GERMANY LAW AND PRACTICE Contributed by: Dr. Clemens Tobias Steins, Dr. Michael Pfeifer, Dr. Daniel Grohs and Dr. Bianca-Lucia Vos, Hoffmann Eitle
ficient if there is a listing in another database, such as physicians’ software. • Announcement of market entry: A serious and unambiguous specific announcement of intended market entry is generally sufficient for an imminent threat of infringement. • Entering into a rebate agreement with a public health insurance company. However, the following acts do not constitute a patent infringement: • Grant of a market authorisation as well as tri- als and studies in preparation thereof (see 2.3 Acceptable Pre-Launch Preparations below). • Application for reimbursement. • With respect to second medical use pat - ents: Skinny labelling (cf Article 11 Directive 2001/83/EC) – unless the plaintiff can estab - lish that the defendant exploited an existing prescription practice in the protected use (cf HRC Dusseldorf, 2 U 27/18). 2.2 Regulatory Data and Market Exclusivity The originator is responsible for submitting data regarding the initial market entry. The data will be protected for a period of eight years from the date of submission of this application for MA. During this period, the generic company is not permitted to access these documents. Following the eight-year period, the origina - tor is granted a two-year exclusivity period in the market. This indicates that a generic com - pany is permitted to apply for an MA and may be granted such a status but must refrain from sales activity until the application is approved. The originator may request an extension of the market exclusivity period by one year if a new use is authorised within the first eight years and this new use provides additional value.
In total, the periods are described as “8+2+1”. An exception is made for orphan drugs. Orphan drugs are granted a period of ten years of market exclusivity, which can be extended by a further two years. 2.3 Acceptable Pre-Launch Preparations The experimental use exemption under Section 11(2) GPA exempts any acts directed at gain - ing insights into the invention, including proof of function. Following the clinical trial deci - sions (FCJ, X ZR 99/92 and X ZR 68/94), such exempted experimental use may ultimately also be motivated by commercial interests. In addition, the German legislator has opted for a broad implementation of the Bolar exemption in Section 11(2b) GPO, extending the exemption to all studies and tests and the resulting practical requirements undertaken to obtain a marketing authorisation, ie, not limited to generics and also applying to acts undertaken for obtaining non- EU, eg, FDA approval. It is the position of the German courts that third-party suppliers may also benefit from their customer’s exemption under the Bolar and experimental use exemp - tion under strict requirements. A reform of the underlying EU legislation, which may provide for full harmonisation among the EU member states, is under discussion. 2.4 Publicly Available Drug and Patent Information The Federal Institute for Drugs and Medi - cal Devices publishes a monthly updated anonymised list of pending applications for mar - keting authorisations; granted MAs are compiled and publicly accessible in the AMIce database. No notice or other information will be given to the MA holder.
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