Intellectual property on demand

As covid-19 cases continued to soar in many parts of the world through the summer, IAM asked a group of leading law firms to assess how governments might relax IP rights in relation to a vaccine or other treatments

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The fight against covid-19 has seen governments and companies across the world take swift action to develop treatments and a possible vaccine to combat the disease. However, the pandemic has also brought into focus the steps that national governments can take to circumvent IP rights related to any possible cure or treatment for the virus.

One reaction has been to introduce initiatives spearheaded by companies, academic institutions and other entities (eg, the Open COVID Pledge) to ensure that disputes over IP rights do not prevent a cost-effective treatment being made widely available. However, the tool that is never far from discussions is the compulsory licence.

In this, IAM’s first tracker to focus on compulsory licensing, we invited some of the world’s leading law firms from 14 countries in Europe, Asia and the Americas to offer their insight on what actions the government in their respective jurisdictions can take to amend IP rights in relation to the fight against covid-19.

We asked each firm to frame their response around three questions:

  • What powers are there in your jurisdiction to circumvent patent rights and other exclusivities belonging to owners of covid-19-related innovations?
  • What, if any, actions have been taken by the government of your jurisdiction in recent months to use or enhance these powers?
  • How likely is it that compulsory licensing (or similar provisions) will be used in the near future?

We then asked the firms to give a mark out of 10 for the strength of action that their government can and is likely to take, with full marks reserved for those countries where the government has announced that it will impose compulsory licensing for a covid vaccine and/or other treatments.

The Americas

Brazil

Score – 4/10

Brazil

The Brazilian government has well-defined tools to prevent the abuse or misuse of patent rights. In case of covid-19-related inventions, the government can consider one specific patent of public interest and issue a compulsory licence. However, it must be demonstrated that the patent owner has made only limited efforts to provide the product to the Brazilian population or, in case of abuse, to adjust pricings during the negotiation process.

There are currently three main bills before Congress designed to ease the granting of compulsory licences due to covid-19 (1,184/20201,320/2020 and 1,462/2020). Bills 1,320/2020 and 1,462/2020 could have a significant impact if approved as they provide for an automatic compulsory licence for all patents covering technologies related to the treatment of the virus.

So far, none of the bills have been included in Congress’s agenda.

Whether the executive branch supports compulsory licences is unclear. Brazilian president Jair Bolsonaro has been criticised for downplaying the severity of the pandemic and is yet to formally comment on any intention to use compulsory patent licences in the fight against covid-19.

It is unlikely that the government will simply issue a compulsory licence against inventions that would help the population during the pandemic. However, the situation could change if any abuses come to light.

On 27 June the government announced an agreement to start local production of the experimental vaccine developed by AstraZeneca and Oxford University. This partnership shows that the Brazilian government and industry are on the same page in terms of balancing different interests.

Roberto Rodrigues is an attorney at law at Licks Attorneys

Canada

Score – 5/10

Canada

The Patent Act was amended in 1993 to repeal provisions relating to the compulsory licensing of medicines. There are rarely used provisions in the act that allow for the commissioner of patents to authorise use of a patented invention in cases of:

  • abuse of patent rights (Section 65);
  • government application (Sections 19.1-19.3); and
  • export for humanitarian purposes (Section 21.01-21.2).

An application for an authorisation based on abuse of patent rights can be made three years after patent grant and in limited circumstances (eg, demand for the patented article is not being met on reasonable commercial terms). Government applications have generally been sought only during times of war or within the context of defence. Only one authorisation to allow export for humanitarian purposes has ever been granted (Apo-TriAvir for export to Rwanda).

On 25 March 2020 the government enacted the COVID-19 Emergency Response Act, granting the commissioner the power to authorise use of a patented invention to the extent necessary to respond to a public health emergency.

Section 19.4 was added to the Patent Act to allow applications by the minister of health. Authorisation may be granted to the Canadian government or any other person, while an application must include confirmation that the chief public health officer believes that there is a public health emergency that is a matter of national concern.

