[Ip-health] German Government Plans Possibilities to Limit Patents In View of Corona Pandemic - Kluwer Patent Blog

James Love james.love at keionline.org
Wed Mar 25 11:10:51 PDT 2020


Marco Alves from MSF saw this.

http://patentblog.kluweriplaw.com/2020/03/24/german-government-plans-possibilities-to-limit-patents-in-view-of-corona-pandemic/

German Government Plans Possibilities to Limit Patents In View of Corona
Pandemic
Thomas Musmann (Rospatt Osten Pross)/
March 24, 2020
by Dr. Simon Klopschinski

In the wake of the evolving Corona pandemic the German government intends
enacting amendments to the German Act on the Prevention and Control of
Infectious Diseases in Humans (Gesetz zur Verhütung und Bekämpfung von
Infektionskrankheiten beim Menschen – Infektionsschutzgesetz – IfSG), which
could also have an impact on patents. The bill of 23 March 2020 is
available here.

The bill foresees that the Federal Government would have the competence to
determine that there is a so-called ‘epidemic situation of national
significance’ (epidemische Lage). Such ‘epidemic situation’ would require
the following:

‘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 Organisation 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 dynamic spread of a threatening communicable
disease across several states in the Federal Republic of Germany.’

According to news reports dated 24 March 2020 the bill has been amended in
the meantime so that it would be up to the German parliament, the Federal
Diet, to find that there is an ‘epidemic situation’. It is apparently
planned that the Federal Diet will declare an ‘epidemic situation’ on 25
Mach 2020 (see here).

If pursuant to the bill an ‘epidemic situation’ was found, the Federal
Ministry of Health would gain additional competences in the fields of
prevention and control of infectious diseases.

For instance the Federal Ministry of Health would be authorised to order by
way of statutory instruments various measures for ensuring the supply of
medicines, narcotics, active substances, starting and auxiliary materials,
medical devices, laboratory diagnostics, aids, items of personal protective
equipment and products for disinfection.

In addition the intended changes stipulate with regard to patents that in
an ‘epidemic situation’ the Federal Ministry for Health would be authorized
to order pursuant to section 13 (1) of the Patent Act that an invention
relating to one of the above mentioned products shall be used in the
interest of public welfare or in the interest of the security of the
Federal Republic of Germany. The bill provides the following explanations
for this provision:

‘In order to ensure supply of products in the event of a crisis, the effect
of a patent can also be restricted in accordance with § 13 Patent Act, for
example, in order to be able to produce vital active ingredients or
medicines.’

Section 13(1) of the Patent Act is a provision which has apparently never
been used after 1945 and which in its current form reads as follows:

‘(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.’

According to legal scholarship the term ‘public welfare’ pursuant to
section 13(1) Patent Act is narrower compared to the concept of ‘public
interest’ under section 24(1) Patent Act, which provides for compulsory
licenses. ‘Public wellfare’ covers for instance pandemics. Under section
13(3) Patent Act the patentee is entitled to an ‘equitable remuneration’
vis-à-vis the German government, e.g. in form of a reasonable royalty.

http://patentblog.kluweriplaw.com/2020/03/24/german-government-plans-possibilities-to-limit-patents-in-view-of-corona-pandemic/


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