Criminal Patent Infringement
July 26 2005

In a seminal decision, the Colombian Attorney General’s Office has confirmed an indictment against a local pharmaceutical manufacturer charging it with criminal patent infringement.  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.  The judge will decide whether or not criminal infringement was proven and make a final decision concerning the disposition of the seized infringing product.

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.  The infringing product was a tablet that contained both the claimed polymorph as well as additional excipients including lactose, a crystalline product.  When the tablet was initially examined, it presented a complex XRD pattern that combined the signatures of the polymorph and the lactose.  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.

The defendants have never questioned whether or not their product was an infringement.  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.  However, the AG considered that the certification alone was insufficient to create a good faith effort.  The AG considered the pharmaceutical industry is a sophisticated one that required market players to carefully review the patent landscape.  It specifically held that not obtaining a favorable opinion from competent patent counsel (a trademark lawyer was insufficient) was tantamount to reckless disregard.  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.

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.  The case is also important because it establishes a minimum code of conduct for generic companies that wish to market a product.  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.

Author: Carlos R. Olarte

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