Does European patent law unfairly discriminate against medical devices as compared with pharmaceuticals?

Abstract

In this article, the question is addressed as to whether European patent law discriminates against medical devices and in favor of pharmaceuticals, and, if so, whether such discrimination is unfair to the medical devices sector. Three forms of discrimination are identified: the availability of Supplementary Protection Certificates for pharmaceuticals; the allowance of first medical indication claims for pharmaceuticals; and the allowance of second and further medical indication claims for pharmaceuticals, now enshrined in the most recent version of the European Patent Convention. The first two forms of discrimination are found to be arguably justifiable, whereas the third is not.

Keywords:

• Europe
• first medical indication claims
• medical devices
• patents
• pharmaceuticals
• second medical indication claims
• supplementary protection certificates

1. Introduction

Article 27 of the Agreement on Trade Related Aspects of Intellectual Property Rights of the World Trade Organization Agreement provides that patents should be granted for all fields of technology but allows for certain exclusions, including in particular methods of medical treatment [1]. The dominant European patent law, the European Patent Convention (EPC), makes use of this exclusion, and to that extent discriminates equally against pharmaceuticals and medical devices such that they themselves and their production are patentable, but their uses are not (see Article 53(c) EPC) [2].

Patents grant legal monopolies, and, monopolies being generally socially and economically undesirable, they are only granted for a short period. There have been arguments made that the term of a patent should be variable according to the nature of the invention, so as to maximize the positive effects of patents while minimizing their negative ones [3]. However, a case-by-case determination of the appropriate patent term would place an unbearable burden on the patent offices and the courts, so in general patent term has been fixed in recent years as 20 years.

2. Pharmaceuticals versus medical devices: three forms of discrimination

2.1 Supplementary Protection Certificates

For technologies that require extensive investment and time delay between the conception of an invention and its availability on the commercial market, the ‘useful’ patent term can be significantly restricted. For some inventions, such as spacecraft, investment and delay are to a great extent the result of having to make further technical developments in order to achieve a technically viable product – however, these developments may result in further patents and so the patent term for the viable product need not be unduly curtailed.

For certain other inventions, and most particularly for new drugs, the delays and investment can, to a large extent, be attributed to the hurdles the product has to overcome to achieve regulatory approval for commercial sale. For drugs, as such a special case, this has been addressed in Europe by means of Supplementary Protection Certificates which come into effect when the patent on a substance which is a medicinal product expires and give that substance a form of protection which is the same as a patent to the substance would. Supplementary Protection Certificates are not themselves patents or even extensions of the original patent, but given the patent-like protection they afford, they are relevant to the present discussion. Such certificates clearly represent a discrimination in favor of pharmaceuticals relative to medical devices.

2.2 First medical indication

In another respect, the drafters of the EPC introduced a specific clause which favored the patenting of drugs over all other inventions, namely by allowing patenting of a known substance, previously not known to have any medical application, when it was first found to have such an application. In the absence of this specific clause, the substance itself, its known manner of production and its use in medical treatment would not have been patentable. Hence the likelihood of any commercial operator undertaking the expense of obtaining regulatory approval for its medical use would have been small, and society would risk never enjoying the benefits of the medical use of the substance. Accordingly, the EPC allowed the patenting of a drug for a first medical indication using the claim format ‘drug X for use in medicine’ (see Article 54(4) EPC 2000, previously Article 54(5) EPC 1973). Under conventional patent claim interpretation, the words ‘for use’ would have had no limitative effect when considering novelty, and hence such a claim would have been rejected.

Conceivably, the same argument, that is, that the development costs would not have been justified in the absence of any patent protection, could have been made for a few devices found for the first time to be useful in medicine, for example, the laser. Hence the abovementioned clause could have been drafted to apply to devices as well as to substances, yet it was not. However, unlike known chemical compounds, known pieces of apparatus might normally be expected to require significant technical alterations to make them suitable for medical use. Such alterations might of course allow patent protection for the medically usable device itself. As a result, the first medical indication regime was arguably unnecessary for devices.

2.3 Second and further medical indications

Shortly after the EPC came into operation, a number of pharmaceutical companies, most likely emboldened by the West German courts’ approval of claims of the format ‘the use of known drug X for a new medical indication’, sought to obtain European patents for drugs with a second medical indication. Since the German claim format seems clearly to cover methods of medical treatment, which are excluded from patentability in Europe, a solution proposed by the Swiss patent office was adopted, namely that the ‘second medical indication’ should be claimed in the format ‘use of known drug X for the manufacture of a known medicament for use in a new medical treatment’ (the so-called Swiss-type use claim).

Despite the fact that such a claim clearly lacked novelty over the processes already known for producing pharmaceuticals incorporating the known drug, and without any support in the EPC for allowing the words ‘for use’ to confer novelty for anything beyond a first medical indication, in its very first decision the Enlarged Board of Appeal of the European Patent Office (EPO) approved the Swiss-type use claim format. It should be noted that in the deliberations leading up to the adoption of the EPC in 1973, the possibility of allowing the ‘for use’ exemption for second and further medical indications was rejected – thus, the Enlarged Board of Appeal was going against the intention of the EPC legislators [4].

