Overcoming Patent Barriers in IBD Therapeutics: A Path to Affordable Access
Background:
Patents are a root cause of the unaffordability of therapeutics within the United States. The excessive patenting of many therapeutics indicated for inflammatory bowel diseases (IBD) is a driver of increased healthcare costs and widespread unaffordability for patients. The lack of timely biosimilar and generic availability are significant health policy concerns under the Biden Administration, and there is a need for greater physician and patient awareness of the over-patenting of IBD therapeutics. We aimed to evaluate the types of patents granted using two case examples of biologic medications indicated for IBD and broader opportunities for advocacy in patent reform.
Methods:
A literature review on Humira (brand name for adalimumab) and Stelara (brand name for ustekinumab) was conducted using databases including the Initiative for Medicines, Access, and Knowledge, Google patents, and the Orange and Purple books. The patents were quantified and categorized as being filed before or after approval from the Food and Drug Administration (FDA). The five codes of patent categories used were method of treatment, method of production/process, device, product, and formulation/combination. The coding helped determine the types of patents most issued for the two case examples of biologics.
Results:
Of the 10-top selling drugs in the United States in 2021, Humira was the first on the list and Stelara was ranked sixth. About 311 patent applications have been filed on Humira and 287 of the total patent applications were filed after FDA approval. Humira has approximately 134 active patents. Approximately 76 patents have been filed on Stelara and 57 of total patent applications were filed after FDA approval. Stelara has approximately 16 active patents. Of the four codes used, both Humira and Stelara had the most patent applications for their method of treatment. This data highlights the need for enhancing the novel FDA and United States Patent and Trademark Office (USPTO) collaboration for greater sharing of information about a patent applicant. Further, patent examiners need access to a wider array of information when conducting prior art searches, including updated information from the Orange and Purple Books, FDA decisions, and scientific information.
Conclusions:
There is excessive patenting beyond the primary patent issued. For both Humira and Stelara, the majority of patents were filed after FDA approval. Solutions include patent reform through regulatory agencies, Congress, and the White House. Continued efforts should be made for increased collaboration between the USPTO and the FDA. Further, sponsors should be better held accountable to show robust evidence, diversity in clinical trials, and adequate documentation of safety data earlier on before being issued secondary patents. More patient experiences should be represented within patent reform and there should be greater physician advocacy to create a more meaningful and equitable patent system.
