GERMANY LAW AND PRACTICE Contributed by: Dr. Clemens Tobias Steins, Dr. Michael Pfeifer, Dr. Daniel Grohs and Dr. Bianca-Lucia Vos, Hoffmann Eitle
3.4 Publicly Available Drug and Patent Information There are no differences between biosimilars and generics in terms of publicly available drug and patent information (see 2.4 Publicly Avail- able Drug and Patent Information above). 3.5 Reimbursement and Pricing/Linkage Markets There are no differences between biosimilars and generics in terms of reimbursement and pricing/ linkage markets (see 2.5 Reimbursement and Pricing/Linkage Markets above). 4. Patent Term Extensions for Pharmaceutical Products 4.1 Supplementary Protection Certificates In Germany, supplementary protection certifi - cates (SPCs) are available for patents relating to active ingredients of medicinal products as well as plant protection products. The holder of a patent for a new medicinal product or plant protection product must refrain from placing it on the market until it has received the neces - sary authorisation. This reduces the period of effective protection of the patent. SPCs have been established to partly make up for this loss of exclusivity. German SPCs for medicinal products are gov - erned by Regulation (EC) No 469/2009, which has been translated into national law. Relevant provisions can be found in Section 16a and Sec - tion 49a GPA. Any active ingredient or combination of active ingredients protected by a patent and subject matter prior to being placed on the market as a
Marketed pharmaceuticals are included in the Lauer-Taxe, updated twice a month, with updates visible a few days before becoming effective. 2.5 Reimbursement and Pricing/Linkage Markets MAs and reimbursements are granted without consideration of the patent status (no patent linkage system). The private company IFA is entrusted with issuing tag numbers for phar - maceuticals (PZN) and compiles the data on commercialised pharmaceuticals (which is then published, eg, in the Lauer-Taxe) and is at least partly acting as a gatekeeper against generic launch (see Germany Trends and Developments for details). Public health insurers may, at least in theory, resort to indication-specific tendering as generic bidding on unlimited tenders may constitute an act of infringement if use patents still cover cer - tain indications. There are no differences between biosimilars and generics in terms of infringement (see 2.1 Infringing Acts above). 3.2 Data and Regulatory Exclusivity There are no differences between biosimilars and generics in terms of data and regulatory exclusivity (see 2.2 Regulatory Data and Market Exclusivity above). 3.3 Acceptable Pre-Launch Preparations The Bolar exemption under German law also covers biosimilars (see 2.3 Acceptable Pre- Launch Preparations above). 3. Biosimilar Market Entry 3.1 Infringing Acts
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