COVID-19 and public compulsory licensing of drugs in Europe

In the early days of the COVID-19 pandemic, Sir Colin Birss gave a speech at the MIP International Patent Forum in which he asked a couple of important questions: does the patent system provide sufficient incentives to companies to produce antiviral drugs for the various coronaviruses that have emerged in recent years: SARS, MERS and now COVID-19? Given this history of coronaviruses, why isn't a broad spectrum solution already in place? The judge also raised the possibility of greater collaboration between research companies in this area, borrowing from the standards essential model in the mobile communications sector.

As the pandemic has quickly developed, so has the rush for pharmaceutical companies to find vaccines and treatments to fill the gap the judge identified. To date there are several dozen such companies, many collaborating. Other companies with the know-how to do so have turned their production lines to making essential equipment for protecting medical staff and treating patients.

In the face of public need, some companies have said they will not enforce their patent rights on drugs. An example is AbbVie' antiviral drug Kaletra, which is currently undergoing trials for use against COVID-19 infection.

As welcome as such actions are, many governments may not have to wait for companies to waive their patent rights. In emergency situations, to ensure that sufficient supplies are available to meet the urgent need of the public, governments may be able to rely on compulsory licensing powers instead. Here we examine the powers that exist in the UK, Belgium, Germany and the Netherlands.

Crown use in the UK

Section 55(1)(a) UK Patents Act 1977 provides that "any government department and any person authorised in writing by a government department may, for the services of the Crown" do various acts including making, using, importing and keeping, "without the consent of the proprietor of the patent…". The acts also extend to selling or offering to sell for the production or supply of specified drugs and medicines. Products of a patented process and the use of the process itself are also covered.

Crown use is a potential defence to patent infringement by a third party authorised to do these acts. Claims to compensation by patent holders whose patents have been subject to Crown use is also provided for in section 57A.

There is little in Section 55 alone to guide anyone on when it may apply, although Section 56(1)(b) does provide that "services of the Crown" in this section includes "the production and supply of specified drugs and medicines". But, because Crown use effectively provides the British government with a discretion to requisition patented technology, it is regarded as a serious step, which should only be considered in rare and narrow circumstances.

Periods of emergency

Specifically, section 59 Patents Act provides for Crown use in the context of a "period of emergency":

• During any period of emergency within the meaning of this section the powers exercisable in relation to an invention by a government department or a person authorised by a government department under section 55 above shall include power to use the invention for any purpose which appears to the department necessary or expedient—
  
  (c) for securing a sufficiency of supplies and services essential to the well-being of the community;
  
  (3) In this section “period of emergency” means any period beginning with such date as may be declared by Order in Council to be the commencement, and ending with such date as may be so declared to be the termination, of a period of emergency for the purposes of this section.

Here, the uses are not limited to "use for the service of the Crown" and, although not exhaustive, specifically include "securing a sufficiency of supplies and services essential to the well-being of the community".

Recent authority on Crown use

The draconian nature of the Crown use provisions means that case law is scant and successful uses of the defence even rarer. But the recent case of IPCom GmbH & Co KG v Vodafone Group Plc [2020] EWHC 132 (Pat), although it concerns telecommunications patents, provides one example in which the Crown use provisions have been used successfully to defend against a claim of infringement.

IPCom states that "for services of the Crown" in Section 55 does not necessarily mean that the use has to directly benefit the Crown itself. Furthermore, authorisation must be in writing from a government department[1] and may be implied[2]. The latter point was the subject of much debate in the case and is particularly important. Does an authorisation to do a specific act imply an authorisation to infringe a specific patent?

It was held in IPCom that what mattered is the written authorisation to do the relevant act. In this case the authorisation was requested from a Police Gold Commander who was acting pursuant to Cabinet Office authority. Vodafone did not need to show that it was necessary for them to infringe the particular patent at issue to make use of the defence – "authorisation" is defined by the acts authorised rather than the patents that may be infringed. It is an authorisation of the kind "you are hereby authorised to operate process Y/make product Z", which does not expressly identify the specific patent or patents in question. In other words, it does not need to be shown that it is necessary to infringe patent X when carrying out that authorized act in order for the defence of Crown use to a claim of infringement of patent X to apply.

