Machine learning, neural networks and gene therapies in the new approach of the Polish Patent Office
Publication date: December 6, 2023
Polish industrial property law provides for the protection of intangible assets that have industrial applications. One of the possible subjective rights that protect the rights of the owner of intangible property is a patent, which is granted for an invention and gives the exclusive right to use it for profit, professionally and as a subject of legal transactions.
An invention is not clearly defined in the Polish Industrial Property Law Act, but it is considered to be a product that is a technical solution that should be new, have a level of invention and have industrial application.
The notion of novelty means that a given solution is not part of the state of the art and has not been made publicly available. An invention constitutes an inventive step if it is not obvious to a person skilled from prior state of art. This means that the product is a solution that someone with extensive knowledge of a given field could not easily come up with. The requirement for industrial use means that the use of a given solution always brings the same effect and can be used in any industrial activity, including agriculture.
We can distinguish 4 categories of inventions: products, devices, applications and methods. There are cases in which it is not possible to sufficiently determine the characteristics of the product, consisting in structure, composition or physical and chemical parameters appropriate to the category of the invention. In such a case, it is possible to patent the manufacturing method.
A method is a process of conduct, the result of which is a material product, which may consist of activities, operations or technological processes and take into account the sequence, impact on matter, tools, materials, raw materials used and determine the conditions under which the activities are to be carried out.
The granting of a patent requires meeting formal requirements. The product itself should be patentable, and the description of the invention should indicate that it is not possible to sufficiently present the features of the invention without taking into account the process of its production.
Implementation of a specific manufacturing method should lead to the same results every time.
Pursuant to Article 64(1) of the Polish Industrial Law Act[1], a patent obtained for a method also protects the product obtained in this way. To illustrate with an example; the patent on the method of producing a given vaccine also covers the manufactured vaccine.
PATENTS IN THE MEDICAL INDUSTRY
In the medical market, property rights are a key element of business, as this market is characterized by extremely strong competition. The granting of a patent, and therefore a temporary monopoly on a given medical device, is a kind of compensation for the research costs incurred.
Scope of patent protection and biotechnological invention
In this industry, patents are granted for all categories of inventions; products (e.g. substances, products consisting of biological material), tools (e.g. used in surgery) as well as methods (manufacturing, processing substances). It is also possible to obtain a patent for a new use of an already known substance.
In the Polish Patent Law, a biotechnological invention is separately defined as relating to a product consisting of or containing biological material or involving a method of producing, processing or using such material.
The processing of fluids and tissues originating from the human body is not excluded from patentability if the fluids and tissues in question do not return to the patient’s body after processing. To illustrate this, it is possible to patent a method of processing blood for research, but it would not be possible to obtain a patent for processing blood in the dialysis process, as the blood returns to the patient’s body.
Patent and additional protection right
The additional protection law was implemented into the Polish Act on the basis of the European Union regulations on the introduction of additional protection certificates for medicinal products. In the case of the pharmaceutical industry, the monopoly period for the manufactured drug is very important. The patent is granted for 20 years, with the patent protection period starting on the date of filing. Years can pass between filing and receiving a patent, which actually shortens the time in which you can exercise the exclusive right to your invention. The additional 5 years of protection are intended to compensate for the time during which the patent was considered.
Regulatory privilege (Bolar exception) and pharmacy exception
The legislator provides for the possibility of limiting a patent to a permitted method of encroaching on someone else’s property. This is the so-called fair use of the patent.
In the case of the medical industry, when it comes to restrictions, it is worth mentioning regulatory and pharmacy privileges.
The first one, also called the Bolar exception, gives producers of generic drugs (reproductive drugs containing the same active substance as the original drug covered by the patent) the opportunity to conduct research on their drug that could violate the original patent.
Thanks to this, the generic drug is ready to be introduced to the market when the competitor’s patent expires.
Pharmacy privilege, on the other hand, consists in permission to dispense a given drug in a pharmacy under a doctor’s prescription.
Exemptions from patenting
Article 29 of the Polish Patent Law provides for exclusions from patentability of technical solutions (inventions) which, by their nature, cannot be covered by a patent. The only exception consists of methods of treating people. This exclusion is intended to ensure equal access to treatment for all people and to prevent a situation in which someone cannot use a surgical or therapeutic method due to applicable exclusive law.
PATENTING AN INVENTION BASED ON OR USING A COMPUTER PROGRAM
As a rule, a computer program considered to represent an algorithm is treated as a literary work and protected under copyright law. Also, the computer program itself is mentioned in Art. 28 of the Polish Patent Law as not being an invention and therefore not subject to patenting.
However, with the development of technology, technical solutions began to be created that were somehow based on or used as a computer program.
The Polish Patent Office was reluctant to grant patents for such solutions. Many people sought the protection of a European patent, which was easier to obtain in this situation.
