Legal and Regulatory Excellence in Drug Repurposing: BIPC’s Comprehensive Support for Scientists and SMEs

<p xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="first" dir="auto" id="d14727001e71">Drug repurposing offers a cost-efficient and time-saving alternative to traditional drug development, but it also raises complex regulatory and intellectual property challenges. Further the term conveys the connotation of inability to create a sufficient economic return to support investment. The United States has a multi-payer pharma regulatory system that offers unique opportunities to obtain legal exclusivity and reasonable reimbursement for repurposed products. Focusing on the US market initially offers that opportunity to create a profitable product that can fund further development in the rest of the world. Buchanan Ingersoll &amp; Rooney PC’s (BIPC) Life Sciences Industry Group has worked to develop unique groups and patented processes to mine the existing Food and Drug Administration data bases to facilitate this process, especially for rare and orphan diseases. This process serves as a particularly useful tool for patient advocates, scientists and the small-to-medium enterprises (SMEs) that are the life blood of this space. Buchanan’s team has worked with most FDA reviewing divisions and dealt with the various governmental and private payers. This experience helps us navigate this landscape and translate promising concepts into approved therapies for which reimbursement is obtained. <p xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" dir="auto" id="d14727001e73">BIPC’s FDA regulatory team supports the full repurposing lifecycle, from early concept evaluation to market authorization, with particular expertise in the 505(b)(2) pathway. This enables innovators to leverage existing safety and efficacy data while meeting stringent regulatory requirements. <p xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" dir="auto" id="d14727001e75">Equally critical is intellectual property protection. With more than 45 USPTO-registered practitioners, BIPC advises on method-of-use patents, formulation strategies, and global patent protection—helping clients secure value in a competitive field. The firm also brings deep experience in Hatch-Waxman litigation and PTAB proceedings. <p xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" dir="auto" id="d14727001e77">Beyond regulatory and IP services, BIPC assists with strategic partnerships, corporate development, and risk management. This includes facilitating licensing deals, venture capital engagement, and cross-border collaborations. Their antitrust and litigation experts further ensure that repurposing projects remain compliant and resilient in competitive markets. <p xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" dir="auto" id="d14727001e79">Finally, BIPC’s government relations team provides intelligence on policy and pricing trends that directly affect repurposing strategies, enabling clients to anticipate change and position themselves effectively. <p xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" dir="auto" id="d14727001e81">Through this integrated approach, BIPC empowers scientists and SMEs to advance drug repurposing projects with a strong legal, regulatory, and strategic foundation—bridging the gap between scientific innovation and successful commercialization.