MedicineLakex

Skwschwarz.de

Magnus Hirsch, Markus von Fuchs and Margret Knitter
SKW Schwarz Rechtsanwälte Trademarks
A Global Guide

SKW Schwarz:
independent and business-minded
The Law Firm
Areas of Work
SKW Schwarz is an independent German law firm. Banking and Finance We advise companies of all sizes ranging from owner- Commercial and Distribution managed firms to listed corporations as well as private Corporate / M & A clients in all major areas of national and international commercial law. With offices in Berlin, Dusseldorf, Frankfurt/Main, Hamburg and Munich, we are present Insolvency / Restructuring at major German business centers.
IP / Competition Law With more than 100 lawyers, we regard ourselves as a mediumsized firm, which can yet take on international IT & Digital Business assignments that are usually the domain of large Litigation / Arbitration / Mediation law firms. Our cooperation procedures across office Media and Entertainment locations enable us to set up teams for more complex transactions which are comparable to those ofconsiderably larger competitors. Furthermore, our membership in international law firm associations and our cooperation with selected partner firms ensure that we can offer our clients excellent support around the world at any time.
SKW Schwarz is a firm which combines tradition and cutting edge service standards. Some of our offices have existed for several decades. Many of our client relationships have been in place for years – a clear example of the importance we attach to stability.
www.skwschwarz.de
Berlin Düsseldorf Frankfurt / Main Hamburg München
SKW Schwarz:
independent and business-minded SKW Schwarz Rechtsanwälte The Law Firm
Areas of Work
SKW Schwarz is an independent German law firm. Banking and Finance We advise companies of all sizes ranging from owner- Commercial and Distribution managed firms to listed corporations as well as private Corporate / M & A clients in all major areas of national and international commercial law. With offices in Berlin, Dusseldorf, Frankfurt/Main, Hamburg and Munich, we are present Insolvency / Restructuring at major German business centers.
IP / Competition Law With more than 100 lawyers, we regard ourselves as Magnus Hirsch, Markus von Fuchs and Margret Knitter
a mediumsized firm, which can yet take on international IT & Digital Business assignments that are usually the domain of large Litigation / Arbitration / Mediation Selection, clearance and registration
influence how a pharmaceutical product By law, a company can market a pharmaceutical or active substance is evaluated in order to law firms. Our cooperation procedures across office Media and Entertainment product only once it has received marketing mislead consumers regarding its quality locations enable us to set up teams for more complex authorisation. Marketing authorisation (Section 8 of the Medicinal Products Act).
transactions which are comparable to those of can be obtained through either a national application made in Germany or a centralised The Community codes for considerably larger competitors. Furthermore, our application for all EU member states and the pharmaceuticals for human use are set out membership in international law firm associations and European Economic Area countries (ie, Iceland, in the EU Medicinal Products Directive our cooperation with selected partner firms ensure that Liechtenstein and Norway).
(2001/83/EC), which has been transposed The competent authorities in Germany are into the Medicinal Products Act. They we can offer our clients excellent support around the the Federal Institute for Drugs and Medical provide the legal framework for the world at any time.
Devices (BfArM) and the Paul Ehrlich Institute authorisation, manufacture and distribution (PEI). The authorisation process is outlined of pharmaceuticals in the European Union. in the Medicinal Products Act. Medicinal The name of the pharmaceutical may be SKW Schwarz is a firm which combines tradition and products or active substances with misleading an invented name which is unlikely to be cutting edge service standards. Some of our offices names, descriptions or appearances cannot confused with a common name, a common or be manufactured or placed on the market. In scientific name accompanied by a trademark have existed for several decades. Many of our client particular, the following are considered to be or the name of the marketing authorisation relationships have been in place for years – a clear holder (Article 1(20) of the directive). The example of the importance we attach to stability.