The authorisation must be granted by 30 September 2020 and will have a maximum term of one year from grant. The term may be shorter if the minister notifies the commissioner that the authorisation is no longer necessary to respond to the public health emergency. Further, if the authorised user acts outside the scope of the authorisation, the patentee has recourse to the Federal Court.

If the authorisation is granted, the patentee will be notified and entitled to adequate remuneration, as determined by the commissioner. So far, no such authorisation has been granted.

It seems unlikely that the new provisions in the Patent Act relating to public health emergencies will be used. As noted earlier, the current provisions relating to compulsory licensing are rarely engaged and thus far no single authorisation has been granted under Section 19.4. This section also requires the minister to identify relevant patents, which may be difficult, leaving the possibility of launching at risk. The scope and duration of the authorisation is also unlikely to encourage companies to seek such a licence.

To the extent that a third party wishes to use a patented invention, there are other options available that provide greater business certainty, including options to invalidate relevant patents or to seek a licence from a patentee where the domestic market is not being supplied.

Daphne Lainson and Sheldon Hamilton are partners at Smart & Biggar

Mexico

Score – 8/10

Mexico

In the context of the covid-19 pandemic, concerns have been raised regarding public access to drugs and healthcare products necessary to counter the effects of the disease or to prevent the spread of the virus.

The Mexican IP Law foresees the possibility of requesting and obtaining public compulsory licences to give the public access to patents covering health supplies to fight the virus.

According to the law, the Mexican Institute of Industrial Property (IMPI) may declare through a publication in the Official Gazette that certain patents may be worked under the coverage of a public compulsory licence, for reasons of national emergency or security, and for as long as those reasons exist – including the outbreak of serious diseases declared as a matter of national priority by the General Health Council, when the lack of a licence would hinder or overvalue the production, supply or distribution of basic goods to the population.

On 23 March 2020 the General Health Council (GHC) published an executive order declaring that covid-19 was a serious disease that requires undivided attention. However, IMPI has not yet published any list of patents that could be subject to a public compulsory licence.

If IMPI publishes such a list, any pharmaceutical company will be entitled to apply for and be granted a public compulsory licence. IMPI would then grant the licence after hearing the parties, in accordance with the opinion of the GHC. The compulsory licence must be granted within 90 days of the application’s filing date. The amount of royalties will be determined by IMPI, after hearing arguments from both parties.

The scope of the licence may include the right for the licensee to use, sell, offer for sale or import the patented product without the patentee’s consent.

The Ministry of Health will then determine the conditions of production and quality, duration and scope of the compulsory licence, as well as the classification of the applicant’s technical ability to work the invention.

In view of the ongoing pandemic and the uncertainty regarding the ability of potential patentees to produce and distribute a vaccine worldwide, compulsory licence provisions will likely be used to help fight covid-19.

Indeed, the federal government has been actively taking measures to fight the virus; therefore, IMPI is likely to begin granting public compulsory licences in the near future.

Sergio L Olivares Jr and Daniel Sánchez y Béjar are partners, Jorge Alejandro Juárez Oceguera is an engineer and Manuel Mateos Maya is an attorney at OLIVARES

United States

Score – 3/10

United States

In the United States, the following legislation may be used to circumvent patent rights:

