The Pharma Legal Handbook: Germany
The Pharma Legal Handbook: Germany answers essential questions about the legal and regulatory environment for pharmaceuticals in Germany. It is a must-have for any company operating in the country or looking to enter the market.
Prepared in association with Heuking Kühn Lüer Wojtek, a leading German law firm, it should answer any questions linked to regulation, pricing, clinical and preclinical trials, marketing, manufacturing, trademarks and patents.
If legal handbook content is updated, you will receive a free updated PDF for up to one year after purchase.
June 2019
1. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Germany
Want to know more about cannabinoid drugs, medicinal cannabis and opioid drugs in Germany? Read on! Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.
Cannabinoid Drugs
1. Are Cannabinoid Drugs authorized in your country?
There is no uniform answer to this question.
In Germany, some Cannabinoid Drugs are subject to restrictions under the Narcotic Drugs Act (“BtMG”) or the New Psychoactive Substances Act (“NpSG”).
Tetrahydrocannabinol, for example, is classified in Germany as a marketable but non-prescription narcotic drug; Annex II to the Narcotic Drugs Act. On the other hand, Tetrahydrocannabinol (Dronabinol) used for medical purposes is marketable and a prescription drug under Annex III to the Narcotic Drugs Act. In turn, isomers of Tetrahydrocannabinol such as delta6a(10a)-THC are not marketable according to Annex I to the Narcotic Drugs Act.
Nabilone is marketable and a prescription drug in accordance with Annex III to the Narcotic Drugs Act.
On the other hand, products used as medicinal products and containing cannabidiol and having a THC content of less than 0.2% are classified as prescription drugs in Germany; Ordinance on the Prescription of Medicinal Products (“AMVV”), Annex 1 (to section 1(1) and section 5) Substances and preparations pursuant to section 1(1) intended for medical purposes. In addition, cannabidiol was granted the orphan drug status by the EU for the treatment of special forms of epilepsy; cf. Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products. In Germany, medicinal products may in general only be placed on the market if previously authorized or registered as such or if they have an appropriate authorization from the European Commission in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
Pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, the European Medicines Agency (“EMA”) is the competent body for the marketing authorization of medicinal products in the European Union and the EEA States on the basis of a centralized procedure. Orphan drugs, therefore, require mandatory authorization by the EMA in the centralized procedure.
In addition, solely national authorization in only one EU Member State is generally feasible unless – as is the case with orphan drugs – EMA’s exclusive competence is stipulated for. Moreover, national applications for authorization of the same product in more than one EU Member State are not admissible. In Germany, the Federal Institute for Drugs and Medical Devices (“BfArM”) is responsible for the approval of “normal” drugs. BfArM also performs the tasks of the Federal Opium Agency. The agency’s major tasks are the following:
- granting general licenses to trade in narcotic drugs, psychotropic substances and precursors,
- supervising the trade in narcotic drugs, psychotropic substances and precursors among license holders (manufacturers, traders, importers, exporters, cultivators and scientific institutions) by checking the reports submitted under Section 18 Narcotic Drugs Act and Article 9 of Commission Delegated Regulation (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, and repealing Commission Regulation (EC) No 1277/2005 and Article 10 of Commission Implementing Regulation (EU) 2015/1013 of 25 June 2015 laying down rules in respect of Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and of Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors as well as inspecting manufacturing sites, trading enterprises, and storage facilities,
- issuing import and export authorizations for narcotic drugs and psychotropic substances
- granting import and export authorizations for precursors
- preparing and distributing special prescription forms for narcotic drugs.
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
There is no specific legal framework for and limited to Cannabinoid Drugs.
If Sativex® or Canemes® are prescribed in Germany within the approved indication areas (“in label”), the health insurance is obliged to cover the costs. If the physician prescribes one of the preparations in an indication that is not covered by the existing authorization (“off label”), however, patients must have their health insurance individually confirm in advance that the costs will be borne by the health insurance.
The situation is different for Dronabinol and Cannabidiol, however, which must also be prescribed by a physician, but the fact that these may or must be prescribed does not constitute a fundamental obligation for health insurance to bear the costs of the preparations. In these cases, separate declaration of coverage of the related costs by the health insurance is always required. It is thus at the discretion of the health insurance whether or not these costs will be covered. They may be obligated to bear the costs, however, if the patient suffers from a life-threatening or regularly fatal illness, if no other generally recognized treatment in accordance with the standard of care is available, and if there is a not entirely remote prospect of a cure or a noticeable positive effect on the course of the illness; cf. Federal Constitutional Court, December 6, 2005 – 1 BvR 347/98, NJW 2006, 891.
