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Securing IP protection in Brazil for the ‘bio-ink’ used to print new human tissue has challenges but composition is key, say Priscila Kashiwabara and Breno Souza of Kasznar Leonardos.
3D printing, also known as additive manufacturing, has proven to be a disruptive tool for many technological fields, including medicine.
This technology enables objects to be “printed” by successively adding their layers. In this sense, printing has moved beyond paper and taken on a three-dimensional form in our physical space. Its products can be used as components or even as the finished article in various human activities.
In a simplified manner, the first step of 3D printing involves creating a digital model of the object to be printed. This is typically done using computer-aided design (CAD) modelling software or by utilising dedicated online services provided by some of the 3D printing platforms.
3D printing of biological materials
Until recently, 3D printing was primarily used for repairing and printing spare parts for objects. The next step in this revolution has been the ability to produce entire and functional products.
However, thanks to the continuous development of technological infrastructure, 3D printing has expanded its boundaries and is now being used to repair and reproduce human cells, tissues, and body parts.
This recent breakthrough in biotechnology has turned science fiction scenarios into reality, where human tissues and organs can be printed on-site and on-demand.
With some frequency, 3D printing has already been used in medicine, such as in pre-surgical planning and the intra-operative use of personalised instrumentation, surgical guides, and models based on the patient’s own computed tomography and magnetic resonance imaging data, especially in the field of orthopedics.
However, with the advancements in technology and the increased resolution of such printers, the development of 3D bioprinting has become possible. This involves the “printing” of a biological ink, layer by layer, in such a way that living cells are simultaneously deposited along with their respective growth factors to create a framework for growing human cells or tissues.
3D bioprinting combines the principles of rapid prototyping engineering with tissue engineering science in a controlled environment to accelerate cell adhesion, proliferation, and differentiation, ultimately producing living and functional tissues.
The purpose of this article is to assess the patentability of 3D printing technology for biological materials in light of current industrial property legislation and the technical guidelines published by the Brazilian Institute of Industrial Property (BRPTO).
The patentability of 3D printing and its products in Brazil
3D printing, when related to the life sciences field, can generally generate two types of products: prosthetics and biological material per se.
The importance in the prosthetic field is undeniable; however, this is not the focus of the present article, which specifically focuses on the printing of biological materials per se.
In this regard, the Brazilian Industrial Property Law (BIPL) provides that whole or part of natural living beings and biological materials found in nature are not considered inventions.
Additionally, whole or part of living beings, except for transgenic microorganisms, are not patentable (pursuant to Article 10, Section X, and Article 18, Section III).
This could initially be considered an obstacle to biological products produced by 3D printing, such as a human organ or a piece of human skin.
However, “natural”, could be understood as “referring to nature”, “produced by nature”, “in which there is no work or intervention by man”, thus allowing the construction that it means “discoveries” or absence of creative process by man that results in an invention.
Moreover, the Guidelines define a “natural biological process” as any biological process that occurs spontaneously in nature, and wherein human intervention does not affect the final outcome. In this context, the definitions of “produced by nature” and “in which there is no work or intervention by man” open up a range of possibilities in which biological products from 3D printers could be included.
Firstly, it is clear that the product of a 3D bioprinter is a biological material. In this sense, if we are dealing with an invention that uses cells as a “bio-ink” that is printed onto a biocompatible matrix through an automated, computer-aided, three-dimensional deposition process of cells by a three-dimensional release device (in this case, the bioprinter), the final product is a tissue itself that could be used in tissue regeneration in patients affected by certain diseases.
For instance, if the bio-ink is a liver cell, a patient with liver disease could be treated by such bioprinted organ or tissue.
However, the BRPTO’s Guidelines for Examination of Patent Applications in the Area of Biotechnology specifically highlights that:
The whole or part of natural living beings and biological materials found in nature—even if isolated from it, or produced synthetically that have naturally occurring counterparts, with no way to distinguish them from natural ones—are considered natural biological products, and not will be considered as an invention, as they fall within art. 10 (IX) of the BIPL. (in verbis)
As such, not only isolated parts of natural living beings, but also synthetically produced parts of living beings which are identical to their natural counterparts, would not be eligible for protection.