  • Government Use of Patents (28 USC §1498(a)) – this may be used to effectively create compulsory licences by providing private parties with immunity against patent infringement when acting on behalf of the US government. The patent owner’s sole remedy for infringement is a claim against the government for reasonable compensation.
  • The Defence Production Act 1950, as amended (50 USC §§4501 et seq) – this authorises the president to order private parties to accept and prioritise government contracts and to allocate and control materials, services and facilities during situations of war, natural disasters and terrorist attacks. Private companies performing such federal contracts under the act will be entitled to immunity from patent liability under Section 1498 of Title 28 of the US Code.
  • The Public Readiness and Emergency Preparedness Act (PREP Act) (42 USC §§247d-6d and 247d-6e) – this authorises the secretary of the Department of Health and Human Services to issue declarations providing immunity for all (not including wilful misconduct) personal injury and damage to property claims during public health emergencies to parties involved in the manufacture, distribution or dispensing of covered medical countermeasures, and is not limited to parties with federal contracts. As patent infringement has been recognised as a tort, whether the PREP Act provides insulation from patent infringement liability poses a question of first impression.
  • The Bayh-Dole Act (35 USC §§200 et seq) – under this the US government has the authority to march in and obtain title of intellectual property stemming from federally funded work if the federal funding recipient fails to comply with certain formalities (eg, reporting requirements) or declines to take title. Further, the US government retains a “nonexclusive, nontransferable, irrevocable, paid-up license” to the patent for uses made “for or on behalf of the United States” (15 CFR §296.11(b)(3)).

On 17 March 2020 the secretary of the Department of Health and Human Services issued a declaration defining covered countermeasures as “any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product”. The declaration was later amended to include countermeasures authorised by the Coronavirus Aid, Relief and Economic Security Act – namely, respiratory protective devices approved by the National Institute for Occupational Safety and Health and all products that may limit the harm that a pandemic or epidemic might cause.

President Trump first invoked the Defence Production Act in response to covid-19 on 18 March 2020, ordering the prioritisation and allocation of medical resources, personal protective equipment and ventilators. He subsequently issued several executive orders and memoranda orders pursuant to the act, and ordered two specific companies to prioritise contracts: General Motors Company on 27 March 2020 and 3M Company on 2 April 2020.

It seems unlikely that compulsory licensing provisions will be enacted and/or used in the near future. Instead of requiring licensing, the federal government has in the past preferred to deliberately violate patent rights and then pay a reasonable royalty pursuant to Section 1498 of Title 28 of the US Code (as it did with generic drugs in the 1960s).

The United States has made no announcements regarding compulsory licensing. The country’s actions have been limited to activation of the Defence Production Act and the PREP Act. While the government can utilise Section 1498 to effectively create a compulsory licence, it has not done so since the 1960s. As a result of government inaction in this context, private companies have proactively created the covid pledge, which grants participants a non-exclusive, royalty-free, worldwide licence to such intellectual property “for the sole purpose of ending” the covid-19 pandemic.

Michael Renaud and Tom Wintner are members and Rithika Kulathila and Nana Liu are associates at Mintz

Asia

China

Score – 2/10

China

Although no compulsory licence has ever been granted in China, the rules of compulsory licensing have been in existence since the patent system was established in 1985. At present, the following grounds are available to grant a compulsory licence:

  • insufficient exploitation of the patent by the patentee within three years of the patent grant date;
  • use as a remedy for anti-monopoly law violations by the patentee;
  • the patentee of a dependent patent cannot obtain a licence from the earlier granted patent;
  • state emergency or public interest; and
  • supply to the least developed countries, according to the Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights.

There are no signs of China taking any action to use or enhance the powers related to compulsory licensing to deal with covid-19. There were some discussions within IP circles about the idea of compulsory licensing in early 2020, when Remdesivir was widely reported as a wonder drug and possible treatment. But such talk quickly faded away as it soon became clear that China was on the leading edge in development of covid-19 vaccines and the pandemic seems now to be under control in the country. The government has even announced that after successful development, covid-19 vaccines will be provided to other countries as global public goods. The National Medical Products Administration has also announced measures to accelerate the launch of new drugs through a conditional approval mechanism, which may directly benefit those vaccines in Phase 3 clinical trials.

All this indicates that China has neither the need nor the motivation to impose any sort of compulsory licensing to fight covid-19.

He Jing is the founder and Lu Yong is a senior counsel at GEN Law Firm

India

Score – 7/10

India

The Indian Patents Act provides the Indian government with various options to circumvent or amend patent rights in the event of a pandemic such as covid-19. These provisions may broadly be categorised as follows.

