近期判例法与欧洲专利局有关数学方法的指南之间的偏差

欧洲专利局上诉委员会最近的一项T决定（T 1741/22*1）涉及接收患者血液中的葡萄糖水平测量值，并从中得出最大和最小测量葡萄糖值，以便发现潜在的医疗异常值。

A recent T-decision by the Boards of Appeal (T 1741/22*1) involved receiving measurements of glucose levels in a patient's blood, and generating from them maximum and minimum measured glucose values, so that potential medical outlier values can be spotted.

*1 https://www.epo.org/en/boards-of-appeal/decisions/t221741eu1

尽管此类计算机程序在欧洲不具有专利性，但通常情况下，该决定所涉及的主题有望获得专利，因为它通过提供有关现实世界（人体）的信息做出了“技术贡献”。早在2018年，欧洲专利局审查指南（以下简称《审查指南》）就进行了修订，以提供一系列数学方法可以做出技术贡献的示例（指南G-II，3.3*2）。其中一个例子是“通过自动系统处理生理测量数据提供医学诊断”。事实上，另一个针对非常相似案例的决定（T 2681/16*3）承认了“提供葡萄糖变异的整体测量……以及血糖事件的预测”是技术性的。这与扩大委员会的决定G 1/19*4一致。正如其理由99所述，“人们普遍认为，测量具有技术性，因为测量方法一开始就基于与物理现实的相互作用”。正如理由89所述，“在计算机执行的流程中”，“技术效果”可能发生在“流程的输入端”，此时计算机执行的流程接收“可能包含测量的技术输入”。

Even though computer-programs as such are not patentable in Europe, the subject of this decision would normally be expected to be patentable because it makes a “technical contribution” by providing information about the real world (a human body).  Back in 2018, the EPO Guidelines for Examination were updated to provide a list of examples in which a mathematical method can make a technical contribution (Guideline G-II, 3.3*2). One of these examples is, “providing a medical diagnosis by an automated system processing physiological measurements”. Indeed, another decision (T 2681/16*3) for a very similar case acknowledged that, “providing an overall measure of the glucose variability… and a prediction of glycemic events”, was technical. This is in line with Enlarged Board decision G 1/19*4. As stated in its Reason 99, “It is generally acknowledged that measurements have technical character since they are based on an interaction with physical reality at the outset of the measurement method”. As stated in Reason 89, “in the context of a computer-implemented process”, “technical effects” can occur “at the input of the process” when a computer-implemented process receives “technical input which may consist of a measurement”.

*2 https://www.epo.org/en/legal/guidelines-epc/2024/g_ii_3_3.html

*3 https://www.epo.org/en/boards-of-appeal/decisions/t162681eu1

*4 https://www.epo.org/en/boards-of-appeal/decisions/g190001ex1

然而，目前的判决T 1741/22与T 2681/16和《审查指南》中的示例均存在偏差。在T 1741/22的2.3.6理由中，委员会指出，“在本案和T 2681/16所依据的案件中，“物理现实”通常是“患者的血液”， 一旦进行血糖测量，与物理现实的相互作用就结束了……提供总体血糖变异性和预测血糖事件是数学步骤或智力活动，这些步骤或活动是在没有与物理现实相互作用的情况下进行的，因此不是这个意义上的“测量”。换句话说，不包括人体测量步骤的专利申请不具有技术贡献。根据这一逻辑，如果软件或设备直接侵犯了专利权，而该专利权又涉及其他设备测量数据的处理，则无法获得专利权。这不仅适用于医学领域，也适用于其他任何领域。的确，如果一项专利的所有权利要求都包含测量现实世界（例如人体）的步骤，那么该专利可能会被只处理测量数据的软件“间接侵权”，但提起间接侵权诉讼并不总是那么简单。

However, the current decision T 1741/22 deviates from both T 2681/16 and the example given in the Guidelines. At Reason 2.3.6 of T 1741/22, the Board stated that, "In the present case and in the case underlying T 2681/16, where the "physical reality" is typically the "patient's blood", the interaction with the physical reality ends once blood glucose measurements are carried out… The provision of overall glucose variability and a prediction of glycemic events are mathematical steps or intellectual activities which take place in the absence of this interaction with the physical reality and are therefore not "measurements" in this sense". In other words, a claim which does not include a step of measurement of the human body does not make a technical contribution. By this logic, it is not possible to obtain a patent which is directly infringed by software or equipment for processing data measured by other equipment. This would be true not just in medical fields, but in any other field too. It is true that a patent in which all the claims include a step of measuring the real world (e.g. the human body) might be “indirectly infringed” by software which just processes measured data, but bringing an action for indirect infringement is not always straightforward.

