In this decision, the European Patent Office refused to grant a software patent on a digitalized approach for distributing product inserts. Here are the practical takeaways of the decision T 0223/18 (Product insert update/BIO-RAD) of 18.2.2020 of Technical Board of Appeal 3.5.05:
This European patent application concerns the digitalization of the existing workflow for distribution of product inserts. According to the application, conventional product inserts were printed and packaged with control products on the basis of information available at the date of manufacture. The invention provided an easy, cost-efficient and targeted way of distributing product insert information.
Here is how the invention is defined in claim 1:
Claim 1 (main request)A method of providing parameters of operating results for one or more control products used in biological reactions, the method comprising;
creating, by a development system (840), one or more parameters by analyzing data points of different results relating to one or more tests;
storing the one or more parameters in a development database (850);
receiving, by the development system (840), approval of the one or more parameters;
based on the approval, sending the one or more parameters to a user database (820), wherein a server system is communicably coupled with the user database;
receiving, by the server system, from a customer, a request for the one or more parameters relating to the one or more tests, each test operable to test one or more analytes in a biological reaction to generate one or more analyte results and operable to test the one or more control products in a biological reaction to generate one or more control results, the one or more control results operable to confirm a quality of the one or more analyte results, wherein the request identifies the one or more analytes and the one or more control products;
accessing the user database (820) to identify, by the server system, the one or more parameters corresponding to the request, wherein the one or more parameters specify one or more updated acceptable values for the one or more control results for confirming the quality of the one or more analyte results; and
sending the one or more parameters to the customer.
Is it technical?
The first instance examining divison had refused the patent application based on the argument that the subject-matter of the claim is the straightforward implementation of an administrative method using notorious technical means such as servers and databases, and consequently does not involve an inventive step. On the appeal stage, the appellant argued that the invention indeed had some business aspects, but that it nevertheless provided an easy, cost-efficient and targeted way of distributing product insert information.
The board was not persuaded:
The board does not doubt that, but the subject-matter of claim 1 does not go beyond the straightforward digitalization of the existing workflow for distribution of product inserts. It uses databases instead of paper for the storage of test data and the parameters derived from them, and servers for their distribution. It is evident that digitized information can be distributed much more easily, frequently, without the costs associated with printing, and that database management systems reply to queries unlike paper which does not.
The appellant also argued that the technical effect was to prevent the distribution of data that might not be accurate. Only when an insert was approved would that insert be transmitted to the end user insert database.
But also this argument did not convince the board:
However, as paragraph  of the application also points out, production of control product inserts is regulated by well-defined FDA-approved procedures that dictate inter alia how insert values are approved. There are equivalent legal or regulatory requirements in every jurisdiction. These requirements for accuracy of parameter values and their approval have to be met, as a matter of course, by conventional printed product inserts that the appellant describes as the prior art. Therefore, the subject-matter of claim 1 cannot have the alleged effect with respect to the prior art.
Lastly, the appellant argued that the method of claim 1 generates more accurate parameters by analyzing data to see if changes occur. However, the board noted that neither claim 1 not the description revealed any information regarding how the data is analyzed and thus the alleged effect was found to be merely speculative.
As a result, the board confirmed the first-instance decision that claim 1 concerned merely the straightforward implementation of an administrative method using notorious technical means such as servers and databases. Consequently claim 1 was found not to involve an inventive step, and the appeal was dismissed.
You can read the whole decision here: T 0223/18 (Product insert update/BIO-RAD) of 18.2.2020