Use by the government: royalty-free use by the government “for the purpose merely of its own use”. While there is some debate on what constitutes “merely of its own use”, one High Court decision extended this to a contractor satisfying a tender issued by the central government. This provision also allows the government to import any medicine or drug for distribution in any dispensary, hospital or other medical institution involved in public service. The royalty-free use of a patented invention by the central government is a condition for granting a patent in India and can only be undertaken by the government, a government undertaking or a person authorised by the government for the “purposes of government”.

Acquisition by the government: acquisition of the patent by the government for a public purpose on payment of compensation to be agreed between the central government and the patentee. If an agreement is not reached on the compensation, it will be determined by the High Court based on relevant factors including the expenditure incurred, the patent term and the manner and extent to which the patent has been worked.

Compulsory licences: compulsory licences in case of national emergency, extreme urgency or public non-commercial use on notification in the Official Gazette. Once notified, a compulsory licence will be issued to any interested person on terms and conditions to be decided by the controller of patents. An interested person includes a person engaged in or promoting research in the same field as that to which the invention relates.

Compulsory licences for the export of a patented pharmaceutical product to a country having insufficient or no pharmaceutical manufacturing capacity for the concerned product are also an option. The country to which export of the pharmaceutical is intended should issue either a compulsory licence or a notification allowing importation from India.

A compulsory licence may also be granted to any interested person after three years from the date of grant of a patent, on the grounds that the reasonable requirements of the public have not been met, the patented invention is not available to the public at a reasonably affordable price or the patented invention is not worked in India.

Essenese Obhan is founding partner at Obhan & Associates

Indonesia

Score – 8/10

Indonesia

The Indonesian Patent Law (13/2016) provides that the government may implement a patent for “urgent needs for public interest”, which is understood in the healthcare sector as referring to medicines which are required to cure endemic diseases. This right allows the government to use a patent, including pharmaceutical and/or biotechnology products that are expensive and/or necessary to cope with diseases that may cause the unforeseen death of people in large numbers and significant disability, and that constitute a public health emergency of international concern.

The most recent example was in 2012 when the government issued a presidential regulation to produce drugs still covered under patents for HIV/AIDS patients. The government still had to pay reasonable compensation to the patent holder, taking into account its economic benefit and the government’s financial capacity to pay.

During the recent pandemic, various ministers – including Indonesia’s foreign minister and coordinating minister for the economy – have spoken publicly on this issue and emphasised that there must be flexibility in the IP regime to encourage the development of affordable vaccines to accommodate at least two-thirds of the population or 170 million people. Indonesian pharmaceutical companies Bio Farma and Kalbe Farma are working with Chinese firm Sinovac and South Korean biotech company Genexine respectively to develop vaccines.

In April 2020 the Indonesian director of patents issued a public notice on its website to reassure the public that coronavirus-related drug patents could still be protected without compromising public interest. The director stated that it is important to recognise the substantial investment and time put in by researchers and that patents can still be granted as there is a mechanism for government use in health-related emergencies.

On 8 July 2020 the government enacted Regulation 77/2020, which sets out procedures for the government to implement patents. Where the government is unable to implement a patent itself, it can appoint a third party to do so, provided that it:

  • has the ability and facility to implement the patent;
  • will not assign the patent implementation to another party; and
  • has good production, distribution and supervision according to the regulation and the law.

The third party will also be responsible for paying reasonable compensation to the patent holder.

Under the current legal framework, the Indonesian government clearly intends – either by itself or through an appointed third party – to implement covid-related patents, if necessary, to meet the urgent needs of the public.

Nick Redfearn is the deputy CEO and Lisa Yong is a principal at Rouse

Japan

Score – 3/10

Japan

Article 93 of the Japan Patent Act stipulates a compulsory non-exclusive licence for public interest. In cases where the implementation of a patented invention is particularly necessary for the public interest, a compulsory licence may be granted to a third party. It is generally understood that a typical situation in which “the implementation of a patented invention is particularly necessary for the public interest” is where the implementation of a patented invention is especially necessary in fields that are directly related to people’s living conditions (eg, people’s lives, conservation of property and construction of public facilities). The covid-19 pandemic may be regarded as such a situation.

