Patent thicket strategy with terminal disclaimers helps block biologic competition, JAMA letter shows

Bi­o­log­ics de­vel­op­ers are pro­tect­ing their most lu­cra­tive as­sets with a par­tic­u­lar type of patent that they can quick­ly pile up and dri­ve cost­ly lit­i­ga­tion around, pre­vent­ing com­pet­i­tive biosim­i­lars from com­ing to the US quick­ly, ac­cord­ing to a new JA­MA re­search let­ter.

The re­search points to so-called “ter­mi­nal dis­claimer” patents. The patents ex­pire at the same time as the orig­i­nal patent and can be ap­plied late in a bi­o­log­ic’s ex­clu­siv­i­ty pe­ri­od, but al­low man­u­fac­tur­ers to quick­ly build a fortress of patents around triv­ial changes. That “can trig­ger lengthy and cost­ly lit­i­ga­tion and add un­cer­tain­ty for biosim­i­lar man­u­fac­tur­ers who must in­val­i­date or de­sign around all patents in a bi­o­log­ic’s port­fo­lio,” said the re­searchers from the West Vir­ginia Uni­ver­si­ty Col­lege of Law, Fre­se­nius Kabi USA, and Har­vard.

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