In order for Dronabinol or Cannabidiol to be included as a standard therapeutic agent in the health insurance’ catalogue of services, a recommendation of the Joint Federal Committee is required pursuant to Section 135 Social Code Book Five – Statutory Health Insurance, at the request of the Federal Association of Statutory Health Insurance Physicians, a Statutory Health Insurance Physicians’ Association, or of a Central Association of Statutory Health Insurances. To the best of our knowledge, neither Dronabinol nor Cannabidiol are currently the subject of any such request or recommendation.
4. Which are the cannabinoid drugs that have received market approval to date?
As narcotic drugs, Dronabinol and Nabilone are marketable and classified as prescription drugs in Germany. Cannabidiol is available as a prescription drug in Germany.
Sativex® Spray (Nabiximols: THC and CBD from Cannabis sativa extract) and Canemes® Capsules (Nabilone) have received market approval as proprietary medicinal products. Epidiolex® (Cannabidiol) has been submitted for market authorization. Pharmacies may also apply to BfArM for permission to import Marinol® (Dronabinol) or contact one of the importers who already hold an import license for this product.
5. Who can prescribe Cannabinoid Drugs?
Generally, licensed physicians of any specialty; for Dronabinol, this applies with the exception of dentists and veterinarians; cf. sections 2 et seqq. Ordinance on the Prescription, Dispensing, and Verification of Dispensing of Narcotic Drugs (Narcotic Drugs Prescription Ordinance – “BtMVV”).
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
A specific list does not exist. The Medical Associations of the German States are able to recommend a physician.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
In cases of sufficient medical indication, there are no specific restrictions.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
Sale is only possible through drug wholesalers and pharmacies.
9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?
The Pharmacist Chambers of the German States provide information about pharmacies. All full-supply pharmaceutical wholesalers are organized in the Federal Association of Pharmaceutical Wholesalers – PHAGRO e. V.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
No.
11. When are they likely to come into force?
Not applicable.
Medicinal Cannabis
12. Is Medicinal Cannabis authorized in the country?
Medicinal Cannabis is authorized in Germany.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
In Germany, a government agency, the Cannabis Agency, has been established at the Federal Institute for Drugs and Medical Devices, which controls and monitors the cultivation of Medicinal Cannabis in Germany.
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
The quantities of Medicinal Cannabis that may be prescribed are governed by law. In accordance with section 2(1) Narcotic Drugs Prescription Ordinance, physicians must comply with the stipulated maximum quantities: within 30 days, they may prescribe up to 100,000 milligrams of Cannabis in the form of dried flowers or alternatively up to 1,000 milligrams of Cannabis extract (based on delta 9 THC content) per patient. Exceptions are possible in justified individual cases, if a patient is under permanent treatment and the necessary safety of narcotics trading is observed and maintained. The law does not govern the maximum active substance content in this respect, however.
Prior to starting a Cannabis therapy, the health insurance must approve the coverage of the related costs. In these cases, the health insurance usually consults the Medical Service of the Health Insurance Funds to obtain a professional assessment of the indication. A decision must be made within three weeks, and if an assessment is made by the Medical Service of the Health Insurance Funds, within five weeks. Health insurance may only reject an application in exceptional cases. If Cannabis therapy is to be carried out as part of specialized outpatient palliative care, the approval period is only three days.
Any therapy with Medicinal Cannabis must be documented for an accompanying study, which serves scientific purposes only. The physician transmits anonymized treatment data to BfArM. Without participation in the accompanying study, the costs will not be covered by the respective health insurance. The accompanying survey is intended to run until 2022.
Dried Cannabis flowers are about EUR 22.00 per gram. Costs of a therapy with Medicinal Cannabis are therefore in a range between EUR 300.00 and EUR 2,200.00 per month.