A third party intending to implement the patented invention should first request that the patentee hold consultations to discuss granting a non-exclusive licence. Where no agreement is reached by way of those negotiations or no consultations can be held, the party may request the minister of economy, trade and industry to grant a non-exclusive licence.

There have been no cases in which this type of licence has been granted in Japan.

Therefore, it is unlikely that such a licence system will be used in the near future; however, if covid-19 becomes more harmful going forward, there is a possibility that this system will be used in some areas (eg, medical equipment, medicines and masks).

Toyotaka Abe is a partner at TMI Associates

South Korea

Score – 2/10

South Korea

Compulsory licences are available under the Korean Patent Act in two situations. First, the South Korean government (or a private party designated by the government) can receive a compulsory licence during a national emergency or in the public interest (Type 1). Second, the director of the Korean Intellectual Property Office (KIPO) can grant a compulsory licence to a willing licensee if:

  • the patent has not been practised for three years without any justifiable grounds;
  • such a licence is indispensably in the public interest; or
  • the licence is necessary to export drugs to countries willing to import it to treat diseases causing a public health issue within the importing country (Type 2).

As part of the government’s efforts to combat covid-19, it may adopt compulsory licensing to circumvent patent rights belonging to owners of covid-19-related innovations. In fact, during recent committee meetings at the National Assembly and the Covid-19 Government Taskforce, Type 1 compulsory licensing was discussed several times.

However, there is a low likelihood that these ongoing discussions will lead to compulsory licensing for covid-19-related innovations because the South Korean government has imposed compulsory licensing only once. In 1980 KIPO imposed Type 2 compulsory licensing for a patent that had not been practised for three years. In other cases, the government and KIPO have consistently declined to impose compulsory licensing for drugs relating to leukemia, HIV and avian flu for several reasons, including:

  • the lack of imminent threat;
  • a sufficient domestic or overseas supply of a patented product; and
  • the need to promote technological innovation.

While the likelihood is low, the South Korean government may impose compulsory licensing if:

  • the spread of covid-19 rapidly increases;
  • it cannot secure a sufficient supply of vaccines or other treatments; and
  • governments of other major developed countries decide to impose compulsory licensing.

Jeong Yeol Choe is a partner, Kyung Ae Yoon is a senior patent attorney, Cho Rong Yun is an associate and Son Jin is a foreign attorney at Yulchon LLC

Europe

France

Score – 7/10

France

There are three main mechanisms provided by French law that could be used to acquire a compulsory patent licence over covid-19-related innovations.

First, the French government can subject a patent to an administrative compulsory licence if “the interest of public health requires it”. However, for this to apply it must be established by special commission of public executives and health experts that the relevant products are only made available in insufficient quantities or at an abnormally high price by the patentee. Once the compulsory licence regime is set, any company with the relevant qualifications can request a licence before the relevant ministry, which will then set out its scope and duration. If no agreement on the licence’s price is found, it will be set by court decision.

Another way to obtain a compulsory licence is through judicial action. As from four years after the filing of a patent, any person with the relevant qualifications can apply for a compulsory non-exclusive licence before the French courts. The applicant must show that the patentee is not commercialising the patented product in sufficient quantities to satisfy the needs of the French market, without any “legitimate cause”. The applicant must also have failed to obtain a fair and reasonable licence on an amicable basis. The court’s decision fixes the licence’s terms.

There is also a possibility of obtaining a compulsory licence on the ground that it is required for the exploitation of a junior patent, insofar as the latter embodies a progress of considerable economic significance in relation to the invention claimed in the senior patent. Such requests must be made before the Paris Court of First Instance.

In response to the covid-19 pandemic, France has adopted a law on the state of health emergency allowing the government to “take all measures aimed at making available to patients the drugs adapted to eradicate the health catastrophe, where necessary”. However, the French government does not seem to have publicly taken any such measure yet.

