Although many life-saving pharmaceuticals on the market have already seen their patents expire, there are countless life-saving pharmaceuticals that still have patent protection, and many more are currently or will be seeking patent protection. Some of these pharmaceutical inventions still have patent protection despite the initial patents having been filed as far back as 1985. The top-ten bestselling brand-name pharmaceuticals have an average projected duration of 40.5-years of patent protection, double the twenty-year statutory term of a patent, through an average of seventy-four patents. This practice of obtaining extended patent protection is known as evergreening. But this is not the only practice that pharmaceutical companies employ to extend patent protection. Other practices include product hopping and pay-for-delay settlement agreements with generic pharmaceutical manufacturers, both of which prevent the dispensing of generic pharmaceuticals. Part I of this Note will provide background information regarding the requirements to obtain a patent, what rights are conferred by a patent, and the process by which generic pharmaceuticals obtain FDA approval. Part II of this Note will discuss the main practices that brand-name pharmaceutical companies employ in order to obtain extended patent protection. It will also highlight the top-ten bestselling brand-name pharmaceutical inventions, all of which have extended patent protection. Part III of this Note will discuss the effects that these practices have on the integrity of the patent system and a patient’s ability to access life-saving pharmaceuticals. Finally, Part IV of this Note will discuss potential solutions to curb these practices so as to ensure that the patent system is neither stifling innovation nor injuring the public health.
To read this Note, please click here: Pharmaceutical Patent Protection Beyond the Twenty-Year Statutory Term
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