Summary effect

The COVID-19 crisis may lead to government authorisation under sections 55 or 59 of the Patents Act of medical equipment or medicine manufacture. If so, the Crown use defence, apparently unrestricted by the need to show the necessity of using particular patented technology, may lead to questions about the extent to which that technology was covered by recipients of the authorisation – and so the application of the defence –  and the compensation due to the patent holder from Government.

Government granted licences in Belgium

The Belgian patent legislation does not provide for a similarly broad defence to patent infringement as Crown use in the UK Patents Act 1977. The Belgian patent legislation does however provide for compulsory licensing in certain specific circumstances. As such, when deemed in the interest of public health, the Government may grant a license for the exploitation and application of an invention protected by a patent. Such compulsory licence has never been granted yet, but as the rapidly spreading COVID-19 outbreak has been declared a pandemic, this option may be considered.   

Compulsory licensing

Article XI.38 of the Belgian Code of Economic Law (BCEL), containing all patent related legislation, provides for a compulsory licence in the interest of public health. Such license may be granted by the Government for the exploitation and application of an invention protected by a patent for:

• a medicine, a medical device, a product or medical device used for performing a diagnosis, a derived or combinable therapeutic product
• the process or product necessary for the manufacture of one or more products indicated under a)
• a diagnostic method applied outside of the human or animal body.

To obtain such compulsory licence the applicant should establish that he has the means (or the bona fide intention to obtain these means) necessary for the effective and continuous manufacturing and/or application of the patented invention in Belgium.

The application for such compulsory licence should be filed with the Minister of Economic Affairs with a copy to the Consultative Bioethical Committee. This Committee will issue a non-binding advice after having heard the applicant. Following this advice the Government will take a decision on the licence: if the Government decides to grant a compulsory licence, it will also decide on all aspects of the licence, including the duration of the licence and the licence fee.

In case of a public health crisis, the procedure to obtain a compulsory licence may be accelerated (e.g. by not awaiting the advice of the Consultative Bioethical Committee).

This compulsory licence provides for a defence against a patent infringement allegation, not only after the licence has been granted, but to a certain extent also pending the application. Any infringement proceedings initiated against the applicant in relation to a patent for which a compulsory licence has been applied, is indeed suspended by law until the Government has taken a decision on the application.

Comparison with ‘Crown Use’

Compared to the Crown use in the UK Patents Act 1977 this compulsory license is far more restrictive:

• The procedure is strictly regulated and excludes any “implied” consent.
• The initiative to obtain a compulsory licence lies in principle with the applicant: solely companies are entitled to take the initiative for the compulsory licence (even though the authorities may “nudge” certain companies to apply for such licence).
• The licence only provides for a defence in relation the patents for which a licence has been applied (and thus not for all “acts” that may be necessary to exploit the invention).
• This compulsory licence only relates to public health issues[3] and therefore is not as broad as Crown Use, relating to “the services of the Crown”, a very broad notion.

Summary effect

Even if the compulsory licence under Article XI.38 BCEL is far less broad than the Crown use in the UK Patents Act 1977, it seems an option to consider in the context of the COVID-19 pandemic. This licence indeed cannot only be applied in relation to actual medicines (such as vaccines), which will not be readily available for COVID-19, but also for diagnostic methods and for products or devices used for performing a diagnosis. As the need for diagnostic tests relating to COVID-19 will increase exponentially, any patent rights limiting the manufacturing and/or use of these tests may be subject to a compulsory licence. It will moreover be possible to apply for an accelerated procedure as the current situation certainly can be considered a public health crisis.

Governmental order of use in Germany

The recently enacted Act on the Protection of the Population in Case of an Epidemic Situation of National Significance (Gesetz zum Schutz der Bevölkerung bei einer epidemischen Lage von nationaler Tragweite) of 27 March 2020 which entered into force on 28 March 2020, amending Section 5 of the German Infection Protection Act (Infektionsschutzgesetz) serves as legal basis for the Government to order limitations of patents generally allowed by Section 13 German Patent Act.

With the entry into force of such order of use, the Government itself or any third party authorised by the competent Government entity is able to use the patented technology lawfully without the authorisation of the patent proprietor. Such use includes the manufacturing, offering and marketing of products normally falling under the scope of protection of the patent. However, the third party may not use the invention for his own commercial purposes, but must limit himself to the promotion of public welfare.

The indefinite legal term of public welfare in Section 13 German Patent Act covers all cases in which state care appears to be necessary, in particular the cases of emergency such as epidemic plagues. It has now been specified by the Section 5(2)(v) German Infection Protection Act.

