugs typically undergo rigorous testing and clinical trials to demonstrate their safety, efficacy, and therapeutic benefits. Patent protection allows the pharmaceutical company to retain exclusivity during the development and regulatory review period through data exclusivity.

Data exclusivity is a term used to describe a form of intellectual property protection that provides a period of market exclusivity for the data submitted by pharmaceutical companies to regulatory authorities for the approval of their drugs. However, it's important to note that India does not have specific provisions for data exclusivity in its patent laws or regulatory framework for pharmaceuticals. In India, the regulatory authority responsible for approving pharmaceutical products is the Central Drugs Standard Control Organization (CDSCO). The CDSCO evaluates the safety, efficacy, and quality of drugs before granting marketing approval. The data submitted by pharmaceutical companies for regulatory approval is primarily used to assess the safety and efficacy of the product. While India does not provide data exclusivity as a statutory provision, it does recognize the importance of protecting clinical trial data. The CDSCO maintains confidentiality of the data submitted by pharmaceutical companies during the regulatory review process. The data submitted is treated as confidential information and is not disclosed to third parties.

Patent term extension refers to a mechanism that allows for the extension of the standard term of a patent beyond its original expiration date. It is usually granted in specific circumstances to compensate for delays in the commercialization of an invention due to factors outside the control of the patent holder. The primary purpose of patent term extension is to provide additional exclusive rights and market exclusivity to the patent holder beyond the standard patent term. This extension allows the patent holder to recoup their investment in research and development, and potentially generate additional revenue from the invention. It is provided under Trip plus agreement.

But in India the proposal for patent term extension was initially introduced in the Second Committee established by the Indian government, following a directive from the Delhi High Court in the Nitto Denko case. The primary objective was to consider the possibility of compensating for the time lost during the application processing. The committee ultimately concluded that the current 20-year patent term, which was initially set at 7 years/14 years, already accounts for such delays. It was also noted that applicants or inventors have the option to pursue regulatory approvals and commercialization concurrently while their patent applications are pending.