In the event that a patented product is found to be of critical importance against covid-19, the French government would likely be ready to enforce compulsory licensing provisions. However, it should be kept in mind that compulsory licensing can only be implemented in the absence of an amicable agreement with the patentee.

Stanislas Roux-Vaillard is a partner and Adrien Bonnet is an associate at Hogan Lovells

Germany

Score – 5/10

Germany

On 27 March 2020, in the wake of the covid-19 pandemic, the German government passed a coronavirus crisis package law, the Act for Protecting the Population in the Event of an Epidemic Situation of National Importance, which entered into force on the same day. This law provides for several amendments to existing laws; with regard to patents related to curing covid-19 patients, it authorises the Ministry of Health to issue so-called governmental use orders under Section 13 of the German Patent Act. This section is an often-overlooked regulation that has been around for more than 70 years but has only been applied once in 1949. Such an order is de facto an act of expropriation by the government, which is permissible only in exceptional cases (covid-19 being such under the act) and if adequate compensation is paid by the German government. The ordered use may be delegated to a producing company, which then would not infringe a related patent.

Besides the governmental use orders under Section 13, Section 24 relates to compulsory licences. The addressee of this provision is not the government but rather a company that requests a licence to make use of a specific patent. Such a compulsory licence can only be granted by the German Patent Court in Munich.

Both cases apply only to granted patents, as patent applications can be used regardless, although financial compensation must be paid if the patent is later granted. Use orders and compulsory licences are also available for registered utility models.

The German authorities are not known to have issued any governmental use orders or compulsory licences.

The German minister of health, Jens Spahn, made clear in an interview in late April that Germany is prepared to suspend patent protection should this be necessary in the interest of public health. For now – as he stated – it seems that all relevant companies are willing to sell vaccines at affordable prices and in sufficient quantities in Germany. This leads to the conclusion that Germany would only be prepared to grant use orders if either of these criteria are not met.

Felix Rödiger is a partner at Bird & Bird

Italy

Score – 4/10

Italy

A number of countries have taken steps to set aside patents temporarily or have instituted price controls to ensure the availability of covid-19 tests and treatments. While Italian institutions have yet to take any such steps with regard to covid-19-related innovations such as treatments and vaccines, the debate is very much alive throughout the country regarding the possible adoption of measures at a national level.

Compulsory licensing typically allows companies to license a patent for production, distribution and marketing. In return, the patent holder receives a royalty. For the time being, the Italian government has decided not to introduce specific compulsory licensing regimes with regard to any inventions covering vaccines, tests or treatments aimed at combating the pandemic. For example, no decision has been taken to extend the therapeutic indications of existing drugs to covid-19.

Under Italian law, compulsory licences are provided for in several articles in the Industrial Property Code, starting with Article 70. These provisions are designed to ensure that a patent is actually implemented. Thus, if an invention is not implemented in due course or is implemented in a way that is disproportionate to the country’s needs for more than three years, compulsory licences can be granted to third parties. In light of this, under the Italian legal system and upon the expiration of the three-year period from the grant of the patent (or four years from its filing, whichever is longer), a compulsory licence may be imposed.

Further, according to Article 71 of the Industrial Property Code, a compulsory licence on a patent can also be obtained by the owner of a patent covering a dependent invention.

In order to obtain a compulsory licence, the applicant must first have failed to agree to a licence with the patent owner (ie, refusal to grant a licence under fair conditions) and must then file an application with the Italian Patent Office. This results in a complex administrative proceeding, which might not be ideal when a rapid solution is called for.

