Coronavirus: patents rights and the public interest

Patent pooling is one idea that has been mooted, while there are also backstop powers written into patent laws around Europe that might enable manufacturers to make use of life sciences patents to help address the challenges posed by Covid-19 should the need arise.

Germany

In Germany, new emergency legislation passed by the country's parliament last week is now in force and impacts on patents in the life sciences sphere.

According to Munich-based Marc L. Holtorf of Pinsent Masons, the law firm behind Out-Law, the emergency legislation complements existing provisions in German patent law that enable competent authorities to allow themselves or third parties to make use of patented inventions for public interest purposes.

The Patents Act 1992 (as amended) provides the government with the ability to do certain acts concerning the use of patented inventions if, in the government’s opinion, "exceptional circumstances" are deemed to exist. The current Covid-19 pandemic is likely to be viewed as an 'exceptional circumstance'.

Section 78 of the Patents Act provides that in exceptional circumstances, a government minister, or person authorised by them, can exercise certain powers in relation to products or processes which are the subject of a patent. For example, the minister or authorised person, may use an invention which is the subject of a patent for any purpose which appears to the minister to be necessary or expedient for the following acts, by way of example:

• the maintenance of supplies and services essential to the life of the community;
• securing a sufficiency of supplies and services essential to the wellbeing of the community;
• ensuring the public safety and the preservation of the state

This section affords ministers or persons authorised by them wide powers including to carry out acts which would otherwise constitute patent infringement without the owner’s consent. Those acts might include, for example in the case of medicinal products or devices, the making, using, importing, stocking or selling of the medicines or devices concerned.

According to Henry, the Irish government is unlikely to exercise emergency powers in relation to inventions that are the subject of patents unless there is a dramatic deterioration in events as successive governments have spent decades establishing the reputation of Ireland as a centre of excellence for R&D in pharma and tech. 

Instead, the focus at this point is on collaboration. Henry said there are positive examples featured every day in the news of how the private sector in pharma and tech in Ireland are collaborating and innovating together to serve the interests of the public in Ireland and internationally in the fight against Covid-19.

The UK

As Cerys Wyn Davies of Pinsent Masons explained recently, it is possible in the UK that the government will invoke 'Crown use' provisions of patent law to enable manufacturers to assist in the fight against Covid-19.

The rarely used Crown use exemption from patent infringement can be invoked where future demands for damages or royalties remain a potential risk for third party manufacturers. The exemption, written into the UK's Patents Act 1977, allows the UK government to authorise others to make use of any patent rights without the prior agreement of the patent owner, to the extent they are for the "services of the Crown".

The authorisation only needs to relate to a particular act, such as for example the reproduction of a ventilator design. It does not need to specify the patents being licensed. It is intended that the patent owner would be compensated at a later date by negotiation with the government. Government authorisation can be given retrospectively.

The Crown use exemption was considered in the recent case of IPCom v Vodafone where it was held that Vodafone’s emergency access to the mobile phone network services provided under a contract with the UK government had the necessary written authorisation from government to invoke Crown use and to shelter Vodafone from patent infringement.

Like Germany and other countries that are signatories of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the UK government can grant compulsory licences too. This would mean waiving the obligation on the authorised party to make "efforts to obtain authorisation from the rights holder on reasonable commercial terms and conditions".

Industry initiatives, patent pooling and other schemes

While government intervention to liberate patents for the fight against Covid-19 is one option, another solution around licensing has been put forward.

One group of US and UK-based scientists, lawyers, entrepreneurs and individuals, for example, have developed a formal licence that encourages rights holders to pave the way for others to use their intellectual property, for free, in the fight against Covid-19.

Some pharmaceutical companies and medical technology companies have already taken matters into their own hands as they look to do the right thing.

Gilead, for instance, has asked the US Food and Drug Administration (FDA) to rescind the 'orphan drug' designation it was granted for the investigational antiviral remdesivir for the treatment of Covid-19. It also announced that it is "waiving all benefits that accompany the designation".

Orphan drug designation in the US applies to the development of treatments for rare diseases and provides pharmaceutical manufacturers with a seven year long period of exclusivity for developing their products, as well as other incentives designed to support its development through clinical testing and to launch.

In a similar vein, Abbvie has reportedly said that it will not enforce its patent rights in Kaletra, a drug commonly used to treat HIV, in a move that will enable researchers to study its potential efficacy in treating Covid-19.

Patent pooling is a further option that is being considered.