Pharmaceutical evergreening is a strategy employed by drug companies to extend the lifespan of a patent beyond its original expiration date. Patents, typically granted for 20 years, are designed to protect genuine innovation by giving the creator exclusive rights to sell the product. However, many pharmaceutical companies exploit loopholes by making minor, often non-essential changes to their drugs, such as altering the formulation, dosage, or delivery system, to secure additional patents. These changes rarely result in significant improvements to the drug’s effectiveness or safety but are used to delay the entry of cheaper, generic versions into the market. This practice artificially prolongs monopolies on life-saving medications, driving up costs for consumers and preventing competition. By blocking competition through evergreening, companies ensure higher profits while the public bears the burden of inflated healthcare costs.
To protect market competition and consumer choice, the practice of pharmaceutical evergreening is hereby prohibited. No patent extension shall be granted for minor, non-essential modifications to existing drugs, including changes in formulation, dosage, or delivery methods, unless these alterations demonstrably enhance the therapeutic efficacy or safety of the product. The burden of proof lies with the patent holder to provide clear, independent evidence of significant clinical improvement. Patents are intended to reward true innovation, not to create indefinite monopolies. Upon patent expiration, generics shall be allowed immediate market entry to ensure affordable access to medication.