Federico A Aulmann October 18 2010 Landmark decision issued on pharmaceutical patent enforcement Obligado & Cia | Intellectual Property - Argentina Federico A Aulmann Intellectual Property IntroductionLaw 25,859Procedural requirements for patent temporary injunctions Preliminary injunctions requested after 2004 amendmentIntroductionIn Argentina, patents and utility models are governed by the Patent Law (24,481), as amended by Law 24,572 and Law 25,859, and by Regulatory Decree 260/96.One positive aspect of the Argentine patent regime lies in the fact that the Constitution explicitly sets forth in Section 17 that innovators are entitled to obtain property rights over their inventions.Following the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), several changes were introduced to adapt Argentine legislation to the agreement's minimum standards (eg, the extension of the patent protection term and the availability of patent rights to all fields of technology).Article 50 of TRIPs (decisive for the enforcement of IP rights ruled by the agreement) states that judicial authorities shall have the power to order prompt and effective provisional measures to prevent the infringement of any IP right.Until 2003, Argentine courts had understood that the remedies available to patent owners under Article 50 of TRIPs were already fully enforceable, and that consequently it was possible to use such remedies to prevent an alleged infringement during the prosecution of a substantive infringement action.Law 25,859In 2004 an amendment was introduced to the Patent Law through Law 25,859 following an agreement between the Argentine and US governments, within a World Trade Organisation consultation, basically in connection with the procedural requirements for obtaining temporary injunctions. The amendment imposed new requirements on patent owners wishing to obtain preliminary injunctions.Compliance with the special requirements introduced by the Law 25,859 may take a long time, thus making it increasingly more complex for patentees to obtain temporary injunctions.Procedural requirements for patent temporary injunctions In order to obtain a preliminary injunction against an infringement, the patentee must submit evidence of: a reasonable likelihood of the patent's validity; irreparable harm in case of delay in obtaining a remedy for the infringement; and a reasonable likelihood of infringement. The amendment also states that in order to grant the injunction, the court must weigh the harm caused to the patent holder against the potential harm that could be caused to the alleged infringer if the measure were wrongly granted. This requirement could easily derive in generic allegations disguised as defences that would serve only to weaken what TRIPs set out to achieve in the first place: the provision of effective tools for the protection of its established minimum rights.In addition, the amended procedure for obtaining temporary injunctions requires that a report be prepared by a court-appointed expert on the likelihood of the patent's validity and infringement.The procedure should be bilateral, giving the infringing party the possibility to try to delay or stall the proceedings. The preliminary injunction will be granted inaudita altera parte (without hearing the alleged infringer's defences before granting the measure) only in exceptional cases (eg, when there is a significant risk of evidence being destroyed). If the temporary injunction is granted, a bond should be posted.Preliminary injunctions requested after the 2004 amendmentFew patent infringement cases are filed each year in Argentina. This is not because competitors are morally compelled not to copy inventions, but rather due to the huge backlog of applications before the Patent and Trademark Office and the time that it takes for pharmaceutical-related patent applications to be granted.Bristol-Myers Squibb Co v Laboratorios Richmond SAWithin the framework of the amended law, in Re Bristol-Myers Squibb Co v Laboratorios Richmond SA for temporary injunctions filed in February 2007, the first instance judge decided that the remedies provided in Article 50 of TRIPs were still fully enforceable and ordered a temporary injunction against the defendant.When the temporary injunction was appealed, the Federal Civil and Commercial Court of Appeals for the First Circuit revoked the temporary injunction. The court's argument for revocation was that the procedure for issuing the temporary injunction should have been that established in the amended Patent Law (2004), and not the direct application of the TRIPs remedies, as had been allowed in the past.Novartis AG v Laboratorios Richmond SAAfter the above-mentioned case was resolved by the court of appeals, a temporary injunction was requested for an alleged infringement of Novartis's patent for its product Glivec (imatinib).In Re Novartis AG v Laboratorios Richmond SA for temporary injunctions the first instance judge ordered that a court-appointed expert prepare a report as established in the new procedural regulation. After the expert report had been submitted to the court, the plaintiff requested the issuance of the temporary injunction against the defendant, but without previously serving notice to the defendant of the temporary injunction request and the expert's report.Laboratorios Richmond SA appealed the temporary injunction and in July 2009 the court of appeals revoked the temporary injunction because it did not comply with the amended procedure for temporary injunctions. Sanofi-Aventis v Sandoz SAIn September 2009 Sanofi-Aventis filed a temporary injunction request against Sandoz SA before the Argentine courts. The case was prosecuted following the amended procedure for temporary injunctions under the Patent Law. The first instance judge appointed an expert who prepared a report on the likelihood of validity and infringement. The defendant was served notice of the temporary injunction request and the court-appointed expert report. The judge then issued the resolution.In Re Sanofi-Aventis v Sandoz SA for temporary injunctions the first instance judge ordered a temporary injunction against Sandoz for alleged patent infringement of the process patent for the manufacture of irbesatan. The court ordered Sandoz to cease the manufacture, import, export, distribution, promotion and sale of any product that contained irbesatan obtained through the patented process, and to recall from the market all products that were manufactured with the active principle covered by Sanofi-Aventis's patent. Sandoz appealed the injunction.The appeal was heard by the Federal Civil and Commercial Court of Appeals for the Second Circuit, which recently issued a resolution that maintained and confirmed the temporary injunction ordered against Sandoz.The temporary injunction will remain in force until a final resolution on the merits of the patent infringement case has been issued.By means of its decision, the court of appeals has restored confidence to patent owners with regard to patent enforceability in Argentina. Consequently, the decision constitutes a landmark for IP enforcement in Argentina in general, and for pharmaceutical patent enforcement in particular.For further information on this topic please contact Federico Augusto Aulmann at Obligado & Cia by telephone (+54 11 4114 1100), fax (+54 11 4311 5675) or email ([email protected]).