The Essential Role of Intellectual Property Expertise in a Pharmaceutical API Company

In the highly regulated pharmaceutical industry, and particularly in generic drug development, intellectual property (IP) expertise is a cornerstone of business success. The importance of this expertise cannot be overstated, as it plays a pivotal role in ensuring product integrity, legal compliance, and a company’s competitive edge. Neuland Laboratories has made IP management an integral part of its operations, enhancing its ability to innovate and protect both its own and its clients' interests. With a deep commitment to research, innovation, and IP protection, Neuland Labs, a respected provider of active pharmaceutical ingredients (APIs) stands out as a trusted partner for pharmaceutical companies around the world. To shed more light on the essential role of IP in an API company, we spoke with Sucheth Davuluri, CEO of Neuland Labs.

Sucheth, intellectual property (IP) is a critical but sometimes overlooked aspect of the pharmaceutical industry, particularly in API manufacturing. Can you explain why IP expertise is so important for companies sourcing APIs?

Absolutely. When a pharmaceutical company sources APIs for generic drug manufacturing, product quality and supply chain reliability are often top considerations, but IP expertise is just as critical. If an API supplier doesn’t respect third-party IP rights, it can expose the generics company to legal risks. Our IP expertise at Neuland helps our clients avoid those risks and even gives them a strategic advantage by identifying opportunities to expand and gain a competitive edge.

It sounds like managing IP is about much more than just compliance. How does innovation play into IP management at Neuland?

Innovation is indeed at the core of effective IP management. At Neuland, we focus on developing alternative manufacturing processes that not only improve efficiency but also avoid infringing on existing patents. Our R&D team has developed over 300 API processes and filed more than 970 drug master files (DMFs). These innovations allow us to create patentable processes, which are crucial for protecting both our and our clients’ interests. Neuland has filed 246 patent applications for API manufacturing processes & polymorphs in various countries, and 79 patents were granted, and the remaining patent applications are in different stages of the grant.

That’s impressive. Can you elaborate on how Neuland’s IP department supports this innovation?

Our IP department plays a significant role. We invest in training our scientists on IP rights so they can develop processes that are not only efficient but also patentable. We also manage product in-licensing and out-licensing, making informed decisions based on the competitive advantages these IP deals provide. Our approach ensures that we can offer our clients a robust IP strategy that goes beyond just supplying APIs.

How does Neuland use IP management as a tool for competitive advantage in the market?

We have a comprehensive approach to IP management. It starts with freedom-to-operate analyses to ensure that our products don’t infringe on third-party patents in any of the markets we operate in. We also perform infringement analyses to safeguard our own IP. Additionally, our IP team provides in-depth market intelligence reports, covering everything from patent invalidity and patentability to white space analysis. This information is not only vital for our internal strategy but also helps our clients identify new opportunities for market expansion.

You mentioned helping clients with market expansion. Can you talk about how Neuland supports clients’ generic drug launch strategies?

Yes, one of the ways we add value is by helping our clients assess global markets and develop strategic launch plans. We monitor worldwide patent expiries and conduct white space analysis to find opportunities for early product launches. Timing is critical in this industry, and our insights allow clients to enter markets earlier than their competitors, giving them a significant advantage.

Paragraph IV filings are known to be a powerful strategy for early market entry. How does Neuland assist clients with this?

Paragraph IV filings are a key focus for us because they offer a 180-day market exclusivity period for successful filers. Our team’s expertise in Paragraph IV filings, combined with our innovative process development, helps clients file abbreviated new drug applications (ANDAs) that can give them an edge over both branded and generic competitors. This strategy allows our clients to enter the market early, often capturing significant market share from the innovators while maintaining competitive pricing.  

Beyond the launch phase, how does Neuland ensure ongoing IP protection for both the company and its clients?

Effective IP management is a continuous process. We conduct regular audits, due diligence, and infringement monitoring to ensure that both Neuland and our clients are protected from potential legal challenges. Our E-Patent management system provides real-time IP data, making it easier for our staff and clients to make informed decisions. This ongoing vigilance is a critical aspect of our corporate risk management strategy.

Neuland’s achievements in IP management have been recognized externally as well. Can you tell us about that?

We’re proud to have received numerous awards from prestigious organizations like Pharmaceuticals Export Promotional Council of India (Pharmaexcil), ASSOCHAM, NITI Aayog (the Indian Government’s economic development authority),Legal Era, the Global Intellectual Property Convention, and others. These accolades affirm our commitment to excellence in IP management and innovation. They also demonstrate the trust our clients place in us as a strategic partner in their success.

In conclusion, how would you sum up the role of IP management in Neuland’s overall business strategy?

At Neuland, we see IP management as a strategic tool that not only protects our business but also enables growth. Our expertise in IP rights allows us to provide high-quality, legally compliant APIs while helping our clients navigate complex markets and seize new opportunities. It’s this holistic approach to IP management that ensures long-term sustainability and success for both Neuland and our clients in the competitive pharmaceutical landscape.