BIOTECHNOLOGY AND INTELLECTUAL PROPERTY RIGHTS
Journal: Publication No.2 2024
Abstract
Continuous advancements in biotechnology have brought about significant transformations in society,
particularly in the fields of molecular biology and genetics, where biotechnology has introduced new approaches
to medicine and healthcare. Subsequently, the vast potential of biotechnological developments to yield commercial
outcomes has led to the intersection of Biotechnology with Intellectual Property rights, where industries and
intellectual property developers aim to incorporate new biotechnological inventions through IP protection. The
intertwining of Intellectual Property legislation and biotechnology has posed numerous legal and ethical
challenges at the international level, which are also reflected in the domestic legal framework. This paper aims to
shed light on the understanding of biotechnology by exploring the legal framework regulating biotechnological
patents. Furthermore, the paper presents discussions on the necessity of patent protection for biotechnology and
the legal hurdles identified for such protection. By analyzing the implementation of Directive 98/44/EC concerning
the legal protection of biotechnological inventions within the European Union framework, as well as legislative
developments in a comparative scope across different jurisdictions, and considering scientific perspectives along
with judicial practice in this field, the paper aims to provide insight into this complex legal framework by focusing
on the balance between fostering innovation through patents and ensuring access to essential biotechnological
advancements.
Keywords: biotechnology, intellectual property, patents, microbiological process, cloning, public order
Bibliography
1. Aboy M and others. ‘After Myriad, What Makes a Gene Patent Claim “Markedly Different” from
Nature?’ (2017) 35 Nature Biotechnology 820.
2. Ann C. ‘Patents on Human Gene Sequences in Germany: On Bad Lawmaking and Ways to Deal with It’
(2006) 7 German law journal 279.
3. Beyleveld D and Brownsword R, Mice, Morality and Patents: The Onco-Mouse Application and Article
53(A) of the European Patent Convention (Intellectual Property Institute 1993) 57.
4. Burgess R. ‘Introduction to Stem Cells’ in Stewart Sell (ed), Stem Cells Handbook (Humana Press 2013)
5. Chen F-C and others. ‘Genomic Divergence between Human and Chimpanzee Estimated from LargeScale Alignments of Genomic Sequences’ (2001) 92 The Journal of heredity 481.
6. Cinalli RM, Rangan P and Lehmann R. ‘Germ Cells Are Forever’ (2008) 132 Cell 559.
Emri i Autorit
7. Cole P. ‘Patentability of Genes: A European Union Perspective’ (2015) 5 Cold Spring Harbor
perspectives in medicine.
8. Gilabert P. Human Dignity and Human Rights (Oxford University Press 2018) 3.
9. Heselhaus S and Hemsley R. ‘Human Dignity and the European Convention on Human Rights’ in Paolo
Becchi and Klaus Mathis (eds), Handbook of Human Dignity in Europe (Springer 2018).
10. Isasi RM and Knoppers BM. ‘Beyond the Permissibility of Embryonic and Stem Cell Research:
Substantive Requirements and Procedural Safeguards’ (2006) 21 Human Reproduction 2474.
11. Melullis K-J. ‘Article 1a: Menschliche Gene’ in Georg Benkard and and others (eds), Patentgesetz:
Gebrauchsmustergesetz, Patentkostengesetz (Beck’sche Kurz-Kommentare) (CHBeck 2015).
12. Melullis K-J. ‘Article 2a: Pflanzen Und Tiere’ in Georg Benkard and Klaus Bacher (eds), Patentgesetz
Gebrauchsmustergesetz, Patentkostengesetz (München, CH Beck 2023).
13. Parkinson J and Blaxter M. ‘Expressed Sequence Tags: An Overvieë’ in John Parkinson (ed), Expressed
Sequence Tags (ESTs) Generation and Analysis (Humana Press 2009).
14. Patentgesetz in der Fassung der Bekanntmachung 1980.
15. Prawo własności przemysłowej 2000.
16. Resnik DB. ‘The Commercialization of Human Stem Cells: Ethical and Policy Issues’ (2002) 10 Health
Care Analysis 127.
17. Skubisz R. Industrial Property Laë. Private Laë System. Volume 14A (2nd edn., CH Beck 2017) 391.
18. Spranger TM, ‘Ethical Aspects of Patenting Human Genotypes according to EC Biotechnology Directive’
(2000) 31 IIC; international revieë of industrial property and copyright laë 373.
19. Shoqata për Patologji Molekulare et al v Myriad Genetics, Inc.
20. T 0356/93 (Plant cells) 21-02-1995 (ECLI:EP:BA:1995:T03569319950221).
21. Tiedemann, Paul. Philosophical Foundation of Human Rights. Springer Nature, 2020.
22. Wartburg VWP and Liew J, Gene Technology and Social Acceptance (University Press Of America
1999) 128.
Legjislacion
1. Code de la propriété intellectuelle 2021.
2. Codice della proprietà industriale 2005.
3. Direktiva 98/44/KE e Parlamentit Evropian dhe e Kwshillit e datws 6 korrik 1998 mbi mbrojtjen ligjore
të shpikjeve bioteknologjike 1998.
4. Konventa për mbrojtjen e të Drejtave të Njeriut dhe Dinjitetit të Qenieve Njerëzore në lidhje me Aplikimin
e Biologjisë dhe Mjekësisë: Konventa për të Drejtat e Njeriut dhe Biomjekësinë 1997.
5. Ligj 9947 datë 07.07.2008 “Për Pronësinë Industriale (i ndryshuar).
6. Ligji i Patentave (i ndryshuar) 1977.
7. Ligji Nr. 9590, datë 27.07.2006, Marrëveshja e Stabilizim-Asociimit, ndërmjet Komuniteteve Evropiane
dhe Shteteve Anëtare të tyre, të njërës pjesë, dhe Republikës së Shqipërisë, nga ana tjetër. L. 107 / 166,
Gazeta Zyrtare e Bashkimit Evropian 28.04.2009.
8. Marrëveshja TRIPS 1995.
9. Propozim për një Direktive të Parlamentit dhe Këshillit Evropian për mbrojtjen ligjore të Shpikjeve
Bioteknologjike 1989.
10.Propozim për një Direktive të Parlamentit dhe Këshillit Evropian për mbrojtjen ligjore të Shpikjeve
Bioteknologjike 1995.
11.Vendim Nr. 350 datë. 26.05.2022, Për miratimin e Strategjisë kombëtare të Pronësisë Intelektuale, 2022-
2025. Fletore Zyrtare Nr.85 datë 07.06.2022.
Jurisprudencë
1. C-34/10 - Brüstle
2. C-364/13 - International Stem Cell
Revista Studime Juridike Nr. 2, 2024
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3. C-377/98 - Netherlands v Parliament and Council
Web faqe
1. Hobbes T, The Project Gutenberg EBook of Leviathan (St Paul’s Churchyard 2002)
accessed 29 March 2024.
2. Joseph S, ‘Genpatentierung – Eine „Abstruse Idee“?’ (2000) 97 Dtsch Arztebl
accessed 29 March 2024.
3. Zeleny E, ‘Michael Jackson’s Anti-Gravity Illusion - Ëolfram Demonstrations Project’
(demonstrations.ëolfram.com2011) accessed 29 March 2024.