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
In the future, Cannabis will be grown in Germany exclusively for medical purposes. Cannabis is therefore a medicinal product. Consequently, only Cannabis grown in accordance with the Good Agricultural and Collection Practice (GACP) which specifically meets the requirements of the “Cannabis Flowers” monograph and also meets the requirements of the other relevant monographs and guidelines may be used. This is intended to ensure the availability of Cannabis in Germany for medical purposes in reproducible quality in accordance with any applicable drug law requirements. Medicinal Cannabis is therefore also subject to the statutory provisions of the Narcotic Drugs Act.
a) Demand is covered by imports, for which the Cannabis Agency as such is not responsible, but only until Medicinal Cannabis is available from German cultivation. The Federal Opium Agency at the Federal Institute for Drugs and Medical Devices issues the relevant authorizations.
b) The Cannabis Agency’s first cannabis tender process for cultivation of Cannabis in Germany was canceled by a court in March 2018. In July 2018, however, a new tender process was launched for the cultivation and harvesting of Medicinal Cannabis with a deadline for submission of bids at December 11, 2018. In April 2019, the first contracts were awarded for cultivation and harvesting for a total of 7,200 kg of Cannabis for a period of four years. BfArM expects that cannabis from cultivation in Germany will be available from 2020.
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
a) Anyone wishing to participate in trading, here the import of narcotic drugs, requires the general license of BfArM – Federal Opium Agency – in accordance with section 3 Narcotic Drugs Act. In addition, for each individual import transaction, the licensee will require a separate import permit from BfArM – Federal Opium Agency.
b) Anyone wishing to grow Cannabis in Germany in the future must take part in any future tender process initiated by BfArM – Cannabis Agency – and be awarded the relevant contract. Future tender offers will be published in the Official Journal of the European Union.
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
Trading in narcotics and psychotropics and precursors is comprehensively governed by the Narcotic Drugs Act and the relevant ordinances – Foreign Trade Ordinance on Narcotic Drugs, Internal Trade Ordinance on Narcotic Drugs, Prescription Ordinance on Narcotic Drugs – and by Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors and by Commission Delegated Regulation (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, and repealing Commission Regulation (EC) No 1277/2005 and Commission Implementing Regulation (EU) 2015/1013 of 25 June 2015 laying down rules in respect of Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and of Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors and the Precursors Monitoring Act supplementing it.
In certain cases, physicians may prescribe pharmaceutical-quality Medicinal Cannabis on a narcotic drug prescription to patients with serious illnesses with the appropriate indication and in the absence of alternative therapies. According to Annex III to the Narcotic Drugs Act, Cannabis (marijuana, plants, and parts of plants belonging to the genus Cannabis) is only considered as marketable and prescription narcotic drug in Germany if grown for medical purposes under State control in accordance with Articles 23 and 28(1) of the Single Convention on Narcotic Drugs of 1961 and in preparations authorized as finished medicinal products.
18. How can patients obtain Medicinal Cannabis?
Patients need a narcotic drug prescription with which they may obtain Medicinal Cannabis in a pharmacy.
19. Who can prescribe Medicinal Cannabis?
Generally, licensed physicians of any specialty, with the exception of dentists and veterinarians; cf. sections 2 et seqq. Narcotic Drugs Prescription Ordinance.
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
A specific list does not exist. The Medical Associations of the German States are able to recommend a physician.
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
In cases of a sufficient medical indication, there are no specific restrictions. It must be a serious disease with a corresponding indication and with no alternative therapies.
22. Where is Medicinal Cannabis available?
Sale is only possible through drug wholesalers and pharmacies.
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
The Pharmacist Chambers of the German States provide information about pharmacies. All full-supply pharmaceutical wholesalers are organized in the Federal Association of Pharmaceutical Wholesalers – PHAGRO e. V.
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
No.
Opioid Drugs
25. Are Opioid Drugs authorized in your country?
There is no uniform answer to this question, as well. There are Opioid Drugs listed in Annex III to the Narcotic Drugs Act and therefore classified as marketable and prescription drug narcotics in Germany, such as Morphine, Sufentanil, Remifentanil, Fentanyl, Alfentanil. There are, however, also Opioid Drugs listed in Annex I to the Narcotic Drugs Act and therefore not marketable in Germany, such as Ohmefentanyl. There are also Opioid Drugs that are not relevant under the narcotic drugs laws, but are prescription drugs in Germany, such as Nalbuphin.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
Where Opioid Drugs are medicinal products, the EMA and BfArM are the competent bodies. If the Opioid Drugs are narcotic drugs, the Federal Opium Agency of BfArM is competent.