• disingenuous claims regarding the directive defines a ‘common name' as therapeutic efficacy or effects of certain the international non-proprietary name pharmaceuticals or active substances; (INN) recommended by the World Health • the false impression that a successful Organisation or, if one does not exist, the outcome is certain or that no harmful usual common name.
effects will occur when the pharmaceutical Marketing authorisations for product is used for its intended purpose or pharmaceutical products are limited to for a prolonged period; and five years, but can be extended by filing • names, descriptions or appearances that an application to BfArM or PEI. Further, Berlin Düsseldorf Frankfurt / Main Hamburg München www.WorldTrademarkReview.com
Pharmaceutical Trademarks 2015/2016   55 GERMANY SKW SCHWARZ RECHTSANWÄLTE SKW SCHWARZ RECHTSANWÄLTE GERMANY marketing authorisation can be obtained The German Patent Court rejected the from the European Medicines Agency likelihood of confusion between the marks (EMA). Under a centralised procedure, PANTOPREM and PANTOPAN (MEDA Pharma pharmaceutical companies submit a single GmbH & Co KG v Takeda GmbH, 25 W (pat) marketing authorisation application to 72/12). The court acknowledged that the the EMA. Once granted by the European opening syllables of the opposing mark (‘panto') Commission, a centralised marketing referred to the active ingredient pantoprazol authorisation has EU-wide effect. The – a proton pump inhibitor used particularly centralised authorisation procedure is based in gastrointestinal preparations – and that the on EU Regulation 726/2004.
relevant public would recognise this. Therefore, it had to be presumed that attention would have Confusion with INNs
focused on the additional word components or Trademarks in the pharmaceutical sector are endings rather than the beginning of the marks. commonly created from descriptive terms, However, the differences between the compared especially from INNs. One advantage of such marks would not have gone unnoticed in the trademarks is the link they create for patients overall aural and typographical impressions.
between the pharmaceutical product and its application. However, INNs are excluded Parallel imports and repackaging
from trademark protection because they are While parallel imports from outside the merely descriptive and thus are indistinctive. European Union clearly violate trademark However, under German law small changes law and can easily be prevented by civil and to the INN can make it a registrable sign – customs actions, especially as the burden of for example, ROXIMYCIN was accepted as a proof generally rests with the infringer, parallel trademark, while the INN was Roxythromycin. imports within the European Union can also Further, such trademarks have a limited scope be prevented under certain circumstances. of protection under German law. According In line with trademark law, it is essential that to settled case law, the greater the distinctive brand recognition, origin and the guarantee of character of the prior trademark, the greater the trademark are maintained. However, it is the likelihood of confusion. This means that equally important to guarantee repackaging for trademarks inspired by descriptive elements the importer. Otherwise, general enforcement have a limited scope of protection. by the rights holder would lead to market foreclosure. Thus, the European Court of Justice and the German Federal Court of Justice have established the following requirements, which must be fulfilled simultaneously: • The reliance on trademark rights by the According to settled rights holder contributes to the artificial partitioning of markets between member case law, the greater the • Repackaging does not affect the original distinctive character of condition of the product inside the the prior trademark, the • The new packaging clearly states who greater the likelihood of repackaged the product and the name of the manufacturer.
confusion. This means • The presentation of the repackaged that trademarks inspired product is not liable to damage the reputation of the trademark or the rights by descriptive elements • The importer notifies the rights holder have a limited scope of before the repackaged product is put on sale and supplies it with a sample on demand.
