In pharmacology, “me-too” medicinal product is identical to a branded or generic version of a product in terms of its mode of action, mechanism of action or clinical pathway. Me-too products are usually under the same molecular class with other previously approved drugs. For instance, statin- a HMG-CoA reductase inhibitor products are good examples of me-too products. Statin product lowers cholesterol level by inhibiting HMG-CoA reductase. Some of the statin class products includes Lovastatin-Mevacor, Atorvastatin-Lipitor, Fluvastatin-Lescol, Pitavastatin-Livalo, Pravastatin-Pravachol, Rosuvastatin-Crestor, Simvastatin-Zocor etc. Lovastatin molecules were isolated from Aspergillus terreus (fungus) and became the first approved statin product in the market. The rest are me-too products. Me-too drugs are essential for cost control and affordability of a product. In orders words, me-too may not trigger the reduction in the price of a branded product, but the cost of a me-too product is between 15-20% cheaper than a “superior” brand product (Ashbrook, & Whitmore, 2013). If the reduction in price and affordability of a me-too drug is the only incentive therein in the art of science, then the art of innovation may not be currently optimized. For instance, developing several me-too drugs that may pose similar adverse events with no added effectiveness, optimizations and reductions of adverse events may not represent a creative art in science. If this is the case in many me-too products, one may argue that there are no scientific, public-health or safety benefits associated with me-too development practices. However, the main issue that is needed to be addressed in conjunction with product improvement strategy is the patent Act modification. The idea to modify the patent Act should address the “utility” clause in association with added improvements that a me-too or any other similar product should have or lack thereof in the area of adverse event and well-being of patients. Currently in the US and most part of the world, research on patented products are limited to “amusement” and “curiosity” purposes. It simply means that any research conducted for marketing purposes other than amusement or curiosity constitutes an infringement of the product’s patent. Research exploration takes 12-15 years to bring a new product in the market. While patent exclusivity for medicinal products last for 20 years under normal circumstances. Therefore, 20 years for an/a “amusement” or “curiosity” research may delay any potential improvement of a patented product. Introduction of new medicinal products in the market will be efficient and expedient if the patent Act accommodates research (freedom to operate) for commercial intent in concurrent with the patent life span. Although, to allow the pioneer company to recoup costs and gain benefits within the 20 years of the patent term, no issuance of market approval may be allowed to any competitor until the current patent runs out, unless under some specified provisions or circumstances. This concept may also incentivize the “pioneer” company to continue product optimization in the area in question. More importantly, no medicinal product is foolproof or guaranteed to be safe. However, product’s safety is optimized through extensive quality design and optimal modifications when quality is designed into a product (Whitmore, 2004).

Reference

Ashbrook, C & Whitmore, E.(2013). Intellectual property and patent. Retrieved from https://class.waldenu.edu/webapps/portal/frameset.jsp?tab_tab_group_id=_2_1&url= %2Fwebapps%2Fblackboard%2Fexecute%2Flauncher%3Ftype%3DCourse%26id %3D_2099284_1%26url%3D.
Schacht, W., & Thomas, J. (2005). Patent Law and Its Application to the pharmaceutical industry….patent term and restoration act of 1984. The Hatch-Waxman Act. Retrieved from http://www.law.umaryland.edu/marshall/crsreports/cr sdocuments/rl3075601102005.pdf.
Whitmore, E. (2004). Development of FDA-regulated medical products: Prescription drugs, biologics, and medical devices. Milwaukee, WI: ASQ Quality Press.