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
Compared to other drugs, there are no specific rules for authorization, pricing, and reimbursement of Opioid Drugs. It is a condition precedent to reimbursement that the drug is a prescription-only drug. Most of the Opioid Drugs used are standard therapeutics which are included in the service catalogue of the health insurance.
28. Which are the Opioid drugs that have received market approval to date?
A large number of Opioid Drugs have received market approval, including, but not limited to Codeine, Tilidine, Sufentanil, Remifentanil, Fentanyl, Alfentanil, Buprenorphine, Hydromorphone, Methadone, Oxycodone, Morphinesulphate-Pentahydrate or Morphinehydrochloride_Trihydrate (“morphine”), Piritramide, Tapentadol, Dihydrocodeine, Tramadol.
29. Who can prescribe Opioid Drugs?
Generally, any licensed physician. Special provisions are contained in sections 2 et seqq. Narcotic Drugs Prescription Ordinance. There is another restriction relating to Diacetylmorphine: prescribing physicians must be physicians qualified in addiction medicine and their qualification must extend to treatment with Diamorphine or they must have worked as physicians for at least six months as part of the “heroin-assisted treatment of opiate addicts” model project; section 5a Narcotic Drugs Prescription Ordinance.
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
A specific list does not exist. The Medical Associations of the German States are able to recommend a physician.
31. What approvals or notifications are required to prescribe Opioid Drugs?
See above under item 29.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
Sale is only permitted via the wholesale trade in drugs and pharmacies.
33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?
The Pharmacist Chambers of the German States provide information about pharmacies. All full-supply pharmaceutical wholesalers are organized in the Federal Association of Pharmaceutical Wholesalers – PHAGRO e. V.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
No.
35. When are they likely to come into force?
Not applicable.
Also from this Legal Handbook
2. Germany: The Essential Requirements on Trading Medical Cannabis under the 1961 Single Convention on Narcotic Drugs
Dentons Germany’s Peter Homberg outlines the key requirements that companies need to fulfil in order to import medical cannabis into Germany and how attitudes and legislation on the topic are shifting across Europe.
In order to import medicinal cannabis from another country to Germany, like many other countries, the essential factor is that such medicinal cannabis has to be cultivated in a country compliant with Art. 23 and 28 para. 1 of the 1961 Single Convention on Narcotic Drugs
The European medicinal cannabis market is constantly changing these days. A number of new competitors are entering the market presenting business ideas of exporting medicinal cannabis from all over the world like Israel, Columbia, Malta, Macedonia or Australia to name just a few. Germany is Europe’s biggest medicinal cannabis market and therefore in the centre of attention of many in the business. But what exactly is the key requirement for importing medicinal cannabis to Germany?
In order to import medicinal cannabis from another country to Germany, like many other countries, the essential factor is that such medicinal cannabis has to be cultivated in a country compliant with Art. 23 and 28 para. 1 of the 1961 Single Convention on Narcotic Drugs. Accordingly, the respective exporter must carry out the cultivation of cannabis for medical purposes under state control and offer cannabis of medicinal quality. This means that the exporting country has to establish a government agency whose task is to license and monitor the cultivation and supply of cannabis. In Germany, this is the Cannabis Agency at the Federal Institute for Drugs and Medical Devices. This agency has the task to designate areas in which cultivation of medicinal cannabis shall be permitted, to give licenses to authorized cultivators and to purchase and take physical possession of the crops.
According to a statement by the Federal Institute of Drugs and Medical Devices of May 2019, imports to Germany are so far only being carried out from Canada and the Netherlands. Israel is said to fulfil the conditions as well. In January 2019, the Israeli government also admitted medical cannabis for export, but there are still a few hurdles in the way for exports from Israel.
For international trade in medical cannabis, the 1961 Convention stipulates further that every single import and export requires a license and that the export license may only be granted if the law of the recipient country permits the import and use of cannabis for medical purposes. In addition, the respective permits may only be granted within the framework of the recipient country’s forecasts of its needs.