56   Pharmaceutical Trademarks 2015/2016 www.WorldTrademarkReview.com
SKW SCHWARZ RECHTSANWÄLTE GERMANY Pharmacists are required to dispense generic pharmaceuticals in cases where the panel physician has prescribed a pharmaceutical product using its active substance name only or has not ruled out replacing the pharmaceutical product with an alternative The Federal Court of Justice recently dealt the relevant market. As the distribution of with the first of these requirements (Micardis, 30-tablet packets imported from France was I ZR 99/12). The court addressed the question prohibited in the 100-tablet packet sub-market, of whether market foreclosure occurred when they needed to be repackaged in 100-tablet the defendant was denied permission to packets; therefore, repackaging was permitted.
import pharmaceutical tablets from Romania However, if the importer can use the and England into Germany and repackage original packaging, by attaching new labels them. In Romania and England, a 28-tablet and adding more blister packs, there may be packet was standard, compared to a standard no need to repackage. In the present case, it 98-tablet packet in Germany. Further, in was held that the importer could add more England and Romania 98-tablet packets blister packs to change the packet size from 28 were unavailable. The court held that market tablets to 56 tablets and then repackage. The foreclosure occurs once the parallel importer importer always bears the burden of proving is forced to repackage the tablets due to the need to repackage.
objective circumstances. These circumstances are satisfied as soon as the importer is unable Anti-counterfeiting and enforcement
to meet the demands of the importing member The damage caused by counterfeit state. Thus, market foreclosure occurs once pharmaceutical products is a major issue the importer is excluded from a sub-market in the European Union and Germany. Most (eg, the 98-tablet packet market). Further, the counterfeit products arrive in Germany from court stated that the exclusion did not depend non-EU member states. Regarding non-EU on whether it was possible in principle to goods, Customs can act on the basis of EU distribute the packaging size unchanged.
Regulation 608/2013. The application of the The Federal Court of Justice dealt with regulation may be limited to customs action at a further issue, as the defendant wanted to the German border or to action in two or more import tablets from France to Germany. In member states (national or EU applications).
France, the relevant tablets were available in When suspect goods are detected at the 30-tablet and 100-tablet packets, whereas in border, the German customs authorities Germany a 100-tablet packet was standard. It will seize them, notify the declarant of was questionable whether the importer could their detention and allow the declarant 10 be allowed to import the 100-tablet packets working days to consent or object to their from France without repackaging the 30-tablet abandonment for destruction. Customs will packets. The court held that the importer could also notify the rights holder and disclose not use only the 100-tablet packets. The test information on the shipment and the for exhaustion and necessity of repackaging parties involved. Goods are considered to be was whether the specific imports needed abandoned for destruction when the rights to be repackaged in order to be traded on holder confirms that they infringe an IP right www.WorldTrademarkReview.com
Pharmaceutical Trademarks 2015/2016   57 GERMANY SKW SCHWARZ RECHTSANWÄLTE SKW SCHWARZ RECHTSANWÄLTE GERMANY and requests their destruction, unless the declarant objects within the 10-day period. • the means of transport and identity of the If the declarant objects to the detention, the carrier involved; and rights holder has 10 working days to initiate • the country or countries of production and infringement proceedings. Otherwise, the routes used by traffickers.
Customs will release the goods.
When filing an application, it is advisable Advertising
to submit as much information as possible to The Act Against Unfair Competition and the enable Customs to analyse and assess the risk regulations of the Medications Advertising Act of an IP infringement, such as: about product-related ads for pharmaceutical • the port or country from which the goods products apply to the advertising of were consigned and their intended port of pharmaceutical products. While prescription arrival in the European Union or Germany; pharmaceuticals can be advertised to experts • details identifying the consignment or only (eg, physicians, pharmacists and Markus von Fuchs
Magnus Hirsch advises and represents Markus von Fuchs is a partner in SKW national and international clients in all Schwarz's Berlin office. His client portfolio IP-related matters. He is a certified IP comprises some of Germany's leading specialist and a frequently recommended companies in the medical devices industry, IP lawyer in Germany who was recently the healthcare sector and several other named one of Germany's Best IP fields of healthcare-related technology. Lawyers for 2014. He is a member of the Since 2005, Dr von Fuchs has been legal International Trademark Association, the counsel for Spectaris, a German industry Pharmaceutical Trademarks Group and the association for the medical device Intellectual Property Rights and Copyrights industry. In particular, he advises on the Association. Dr Hirsch is chief editor of enforcement of IP rights, R&D agreements, TerraLex's global IP Newsletter and its all matters deriving from German Medical global IP chair. He joined SKW Schwarz in Devices Law and the Medicinal Products 2007, previously practising as a lawyer and Advertising Act, as well as compliance partner at Baker & McKenzie in Frankfurt matters and regulatory affairs. Dr von and Hong Kong from 2001 to 2007. After Fuchs is a member of the firm's life science graduating from the University of Passau, practice group and head of the IP and Dr Hirsch practised with Lovells in competition group.
