Chapter excerpt from the ebook MedTech IP: Lessons and Strategies for Success - view all chapters here.
The European Patent Convention states that the following shall not be regarded as inventions:
"schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers"
At first sight it appears that "programs for computers" are not regarded as inventions and therefore cannot be patented in Europe.
However, a computer program which controls an apparatus in an improved way is patentable subject-matter at the EPO. As a result, a MedTech apparatus can be patented even in cases where the only new feature is a new computer program, provided the computer program controls the apparatus in an improved way so as to solve a technical problem.
Many MedTech devices which are controlled by computers or microprocessors thus fall within the realm of patentable devices.
Let's take a look at one of the earliest examples of these principles...
Back in 1987 the EPO decided a foundational case relating to the patenting of computer implemented MedTech inventions. The case, known as Koch & Sterzel, T 0026/86, related to a computer-controlled X-ray apparatus, and we shall discuss it in this chapter.
In the next chapter we shall look at a more recent case, also relating to computers and X-rays, which was decided some 35 years after the Koch & Sterzel decision.
In 1978 the German company Koch & Sterzel GmbH & Co filed European patent application no. 78101198.6 relating to a microprocessor-controlled X-ray machine. The invention was made by an inventor with the delightful name of Melbourne J. Hellstrom from Severna Park, Maryland, USA. The idea of the invention was to use a computer to control the X-ray generator in such a way as to produce the best possible image resolution while at the same time not overloading the X-ray tubes, so as to prolong the life of the X-ray tubes. It was known that to improve image quality it was desirable to keep the image exposure time as short as possible, to avoid the effects of voluntary or involuntary motion of the patient (e.g. due to respiration) leading to blurring of the image. However, shorter exposure times needed to be balanced against the capacity of the X-ray tube to withstand the larger amounts of heat generated by shorter exposure times.
The patent was granted by the EPO in 1983, but was then opposed by both Siemens and Philips. The oppositions were unsuccessful, but the opponents then appealed against the decision of the opposition division.
The opponents argued that the invention was excluded from patentability under Article 52(2) (reproduced below) because the X-ray apparatus itself was known, and the only new part of the invention related to a program for a computer.
Article 52(2)
The following in particular shall not be regarded as inventions...:
(c)schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers;
On the face of it, the opponents appeared to have a strong argument. If the only new part of the system related to the computer program, and programs for computers were not to be regarded as inventions, then how could a valid patent be granted?
Koch & Sterzel argued that it was not possible to split the invention into technical and non-technical parts. Instead, the invention needed to be considered as a whole, and viewed as a whole it could be seen that the system produced a technical effect, in the form of the advantages stated above.
So how would the appeal board reconcile these competing views?
The appeal board first noted that the exclusion of Article 52(2) only applies to the extent that the invention relates to a computer program as such. This follows from Article 52(3), which states:
Article 52(3)
Paragraph 2 shall exclude the patentability of the subject-matter or activities referred to therein only to the extent to which a European patent application or European patent relates to such subject-matter or activities as such.
Article 52(3) effectively narrows the scope of the exclusion relating to computer programs.
The board stated that to decide whether the invention is excluded under Article 52(1) EPC it is necessary to determine whether or not it is a computer program as such.
The board considered that the invention was not "a computer program on its own and divorced from any technical application." Instead it was "an X-ray apparatus incorporating a data processing unit operating in accordance with a routine which produces a technical effect in the X-ray apparatus." A technical effect arose because, "optimum exposure is combined with adequate protection against overloading of the X-ray tubes."
The invention was therefore considered to be patentable irrespective of the fact that the X-ray apparatus itself was already known.
It is therefore a general principle that a computer program which controls an apparatus in an improved way is patentable subject-matter at the EPO.
The opponent objected that allowing this application "would render Article 52(2)(c) EPC totally ineffectual because even an ordinary computer program used in a general-purpose computer could then be regarded as an invention under Article 52(1) EPC since each computing operation is carried out with the aid of natural, i.e. electromagnetic, forces."
In response to this the board said, "if the program controls the operation of a conventional general-purpose computer so as technically to alter its functioning, the unit consisting of program and computer combined may be a patentable invention." This is effectively a second way in which computer programs may be patentable - i.e. if the program improves the functioning of the computer itself, for example by increasing the speed of the computer or increasing its virtual memory. For the purpose of MedTech inventions we do not generally need to be concerned with this second route to patentability, but we note it here for completeness.
Many MedTech inventions are nowadays controlled by computers or microprocessors. These inventions are patentable at the EPO thanks to the principle set out in the Koch & Sterzel decision, which has been widely cited in subsequent EPO decisions.
Although the company Koch & Sterzel GmbH no longer exists, I am eternally grateful for their patent application every time I deal with a patent for a computer controlled device. As for the inventor, Melbourne J. Hellstrom, I have not been able to find out much more about him, except that an obituary online states that he died in 2004 in Severna Park, Maryland, USA, exactly where he made this invention back in 1977.
