Inventions for dosage regimens often arise after the pharmaceutical product has been dosed in patients and more information is known about the in vivo and pharmacokinetic properties of the medical agent. However, securing patent protection for this type of invention has been difficult because dosage inventions are considered to be simple medical methods whose protection is believed to limit doctors’ choices in clinical practice. Moreover, novel dosage inventions are also considered to involve a process that does not enjoy the same scope of patent protection as new chemical entities despite their superior therapeutic potential. This article examines the nature of dosage inventions under an increasingly personalized clinical setting and argues that traditional patent jurisprudence might not apply to such inventions in personalized medicine. Therefore, more liberal approaches are needed to foster inventions in this field of technology.
*Jerry I-H Hsiao, PhD & Wei-Lin Wang, JSD