The invention relates to the administration of medication, with interesting aspects of technical subject-matter and method of treatment (Art. 53(c) EPC – Exception to patentability subject matter)

The Examining Division alleged that the invention lacked an inventive step as it saw no technical problem that was solved over the prior art. In addition, it expressed doubts about the allowability of selecting a medication concerning Article 53(c) EPC.

However, the Board noted that enabling the clinician/caregiver to choose the correct medication from a plurality of medications is a technical effect and solves the technical problem such that the “five rights” are still ensured in the presence of a plurality of medications. And since selecting a medication only concerns operating the medical device such that human handling errors are avoided, it has no functional link to the effects of the (unclaimed kind of) medication on the body of the patient. Thus, it is not a method of treatment that forms a barrier to patentability (Art 53(c) EPC).

Here are the practical takeaways from the decision T 3124/19 (Automatic association of medical elements/CAREFUSION) from December 12, 2023 of the Technical Board of Appeal 3.4.03.

Key takeaways

Enabling the clinician/caregiver to choose the correct medication from a plurality of medications is a technical effect and solves the technical problem of how to improve such that the “five rights” are still ensured in the presence of a plurality of medications.

Selecting a medication for a patient can have a therapeutic effect only if the selection is performed taking into account the kind of illness to be treated, in the sense that a medication is selected that has, for that kind of illness, a known, beneficial effect on the body of the patient.

However, selecting a medication only concerns operating the medical device such that human handling errors are avoided has no functional link to the effects of the (unclaimed kind of) medication on the body of the patient. Thus, it is not a method of treatment that forms a barrier to patentability (Art 53(c) EPC).

The invention

The Board summarized the invention as follows:

The application and the invention relate to providing an improved automated process to ensure the “five rights” of medication administration (right patient, right time, right medication, right route of administration, right dose) in a hospital (see paragraph [0002] of the description). In particular, the time-consuming steps of manually scanning bar codes to identify, e.g., the patient, the caregiver and the medication can be eliminated using a real-time locating system (paragraphs [0003] to [0006].

  • Claim 1 (sole request - labeling added by the Board)

Is it patentable?

In the decision under appeal, the Examining Division refused the application as it saw no technical problem that was solved over the prior art. In addition, it expressed doubts about the allowability of selecting a medication concerning Article 53(c) EPC. According to the Decision, the prior art document D2 (US 2004/019464 A1) was summarised as follows:

2. The relevant prior art

D2 discloses a patient care system. Although not explicitly mentioned as such, ensuring the “five rights” of medication administration is one of the aims of D2 (see paragraph [0055]). The disclosed system involves identifiers of clinicians, patients, medications and medical devices (see paragraph [0052]). The embodiments described in detail use bar code scanning for identification purposes, but D2 also refers to the use of RFID (see paragraphs [0022] and [0066]), that is to a real-time locating system.

The Board then considered D2 as the closest prior art and identified that it failed to disclose how a particular medication is selected when more than one medication is detected. Based on this, the Board formulated the problem as follows:

5.4 Technical effect / objective technical problem

When RFID is used to identify objects, more than one object of the same type may in the range of the system and consequently be detected. This may, in principle, also happen in a hospital where medications are to be detected by RFID. The technical effect of the distinguishing features is thus that the clinician/caregiver is enabled to choose the correct medication in such a situation. The objective technical problem might then be formulated as how to improve the system of D2 such that the “five rights” are still ensured in the presence of a plurality of medications.

Then, the Board assessed if it was obvious for a skilled person to arrive at the solution starting from document D2.

5.5 Obviousness

5.5.1 In its detailed embodiments, D2 refers to bar code scanning. With this technology, a plurality of medications present at the treatment location would not be a problem, because only one of them would be bar code scanned by the clinician. When the bar code scanning referred to in the detailed embodiments of D2 is to be replaced by its alternative RFID suggested in paragraphs [0022] and [0066] of D2, the skilled person would normally consider to use an RFID system with a similar range as bar code scanning, that is a few centimetres (using e.g. an NFC system). In that case, the above-mentioned problem would not arise, either.

It is thus likely that the skilled person, starting from D2, would not come across the issue addressed by the distinguishing features.

The skilled person, starting from D2, would thus probably not even consider that the above-mentioned problem needs to be solved.

5.5.3 The board thus concludes that the skilled person, starting from D2, would first of all not be aware that the objective technical problem defined above was to be solved at all. Further, even if it was aware of that problem and tried to solve it, it would arrive at a different solution than the one presented in claim 1.

Therefore, the subject-matter of claim 1 of the main request is inventive in view of D2 and the common general knowledge. Since D1 does not refer to medications at all, it has no relevance for the assessment of inventive step.

Finally, the Board addressed the doubt expressed by the Division if such a method would be considered a method of treatment and thus fall under the exception to patentability:

6. Exceptions to patentability – Article 53(c) EPC

The examining division expressed “considerable doubt” as to whether the step of selecting a medication constituted medical treatment and thus formed a barrier to patentability.

The board is of the opinion that selecting a medication for a patient can have a therapeutic effect only if the selection is performed taking into account the kind of illness to be treated, in the sense that a medication is selected that has, for that kind of illness, a known, beneficial effect on the body of the patient.

In the present case, however, the kind of illness does not play a role. Instead, the purpose of the claimed selection step is to make sure that a medication is administered that was previously chosen as appropriate, in a step preceding and therefore not being part of the claimed method.

That is, in the present case, the step of selecting a medication only concerns operating the medical device such that human handling errors are avoided. It has no functional link to the effects of the (unclaimed kind of) medication on the body of the patient (see section 4.3.2 of the Reasons for the Decision of decision G1/07).

The board therefore believes that in the present case, the step of selecting a medication (features e4) and e4′)) does not form a barrier to patentability of the independent claims, contrary to the remark of the examining division.

The Board considered the invention solved a technical problem and that Article 53(c) EPC also does not apply. Therefore, the case is remitted with the order to grant a patent.

More information

You can read the full decision here: T 3124/19 (Automatic association of medical elements/CAREFUSION) from December 12, 2023 of the Technical Board of Appeal 3.4.03.

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