A NEW APPROACH OF THE POLISH PATENT OFFICE ON PATENTS IN THE BORDERLINE OF INFORMATION TECHNOLOGY (IT) AND LIFE SCIENCE INDUSTRY
At the beginning of 2023, the approach of the Polish Patent Office has brought considerable changes, along with updating the guidelines of the President of the Polish Patent Office published in “Bulletin of the Patent Office” No. 2/2023. In this document, the Polish Patent Office referred to specific examples from patenting practice, issuing so-called guidelines, among others, on the understanding and patentability of mathematical methods and computer programs, which, due to the importance and essence of the problem, we quote in full[2].
This is important for correcting the conservative approach of refusing to patent software in Poland, especially open-source solutions and mathematical solutions of binary language.
Regarding the assessment of mathematical methods from the perspective of patent law, the Polish Patent Office stated that: “A method “as such” is recognized when the claim / application concerns a purely abstract mathematical method and does not require any technical means”.
FOURIER METHOD WITHOUT A PATENT
For example, a method of performing a fast Fourier transform (FFT) on abstract data, which does not specify the use of any technical means, is a mathematical method itself. Furthermore, a purely abstract mathematical object or concept, e.g. a particular type of geometric figure or a graph with nodes and edges, is not an invention because it lacks a technical nature. If the objection concerns a method involving the use of technical means (e.g. a computer), it is a “not as such” method. However, when assessing the contribution of a mathematical method to the technical nature of the invention, it should be taken into account whether this method, in the context of the invention, produces a technical effect serving a technical purpose.
TECHNICAL CONTRIBUTION = PATENT
Examples of the technical contribution of a mathematical method (i.e. not a mathematical method as such) are: improvement or analysis of digital sound, image or video, e.g. noise removal, detection of people in a digital image, assessment of the quality of a transmitted digital audio signal; data encoding for reliable and/or efficient transmission or storage (and corresponding decoding), e.g. error correction coding of data for transmission over a noisy channel, compression of audio or sensor data; providing a genotype estimate based on analysis of DNA samples, as well as providing a confidence interval for this estimate to quantify its reliability; providing medical diagnosis through an automated system that processes physiological measurements.
SYSTEM CONTROL = PATENT FREE
However, a general purpose such as “control of a technical system” is not sufficient to make a mathematical method technical. The technical goal must be specific. Even the mere fact that a mathematical method can serve a technical purpose is also not sufficient. The disclaimer must be functionally limited to a technical purpose, either expressly or implicitly.
If the steps of a mathematical method are used to obtain or predict the physical state of an existing real object from measurements of physical properties, as in the case of indirect measurements, these steps make a technical contribution regardless of how these results are used.
Artificial intelligence and machine learning are based on computational models and algorithms for classification, clustering, regression and dimension reduction, such as neural networks, genetic algorithms, support vector machines, k-means algorithm (clustering), kernel regression and discriminant analysis. Such computational models and algorithms are per se abstract mathematical in nature, regardless of whether they can be “trained” from training data. Terms used there, such as “support vector machine”, “reasoning engine” or “neural network”, may, depending on the context, refer only to abstract models or algorithms and therefore do not necessarily imply the use of technical means. This should therefore be taken into account when examining whether the claimed subject matter as a whole is of a technical nature – in the context of Art. 24 and Art. 28 section 1 and 2 of Polish Patent Law.
Artificial intelligence and machine learning are used in various fields of technology. For example, the use of a neural network in a heart monitoring device to identify irregular heartbeats is a technical contribution. Classifying digital images, videos, audio signals or speech based on low-level features (e.g. edges or pixel attributes in the case of images) are other common technical applications of classification algorithms.
However, the classification of text documents solely according to their content is not considered a technical but a linguistic purpose. Classifying abstract data records or even “telecommunications network data records” without indicating the technical use of the resulting classification is also not a technical goal – per se, even if the classification algorithm can be considered as having valuable mathematical properties.
In the case of simulation, it is not decisive for determining the presence of a technical effect whether the system or process being simulated is technical, or whether the simulation reflects the technical principles underlying the simulated system and how accurately it does so.
Computer-implemented simulations that contain features responsible for interacting with external physical reality at the level of their input or output (“input” and “output” may occur not only at the beginning and end of a computer-implemented process, but also in the middle of that process), can also provide the technical effect associated with this interaction. A computer simulation that uses measurements as input can form part of an indirect measurement method that calculates or predicts the physical state of an existing real-world object and therefore makes a technical contribution regardless of how the results are used.”[3]
In turn, as regards computer programs (Article 28(1)(5) of the Polish Patent Law), the Polish Patent Office provided in the guidelines examples of further technical effects that give a technical character to a computer program, which affects the assessment of the patentability of the software phenomenon:
“A computer program which, when run on a computer, produces a ‘further technical effect’ is of a technical nature and is therefore not patentable. A ‘downstream technical effect’ is a technical effect beyond the ‘normal’ interactions between the program (software) and the computer (hardware) on which it is run, i.e. beyond normal physical effects. The normal physical effects of program execution, e.g. the flow of electrical current in a computer, are not in themselves sufficient to give a computer program a technical character. An example of further technical effects that give a computer program its technical character is the control of a technical process or the internal workings of the computer itself or its interfaces. The presence of a further technical effect is assessed without reference to the state of the art. The mere fact that a computer program serving a non-technical purpose requires less computational time than an earlier program serving the same non-technical purpose does not prove the presence of a further technical effect.
