Appropriate IP Services was founded in Aug 2019 by Dr Bharati Nadkarni. The firm is based on almost two decades of Dr Bharati’s experience in designing and managing global IP strategies for pharmaceutical products. As the head of the global IP team at Sun Pharma (including its group companies Taro and SPARC), Dr Bharati has experience spreading across brand and generic products. This includes patent design-around strategies, patent challenges, and IP creation. Her great understanding of the various functional areas of IP, Business Development and Regulatory Affairs, and the impact of the overlap of these areas on product selection/ development/ filing/ marketing, ensures that she brings a unique value to the table. She is adept at designing practical and business-sensitive strategies for her clients, which includes time and cost efficiencies for the organization, thereby ensuring business viability.

Dr Bharati was responsible for the generic pipeline for US, EU, CA, AU, NZ. This included identification of products upon detailing the following –

• study of the overall market – including generic entry for products in the same therapy area, and entry of new/better products
• generating business case based on IP strategy and competitor activity
• prioritization of the grid for various stakeholders, including cost reduction initiatives

She was responsible for managing annual global IP strategy and budgets of over USD 15 Mn. Her KRA was to save on litigation costs, while ensuring that the business goals are met with. As a result, she helped devise strategy at the time of product selection. Over the last more than two decades, Dr Bharati has been involved in strategy, filing and litigation management of over 250 products. While at Sun Pharma, she was involved with over 120 para IV filings in the US that included –

• First-To-File ~60
• NCE-1 ~40
• settlements ~25

She has also been responsible for managing ex-US litigations in IN, CA, AU, MY, SG, EU and JP, among others. Global IP strategy was important for effective management of these matters.

Dr Bharati has worked extensively with cross-functional teams, leading to good understanding of regulatory and marketing aspects. This has helped her in designing strategies that are practical and feasible. She has a good understanding of regulatory matters such as bio guidances, citizen petitions, filing requirements, label issues, certifications, REMS, RLD procurement and the like. A good understanding of the business aspects and marketing strategies has helped her define better strategies, as well as obtain valuable settlements in litigations.

At Appropriate IP Services Dr Bharati and her team now provide support to pharma companies and law firms on matters related to patents, and overall business strategy. She also helps client build IP protection for critical 505(b)(2) and hybrid applications. They have commendable expertise in handling small molecules and biologics/biosimilars, and work closely with pharma companies as well as law firms in US & EU, to provide bases for challenging patents at IPR and in court proceedings.