European Bolar Provisions in Germany

1. How is Bolar implemented?

In order to implement the amendments of Directive 2004/27/EC to Article 10 Paragraph 6 Directive 2001/83/EC and to Article 13 Paragraph 6 Directive 2001/82/EC into the German Patent Act (Patentgesetz, PatG – “GPA”), a new Section 11 No. 2b to the GPA was introduced. The amendments came into effect on 6 September 2005 by Article 3 of the 14th Law amending the Medicinal Products Act. 

2. How does the Bolar provision work?

Section 11 of the GPA provides with respect to trials and in particular in connection with trials necessary for a marketing approval of a medicinal product the following: 
“The effect of a patent shall not extend to

1. …
2. acts done for experimental purposes relating to the subject-matter of the patented invention;
2a. …;
2b. studies, experiments and the practical requirements resulting therefrom which are necessary for obtaining authorisation to place medicinal products on the market in the European Union, or which are necessary for obtaining authorisation to place medicinal products on the market in the Member States of the European Union or in third countries;
3. …”

These two exemptions from the protective effect of a patent are applied in general according to the following guidelines: 

  1. Section 11 No. 2 GPA allows acts for experimental purposes in relation to the patented invention. This comprises any act that makes use of the patented invention and aims at obtaining knowledge about the invention irrespective of the intended use of such knowledge. The experiment must serve the purpose of resolving any kind of uncertainty, e.g. in order to find out something unknown; to verify a hypothesis; or to find out whether something known will also function under other conditions. 
    Whether or not a test or experiment is considered merely academic is irrelevant as long as the purpose of the experiment is, at least partly, to enhance the technical progress with respect to the subject matter of the patented invention. An experiment “in relation to the subject matter of the patented invention” means that the teaching of the patent is the object of the experiment for the purpose of obtaining knowledge about the subject matter. This privilege does not allow the use of the teaching merely as a means for an experiment whose object is actually something else. However, it is not prohibited to make use of a teaching in order to check the options of further developments or alternatives to the patented invention. Further, a patent will not be infringed if the teaching is used for acts to gain knowledge as to uncertainties of effects of an active pharmaceutical ingredient, and if clinical trials are performed on humans in view of  obtaining an authorisation for a pharmaceutical composition e.g. in another indication (the latter case will also be exempt by  the  more  specific rule of Section 11 No. 2b GPA). A patented invention may also be used for clinical trials in order to find out if, and to what extent, an active pharmaceutical ingredient is eligible to cure or relieve further disease. Such trials may be performed in part by other parties who act on behalf of the responsible party. However, according to the German courts' decision practice Section 11 No. 2 GPA is not applicable for bioequivalence studies in connection with abbreviated marketing authorisations for generic medicinal products. Here Section 11 No. 2b GPA comes into play.
  2. Section 11 No. 2b GPA does not only relate to experiments, but also to other surveys and the relevant practical needs in connection therewith for the purpose of obtaining a marketing authorisation for (generic) medicinal products. The performance of clinical studies and trials is not subject to the use of a teaching of a patented invention as the object of the experiment. Accordingly, all acts (“practical requirements”) are privileged that are necessary in order to obtain the intended pharmaceutical authorisation. This may include the manufacture of pharmaceutical ingredients if, and to the extent necessary, for the performance of clinical studies and trials. However, any such activities must be directly connected with the purpose of, and required for applying for, a marketing authorisation, i.e. any pre-field research study which does not produce data and information necessary for marketing authorisation application is not covered by the exemption.

3. Is Bolar restricted to exempting studies for generic marketing authorisations?

Bolar is not restricted to exempting studies for generic marketing authorisations. Rather, studies and activities conducted by an originator pharmaceutical company directly related to and required for marketing authorisation application (e.g. in another indication) are also covered.
According to the ruling of the Düsseldorf Regional Court (LG Düsseldorf, 26 July 2012 – docket no. 4a O 282/10), Section 11 No. 2b GPA may also extend to the manufacture of the protected product, the importation of the active pharmaceutical ingredients required for this purpose as well as to its delivery to a testing laboratory for the purpose of conducting trials. Even the conduct of the tests and experiments for the purpose of preparation of an application for a marketing authorization by a third-party provider to a company intending the marketing authorisation application is also covered by the exemption in Section 11 No. 2b GPA. 

4. Has Bolar been litigated in your jurisdiction?

Bolar has been litigated in the Astellas Pharma Inc. vs. Polpharma SA Pharmaceutical Works case before the Düsseldorf courts (Düsseldorf Regional Court, docket no. 4a O 282/10; Düsseldorf Higher Regional Court, docket no. 2 U 68/12). The Higher Regional Court made a referral for preliminary decision to the ECJ for the relevant question whether and under which conditions the third-party supplier of the patented active pharmaceutical ingredient (cf. below). 

5. Are exempted activities covered by a local exemption regardless of where regulatory approval is ultimately sought? 

The exempted activities are covered by the local exemption regardless of where regulatory approval is ultimately sought. The wording of Section 11 no. 2b GPA explicitly clarifies that the activities must be necessary for an approval in the member states of the EU or in non-EU countries. 