The International Narcotics Control Board (INCB), an independent expert body established by the 1961 Single Convention, issues yearly estimates for each country’s demand in medicinal cannabis. In Germany, the estimated demand is around 15 tons for 2019. The trend is definitely rising. To stick with the German example, the cultivation of cannabis is also possible since the tendering procedure has ended this year and three companies have been awarded the cultivation licenses. The tender covers a total of 10,400 kg of cannabis, spread over four years with 2,600 Kg each year. The first harvest of medicinal cannabis from cultivation in Germany could take place in 2020. The rest of the demand is covered by imports. For the direct care of patients through pharmacies in Germany, a total of around 1200 kg of cannabis flowers was imported in 2017 and approx. 3000 kg in 2018, marking a significant undersupply of the market. As of May 2019, there were a total of 19 companies holding a permit to import medical cannabis to Germany.
The World Health Organization (WHO) has recently carried out an in-depth review of cannabis and cannabis products in which the positive and negative effects of these substances have been scientifically investigated. As a result, the WHO has formulated recommendations for a change in the classification of cannabis, which would also lead to a change in the respective control regime. The decision of the United Nations Commission on Narcotic Drugs has so far been postponed.
It is to be expected that in the near future more and more countries will legislate on cannabis for medical use. Part of this development is also the European Parliament resolution of February 2019 on the use of cannabis in medicine. It states that there is evidence that cannabis can have a therapeutic effect. The Parliament, however, stressed the importance of making a clear distinction between cannabis-based medicinal products and other forms of cannabis treatment and called for further scientific research in the therapeutic effects of cannabis.
Also from this Legal Handbook
3. Regulatory Reform: Germany
All legal aspects surrounding regulatory reform in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
Two reforms came into law on January 1, 2019. The first one concerns the reduction of health insurance premiums for employees. It is named the “GKV-Versichertenentlastungsgesetz” (GKV-VEG) which provides the employers will again pay 50% of the health insurance contribution. The private health insurers are still permitted to require supplemental contributions from their members to meet the costs. The average supplement will be about 0.9% in 2019 so that the total contribution is 15.5% of the gross salary.
The second reform is referred to as the “Pflegepersonal-Stärkungsgesetz” (PpSG)” which concerns the nursing care insurance (Pflegepflichtversicherung). Due to the low pay and significant lack of nursing staff in geriatric care institutions, significant increases in pay and nursing staff are required and need to be funded. Nursing care insurance premiums are, therefore, expected to increase by at least 0.5% (max. cost 150 € per month).
2. When are they likely to come into force?
In an attempt to fund the system as a whole, further reforms can be expected which will probably mean that benefits will be further restricted and premiums will continue to increase.
Also from this Legal Handbook
4. Patents & Trademarks: Germany
The legal framework for patents and trademarks in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
1. In Germany, the Patent Act (Patentgesetz, PatG of 16 December 1980, as last amended on 8 October 2017 forms the legal basis for patents, while the Trade Mark Act (Act on the Protection of Trade Marks and other Signs, Markengesetz, MarkenG, of 25 October 1994, as last amended on 17 July 2017) is the legal basis for trademarks.
If one disregards the possibilities of a European patent, European Union trademark and/or international registrations, national German patents and trademarks will be granted by the German Patent and Trade Mark Office (DPMA) upon application if the respective requirements are fulfilled.
2. A patent is granted for a technical invention which (i) is new, (ii) is based on an inventive step and (iii) is susceptible of industrial application; if none of the statutory exclusions applies.
3. As for trademarks, basically, all signs, objects and designs, but also sounds, three-dimensional shapes, colours and theoretically also smells that are capable of distinguishing products and services from competitive offerings can be protected. In light of a recent change, German trademarks no longer have to be graphically representable. All trademarks which can be represented in the trademark register in such a way that the competent authorities and the public can clearly and unambiguously determine the subject-matter of trademark protection will be admitted for registration.
2. What agencies or bodies regulate patents and trademarks?
The German Patent and Trade Mark Office (DPMA) is the competence centre for all national intellectual property rights – patents, utility models, trademarks and designs.
More information can be found at: https://www.dpma.de/dpma/index.html
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
1. Patents can protect:
products (like devices or compounds used in surgery or therapy) or processes (like diagnostic methods, production processes, methods for obtaining known products, substances or compositions), or certain uses (like the use of compound X for the treatment of Y).
Certain categories of products and processes are expressly excluded from patent protection by law. The most relevant are:
- Mere discoveries, scientific theories and mathematical methods.
- Materials or substances already existing in nature and nuclear materials.
- Aesthetic creations.
- Schemes, rules or methods for intellectual acts, playing a game or doing business and computer programs.
