ПАТЕНТНЫЕ ПРАВА
НА РЕЗУЛЬТАТЫ ГЕНЕТИЧЕСКИХ ИССЛЕДОВАНИЙ:
УСЛОВИЯ ПРЕДОСТАВЛЕНИЯ, ДОПУСТИМЫЕ
ИЗЪЯТИЯ И ОГРАНИЧЕНИЯ

А.С. ВОРОЖЕВИЧ,
кандидат юридических наук, ассистент кафедры гражданского права юридического факультета МГУ им. М.В. Ломоносова

DOI: 10.24031/1992-2043-2020-20-2-176-216

В статье анализируются проблемы патентования результатов генной инженерии. На основе анализа зарубежного опыта и взвешивания возможных негативных и положительных эффектов автор оценивает патентоспособность выделенных генов, трансгенных животных, способов генной коррекции: выключения и редактирования генов. Кроме того, исследуются вопросы, при каких условиях на запатентованные результаты генетических исследований могут выдаваться принудительные лицензии; существует ли необходимость в установлении дополнительных случаев свободного использования применительно к рынку биотехнологий.


Ключевые слова: исключительное право; патент; биотехнологии; гены; редактирование генов; принудительное лицензирование.

References

Ворожевич А.С. Защита исключительных прав на патентоохраняемые объек-
ты: монография [Vorozhevich A.S. Protection of Exclusive Rights to Patent Protected
Objects: Monograph] (in Russian). Moscow: Statut, 2020.
Ворожевич А.С. Пределы защиты исключительного права патентообладате-
ля [Vorozhevich A.S. The Limits of Protection of the Exclusive Right of the Patent
Holder] (in Russian) // Patents and Licenses. 2019. No. 8.
Ворожевич А.С. Пределы осуществления исключительных прав на стандарт –
необходимые патентоохраняемые объекты и программное обеспечение. Усло-
вия FRAND [Vorozhevich A.S. The Limits for the Exercise of Exclusive Rights to the
Standard Are the Necessary Patent-Protected Objects and Software. FRAND Terms]
(in Russian) // Journal of the Intellectual Property Court. 2018. No. 20.
Ворожевич А.С., Третьяков С.В. Об утилитарности интеллектуальных прав, при-
нудительных лицензиях и бюрократических рентах [Vorozhevich A.S., Tretyakov S.V.
On the Utility of Intellectual Rights, Compulsory Licenses, and Bureaucratic Rents]
(in Russian) // Law. 2017. No. 8.
Мельников В.Н. От патентования генов – к патентованию форм жизни высо-
кого уровня [Melnikov V.N. From Patenting Genes to Patenting High-Level Life
Forms] (in Russian) // Patents and Licenses. 2005. No. 3.
Парфенчик О.С. Директива о правовой охране биотехнологических изобре-
тений: анализ основных противоречий [Parfenchik O.S. Directive on the Legal
Protection of Biotechnological Inventions: Analysis of the Main Contradictions]
(in Russian) // Private International Law. 2011. No. 4.
Calabresi G., Melamed A.D. Property Rules, Liability Rules, and Inalienability: One
View of the Cathedral // Harvard Law Review. 1972. Vol. 85. No. 6.
Cho M., Illangasekare S., Weaver M.A., Leonard D.G., Merz J.F. Effects of Patents and
