In our new oncology report, we analyzed paragraph IV certification and post-grant patent litigation trends impacting generic drug strategies on antineoplastic and immunomodulating therapies. Our analysis suggests notably that the jurisdictions chosen for infringement and validity challenge cases over the past 10 years are changing, and past favorites may no longer be the most strategic.
According to the 2021 Centre for Medicines Research (CMR) factbook, cancer and immunomodulating treatments represent the therapeutic areas with the greatest R&D spending. These areas account for 47.6% of all R&D expenditures in this field, totalling more than $38bn USD.
In our new report, Revealing insights on the oncology patent landscape to drive litigation strategy, we revealed the most strategic choices for litigating patents relating to antineoplastic (chemotherapy) and immunomodulating therapies in order to bring a generic drug to the market.
India and Germany are the two most patentee-friendly countries when it comes to infringement cases
Combining the two assessed criteria—infringement rate and duration of first instance infringement proceedings—suggests strongly that India and Germany are the two most patentee-friendly countries
While the United States accounts for the majority (69%) of infringement cases, the success rate is not as high as in some other jurisdictions. Even if a successful litigation in the United States would represent a “win” in a country of high market opportunity, infringement litigation may be more successful in Germany or India.
Preferred venues for efficiently invalidating oncology patents may be South Korea and Mainland China
Post-grant patent validity challenge cases are more evenly distributed across countries. However, the top three jurisdictions—European Patent Office (EPO), the United States and Mainland China—account for nearly half of all patent validity challenge cases on antineoplastic and immunomodulating therapies.
Combining the two assessed criteria—revocation rate and duration of first instance patent validity challenge proceedings—suggests strongly that South Korea and Mainland China are the preferred choices for quickly invalidating patents in this therapeutic area.
The most prolific US paragraph IV filers
Analyzing historical trends for the past 10 years reveals that the number of Indian paragraph IV filers continues to grow, while the number of filers in the United States has been stable since 2015. While Mainland China has only been involved in paragraph IV filings since 2015, this volume is increasing significantly.
Moreover, the fact that there are more than six paragraph IV filers by product shows that there is significant competition within the antineoplastic and immunomodulating agents category.
Learn more about oncology patent litigation strategy
In this blog, we revealed what should be the most strategic choices for litigating patents relating to antineoplastic (chemotherapy) and immunomodulating therapies to bring a generic drug to the market. We also discuss which companies are and will be the most prolific US paragraph IV filers.
Interested in learning more? Read about the antineoplastic and immunomodulating therapies patent landscape (and more) in our latest report. To leverage Clarivate litigation and generics intelligence data to shape your IP strategy, contact us here.