Frankfurt and Hamburg from 1997 to 2001. 58   Pharmaceutical Trademarks 2015/2016 www.WorldTrademarkReview.com
SKW SCHWARZ RECHTSANWÄLTE GERMANY hospitals), non-prescription pharmaceuticals ‘Reminder' advertising is when only the name can be advertised to consumers. of the pharmaceutical product, the brand or The Medications Advertising Act lists the name of the manufacturer is advertised, mandatory information to be included in without any medical or health information.
pharmaceutical product ads, such as areas of Generally, health-related information is application, side effects and warnings, which permitted only if it is accurate, unambiguous and must match the package inserts prescribed clear. False advertising with efficacy information in the Medicinal Products Act. In terms of is prohibited and ads featuring efficacy content, such mandatory information must information that is insufficiently documented be clearly separate from other advertising or disputed by conventional medicine are also messages; a distinction is made regarding the prohibited. Only efficacy information that has type of ad (eg, television or a display device). been the subject of pharmaceutical approval In cases of reminder advertising, significantly can be advertised. Even under these restrictive less mandatory information must be provided. conditions, it is possible to advertise modes of action that were not the subject of the approval procedure, but there are particularly strict requirements for scientific proof of such modes. Government agencies need not examine and approve ads for pharmaceuticals before publication; instead, manufacturers must ensure that their ads conform with the law. However, ads featuring efficacy information are frequently the subject of legal dispute. This is because (allegedly) incorrect information not only is monitored and controlled by government supervisory authorities such as BfArM, but can also be challenged by competitors or consumer associations under Section 4/11 of the Act Against Unfair Competition. Accordingly, violations of market [email protected] behaviour rules in the competition process can be pursued by the private sector. Section 3 of the Margret Knitter is a partner at SKW Medications Advertising Act – which governs Schwarz's Munich office, specialising in the prerequisites of permissible ads featuring the fields of trademark law, design law efficacy information – is regarded as such a and unfair competition law. She advises market behaviour rule. Consequently, efficacy her clients on the global administration, information in Germany is closely monitored.
protection, enforcement of trademarks and designs and on structuring and Moreover, pharmaceutical ads must be developing their IP portfolios. In addition, factual and should induce no unnecessary or she advises on anti-counterfeiting, irrational uses. The Medications Advertising licensing and merchandising issues and Act lists impermissible types of ad (eg, those provides transactional support. Ms Knitter using case histories, offering prizes or issuing represents an international clientele ranging from industrial to mid-sized A violation of the Medications Advertising companies. She has special expertise in the pharmaceutical, chemical, crop science, Act not only leads to the prohibition of confectionery, publishing, IT consulting, such ad, but may also result in one year's toy, clothing, mechanical engineering imprisonment for misleading advertising or and luxury goods sectors. She has been a fines of up to €50,000 for other violations.
lecturer at the University of Liechtenstein since 2013 and is a member of the Pharmaceutical Trademarks Group.
