When Science Meets Law

Garimella V S Sesha Kumar of Dr. Reddy’s calls upon his background to help guide an IP legal team in product development and commercialization

Unlike most counsel, Garimella V S Sesha Kumar (aka Venkata S S K Garimella) utilizes a science education to go with his legal bona fides. This allows him to stretch the barriers of a typical intellectual property (IP) department.

As the vice president and head of intellectual property (IP) Proprietary Products R&D and Promius Pharma, which is a subsidiary of Dr. Reddy’s Laboratories, Garimella is actively involved in defining the development strategy of the company’s products from inception through marketing. He also shares his insights to the selection and development of new drugs for the pharmaceutical multinational corporation, even in the early stages of R&D. Under Garimella’s guidance, IP professionals work in conjunction with Dr. Reddy’s scientists to ensure that these therapeutic solutions will succeed in the marketplace.

But success comes down to more than developing a solution that is safe and effective. The product must also differ enough from existing medicines to ensure that it is patentable and will give the company enough time to sell it with exclusive rights in the form of regulatory exclusivity as well as patent rights.

In order to ensure that R&D scientists focus their efforts on solutions that will have sufficient market impact, Garimella’s staff of eight IP professionals are embedded with research teams. Each of these professionals monitors blossoming ideas that help lead to new products. All of them have backgrounds in the field of science, but they also supply IP legal expertise to help research teams decide if a new product concept is worth pursuing.

According to Garimella, IP professionals at Dr. Reddy’s ask question such as: What is the prior art in this space? What are the key elements that bring novelty that prior art can’t solve? Why this particular solution? What are the chances of achieving a similar solution in the present technology area? How effectively can we build a story to stake our claim to this solution? Garimella’s staff, who work with scientists daily, keep the research teams focused on these issues.

Garimella and his IP team also follow up prior art investigations with research into the existing market landscape. As a result, they are well positioned to contribute with market analysis on new solution proposals. They look into questions such as: Is the competition behind us in this area? How far off are they? Is it a one-player market? A two-player market? What will be our share of the market?

Research scientists tend to be motivated by new discoveries and approaches, and IP professionals tend to be more focused on how existing patents could stymie commercialization of scientists’ work. “Scientists have a tendency to come up with a solution quickly and don’t always explore the complete technology space around the identified solution to identify the points wherein the similar solution may present,” Garimella explains. Thus, there is potential for conflict. The company’s organizational framework, however, helps reduce tension. “By having an IP professional dedicated to each project team, they are able to build a good rapport,” he adds.

Open and frequent communication between IP professionals and scientists keep development teams on track to devise market-winning solutions and not waste time on what could be considered dead-end projects. “We explain the reasoning behind our analysis of existing patents and the possible gaps in our patent strategy,” Garimella says.

By raising these issues early in the solution development process, IP professionals are trusted allies so that scientists focus on products with the essentials and methods that can best support patent claims that are most likely to withstand challenges by competitors. Rather than knocking down proposals, Dr. Reddy’s IP professionals strive to encourage researchers to investigate better approaches from an IP standpoint to what they are developing. That could mean, for instance, broadening the number of experiments to establish a unique approach to developing a solution.

Proprietary Products of Dr. Reddy’s develops two types of drugs as classified by the US Food and Drug Administration (FDA). There are 505(b)(1)s, which include new chemical entities, new molecular entities, and new uses that have never been approved by the FDA. Then there are 505(b)(2)s, which are intended to improve performance of existing molecules through variables such as new delivery methods, new formulations, and alternate treatment options. From an IP standpoint, the patents around the former are relatively straightforward to pursue. As novel solutions, there is typically little prior art to consider.

On the other hand, 505(b)(2)s often have extensive prior art. Developers must prove that their take on the solution differs substantially from existing treatments and improves effectiveness in some way. In the case of a drug to treat migraine headaches, for example, Dr. Reddy’s is developing an intranasal product that provides relief faster and includes a better profile than the existing treatment options.

“I am able to quickly understand the claim pattern and white spaces within the patent applications.”

Dr. Reddy’s IP professionals sometimes have a hand in the genesis of a new product by suggesting an area for exploration. In conducting prior art research, they may notice a compound or formula available for licensing that could be converted into a new solution in a hot market. By bringing this to the attention of R&D scientists, they might provide the inspiration for a new blockbuster product. That makes working for Dr. Reddy’s especially exciting for IP professionals.

The opportunity to contribute to the Proprietary Products and Promius Pharma’s strategic direction as a member of the senior management committee is also compelling for Garimella. The committee discusses new areas of opportunity, and Garimella transmits that information to his IP staff, thereby keeping them abreast of important industry developments. This process, of course, works both ways, as Garimella sometimes informs senior management of new IP creation ideas based on the new happenings in the R&D labs that he learns from his team. As a direct report to the head of the business unit, Garimella works closely with other senior colleagues and keeps tabs on business development through those contacts as well.

Dr. Reddy’s is constantly evaluating the landscape for new products, which keeps Garimella and his team quite busy. Garimella has reviewed and supervised more than one thousand patent applications globally since the beginning of his tenure with the company in 2000. Garimella’s master’s in chemistry from Andhra University in India and his PhD in organo-physical chemistry from Gujarat University in India have been essential to his success. “I am able to quickly understand the claim pattern and white spaces within the patent applications,” he says. By bolstering his credentials with a legal degree in India, and working on an LLM at Fordham University in IP law, he has immersed himself deeply in IP law.

Outside counsel also supplements Dr. Reddy’s in-house IP team in the process of evaluating potential new patent applications. “We provide them with our strategy and patent application drafts,” Garimella says. Outside counsel then picks it apart and works closely with Garimella’s team. The more patents Dr. Reddy’s can claim on a particular new solution, the better the chances of fending off competitors’ challenges, so this work is essential. Garimella’s team have already scored several accomplishments by ensuring patents are granted for several of Dr. Reddy’s key products.

It’s all part of a system designed to carefully orchestrate interactions between IP legal minds and scientific experts to produce safe, effective, and sustainable healthcare solutions. For Garimella and his team, moving nimbly between these two worlds every day is essential to the job.

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Stites & Harbison, PLLC:

“Dr. Garimella is a pleasure to work with. His wisdom, legal acumen, and outstanding business judgment enable him to effectively accomplish Dr. Reddy’s Laboratories’ goals.”

—Mandy Wilson Decker, Member