- Presentations of information.
- Inventions whose commercial exploitation is contrary to the public interest or offends common decency, machines for forbidden gambling or for the production of clearly harmful or dangerous food or drinks.
- Plant varieties and animal breeds.
- The human body and the mere discovery of one of its components, including (partial) gene sequences.
- Processes for cloning or modifying the germinal genetic identity of human beings.
- The use of human embryos for industrial or commercial purposes.
- Methods of modifying the genetic identity of animals associated with the suffering of such animals without such methods being of significant medical benefit to humans.
- Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods.
2. The following can be registered as trademarks:
- a sign or set of signs which can be represented in such a way that the subject matter of the trademark protection can be clearly and unambiguously determined.
3. Something completely new under German law is the introduction of the certification mark. A certification mark is a mark which is designated as such at the time of application and for which the owner of the mark guarantees the material, the way in which the goods are manufactured or the services provided, the quality, accuracy or other characteristics. It must be capable of distinguishing itself from marks for which no such guarantee exists. With the certification mark, quality seals or test marks of neutral certification companies can thus obtain trademark protection.
A trademark can only be registered if there are no absolute grounds for refusal. These are, for example:
- Lack of distinctiveness.
- Descriptive indications to be kept free for general use.
- Apparent risk of misleading.
- Violation of public morality or public order.
- Emblem contained in the mark.
4. How can patents and trademarks be revoked?
1. Patents can be revoked in opposition proceedings and nullity actions. Anyone may oppose the grant of a patent within nine months of the publication of the grant of the patent (opposition period). After expiry of the opposition period, a patent can only be attacked in a nullity action before the Federal Patent Court.
Unless a patent is declared void or lapses due to non-payment of the annual renewal fee, the patent is then valid retroactively from the filing date for a maximum of twenty years.
2. In line with the various European Regulations it is possible to receive a supplementary protection certificate (SPC) for certain products, in particular medicinal products, which can, simply said, extend the term of protection for further five years. The Paediatric Medicinal Products Regulation (Kinderarzneimittel-Verordnung) also opens up the possibility of extending the term of protection of a supplementary protection certificate by a further (up to) six months. A prerequisite for this is that the application for the respective medicinal products contains results with regard to medicinal products studies conducted specifically on children that were conducted according to a previously approved paediatric investigation plan.
Grounds for nullity of a German patent may be:
- lack of patentability;
- lack of feasibility;
- inadmissible extension of the subject-matter of the patent compared to the original application as filed;
- unlawful withdrawal of the invention (can only be invoked by an infringer).
The Federal Patent Court will decide by judgment over a nullity action. The contested patent may be maintained (if the action is dismissed) or declared partially or wholly invalid (if the action is partially or wholly successful). If a patent is declared void, the proprietor retroactively loses all legal positions previously based on the application. Appeals against the decision of the Federal Patent Court will be heard by the Federal Court of Justice.
3. As regards German trademarks, proprietors of earlier trademarks have the opportunity to oppose a registration of a new mark in writing within a period of three month after publication of the newly registered trademark. The opposition must be filed with the German Patent and Trademark Office (DPMA). In principle, opposition can be filed if there is a fear that there is a likelihood of confusion between the earlier and newly registered mark. If successful, the newly registered mark will be cancelled.
During the term of the opposition period alternatively, thereafter exclusively, the proprietor of an earlier trademark may also file a cancellation action before the ordinary courts.
A trademark may be cancelled upon application if it has been registered contrary to § 3 or § 8 of the Trademark Act (absolute grounds for refusal):
- if it consists exclusively of a shape which results from the nature of the goods themselves, which is necessary to obtain a technical result, or which gives substantial value to the goods.
- if it is devoid of distinctive character for the goods or services; consists exclusively of signs or indications which have become customary in the current usage or in the bona fide and established practices of the trade to designate the goods or services; is of a nature to mislead the public; is contrary to public policy or to accepted principles of morality; contains certain state symbols or official certification marks which are excluded from trademark protection; has been applied for in bad faith.
In the case of relative grounds for refusal, it must be borne in mind that the likelihood of confusion must always be assessed from the point of view of the end consumer, who is less understanding than the person skilled in the art. In the case of absolute grounds for refusal, it is exactly the other way round: the skilled person is just as familiar with the special labelling habits in the medical sector as he is with the specialist medical vocabulary of the Latin and Greek languages.