There the matter stood for 15 years until, in the preparations for the first major revision of the EPC, the Swiss government delegation proposed that the purpose-limited product claim format for first medical indications should also be approved within the EPC for second and further medical indications. The Swiss delegation argued that this would simply enshrine in the EPC the case law of the Enlarged Board of Appeal. The suggestion was followed and the format approved in Article 54(5) EPC 2000.

Again the matter rested there until after EPC 2000 came into force in 2007. Then the Enlarged Board of Appeal had to address the question as to whether a second medical indication claim could derive its novelty from the dosage regime used rather than from the treatment of a different medical condition. In one of the amicus briefs, a patent attorney argued that the purpose-related product claim for a second medical indication provided protection extending beyond that provided by a Swiss-type use claim. This was discussed at length in the oral proceedings and in its decision the Enlarged Board concluded that, with EPC2000 in force, such purpose-restricted product claims must be granted for second medical indications (including ones characterized by the dosage regime), but that the EPO must stop allowing Swiss-type use claims, thereby in effect accepting that it had been incorrect in allowing them in its first decision [5].

The Boards of Appeal of the EPO have repeatedly held that the extension of patentability to pharmaceutical substances for second and further medical indications is not available to those applying for patents for medical devices [6-11].

Besides not being available to medical devices, second and further indication claims pose particular problems, not least ethical ones. Normally, a drug placed on the market in the European Union must have an accompanying product information leaflet, a Summary of Product Characteristics or SmPC, which should list all dosages and conditions for which the drug may be used. However, where an off-patent drug is the subject of a second indication patent, for a generic manufacturer to list details of the still patented indication would make it liable to being sued for patent infringement. Accordingly, such generic products may be supplied with details of the patented indication omitted from the so-called skinny SmPC [12]. The physician is then faced with a dilemma – whether to prescribe a cheaper generic variant with less than full details in the SmPC or whether to prescribe the patentee’s product which may be difficult for the patient to afford. The High Court of England and Wales has recently sought to force the physicians’ hands by taking the novel step of ordering the English National Health Service, an innocent by-stander to a patent dispute, to issue guidance to its physicians to prescribe the patentees’ product [13].

3. Conclusion

The first way in which European patent law favors pharmaceuticals over medical devices and other inventions is by way of providing Supplementary Protection Certificates, which extend patent life for a pharmaceutical that has received regulatory approval for market entry.

Furthermore, pharmaceuticals are favored over medical devices in two other ways in the EPC, initially by allowing the ‘for use’ exemption for first medical indications and, subsequently, by allowing the same exemption for second and further medical indications. It can thus be concluded that European patent law does favor pharmaceuticals over medical devices.

4. Expert opinion

Supplementary Protection Certificates represent a discrimination in favor of pharmaceuticals relative to medical devices, but is one which is clearly justified by the relatively much higher severity of the patent-term-eroding barriers faced by new drugs.

The second form of discrimination in favor of pharmaceuticals, allowing patentability for first medical indications, is also arguably justified on the basis of the investment in time and money required to bring a compound to the market as a drug for the first time. Although the first medical indication regime could have been drafted to also extend to devices, it was not. Is this unfair? Unlike known chemical compounds, known pieces of apparatus would usually require significant technical alterations to make them suitable for a medical use (a scalpel is not the same as a Bowie knife). Such alterations would normally allow patent protection for the medically usable device and, as a result, this form of discrimination against devices does not seem unfair.

The third form of discrimination, allowing patenting of pharmaceuticals for second and further medical indications, while not offering such protection in the case of medical devices, is arguably unjustified but is not unfair to the devices sector. It is unjustified because the justification for the first and second forms of discrimination is absent here – the substance is known to have a medical use and in general will have already received regulatory approval. Accordingly, patent protection is not implicitly required before the necessary investment to bring the substance onto the market will be forthcoming. However, to remove this third form of discrimination vis-à-vis devices by extending the same exemption to all other technologies (including the non-medical) would surely be a further wrong. Moreover, it would even seem to be ridiculous to do so. Under such a regime, every time a surgeon developed a new surgical technique, he might be able to re-patent the scalpel, a device for which no further investment would be required to get it onto the market. Indeed, extending such a regime to all other technologies would represent a socially and economically unnecessary and undesirable extension of the scope of the patentable. Thus, the only defensible way of removing this unjustified discrimination against the devices sector is to return to the original provisions of the EPC and to favor pharmaceuticals only in relation to their first medical indication.

Article highlights.

• European patent law favors pharmaceuticals over medical devices in three distinct ways: Supplementary Protection Certificates, first medical indication claims and second and further medical indication claims.

• The first and second forms of discrimination are justifiable. The third form is not, but rectifying this should be done by removing the favoring of pharmaceuticals rather than by extending it to devices.

Acknowledgments

The author is deeply grateful to Dr Julian Cockbain for his numerous useful comments.

Declaration of interest

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents, received or pending, or royalties.

Notes

This box summarizes key points contained in the article.