PECULIARITIES OF COMPULSORY LICENSES FOR THE USE OF A PATENTED INVENTION (USEFUL MODEL) RELATING TO A MEDICINAL PRODUCT

AbstractThis article focuses primarily on to what extent novel beings, and particularly, beings which display something akin to human consciousness or agency would be (or should be) patentable under current European patent law. Patents grant the patent holder a right to exclude others from using the patented invention for the period of patent grant (usually 20 years). This allows the patent holder to control how that invention can or cannot be used by others downstream, granting patent holders a governance like function over the patented technology for the duration of the patent. Accordingly, the potential for patentability of novel beings gives rise to a myriad of ethical issues including: to what extent is it appropriate for patent holders to retain and exercise patents over “novel beings”; how issues of “agency” displayed by any “novel beings” would fit within the current patent framework, if at all; and to what extent existing exclusions from patentability might exclude patents on “novel beings” or whether changes within patent law may be needed if patents in relation to “novel beings” are deemed ethically problematic. This article focuses on such issues, and in doing so, also sheds light on the role of ethical issues within the patenting of advanced biotechnologies more generally.

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Momordica charantia L. for Hyperlipidaemia: A Randomised Controlled Assessment of the Ghanaian Herbal Medicinal Product MCP-1

Journal of Herbal Medicine ◽

10.1016/j.hermed.2021.100453 ◽

2021 ◽

pp. 100453

Author(s):

Kwesi Prah Thomford ◽

Ama Kyeraa Thomford ◽

Joseph Yorke ◽

Ronald Yeboah ◽

Alfred Ampomah Appiah

Keyword(s):

Medicinal Product ◽

Momordica Charantia ◽

Herbal Medicinal Product ◽

Herbal Medicinal ◽

Randomised Controlled

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Mechanistic Illustration: How Newly-Formed Blood Vessels Stopped by the Mineral Blocks of Bone Substitutes Can Be Avoided by Using Innovative Combined Therapeutics

Biomedicines ◽

10.3390/biomedicines9080952 ◽

2021 ◽

Vol 9 (8) ◽

pp. 952

Author(s):

Fabien Bornert ◽

François Clauss ◽

Guoqiang Hua ◽

Ysia Idoux-Gillet ◽

Laetitia Keller ◽

...

Keyword(s):

Regenerative Medicine ◽

Bone Formation ◽

Medicinal Product ◽

Blood Vessels ◽

Bone Substitute ◽

Bone Substitutes ◽

Bone Defects ◽

New Bone Formation ◽

Polymeric Component ◽

Bone Filling

One major limitation for the vascularization of bone substitutes used for filling is the presence of mineral blocks. The newly-formed blood vessels are stopped or have to circumvent the mineral blocks, resulting in inefficient delivery of oxygen and nutrients to the implant. This leads to necrosis within the implant and to poor engraftment of the bone substitute. The aim of the present study is to provide a bone substitute currently used in the clinic with suitably guided vascularization properties. This therapeutic hybrid bone filling, containing a mineral and a polymeric component, is fortified with pro-angiogenic smart nano-therapeutics that allow the release of angiogenic molecules. Our data showed that the improved vasculature within the implant promoted new bone formation and that the newly-formed bone swapped the mineral blocks of the bone substitutes much more efficiently than in non-functionalized bone substitutes. Therefore, we demonstrated that our therapeutic bone substitute is an advanced therapeutical medicinal product, with great potential to recuperate and guide vascularization that is stopped by mineral blocks, and can improve the regeneration of critical-sized bone defects. We have also elucidated the mechanism to understand how the newly-formed vessels can no longer encounter mineral blocks and pursue their course of vasculature, giving our advanced therapeutical bone filling great potential to be used in many applications, by combining filling and nano-regenerative medicine that currently fall short because of problems related to the lack of oxygen and nutrients.