Licenses on the Provision of Clinical Genetic Testing Services // Journal of Molecular
Diagnostics. 2003. Vol. 5. Iss. 1.
Cook-Deegan R., DeRienzo C., Carbone J. et al. Impact of Gene Patents and Licensing
Practices on Access to Genetic Testing for Inherited Susceptibility to Cancer:
Comparing Breast and Ovarian Cancers to Colon Cancers // Genetics in Medicine.
2010. Vol. 12 (4 Suppl.).
Gold R., Carbone J. Myriad Genetics: In the Eye of the Policy Storm // Genetics
in Medicine. 2010. Vol. 12 (4 Suppl.).
Hawkins N. A Red Herring – Invalidity of Human Gene Sequence Patents //
European Intellectual Property Law Review. 2016. Vol. 38. Iss. 2.
Hawkins N. An Exception to Infringement for Genetic Testing – Addressing
Patient Access and Divergence Between Law and Practice // International Review
of Industrial Property and Copyright Law. 2012. Vol. 43. Iss. 6.
Hawkins N. The Impact of Human Gene Patents on Genetic Testing in the UK //
Genetics in Medicine. 2011. Vol. 13. No. 4.
Hildyard N., Sexton S. No Patents on Life // Forum for Applied Research and
Public Policy. 2000. Vol. 15. Iss. 1.
Hoedemaekers R. Commercialization, Patents and Moral Assessment of Biotechnology
Products // Journal of Medicine & Philosophy. 2001. Vol. 26. Iss. 3.
Lee W.F., Melamed A.D. Breaking the Vicious Cycle of Patent Damages // Cornell
Law Review. 2015. Vol. 101. Iss. 2.
Love J.P. Recent Examples of the Use of Compulsory Licenses on Patents // Knowledge
Ecology International. KEI Research Note 2 (2007).
McMahon A. Gene Patents and the Marginalisation of Ethical Issues // European
Intellectual Property Review (Forthcoming 2019).
Park S. Gene Patents and the Public Interest: Litigating Association for Molecular
Pathology v. Myriad Genetics and Lessons Moving Forward // North Carolina Journal
of Law & Technology. 2014. Vol. 15. Iss. 4.
Roberson A. The Role of DNA Patents in Genetic Test Innovation and Access //
Northwestern Journal of Technology and Intellectual Property. 2011. Vol. 9. Iss. 7.
Saw Lim C. Whither Gene Patenting and the Patenting of Diagnostic Methods Post-
Mayo and Myriad? The Need for Certainty in Navigating the High Seas of Policy //
Singapore Management University School of Law Research Paper No. 4/2017.
Sterckx S. Some Ethically Problematic Aspects of the Proposal for a Directive on
the Legal Protection of Biotechnological Inventions // European Intellectual Property
Review. 1998. Vol. 20. Iss. 4.
Storz U. CRISPR Cas9 – Licensing What Can’t Be Licensed // https://www.kiip.
re.kr/webzine/1807/resource/file/Library08.pdf.
Torrance A. Metaphysics and Patenting Life // University of Missouri-Kansas
City Law Review. 2007. Vol. 76. Iss. 2.
Van Zimmeren G., Van Overwalle G. A Paper Tiger? Compulsory License Regimes
for Public Health in Europe // International Review of Intellectual Property and
Competition Law. 2011. Vol. 42. Iss. 1.


