Innovation in the Pharmaceutical Market: An Analysis of the Patents of Monoclonal Antibodies

OBJECTIVES: This study aims to characterize the market for mAbs through patent analyses.

METHODS: A quantitative cross-sectional analysis of patents was conducted. The starting point was all the patents associated with mAbs registered in the USPTO between 1975 and 2019. PATSTAT was the primary data source. Other complementary databases were the Antibody Society, the Purple Book, the FDA, and the Veteran Affairs website. The data analysis is divided into four sections: analysis of mAb patents, patent holders and producers, and innovation indicators.

RESULTS: The study sample included 63 mAbs. The number of molecules approved yearly by the FDA has increased since the market’s inception. These mAbs were associated with 1,732 unique patents. Most patents were related to drugs, being described as “New Use Related to Main Indication” (N=395), “Molecule Patents” (N=328), and “Dosing Regimen/Administration Conditions” (N=173). 214 indications were identified. About 36.5% of the mAbs had only one indication in the period. The average number of secondary indications was 3.775 (SD=3.293). The 63 mAbs in the analysis are associated with 89 active pharmaceutical ingredients and 34 producers. The pharmaceutical companies Roche (13 molecules), Johnson & Johnson (6), Eli Lilly (5), Amgen (4), and Novartis (4) stand out in the production of reference medicines. Amgen (5 molecules) and Pfizer (5) stand out in the production of biosimilars. Partnerships between individuals and companies for the development of new drugs were common. Other partnerships also happened but with lower frequency. Pharmaceutical companies participated in developing 79% of the patents.

CONCLUSIONS: Cancer and autoimmune diseases remain the most common indications for mAbs. Most mAbs have multiple uses, and their indication has become more diverse. The market of mAbs has been dominated by the same companies over the last decades.