The cost explosion in the German health system has prompted the legislature and www.WorldTrademarkReview.com
Pharmaceutical Trademarks 2015/2016   59 GERMANY SKW SCHWARZ RECHTSANWÄLTE SKW SCHWARZ RECHTSANWÄLTE GERMANY German law generally allows the mail order sale of pharmaceuticals, including prescription pharmaceuticals, if the pharmacy has obtained the relevant permission health insurers to promote the prescription of required to dispense generic pharmaceuticals generic pharmaceuticals by physicians and/or in cases where the panel physician has the dispensation of generic pharmaceuticals prescribed a pharmaceutical product using its by pharmacies as a tool for reducing costs. active substance name only or has not ruled As an innovative compound, a generic out replacing the pharmaceutical product pharmaceutical must be approved with an alternative with the same active initially. This is done through a simplified substance. As a prerequisite, the generic procedure. The manufacturer of the pharmaceutical must contain the same active generic pharmaceutical must provide a substance at an identical strength and in the bioequivalence document with the full same or an interchangeable dosage form.
clinical documentation of the innovative compound. This condition is satisfied if the generic pharmaceutical is equivalent to the German law generally allows the mail innovative compound, exhibits adequate order sale of pharmaceuticals, including pharmaceutical quality and, in applications prescription pharmaceuticals, if the pharmacy for humans, exhibits bioequivalent properties.
has obtained the relevant permission. An approved generic pharmaceutical In addition, pharmacies are subject to that is identical to the active substance German price setting no matter whether can be prescribed by physicians instead the pharmaceuticals are sold by a German of the innovative compound if it features pharmacy or a foreign pharmacy (Section comparable biopharmaceutical properties, as 78/I/4 of the Medicinal Products Act). A it is then regarded as a therapeutic equivalent. breach of the price-setting policy does not This criterion is examined by determining necessarily require a lower price, but is plasma concentration-time profiles and assumed if the pharmacist grants a discount pharmacokinetic evaluations. Dosage with vouchers or similar. form, indication and properties related to In 2014 the Federal Court of Justice the active substance can also play a role in dealt with a case in which German the evaluation. Appropriate information is pharmacies tried to circumvent German provided in the appendix of the Medicinal price setting by advertising pharmaceutical Products Directive entitled "Information on products from pharmacies located in the the Interchangeability of Dosage Forms". Netherlands (Holland-Preise, I ZR 77/09). Pharmacists issuing generic The pharmacy offered customers the chance pharmaceuticals must follow the principles of to pay the cheaper Dutch price as the order the Framework Agreement on the Provision was addressed to a German pharmacy. of Medicinal Products between the National Customers would merely collect their Association of Statutory Health Insurance ordered pharmaceuticals from the German Funds and the German Association of pharmacy or in the Netherlands. When Pharmacists. Accordingly, pharmacists are choosing to collect the pharmaceuticals 60   Pharmaceutical Trademarks 2015/2016 www.WorldTrademarkReview.com
SKW SCHWARZ RECHTSANWÄLTE GERMANY in Germany, customers had to pay a fixed • protection from fraudulent use of payment rate for transportation. Further, the general terms and conditions stated that the place of • invalidity of any waiver of such rights and performance should be the place of business obligations, whether instigated by the (ie, the Netherlands). The court ruled that the consumer or the supplier. German price applied in such cases where German legislation was circumvented. If pharmaceuticals are sold over the Internet, the provisions on distance selling apply, especially the requirement to provide comprehensive information before purchase and confirm such information in a durable medium (eg, in writing), and the consumer's right to cancel the contract within a minimum of seven working days without reason and without penalty, except the cost of returning the goods (the right of withdrawal). Additional provisions pertain to: SKW Schwarz Rechtsanwälte
• the right to a refund within 30 days of the Mörfelder Landstraße 117 consumer cancelling the contract; D - 60598 Frankfurt/Main • the delivery of goods or performance of service within 30 days of the consumer Tel +49 69 6300 010
placing the order; • protection from unsolicited selling; www.WorldTrademarkReview.com
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Source: http://www.skwschwarz.de/files/skw_schwarz_beitrag_germany_in_pharmaceutical_trademarks_2015_2016.pdf