A computer like a human without a patent
Similarly, comparing a computer program with how a human would perform the same task is not an appropriate basis for assessing whether a computer program is technical in nature. A computer program cannot acquire technical character merely by being designed to be automatically executed by a computer. “Further technical aspects” are necessary, usually related to technical considerations of the computer’s internal workings, beyond just finding a computer algorithm to perform the task. They must be reflected in the features referred to in the claims that produce a further technical effect.
A “computer-implemented invention” refers to computers, computer networks, or other programmable devices in which at least one feature is implemented by a computer program. A computer program and the corresponding computer-implemented method are different from each other. The former refers to the sequence of instructions executed by the computer, specifying a method, while the latter refers to the method actually executed on the computer. The objection under Art. 28 section 1 in connection with paragraph 2 of the Polish Patent Law cannot be made with respect to claims regarding a method implemented using a computer, a computer-readable storage medium or devices, because any method using technical means (e.g. a computer) and any technical means as such (e.g. a computer or a readable storage medium by computer) are of a technical nature and therefore constitute inventions within the meaning of Art. 24 of Polish Patent Law.
Software patent – examples
Examples of further technical effects that give a technical character to a computer program running on a computer are:
– through technical process control:
the method of preventing car wheels from locking;
dose determination in an X-ray machine;
image compression;
restoring a distorted digital image;
data transmission encryption;
– by controlling the internal functioning of the computer itself or its interfaces: computer programs that implement security measures to protect boot integrity (i.e. securing the boot process by preventing the installation of malicious software); countermeasures against power analysis attacks (i.e. cryptanalysis using analysis of the electrical power consumed due to the transition of a bit value from “0” to “1” and vice versa); CPU load balancing solutions.
This is different from reading a data type parameter from a file as input to a computer program, rather than defining the data type in the program itself. This is merely a programming option when writing code and is not technical in itself.
The same applies to naming conventions for object names to make program code easier to understand and manage. Defining and providing a programming language or programming paradigm, such as object-oriented programming, does not in itself solve a technical problem, even if its particular syntax and semantics enable the programmer to more easily develop the program.
Facilitating a programmer’s intellectual effort is not a technical outcome in itself. A data structure or format contributes to the technical character of an invention if it has an intended technical use and produces a technical effect when used in accordance with that intended technical use.
This potential technical effect related to the implied technical use should be taken into account when assessing the inventive step. In particular, such an effect may occur if the data structure or format is functional, i.e. if it serves a technical function in a technical system, such as controlling the operation of a data processing device. Functional data inherently includes or reflects the relevant technical characteristics of a device. At the same time, cognitive data (e.g. a photograph of a person or a landscape) are data whose content and meaning are important only for human users and do not contribute to causing a technical effect. The data structure or format may have characteristics that cannot be characterized as cognitive data (i.e., do not serve to convey information to the user) but that nevertheless do not make a technical contribution.
For example, the structure of a computer program may be intended only to facilitate the programmer’s task, which is not a technical result serving a technical purpose. Furthermore, data models and other information models at the abstract logical level are not themselves technical in nature. Database management systems are technical systems implemented on computers to perform technical tasks of storing and retrieving data using various data structures for effective data management. The method performed in the database management system is therefore a method using technical means and is therefore not patentable under Art. 28 section 1 and in connection with paragraph 2 of the Polish Patent Law.”[4]
To sum up, the basic factor determining whether a given solution can be patented is whether it has technical features or implements a process that produces a technical effect. Of course, in addition to its technical application, the invention must be patentable.
Further technical effect
In the case of computer programs, case law provides that they may exhibit the so-called “further technical effect”. This effect refers to all activities that involve more than just the interaction of the program with the computer. Applying a given program produces some effect. This effect may take place virtually or in the real world, e.g. entering the wrong pin several times causes the phone to be blocked or the program allows you to remotely control/switch on the washing machine.
Mathematical methods and software patentable or not?
As a rule, the general principle in Polish law remains unchanged that mathematical methods and software are generally excluded from patentability as they are not inventions. Therefore, a computer program or mathematical methods whose task is to conduct calculations on the given data, e.g. to analyze them effectively, would not be patentable, as they do not cause technical effects and are only of an abstract nature, also from the perspective of assessing mathematical methods.
In order to patent IT solutions, it is necessary to demonstrate a “TECHNICAL EFFECT” related to a specific therapeutic, technical or IT procedure.
[1]Act of June 30, 2000, Industrial Property Law (consolidated text: Journal of Laws of 2023, item 1170), hereinafter referred to as “Polish Patent Law”.
[2] Pursuant to Art. 28 of the Polish Patent Law, neither mathematical methods nor computer programs are, in principle, considered patents under Polish patent law.
[3] https://uprp.gov.pl/sites/default/files/wup/2023/01_1-5/02/wup02_2023.pdf page 71,72 and 73.
[4] https://uprp.gov.pl/sites/default/files/wup/2023/01_1-5/02/wup02_2023.pdf
