In a seminal decision, the Colombian Attorney General\u2019s Office has confirmed an indictment against a local pharmaceutical manufacturer charging it with criminal patent infringement.\u00a0 This decision is the result of almost two years of criminal litigation involving the infringement of a patent claiming a particular crystalline form of a molecule used in the treatment of osteoporosis. The indictment opens the trial phase where the defendant will have the opportunity to request additional evidence and present closing arguments before a criminal judge.\u00a0 The judge will decide whether or not criminal infringement was proven and make a final decision concerning the disposition of the seized infringing product.<\/p>\n
The infringed patent claims a particular crystalline form (polymorph) of a molecule which employs a powder X-Ray diffraction (XRD) pattern to characterize the particular polymorph.\u00a0 The infringing product was a tablet that contained both the claimed polymorph as well as additional excipients including lactose, a crystalline product.\u00a0 When the tablet was initially examined, it presented a complex XRD pattern that combined the signatures of the polymorph and the lactose.\u00a0 This required tests in local laboratories and expert witness testimony, revealing that the signature corresponded to the claimed polymorph. Based on this evidence, the AG found that sufficient indicia of the crime existed and consequently ordered the raid, seized some pure bulk material and effectively confirmed that the active ingredient being used in the manufacture of the infringing product was indeed the claimed polymorph.<\/p>\n
The defendants have never questioned whether or not their product was an infringement.\u00a0 The main line of defense was lack of criminal intent, based on certifications issued by the Colombian Patent Office stating that the compound (not the polymorph) was not patented in Colombia.\u00a0 However, the AG considered that the certification alone was insufficient to create a good faith effort.\u00a0 The AG considered the pharmaceutical industry is a sophisticated one that required market players to carefully review the patent landscape.\u00a0 It specifically held that not obtaining a favorable opinion from competent patent counsel (a trademark lawyer was insufficient) was tantamount to reckless disregard.\u00a0 Additionally, the defendant was unable to explain why it never replied or took action in response to a cease & desist letter sent by the plaintiff.<\/p>\n
This case is of importance because it shows that patent protection in Colombia, even if it involves a polymorph, is effective. This is the first time in Colombia that the legal representative of a company is indicted for patent infringement.\u00a0 The case is also important because it establishes a minimum code of conduct for generic companies that wish to market a product.\u00a0 The onus is on the generic company to perform a thorough search and obtain a freedom-to-market opinion before launching; otherwise it risks criminal patent infringement.<\/p>\n
Author: Carlos R. Olarte<\/p>\n","protected":false},"excerpt":{"rendered":"
In a seminal decision, the Colombian Attorney General\u2019s Office has confirmed an indictment against a local pharmaceutical manufacturer charging it with criminal patent infringement.\u00a0 This decision is the result of almost two years of criminal litigation involving the infringement of a patent claiming a particular crystalline form of a molecule used in the treatment of […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[49,51],"tags":[],"class_list":["post-5447","post","type-post","status-publish","format-standard","hentry","category-publications","category-patents"],"yoast_head":"\n