Available online 8 December 2023, 107051

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Patent filings suggest increasing intensity of antibacterial drug discovery in recent years, but the share of patents published by commercial companies has declined.

Section snippetsINTRODUCTION

Microbial resistance to antibacterial drugs is a major public health concern. A recent study estimates the global attributable mortality burden from resistance at 1.27 million (95% UI 0.911–1.71) deaths in 2019 alone [1]. Routine medical treatment using antibacterial drugs inevitably contributes to the evolution of resistant bacterial strains, necessitating a continuous pipeline of new products in development. However, as of March 2021, the pipeline of new antibacterial drugs is reportedly

MATERIALS AND METHODS

We used Espacenet's searchable patent platform to assemble our analytical database. Espacenet is an online database developed by the European Patent Office (EPO) together with the member states of the European Patent Organisation that allows users to search for published patents and patent applications worldwide. Espacenet's database contains patent information on over 130 million patent documents from 1782 to present. Each patent and patent application in the database is assigned at least one

RESULTS

The total number of antibacterial drug target compound patents (CPC = A61P31/04) published over the 1990-2021 period is 118,795 with an average of 3,712 patent publications per year. Over the same period, the total number of non-antibacterial drug target compound patents (CPC = A61P, excluding CPC = A61P31/04) published is 1,033,781 with an average of 32,306 patent publications per year. Over our period of analysis, the antibacterial drug target compound patent publication trend broadly mirrors

DISCUSSION

Our analysis shows that the level of activity in antibacterial drug discovery has remained high. In fact, the rate of new antibacterial drug target compound patent publications has increased an average of around 11% per year from 2017 through 2021. While commercial companies still publish a sizeable portion of antibacterial drug target compound patents, this share has been declining steadily since 1990 and that decline has accelerated in the last 5 years. Indeed, over the last 30 years, 15 out

CONCLUSIONS

Our study shows that despite the noted late-stage (i.e., from Phase 2b studies designed to determine optimal dosing for intended biological activity through commercialization) challenges for antibacterial drug development, research intensity has increased in recent years. Further, the rate of antibacterial drug discovery is comparable to the trend for all drugs in general over our study period. Until a more comprehensive evaluation of antibacterial drug compound patent quality is performed, it

Funding

Financial support for this study was provided entirely by a contract with the U.S. Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation (ASPE). Funding for that contract was provided to ASPE by the U.S. Food and Drug Administration under Interagency Agreements 224-18-3013S and 75F40119S30008. HHS ASPE Contract No. HHSP233201500055I Task Order No. HHSP23337006T

Ethical Approval

Not required

Sequence Information

Not applicable

Data and materials availability

Data used in the analysis can be obtained from the corresponding author.

References

[1] A. R. Collaborators, "Global Burden of Bacterial Antimicrobial Resistance in 2019: A Systematic Analysis," The Lancet, vol. 399, no. 10325, pp. 629-655. doi.org/10.1016/S0140-6736(21)02724-0, 2022.

[2] D. Hyun, "Tracking the Global Pipeline of Antibiotics in Development, March 2021," 9 March 2021. [Online]. Available: https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2021/03/tracking-the-global-pipeline-of-antibiotics-in-development. [Accessed 20 December 2022].

[3] J. Powers,

CRediT authorship contribution statement

Aylin Sertkaya: Writing – original draft, Supervision, Project administration, Visualization, Conceptualization, Investigation, Methodology, Investigation. J. Daniel McGeeney: Methodology, Investigation, Writing – original draft. Casey Sullivan: Writing – review & editing, Supervision, Conceptualization, Funding acquisition, Methodology, Project administration. Allison Kolbe: Supervision, Writing – review & editing. Trinidad Beleche: Investigation, Supervision. Stephen Murphy: Methodology,

Declaration of Competing Interest

The following authors are employed by the study sponsor: Casey Sullivan, PhD, Allison Kolbe, PhD, Trinidad Beleche, PhD., and Stephen Murphy, PhD. Authors declare that they have no

Acknowledgments

The authors gratefully acknowledge members of the Project Advisory Group at the U.S. Department of Health and Human Services (HHS): John Farley, Thushi Amini, James Byrne, Michael L. Lanthier, Michael R. Craig, Sameer S. Kadri-Rodriguez, John A. Jernigan, Jeffrey Strich, Christopher Houchens, Mark Albrecht, Sue Cammarata, Alan (Laurence) Carr, Jessica Swenson, Ramya Gopinath, Elizabeth O'Shaughnessy, Dmitri Iarikov, Gilbert “Lynn” Marks (formerly at HHS), Tyler Merkeley (formerly at HHS), Erin

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