T 1741/22中的推理似乎与G 1/19号判决中的理由99相矛盾，后者也提到间接测量“仍然与物理现实有关，因此具有技术性，无论结果如何使用”。如上所述，该权利要求包括生成最大和最小测量葡萄糖值的一个步骤，根据G 1/19号决定，这似乎完全属于“间接测量”的范畴。

The reasoning in T 1741/22 appears to be at odds with decision G 1/19, Reason 99 which also mentions that indirect measurements, “are still related to physical reality and thus of a technical nature, regardless of what use is made of the results”. As mentioned above, the claim features a step of generating maximum and minimum measured glucose values, which appears to fall firmly into the category of an, “indirect measurement”, according to decision G 1/19.

关于上文引用的《审查指南》G-II，3.3中的示例，委员会继续说道，“由于提供“医疗诊断”（无论是由医生还是由自动系统提供）都不具备任何技术特征（参见决定G 1/04*5，理由5.3和6.3），因此该示例明显是错误的。由于没有进一步的解释，更没有提及任何判例法，委员会认为没有理由猜测《审查指南》是如何得出这个例子的”：（见T 1741/22号判决的理由2.3.7）。G 1/04号判决实际上涉及的是另一个问题（它规定了一项测试，用于确定一项权利要求是否因缺乏技术特征以外的其他原因而被排除在可专利性之外），但其理由5.3与T 1741/22的总结相同，因此G 1/04和G 1/19之间似乎存在一些矛盾。G 1/04号决定早于G 1/19号决定15年，因此两者之间存在矛盾不足为奇。

In relation to the example in Guideline G-II, 3.3 quoted above, the Board went on to say that, “As providing a "medical diagnosis" - whether done by a physician or by an automated system - is devoid of any technical character (see e.g. Decision G 1/04*5, Reasons 5.3 and 6.3), this example is clearly erroneous. As there is no further explanation, let alone a reference to any case law, the board sees no reason to speculate on how the Guidelines came up with this example” (Reason 2.3.7 of T 1741/22). Decision G 1/04 is actually about a different issue (it sets out a test for determining if a claim is excluded from patentability for reasons other than lack of technical character), but its Reason 5.3 is as summarized by T 1741/22, so there appears to be some contradiction between G 1/04 and G 1/19. Decision G 1/04 predates decision G 1/19 by just over 15 years, so it is not surprising that there are contradictions between them.

*5 https://www.epo.org/en/boards-of-appeal/decisions/g040001ep1

Of note, the Board in T 1741/22 did not mention the COMVIK approach (Guideline G-VII, 5.4*6), which sets out how to assess a claim featuring both technical and non-technical features and stipulates that a feature that could be considered non-technical in isolation might contribute to producing a technical effect within the context of the invention.

总之，T 1741/22号决定与当前存在先例存在重大差异，可能会导致用于分析接收测量数据的软件/设备保护方式发生重大变化，甚至导致此类软件/设备能否得到保护成为问题。最终，可能有必要将此案提交给扩大上诉委员会，以消除这些矛盾。

In conclusion, decision T 1741/22 represents a significant deviation from the current precedent and could be a prelude to large changes in how software/equipment for analysing received measurements can be protected, and indeed, if such software/equipment can be protected at all. Ultimately, a referral to the Enlarged Board of Appeal could be necessary to put the contradictions to rest.

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联系作者 Contact the author

Thomas Storey: tstorey@marks-clerk.com

Tim Watkin: twatkin@marks-clerk.com