Hong Kong High Court, Decision of 8 January 2010, Abbott GmbH & Co KG v. Pharmareg Consulting Co Ltd
In the case Abbott GmbH & Co KG v Pharmareg Consulting Company Limited, the Hong Kong High Court had to decide whether or not to grant a pre-trial injunction which extended beyond the life of the patent, against a number of generics companies which had obtained pharmaceutical product registrations (marketing authorizations) to supply generic pharmaceuticals while Abbott's patent was still in force.
In many countries, there is an exception to patent infringement which permits activities for the purposes of obtaining regulatory approval necessary to market pharmaceuticals. Manufacturers and distributors of generic drugs rely on this exception to conduct clinical trials or to submit samples of their products during the life of another party's patent, in order to obtain marketing approvals so they are ready to launch the generic drug as soon as the patent expires. However, in Hong Kong there is no "regulatory approval" exception to patent infringement.
Abbott is the owner of a Hong Kong Standard Patent covering the compound commonly known as "Sibutramine" used for the treatment of obesity. Abbott alleged that the defendants infringed Abbott's patent by importing and putting on the market OBIRAX, which contains Sibutramine. In April 2009 Abbott obtained a pre-trial injunction which was to be in force until 21 November 2009 when Abbott's patent expired. Abbott also has applied for summary judgment, but this application is unlikely to be decided by the court until later in 2010.
Shortly before Abbott's patent expired it asked the court to extend the pre-trial injunction for an additional nine months, being the period taken by the Hong Kong Department of Health after the defendant filed the applications to grant pharmaceutical product registrations for OBIRAX.
In Hong Kong, an applicant for a pharmaceutical product registration must include a sample of its product as part of its application. Abbott argued that importing and using a patented drug for the purpose of submitting samples of OBIRAX constituted an act of patent infringement. Although the court can grant an injunction to stop sales of an infringing product in Hong Kong, it has no power to order that the defendant's product registrations be withdrawn. In light of this, Abbott argued that the court should continue the injunction beyond the date of expiration of the patent in order to prevent the defendants from unfairly benefiting from any advantage obtained from their acts of infringement committed during the term of the patent. Such injunctions, which are aimed at preventing accelerated re-entry into the market of infringing products covered by existing product registrations after the patent expires, are sometimes called "springboard injunctions".
The court's decision
Abbott had argued that it was just and reasonable for the pre-trial injunction to be extended for a period up to nine months after the patent had expired. The court agreed stating that the fact that the pre-trial injunction being sought related to the period up to nine months after the expiry of the Hong Kong Patent should not make the slightest difference to the usual criteria that had to be applied in deciding whether a pre-trial injunction should or should not be granted.
The court considered that if the pre-trial injunction was not extended, this was likely to cause irreparable harm to Abbott. On the other hand, any damage which may be caused to the defendants if it turned out later that the injunction was wrongly granted would be clearly quantifiable and capable of assessment. Furthermore, Abbott was in a position to pay any damages which may be assessed to the defendants for those additional nine months, should that be the case.
Distributors of generic drugs in Hong Kong often apply for pharmaceutical registrations before the innovator company's patent expires. Because of the requirement to submit a sample with the application, and in the absence of any regulatory approval defense, this will involve an act of patent infringement.
If a patentee becomes aware that a generics company has obtained a product registration for an infringing product, it is usually best if the patentee takes immediate action. Sending warning letters is inadvisable because of the "unjustified threats" provision under Hong Kong patent law. Starting proceedings is generally the best approach and often cases will settle quickly on favorable terms for the patentee. Whether the case settles or continues to trial, a patentee should ask that a generics company which has obtained a product registration during the term of the patent be prevented from selling the generic product for an additional period (usually about six to nine months) after the patent has expired, so that it can maximize its period of exclusivity in the Hong Kong market.