In addition to absolute and relative grounds for refusal which may be raised in a cancellation action, a trademark shall be cancelled upon application if, after registration, the trade mark has not been used within a period of five years. Proof of use of the trademark in dispute is then required.
Finally, the owner of a trademark may waive the trademark at any time, particularly by non-payment of the renewal fee. Until January 2019 registered trademarks were protected for a period of ten years until the end of the month in which the trade mark was applied for. For all new trademarks registered from 14 January 2019, the ten-year term will now expire exactly ten years after the filing date.
5. Are foreign patents and trademarks recognized and, if so, under what circumstances?
1. Because of the territoriality principle, patents and trademarks are valid only in the country for which they are granted. German patents and trademarks granted by the German Patent and Trademark Office (DPMA) are therefore valid for the Federal Republic of Germany only.
However, in addition to a German national application, patent protection can of course also be sought in several countries with one single application in case of European patent or an international registration. Moreover, it is possible to claim the priority of an earlier foreign patent application for the same invention within a period of 12 month following the filing date of the earlier application.
2. European patents are centrally filed and examined at the European Patent Office (EPO). They can be granted for the contracting states of the European Patent Organisation. The procedure is governed by the European Patent Convention (EPC). Once a European patent is granted, a “bundle patent” is created, which then breaks down into several individual national patents (e.g. in those countries where the applicant chose to validate the patent). Once granted, a European patent has the same effect in each contracting state for which it has been granted and is subject to the same regulations as a national patent granted in that state.
3. Trademark protection can also be extended to other countries. A trademark application can directly be filed in the countries where protection is sought.
If it is intended to label products uniformly throughout the EU, registration of a European Union trademark valid throughout the EU can be applied for.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
Yes.
1. The Medicinal Products Act provides for a non-patent related way to extend an exclusive position for medicinal products vis-à-vis generics. Under the Medicinal Products Act, an application for marketing authorisation of a generic medicinal product can only refer to the data of the reference medicinal product if the reference medicinal product has been authorised for at least eight years (data exclusivity).
The generic medicinal product can then only be placed on the market after an additional period of two years (market exclusivity). In addition, market exclusivity can be extended by one more year if the marketing authorisation holder of the reference medicinal product, during the first eight years after marketing authorization, obtains authorisation for one or more new therapeutic indications with significant clinical benefit in comparison with existing therapies. Consequently, the maximum period for data and market exclusivity is eleven years (so-called “8+2+1 provision”).
2. Moreover, Regulation (EC) No 141/2000 on orphan medicinal products applies in Germany.
Therefore, orphan medicinal products enjoy market exclusivity for ten years. Orphan medicinal products are products intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition. During this period another application for a marketing authorisation will neither be accepted nor will a marketing authorisation for the same therapeutic indication be granted for a similar medicinal product. Moreover, an application to extend an existing marketing authorisation for such medicinal product will not be accepted. The period of market exclusivity can be reduced under certain circumstances. There are two exceptions to the exclusive position of the investor: The period can be shortened from ten to six years if the original designation criteria are no longer met after five years.
The purpose of this so-called shortening clause is in particular to regulate the case where, contrary to expectations, an orphan medicinal product develops into a “hit” due to changed circumstances, e.g. a sudden increase in the incidence of the disease in question, and thus the prerequisite for the special protection of competition of this medicinal product is no longer met due to sufficient profitability.
3. In addition, a similar medicinal product may exceptionally be approved before the expiry of the ten (or six) year period if the first holder of an orphan medicinal product license agrees to the second license, if the medicinal product itself cannot be supplied in sufficient quantities, or if the second applicant can prove in his application by means of clinical tests that his medicinal product is safer, more effective or otherwise clinically superior or at least makes a significant contribution to the diagnosis or treatment of patients.
4. On the other hand, for paediatric orphan medicinal products the total term of protection can be extended up to twelve years in accordance with Regulation (EC) 1901/2006 on medicinal products for paediatric use.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
Other than the ones already described, there are no specific restrictions regarding the patent protection of medicines and/or devices.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
No. There is no such requirement. An approval of a license and/or an entry of the license in the patent register is not necessary for the validity of the acquisition of the license.
