Language：English   Publishing type：Research paper (scientific journal)   Publisher：International Association of Online Engineering (IAOE)  

Digital health, such as mobile health apps, has garnered significant attention, leading to an increase in patent applications. This study investigates patent applications related to digital health using smartphones to elucidate the overall state of patenting in this domain and the characteristics of applicants based on nationality and industry type. We analyzed 11,139 patent families filed between 2015 and 2019, featuring the international patent classification (IPC) code G16H (healthcare informatics) and keywords related to smartphones. Our findings indicate that the United States (US) is the most significant market and leader in digital health technology. Correspondence analysis revealed that applications from the US and Europe share similar content, while those from Japan and China exhibit distinct characteristics. Additionally, industry-based correspondence analysis showed that patents from the machinery industry are often related to imaging technology, whereas those from the information technology (IT) sector are primarily associated with medical information-based applications.

DOI： 10.3991/ijoe.v21i02.52327

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Authorship：Lead author   Language：Japanese   Publishing type：Research paper (scientific journal)  

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Authorship：Last author   Publishing type：Research paper (scientific journal)   Publisher：Springer Science and Business Media LLC  

Abstract

Background

The development of orphan drugs (ODs) is challenging from both development and business perspectives because of their small patient populations. To overcome such business challenges, lifecycle management (LCM), which maximizes profits by increasing sales and extending product lifetimes, is important to overcome the business challenges arising from their small patient populations. To clarify the activities of the LCM of ODs, we investigated additional indications that contribute to market expansion and marketing exclusivity using the patent extension and re-examination system of ODs approved in Japan between 2004 and 2019.

Results

The 203 ODs consisting of 173 active ingredients were approved in Japan between 2004 and 2019. Sixty-eight (39%) of the 173 active ingredients have additional indications, of which 57 have at least one non-OD indication. Three-fourths of the 203 ODs had patent rights, and most of them included substance or use claims. Although the re-examination period for most ODs was 10 years after the approval, most patents had a longer duration than the re-examination period.

Conclusions

Pharmaceutical companies were actively adding non-OD indications and were emphasizing the use of patent rights by registering extensions of substance or use patents for exclusive marketing periods. These results indicate that LCM through the addition of indications and registration of patent extensions is carried out as a strategy for many ODs in Japan, similar to the LCM of general non-ODs.

DOI： 10.1186/s13023-022-02456-w

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Other Link： https://link.springer.com/article/10.1186/s13023-022-02456-w/fulltext.html