The patent proprietor is also entitled to receive an appropriate remuneration from the Federal Government.

The measures are only lawful as long as the state of emergency lasts as provided by Section 13 German Patent Act. In accordance with the Patent Act, the newest version of the German Infection Protection Act provides that the order of use are deemed to be revoked upon the repeal of the finding of an epidemic situation of national significance, and otherwise upon expiry of 31 March 2021 (Section 5(4) German Infection Protection Act).

Dutch compulsory licensing in the interests of public health

The Dutch patent legislation provides for the possibility to obtain a compulsory licence in specific circumstances. One of these circumstances is when public health is at stake. A compulsory licence restricts the rights of a patent holder and authorises a third party to produce the patented medicinal product or use the patented processes.

Compulsory licensing under the Dutch Patent Act

Generally, the Dutch Patent Act (‘DPA’) provides for several reasons why a compulsory licences may be granted: 

• public interest
• lack of sufficient use by the patentee (non usus)
• ownership of dependent patents (or dependent plant breeder’s right in respect of the plant variety)
• national defence
• the Euratom treaty.

In the context of the ongoing spread of the COVID-19 virus, the reason of public interest will be discussed. Article 57 DPA stipulates: “The Minister may, if he considers it in the public interest, grant a license under a patent, the contents of which shall be described precisely by him, to a person designated by him”. So far, such compulsory license has never been granted.

Definition of ‘public interest'

Although there is no clear definition of ‘public interest’ and there are no guidelines for assessing the public interest, according to the legislative history, the legislator had the intention that this term would be interpreted rather broadly.

So far a compulsory licence has never been granted in the Netherlands. However, the possibility of issuing a compulsory licence has been discussed by the Dutch government as a potential remedy for medicinal products which are not available due to (excessively) high prices. The Dutch Government has stated that it should be considered whether or not a compulsory licence constitutes an effective means to place a product on the market. One has to take into account other factors such as data and market exclusivity which could block market entry from a regulatory perspective. After such hurdles have been taken, the Minister of Economic Affairs in his capacity of the party which could grant such licence has to decide whether the public interest justifies limiting the rights of the patentee. Factors to take into account include the therapeutic value of the patented pharmaceutical concerned and the negative effects should the pharmaceutical not be available in sufficient amounts. In order to further understand the legal and economic perspective of compulsory licence, a committee has been established by the Dutch government to further research this perspective.

It is thinkable that compulsory licences might become relevant in the current Covid-19-crisis provided that a pharmaceutical to treat or diagnose the disease is technically available but subject to patent protection and the patentee fails to ensure that sufficient amounts are available on the market. In such a situation, it is likely that the Dutch Minister of Economic Affairs will seriously consider to grant such licence.

Procedure

The Dutch Minister of Economic Affairs decides on whether to grant a compulsory license. A prospective licencee may submit a (written) request to the Minister.

The DPA requires that the Minister may only grant a licence after having examined whether the patent holder would grant a license on reasonable terms on a voluntary basis. The patent holder may then comment on this. Although it does not literally follow from the wording of the DPA, it may be assumed that a prospective licencee has previously negotiated in good faith with the patent holder as provided in Article 31(b) TRIPS Agreement once he files a written request for a compulsory licence. Article 57 DPA does not provide guidance on what should be considered as reasonable compulsory licence terms. In case parties cannot agree on the specific conditions of the compulsory licence (licence fees), the court will determine the conditions of the compulsory licence. A compulsory licence becomes effective once it is registered in the Dutch Patent Register. In case of an emergency, the Minister of Economic Affairs may accelerate the procedure by not consulting the patent holder first.

Summary effect

In the current situation, in which we are faced with a global challenge to fight a pandemic, it can be reasonably argued that public interest would constitute a valid reason for a compulsory licence for using patented inventions relating to the treatment and the diagnosis of COVID-19 provided that the patentees do not make such inventions sufficiently available to the market. Therefore, we believe that due to the exception circumstances the Minister of Economic Affairs will seriously consider to grant such compulsory licence.

[1] MMI Research v Cellxion [2009] EWHC 1533 (Pat).

[2] Aktiengelsellschaft fur Aluminium Schweissung v London Aluminium Co Ltd (No 2) (1923) 40 RPC 107.

[3] The Belgian legislation provides for other types of compulsory licenses as well, e.g. in case of non-exploitation.