Strain Scout: A novel device for the discovery and validation of novel mechano-pharmacological targets of disease; Beyond the 20-Year Mark: Strategic Patent Extensions in Pharmaceuticals

My technical project is the development and application of a novel device that can interact with cell culture or tissue to further validate biophysical signals for models of disease, such as cancer or fibrosis. This device, called StrainScout, aims to develop a method of discovery of novel mechano pharmacological targets, which are molecules that respond to mechanical cues and can be modulated by drug. My main research question is whether I can create a 3D-printed device that can further validate biomechanical signaling to improve pharmaceutical discovery in the future. Moreover, how can StrainScout address the missing information in the drug development fields? The intention of Strain Scout is to create different testing conditions more rapidly and efficiently from unanswered questions and make the undertaking of these tests more automated. These two aims will construct a process that does not require much training or niche knowledge in the lab, demonstrated by testing Strain Scout in a lab environment under many conditions. Drug discovery and screening is a tedious process that all big pharma companies invest time and money into. A platform such as StrainScout will not only create an automated and replicable drug screening platform, but also allow for the discovery of potential targets for therapeutics. Mechano-pharmacology and biophysics can help find new ways to target the physical properties of biological systems and how drugs can change them. Researchers have utilized a biomimetic technique in an attempt to discover new proteins expressed in biophysical pathways in order to develop drugs. Biomimetic engineering is the design of materials or systems that imitate natural physiological states. This is very exciting for drug companies because it can open up new possibilities for finding new drugs, testing for toxicity, and creating new models for diseases. Also, the drug industry is always looking for ways to make their drug discovery and development processes faster, more accurate, and at a lower cost. The novel insights from mechano-pharmacology and biophysics could potentially lead to more effective drugs, more efficient ways to deliver drugs to the body, and therefore better downstream outcomes for patients. In my STS paper, I delve into the significant impact of patenting strategies employed by pharmaceutical companies on the cost and availability of drugs. My investigation is rooted in the controversies that arise from the immense profitability of the pharmaceutical industry and the societal repercussions of patent monopolies. I specifically scrutinize the strategic practices of patent extensions and evergreening, which are leveraged by these companies to extend their market exclusivity and uphold elevated drug prices. My patent analysis of the top ten selling drugs revealed a strategic pattern where most patents were filed after FDA approval, leading to a two-fold increase in the number of patents held. This strategy extends the Median Market Exclusivity Duration (MMED) beyond the standard 20-year term, with an average MMED calculated at 14.55 years, indicating an average patent extension of 4.55 years. The analysis also showed a diverse use of patent types, predominantly for new methods of treatment, which suggests a sophisticated approach by pharmaceutical companies to sustain market dominance and high drug prices. The case study of Xeljanz® highlighted the financial impact on consumers, where extended patent protection could lead to significant additional costs due to delayed generic competition. The findings underscore the need for policy reforms to balance innovation incentives with affordable healthcare access. Through a detailed case study of Xeljanz®, I aim to quantify the average duration of patent protection extensions and assess the economic burden they impose on consumers. Additionally, my paper casts a global lens on patent practices, contrasting the influence of patent extensions on medication prices and accessibility in various nations. According to a simple model I made, Xeljanz is expected to have 4.55 additional years of patent extensions. The drug will cost $27,755 during that period in comparison to between $2,776 and $22,204 if it were generic. On average, according to government documentation, the generic drug is supposed to cost 20 to 90 percent less than the patented drug. This means given the worst case scenario the patient will save $5,551. The research methods employed in my STS paper involve a scientific literature-based approach to examine the impact of patent extensions on pharmaceutical pricing and accessibility. The methodology includes patent analysis and comparative policy analysis, supplemented by database extractions to identify patterns across top-selling drugs. Multiple data sources such as patent databases (Google patents, FDA, I-MAK, USPTO, EPO), academic literature, and government records are utilized to gather and analyze information on market exclusivity duration and its implications on drug costs and availability. This review provides insights into the patenting behaviors of pharmaceutical companies and their downstream effects on the healthcare system.

School of Engineering and Applied Science

Bachelor of Science in Biomedical Engineering

Technical Advisor: Tom Barker

STS Advisor: Joshua Earle

Technical Team Members: Madeline Kibler, Joshua Schwartz