Cells as part of a composition
At this point, it is important to draw a parallel with the BRPTO’s understanding in relation to stem cells. The following excerpt from the BRPTO Biotechnology Guidelines stands out:
According to the Brazilian Industrial Property Law (BIPL), cells themselves, whether obtained directly from an animal or through genetic modification, are not patentable under the provisions of Article 10 (IX) or Article 18 (III), respectively. However, compositions containing these cells, the processes for obtaining stem cells, and their applications (uses) can be considered patentable as long as they do not involve or include a therapeutic and/or surgical method (Article 10 (VIII)), and provided that they do not fall under the provisions of Article 18 (I) of the BIPL. (in verbis)
The BRPTO states that stem cells per se are not considered patentable since they are isolated from the body of a living organism (animal or plant). However, when these cells are presented in the form of a composition, they may be considered patentable.
Furthermore, the BRPTO asserts that compositions containing cells and other ingredients (various implants containing cells, cell and matrix formulations, cells and growth factors, etc) and compositions containing mixtures of different types of stem cells, are eligible for patenting.
The understanding applied to stem cells could also be applied to the specific case of 3D printing of biological materials. This is because even when cells are used as “bio-ink”, they are not applied in isolation. The cells are part of a composition with other components since they require nutrients and other compounds to maintain viability.
Therefore, in the event that objections to the protection of the printed organ or tissue are raised, a composition comprising cells for use as bio-ink for tissue printing could be defensible.
Furthermore, there is no doubt that the 3D printing process is patentable since it cannot be characterised as a natural biological process. Printing clearly deviates from the BRPTO’s definition for natural biological process, as set out above.
In light of this specific point, a possibility for protection arises for products derived from this process. It is worth noting that Article 42 of the BIPL states that a patent grants its holder the right to prevent third parties, without their consent, from producing, using, offering for sale, selling, or importing, for these purposes, the process or product directly obtained by a patented process.
Therefore, since 3D printing processes are fully patentable (assuming they meet the patentability requirements), in accordance with Article 42 (II) of the BIPL, the product directly obtained by said process would also be indirectly within the scope of patent protection.
Unlike the process, which would be defined in the patent’s claims, the product would not be listed in the set of claims. This feature creates a distinct scenario if the inventor wishes to enforce their patent rights. Instead of a direct comparison between the allegedly infringing product and the claims in the patent’s claim set, it would be up to the alleged infringer to demonstrate that the tissue or organ was obtained by a process distinct from that which is the subject of the patent’s protection.
In light of the foregoing, it is evident that the BRPTO adopts a restrictive position in accordance with the legal constraints established by the BIPL.
First and foremost, it is essential to underscore the understanding in terms of scope of Articles 10 (IX) and 18 (III) of the BIPL that the BRPTO has incorporated into its Biotechnology Guidelines.
By asserting that biologic materials identical to naturally occurring ones but produced synthetically (through human inventive intervention) are not eligible for protection, the BRPTO takes the position that, even in the presence of human intervention, a product resembling its natural counterpart is not subject to patent protection in Brazil.
This point deserves greater attention, particularly when referring to bio-ink, so that a claim aimed to protect it is not defined solely by comprising cells. Bio-ink is the composition that the machinery will use to shape the targeted biological material.
Considering that such a composition comprises various components, including specific cells of the organ or tissue to be produced, growth factors, and any other elements necessary for the development of these cells, it does not have a natural counterpart and should be considered eligible for patent protection.
Furthermore, it is also important to highlight the implications of Article 42 of the BIPL. Since it establishes that a patent also provides protection for a product directly obtained by a patented process, the possibility of protecting biologic material identical to nature is envisioned, albeit indirectly.
In this case, the burden of proof should fall upon the alleged infringer, who must unequivocally demonstrate that their product is obtained by a process distinct from that protected by a patent.
Priscila Kashiwabara is a partner at Kasznar Leonardos, heading the life sciences patent division. She can be contacted at: firstname.lastname@example.org
Breno Souza is a senior patent specialist at Kasznar Leonardos. He can be contacted at: email@example.com
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