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Processing and Ex Vivo Expansion of Adipose Tissue-Derived Mesenchymal Stem/Stromal Cells for the Development of an Advanced Therapy Medicinal Product for Use in Humans

Cells ◽

10.3390/cells10081908 ◽

2021 ◽

Vol 10 (8) ◽

pp. 1908

Author(s):

Anna Labedz-Maslowska ◽

Agnieszka Szkaradek ◽

Tomasz Mierzwinski ◽

Zbigniew Madeja ◽

Ewa Zuba-Surma

Keyword(s):

Adipose Tissue ◽

Medicinal Product ◽

Stromal Cells ◽

Manufacturing Process ◽

Cellular Therapy ◽

Ex Vivo ◽

Ex Vivo Expansion ◽

Advanced Therapy Medicinal Product ◽

Differentiation Potential ◽

Advanced Therapy

Adipose tissue (AT) represents a commonly used source of mesenchymal stem/stromal cells (MSCs) whose proregenerative potential has been widely investigated in multiple clinical trials worldwide. However, the standardization of the manufacturing process of MSC-based cell therapy medicinal products in compliance with the requirements of the local authorities is obligatory and will allow us to obtain the necessary permits for product administration according to its intended use. Within the research phase (RD), we optimized the protocols used for the processing and ex vivo expansion of AT-derived MSCs (AT-MSCs) for the development of an Advanced Therapy Medicinal Product (ATMP) for use in humans. Critical process parameters (including, e.g., the concentration of enzyme used for AT digestion, cell culture conditions) were identified and examined to ensure the high quality of the final product containing AT-MSCs. We confirmed the identity of isolated AT-MSCs as MSCs and their trilineage differentiation potential according to the International Society for Cellular Therapy (ISCT) recommendations. Based on the conducted experiments, in-process quality control (QC) parameters and acceptance criteria were defined for the manufacturing of hospital exemption ATMP (HE-ATMP). Finally, we conducted a validation of the manufacturing process in a GMP facility. In the current study, we presented a process approach leading to the optimization of processing and the ex vivo expansion of AT-MSCs for the development of ATMP for use in humans.

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Temporomandibular Joint Osteoarthritis: Regenerative Treatment by a Stem Cell Containing Advanced Therapy Medicinal Product (ATMP)—An In Vivo Animal Trial

International Journal of Molecular Sciences ◽

10.3390/ijms22010443 ◽

2021 ◽

Vol 22 (1) ◽

pp. 443

Author(s):

Robert Köhnke ◽

Marcus Oliver Ahlers ◽

Moritz Alexander Birkelbach ◽

Florian Ewald ◽

Michael Krueger ◽

...

Keyword(s):

Stem Cell ◽

Hyaluronic Acid ◽

Medicinal Product ◽

Temporomandibular Joint ◽

Stromal Cells ◽

Stromal Cell ◽

Advanced Therapy Medicinal Product ◽

Animal Trial ◽

Advanced Therapy ◽

Temporomandibular Joint Osteoarthritis

Temporomandibular joint osteoarthritis (TMJ-OA) is a chronic degenerative disease that is often characterized by progressive impairment of the temporomandibular functional unit. The aim of this randomized controlled animal trial was a comparative analysis regarding the chondroregenerative potency of intra-articular stem/stromal cell therapy. Four weeks after combined mechanical and biochemical osteoarthritis induction in 28 rabbits, therapy was initiated by a single intra-articular injection, randomized into the following groups: Group 1: AB Serum (ABS); Group 2: Hyaluronic acid (HA); Group 3: Mesenchymal stromal cells (STx.); Group 4: Mesenchymal stromal cells in hyaluronic acid (HA + STx.). After another 4 weeks, the animals were euthanized, followed by histological examination of the removed joints. The histological analysis showed a significant increase in cartilage thickness in the stromal cell treated groups (HA + STx. vs. ABS, p = 0.028; HA + ST.x vs. HA, p = 0.042; STx. vs. ABS, p = 0.036). Scanning electron microscopy detected a similar heterogeneity of mineralization and tissue porosity in the subchondral zone in all groups. The single intra-articular injection of a stem cell containing, GMP-compliant advanced therapy medicinal product for the treatment of iatrogen induced osteoarthritis of the temporomandibular joint shows a chondroregenerative effect.

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