GERMANY Law and Practice Contributed by: Clemens Tobias Steins, Michael Pfeifer, Daniel Grohs and Bianca-Lucia Vos, HOFFMANN EITLE
1.18 Court Arbiter The plaintiff may commence infringement proceedings or provisional injunction proceedings regarding a pat ‑ ent at any of the twelve regional courts with special ‑ ised patent panels, at least as long as infringing acts are conducted or imminent in the court’s territory. In practice, this gives the plaintiff freedom to forum-shop between these courts. As plaintiffs usually choose an experienced court, the Regional Courts Düsseldorf and Munich handle almost all infringement actions in the field of life sciences. Under German law, different acts related to a generic market entry can constitute patent infringement, as outlined below. • Offering or advertising at trade fairs despite patent protection. • Listing in the Lauer-Taxe: This database contains all available drugs and other medicinal devices in Germany. It is also sufficient 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 acts outlined below do not constitute a patent infringement. • Grant of a market authorisation as well as trials and studies in preparation thereof (see 2.3 Acceptable Pre-Launch Preparations ). • Application for reimbursement. • With respect to second medical use patents: Skinny labelling (Article 11 Directive 2001/83/EC) – unless the plaintiff can establish that the defendant exploited an existing prescription practice in the protected use (HRC Düsseldorf, 2 U 27/18). 2. Generic Market Entry 2.1 Infringing Acts
2.2 Regulatory Data and Market Exclusivity The originator is responsible for submitting data regarding the initial market entry. The data will be pro ‑ tected for a period of eight years from the date of sub ‑ mission of this application for MA. During this period, the generic company is not permitted to access these documents. After the eight-year period, the originator is granted a two-year market exclusivity. This indicates that a generic company 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 author ‑ ised within the first eight years and this new use pro ‑ vides significant clinical benefit. 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 exclusiv ‑ ity, which can be further extended by two additional years. 2.3 Acceptable Pre-Launch Preparations The experimental use exemption under Section 11 (2) GPA exempts any acts directed at gaining insights into the invention, including proof of function. Following the clinical trial decisions (FCJ, X ZR 99/92 and X ZR 68/94), such exempted experimental use may addi ‑ tionally be motivated by commercial interests. The German legislator has also 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 under ‑ taken to obtain a marketing authorisation. The exemp ‑ tion is not limited to generics and also applies to acts undertaken for obtaining non-EU, eg, FDA approval. The position of the German courts is that third-par ‑ ty suppliers may also benefit from their customer’s exemption under the Bolar and experimental use exemptions, subject to strict requirements. A reform of the underlying EU legislation, which may lead to full harmonisation among EU member states, is under discussion.
68 CHAMBERS.COM
Powered by FlippingBook