6. Does Bolar extend to a third party who assists the MAH in carrying out the activities? 

In general, the Bolar exemption in section 11 No. 2b GPA extends to third party service providers working on behalf of and on order of the company intending the marketing authorisation application. It is also undisputed that the manufacturing of patented active pharmaceutical ingredients by the generic company for the purpose of conducting trials and studies in the meaning of Section 11 No. 2b GPA are covered by the exemption. The Bolar exemption extends to third parties to the extent that the tests carried out after handover to a testing laboratory are attributed to the client (i.e. the company intending the marketing authorisation application) as his own actions, provided they were carried out in his own interest. The privilege extends to the testing laboratories themselves due to the performance of the tests. Even if the manufacture of the test samples/materials is done by a contract manufacturer on specific order and limited to the specific requirements of the company intending the marketing authorisation application for such trials and studies, this should be covered as “practical requirements” under Section 11 No. 2b GPA. 
However, in Germany it is still not completely clarified whether and under which conditions the supply of the pharmaceutical ingredients by third parties is covered by the Bolar exemption in Section 11 No. 2b GPA. 

(c) According to the Düsseldorf District Court in its decision in Astellas Pharma Inc. vs. Polpharma SA Pharmaceutical Works (decision of 26 July 2012; docket no. 4a O 282/10), the Bolar exemption has to be applied restrictively. In its reasoning, the court particularly referred to Section 10 Paragraph 3 GPA that stipulates that: “Persons performing the acts referred to in section 11 nos 1 to 3 shall be deemed, within the meaning of subsection (1), not to be persons entitled to exploit the invention.” In other words, even though the company conducting tests privileged under Section 11 No. 2b GPA, e.g. by using the supplied active pharmaceutical ingredients for the patented use, they should not be regarded as authorised users of the patent and, thus, the supplier could – and under normal circumstances would - still be regarded as liable for indirect/ contributory infringement according to Section 10 Paragraph 1 GPA: Further, with respect to the reasoning of the underlying Directive 2004/27/EC the court finds that third parties supplying the active pharmaceutical ingredients to the generic pharmaceutical undertaking are only covered by the Bolar exemption too if they have the same interest of conducting trials and studies in the meaning of Section 11 No. 2b GPA, i.e. if they are to be regarded as co-sponsors of the studies and trials. 

(d) The Düsseldorf Higher Regional Court took a more liberal position in the appeal procedure. The court found that Section 10 Paragraph 3 GPA does not necessarily result in the situation that the third-party supplier is not covered by the Bolar exemption applying in favour of the supplied company intending the marketing authorisation application according to Section 11 No. 2b GPA particularly considering the specific situation of generic pharmaceutical undertakings. 

It must be considered that the third-party supplier could be regarded as indirect or contributory patent infringer only because of the provision of Section 10 Paragraph 3 GPA. According to the opinion of the court, Sections 10 Paragraph 3 and 11 No. 2b GPA must be interpreted in the context of the purpose pursued by the Bolar exemption on the one hand and the rationale behind the concept of the liability for indirect/ contributory infringement. With respect to the latter, one should be liable as indirect/ contributory patent infringer because he/she increases the risk of a direct patent infringement by providing an essential means for realisation of the patented invention although he/she knows or could have known of such patent infringing use by the recipient. On the other hand, as a matter of fact there are many generic companies which do not manufacture all active pharmaceutical ingredients of their generic medicinal products portfolio on their own – some of them source even all of their products from third-party suppliers. Therefore, the implementation of the Bolar exemption would not meet its purpose in many cases if commercial third party suppliers of generic companies would not be covered at all by Section 11 No. 2b GPA. However, it should be expected from such third party suppliers that they apply reasonable precautionary means in order to ensure that the supplied generic companies actually use the supplied quantities of the supplied active pharmaceutical ingredients only for the purpose of and within the limitations of Section 11 No. 2b GPA as long as the relevant patent of the originator company is still in force. Since the court came to this opinion because of an interpretation of the German patent law provisions only in consideration of the European directive, it referred the following questions to the ECJ (referral decision dated 5 December 2013; docket no. 2 U 68/12) for preliminary ruling:

“1. Is Article 10(6) of Directive 2001/83/EC to be interpreted as meaning that the exclusion from patent protection also applies to acts of provision by which a third party for purely commercial reasons offers or supplies to a manufacturer of generic medicinal products a patent-protected active substance which that generic pharmaceutical undertaking has planned to use for conducting studies or trials for a marketing authorisation under medicinal product law as provided for in Article 10(6)?

2. If the first question is to be answered in the affirmative: 

  1. Does the third party’s enjoyment of the exemption depend on the manufacturer of generic medicinal products who is supplied by him actually using the provided active substance for exempted studies or trials under Article 10(6) of Directive 2001/83/EC? Does the exclusion from patent protection apply in such a case even where the third party has no knowledge of the intentions of his customer to use the active substance for purposes covered by the exemption and has also not satisfied himself in this regard? Or, in order for the third party to enjoy the exemption, does it matter only that at the time of his act of provision he can legitimately assume on the basis of all the circumstances (for example, the focus of the undertaking supplied, the small quantity of the active substance provided, the imminent expiry of the patent protection for the active substance in question, experiences as to the customer’s reliability) that the generic pharmaceutical undertaking supplied will use the active substance provided exclusively for exempted trials or studies in the context of a marketing authorisation? 
  2. Must the third party, in connection with performance of his act of provision, take measures of his own to ensure that the active substance is actually used by his customer only for exempted trials or studies and do the measures to be taken by him differ according to whether the patent-protected active substance is only offered or also supplied?”

The ECJ has not made a preliminary ruling on these questions since the case was settled by the parties and the waiver of the action by the plaintiff. Therefore, the application of the Bolar exemption in Section 11 No. 2b GPA on commercial third party suppliers of generic pharmaceutical undertakings, which use the supplied active pharmaceutical ingredient as patented for preparation of the application for a marketing authorisation for a generic medicinal product, is still not fully clarified.