Lara Mastrangelo and Andrea Michelangeli are trainee lawyers and Roberto Valenti is a partner at DLA Piper

Spain

Score – 3/10

Spain

The Spanish Patents Act (24/2015) includes legal tools that enable the state to expropriate or grant a compulsory licence on a patent or patent application on the grounds of public interest, which includes public health-related grounds, lack of supply and other extraordinary situations, which could apply to the covid-19 pandemic. The act provides regulation for the following legal situations:

  • Compulsory licences (Articles 91 et seq of the Patents Act) by means of a royal decree to be rendered by the government – this establishes a fast-track procedure that sets out the subject matter of the compulsory licence, as well as its scope, terms and conditions, including the royalty fee to be paid to the licensor, or to order the Spanish Patent and Trademark Office to set said terms and conditions. The Patent Act sets out five legal situations in which compulsory licences may be applied for and subsequently granted. Each situation has been given a score out of 10 on the likelihood that such measures would be taken for a covid-19 vaccine and/or other treatments:
    • lack or insufficiency of exploitation of a patent within four years after the publication of the application, or within three years of the publication of the grant (2/10);
    • dependence between patents or between patents and plant varieties (2/10);
    • a ban on acts that are declared contrary to EU or national competition law by a final administrative or judicial decision (2/10);
    • the manufacture of pharmaceutical products for export to countries with public health problems, under the EU Compulsory Licensing Regulation (816/2006) (2/10); and
    • public interest (3/10).
  • Expropriation of any patent application or patent on the grounds of public utility or social interest subject to fair compensation (Article 81 of the Patents Act), following the procedure set out in the Spanish Act of Compulsory Expropriation (2/10).

The Spanish government has published no guidelines setting forth criteria on when and how these legal tools might be applied. Nevertheless, since the pandemic was declared in Spain, none of these exceptional mechanisms have been taken for a covid-19 vaccine and/or other treatments. Moreover, it is unlikely that such measures will be taken within the next few months. Between 1986 and 2020, only six applications for compulsory licences were filed with the Spanish patent office. All were rejected.

José Miguel Lissén is a partner and Sara Villalta Alarcón is a lawyer in Bird & Bird’s Madrid Office

United Kingdom

Score – 8/10

United Kingdom

The UK government has the power under statute (Sections 55 to 59 of the Patents Act 1977) to authorise in writing (retrospectively or in advance) acts that infringe a patent, without the consent of the patent owner, for the provision of services to the Crown (known as Crown use). As a power, it is rarely used and is intended for emergencies only; however, it has broad application. Services to the Crown include certain acts (eg, supply, production and use) in the context of foreign defence, atomic energy and specified drugs and medicines. However, in practice, if a formal state of emergency is declared by the Crown on the advice of Parliament, the list expands to encompass almost any act. If Crown use is successfully invoked, the UK government must provide reasonable compensation to the patent owner.

Awareness of the law in this area has been heightened by a recent case in the telecoms sector (IPCom v Vodafone [2020] EWHC 132 (Pat), presently under appeal). Two of the principles clarified in that case were as follows:

  • The list of what constitutes services to the Crown is not exhaustive (the case concerned telecoms infrastructure in the context of use by the emergency services).
  • Importantly, written authorisation from the government to carry out a specific act is sufficient – the authorisation need not mention any specific patent(s).

Therefore, a mechanism exists with which patent obstacles could be compromised in the fight against covid-19. The UK government has not expressly reinforced Crown use in response to the pandemic, but there is no obvious need for it to have done so. The degree to which action may be required inevitably depends on the technology leading the fight. Patents are not traditionally an obstacle to the development of a vaccine product but may have greater relevance to platform manufacturing biotechnologies or to the development of small molecule antiviral drugs.

For completeness, there are also provisions in the Patents Act that allow any person to request a compulsory licence to any patent. This is an application to the comptroller of patents of the UK Intellectual Property Office but is unlikely to be relevant as it carries a number of restrictions (some of which make it difficult to invoke in an emergency situation) and ultimately any application may be denied.

Although there has been no express announcement by the government on the circumvention of IP rights, the existing statutory provisions on Crown use represent a broad and powerful mechanism for enabling the government to deal with health emergencies.

Dominic Adair is a partner and Luke Maunder is a senior associate at Bristows LLP


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