However, it is possible to register the grant of an exclusive license under a patent in the German Patent and Trademark Register, but the entry of the license in the patent register has no material legal significance for the legal relations between the contracting parties and between the licensee and third parties. However, for evidence reasons it is recommendable to conclude license agreements in writing.
Moreover, there are some special rules that apply in the event that a patent or trademark is enforced by a licensee (e.g. standing to sue, entitlement to own damages claims, etc.). For trademarks, most of these rules are stipulated in § 30 of the Trademark Act, as for patents, most of these rules are based on case law.
Also from this Legal Handbook
5. Product Liability: Germany
An insight into product liability in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
Under German law, liability can result from a culpable failure to comply with contractual or quasi-contractual obligations (contractual/quasi-contractual liability), or from a failure to comply with legal obligations which are not at the same time contractual or quasi-contractual obligations (statutory liability). Statutory liability can be further sub-classified as tortious liability (i.e. liability based on culpable illicit behavior) or absolute liability (i.e. liability regardless of default).
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
1. Pursuant to § 84 of the Medicinal Products Act, manufacturers of medicinal products are (regardless of default, i.e. absolutely) liable in case of death or significant damage to the health of a person caused by the use of the medicinal product, provided that the designated use of the medicinal product has an adverse impact exceeding the scientifically justifiable extent, or provided the damage was caused by the fact that labelling, the application instructions or the summary of product characteristics were not in line with the state of the scientific knowledge.
2. If the damage matches the properties of the medicinal product, the causality between use of the product and damage is (rebuttably) presumed. The liability for damage is limited to EUR 600,000 (or instalments of up to EUR 36,000 per year) per person, with a maximum liability of EUR 120,000,000 or annual instalments of up to a total of EUR 7,200,000. If these maximum sums are exceeded by the claims of a multitude of persons, the liability per person is reduced pro rata.
3. A similar absolute liability applies to the manufacturer of medical devices, pursuant to § 1 of the Product Liability Act (Act on Liability for Defective Products, Product Liability Act of 15 December 1989, as last amended on 17 July 2017) if the product is defective in the sense of the law. Liability arises if the product is less safe than one is prompted to believe based on its presentation, its expectable application and the point in time when it has been brought into circulation. The absolute liability for damage caused by a product defect to the health of several persons is limited to a maximum total of EUR 85,000,000; if this sum is exceeded by the claims of a multitude of persons, the liability per person is reduced pro rata.
4. If a medicinal product or a medical device is defective, the manufacturer is in addition also (absolutely) liable for property damages according to the Product Liability Act, with a retention of EUR 500.
5. All aforementioned absolute liability claims are compulsory and cannot be waived in advance. The absolute liability described above does not exclude liability for tort (and/or, as the case may be, contractual/quasi-contractual liability) if the damage has been caused by culpable behavior, and these possible alternative liabilities are not subject to a limitation of liability.
6. Liability under German law aims primarily to compensate the material damage that has been caused, trying to avoid any over-compensation; in other words, there are no punitive damages under German law. In the case of damage to the health of a person, liability can also include a fair compensation for immaterial damages, in particular damages for pain and suffering.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
Absolute liability as described in the answer to question 54 applies only to the manufacturer. If the damage has been caused by an act of negligence or even willful misconduct of a corporate executive, an employee or a representative, these may be held liable based on the general legal provisions on tort.
4. How can a liability claim be brought?
A liability claim can be brought by means of a regular complaint in civil procedure before a court of justice.
5. What defenses are available?
First of all, the manufacturer can try to argue that the prerequisites for his absolute liability as described in the answer to question 54 are not fulfilled; this includes the possibility to rebut the presumption of causality. In addition, the absolute liability for damages caused by medicinal products is excluded if it can be assumed, taking into account all relevant circumstances, that the root cause for the adverse effects of the medicinal product are not in the areas of product development or product manufacturing (e.g., rather caused by inappropriate storage in a pharmacy or the like). In the case of a defective medical device, the manufacturer’s absolute liability is excluded if he can show that the defectiveness of the product has been caused by the manufacturer’s obedience to compulsory legal provisions, or that even using the best available science and technology, the defectiveness of the product could not be noticed when the product was brought into circulation. If the aggrieved person has contributed to the damage by own culpable behavior, liability is reduced pro rata, regardless of whether the defective product is a medicinal product or a medical device. Of course, in both cases the general defenses against any kind of claim, like limitation of action etc., are available as well.