The patent attitude of the German government after the corona

The patent attitude of the German government after the corona

In response to the emerging Corona pandemic, the German government plans to introduce amendments to the German Infectious Disease Prevention and Control Act (the Legislation for Human Infection Prevention and Combating Infectious Disease – the IfSG).

The bill provides for the ability of the Federal Government to assess that an "epidemic condition of national significance" exists. The following will be needed for this 'epidemic situation':

"An epidemic situation of national significance exists if the Federal Government has identified a serious threat to public health in the entire Federal Republic of Germany because

1. the World Health Organization has declared a health emergency of international scope and there is a threat of introduction of a threatening communicable disease into the Federal Republic of Germany or

2. there is a threat of the dynamic spread of a threatening communicable disease across several states in the Federal Republic of Germany."

According to the news reports of 24 March 2020, the bill was updated between now and then to consider an 'epidemic situation' for the Federal Diet, the German Parliament.

The Federal Ministry of Health would obtain additional powers in the field of infectious disease prevention and control if an 'epidemic condition' was established in accordance with the draft legislation.

As a rule, various steps to ensure the supply of drugs, medications and active substances, starter and auxiliary materials, medical instruments, laboratories diagnostics, aids, personal protection equipment, and disinfectant products should be approved by the Federal Ministry of Health.

Moreover, the amendments envisaged stipulated in relation to patent laws that in the event of an "epidemic" the Fed would be entitled, under Section 13(1) of the Patent Act, for the purposes of public health or for the purposes of protection of the Federal Republic of Germany to request that an invention related to one of the items above be applied. The draft law provides for the following reasons:

The scope of a patent can also be limited to the consequences of § 13 of the Patent Act, for example, for the purpose of ensuring supplies of drugs in case of emergencies in order to be capable of producing essential active ingredients or medicines.

Section 13(1) of the Patent Act is a clause which evidently has not been used since 1945 and which reads as follows in its actual form:

“(1) The patent shall have no effect in a case where the Federal Government orders that the invention is to be used in the interest of public welfare. Further, it shall not extend to a use of the invention which is ordered in the interest of the security of the Federal Republic of Germany by the competent highest federal authority or by a subordinate authority acting on its instructions.

(2) The Federal Administrative Court shall be competent to hear an appeal from an order made pursuant to subsection (1) if the order was made by the Federal Government or by the competent highest federal authority.

(3) In the cases referred to in subsection (1), the proprietor of the patent shall be entitled to equitable remuneration from the Federal Republic of Germany. In the event of dispute as to its amount, recourse may be taken to the ordinary courts. A Federal Government order pursuant to subsection (1), first sentence, shall be communicated to the person entered in the Register as the proprietor of the patent (section 30 (1)) before the invention is used. Where the highest federal authority which issued an order or instruction in accordance with subsection (1), second sentence, obtains knowledge of a remuneration claim in accordance with the first sentence, this authority shall communicate this to the person registered as the proprietor of the patent.”

Under section 13(1) of the Patent Act, legal scholarship offers a narrower definition of the 'public benefit' as opposed to that in the case of mandatory licensing under section 24(1) of the Patent Act. 'Public welfare' covers pandemics, for example. Pursuant to Section 13(3) of the Patent Act, the proprietor shall, for example in the form of a fair royalty, be entitled to an 'equitable remuneration' from the German Government.