"Kibow case will encourage strong patent protection scenario in India"

23 December 2013 | Features | By BioSpectrum Bureau

India's patent ecosystem has faced criticism from foreign pharmaceutical and biotech companies, which argue that it lacks robustness and fails to foster innovation or provide sufficient patent protection for research and development activities. However, a recent ruling by the Intellectual Property Appellate Board (IPAB) favoured the US-based biotechnology firm Kibow, led by Natarajan Ranganathan.

The IPAB upheld Kibow's initial patent for its breakthrough probiotic dietary supplement, "Renadyl" capsules, affirming its patentability in India. RenadylTM is designed to help patients with kidney disorders by enabling them to metabolize nitrogenous waste that accumulates in the blood due to impaired kidney function. The probiotics in RenadylTM utilize these nitrogenous wastes as nutrients in the large intestines, thereby promoting healthy kidney function.

Kibow Biotech was granted two patents: one for the process on April 3, 2007, and another for the product on September 29, 2008. The product patent pertains to the dietary supplement capsules, while the process patent relates to how these capsules are prepared. La Renon Healthcare has introduced a competing product named CUDO with a similar composition and has filed for patent registration with the Indian Patent Office, which is still pending. Kibow issued a cease-and-desist notice to La Renon on October 5, 2010, to prevent infringement of its patents. In response, La Renon argued that their product's composition and manufacturing process are unique and superior, asserting that they cannot disclose further details while their patent application is under review.

Subsequently, Kibow Biotech filed a civil suit in 2011 in the Madras High Court alleging infringement of its patents. The IPAB analyzed the case and determined that Kibow's process patent was invalidated because it involved merely mixing known components without any inventive step. The IPAB noted that the patent description failed to adequately explain how the combination produced significant results or any synergistic effects.

In contrast, the IPAB upheld Kibow's product patent for "Compositions for Augmenting Kidney Function," finding it non-obvious compared to prior art cited by La Renon. The IPAB concluded that Kibow's inventive composition included specific probiotic bacteria and other additives that provided a synergistic impact on kidney function enhancement.

La Renon plans to appeal this decision. Currently, La Renon sells CUDO for Rs. 4,500 for a bottle of 30 pills, while Renadyl is expected to retail at Rs. 5,000 for a bottle of 40 pills (a month's supply).

Section 3(e) of the Indian Patent Act poses challenges for multinational pharmaceutical companies by stating that substances obtained through mere admixture are not patentable unless they demonstrate improved effectiveness over existing products. For example, a combination of Paracetamol and Ibuprofen would not be patentable as it represents a simple mixture unless it exhibits unexpected results or synergistic properties.

Despite the invalidation of its process patent, Kibow's upheld product patent remains crucial as it prevents competitors from replicating its capsules and protects its intellectual property rights. This ruling allows Kibow Biotech to enter the Indian market with strong patent protection at a time when India's probiotic market is growing rapidly.

The overall patent prosecution process in India can be complex due to multiple compliance requirements and lengthy timelines from filing to grant. Understanding the necessity of patent protection in specific jurisdictions and navigating the legal landscape is vital for biotech ventures aiming for success. A robust patent system is essential not only for fostering innovation but also for preventing weak patents that could lead to monopolistic practices in the pharmaceutical industry.

15000+

2100

Trusted by Innovators

Proven Expertise

Consider this practical patent example for curing a disease:

Let's say you've developed a new pharmaceutical formulation in India and want to protect the new pharmaceutical formulation under patent rights.

By first filing a non-provisional patent in India and then filing through PCT, you could:

1. Secure your patent priority date in India;

2. Get your claims published to establish your invention's scope;

3. Use the PCT period to conduct clinical trials;

4. Make informed decisions about which markets to enter based on trial results;

5. Finally, select specific countries for patent protection before the 30, 31 months deadline. However, it is advisable to file around 28 or 29 months from the first filing date of the patent application. 

International Patent Services Offered to Global Clients

Expert patent searches and analysis to protect your innovative ideas and intellectual property in India & Internationally.

Comprehensive Patent Searches to determine Innovation Landscape

In-depth global patent landscape analysis and prior art searches for informed decision-making.

Patent Drafting Services for Inventions

Transforming ideas into robust patent applications with our experienced patent attorneys and experts.

Minimize legal risks and maximize value with our freedom-to-operate investigations and assessments by expert patent attorneys with over 20+ years of experience.

Freedom-to-Operate Analysis

Expedite Patent Filing Process in India

The expedited patent filing process in India addresses a significant challenge faced by inventors: the lengthy and often cumbersome patent application timeline. This delay can be detrimental, especially for inventions that have a limited commercial window, as the value of an invention may diminish before a patent is granted.

Client Feedback

Our clients appreciate thorough patent searches and expert legal guidance.

The comprehensive analysis provided by this team was invaluable for our project.

Prateek

Mumbai, India

Their expertise in patent drafting helped us secure our innovative ideas effectively.

Jane Smith

US Inventor

★★★★★

★★★★★

Contact Our Patent Experts Today

Get in touch for comprehensive patent search and analysis services. From initial patentability assessments to filing and prosecution across multiple jurisdictions, we ensure your innovations receive robust protection worldwide.