Information about the author

Vorozhevich A.S. (Moscow, Russia) – PhD in Law, Assistant of the Department of Civil Law of the Faculty of Law of the Lomonosov Moscow State University (1 Leninskie Gory, Bldg. 13 (4th education building), GSP-1, Moscow, 119991, Russia; e-mail: arinavorozhevich@yandex.ru).

PATENT RIGHTS TO THE RESULTS
OF GENETIC RESEARCH: TERMS AND CONDITIONS
OF ACCEPTANCE

A.S. VOROZHEVICH,
PhD in Law, Assistant of the Department of Civil Law
of the Faculty of Law of the Lomonosov Moscow State University

DOI: 10.24031/1992-2043-2020-20-2-176-216

The article analyzes the problems of patenting the results of genetic engineering. Based on the analysis of foreign experience and the weighing of possible negative and positive effects, the author assesses the patentability of the selected genes, transgenic animals, methods of gene correction: turning off and editing genes. In addition, the question is being investigated under what conditions compulsory licenses may be issued for the patented results of genetic studies; is there a need to establish additional cases of free use in relation to the biotechnology market.


Keywords: exclusive right; patent; biotechnology; genes; gene editing; compulsory licensing.

References

Ворожевич А.С. Защита исключительных прав на патентоохраняемые объек-
ты: монография [Vorozhevich A.S. Protection of Exclusive Rights to Patent Protected
Objects: Monograph] (in Russian). Moscow: Statut, 2020.
Ворожевич А.С. Пределы защиты исключительного права патентообладате-
ля [Vorozhevich A.S. The Limits of Protection of the Exclusive Right of the Patent
Holder] (in Russian) // Patents and Licenses. 2019. No. 8.
Ворожевич А.С. Пределы осуществления исключительных прав на стандарт –
необходимые патентоохраняемые объекты и программное обеспечение. Усло-
вия FRAND [Vorozhevich A.S. The Limits for the Exercise of Exclusive Rights to the
Standard Are the Necessary Patent-Protected Objects and Software. FRAND Terms]
(in Russian) // Journal of the Intellectual Property Court. 2018. No. 20.
Ворожевич А.С., Третьяков С.В. Об утилитарности интеллектуальных прав, при-
нудительных лицензиях и бюрократических рентах [Vorozhevich A.S., Tretyakov S.V.
On the Utility of Intellectual Rights, Compulsory Licenses, and Bureaucratic Rents]
(in Russian) // Law. 2017. No. 8.
Мельников В.Н. От патентования генов – к патентованию форм жизни высо-
кого уровня [Melnikov V.N. From Patenting Genes to Patenting High-Level Life
Forms] (in Russian) // Patents and Licenses. 2005. No. 3.
Парфенчик О.С. Директива о правовой охране биотехнологических изобре-
тений: анализ основных противоречий [Parfenchik O.S. Directive on the Legal
Protection of Biotechnological Inventions: Analysis of the Main Contradictions]
(in Russian) // Private International Law. 2011. No. 4.
Calabresi G., Melamed A.D. Property Rules, Liability Rules, and Inalienability: One
View of the Cathedral // Harvard Law Review. 1972. Vol. 85. No. 6.
Cho M., Illangasekare S., Weaver M.A., Leonard D.G., Merz J.F. Effects of Patents and
Licenses on the Provision of Clinical Genetic Testing Services // Journal of Molecular
Diagnostics. 2003. Vol. 5. Iss. 1.
Cook-Deegan R., DeRienzo C., Carbone J. et al. Impact of Gene Patents and Licensing
Practices on Access to Genetic Testing for Inherited Susceptibility to Cancer:
Comparing Breast and Ovarian Cancers to Colon Cancers // Genetics in Medicine.
2010. Vol. 12 (4 Suppl.).
Gold R., Carbone J. Myriad Genetics: In the Eye of the Policy Storm // Genetics
in Medicine. 2010. Vol. 12 (4 Suppl.).
Hawkins N. A Red Herring – Invalidity of Human Gene Sequence Patents //
European Intellectual Property Law Review. 2016. Vol. 38. Iss. 2.
Hawkins N. An Exception to Infringement for Genetic Testing – Addressing
Patient Access and Divergence Between Law and Practice // International Review
of Industrial Property and Copyright Law. 2012. Vol. 43. Iss. 6.
Hawkins N. The Impact of Human Gene Patents on Genetic Testing in the UK //
Genetics in Medicine. 2011. Vol. 13. No. 4.
Hildyard N., Sexton S. No Patents on Life // Forum for Applied Research and
Public Policy. 2000. Vol. 15. Iss. 1.
Hoedemaekers R. Commercialization, Patents and Moral Assessment of Biotechnology
Products // Journal of Medicine & Philosophy. 2001. Vol. 26. Iss. 3.
Lee W.F., Melamed A.D. Breaking the Vicious Cycle of Patent Damages // Cornell
Law Review. 2015. Vol. 101. Iss. 2.
Love J.P. Recent Examples of the Use of Compulsory Licenses on Patents // Knowledge
Ecology International. KEI Research Note 2 (2007).
McMahon A. Gene Patents and the Marginalisation of Ethical Issues // European
Intellectual Property Review (Forthcoming 2019).
Park S. Gene Patents and the Public Interest: Litigating Association for Molecular
Pathology v. Myriad Genetics and Lessons Moving Forward // North Carolina Journal
of Law & Technology. 2014. Vol. 15. Iss. 4.
Roberson A. The Role of DNA Patents in Genetic Test Innovation and Access //
Northwestern Journal of Technology and Intellectual Property. 2011. Vol. 9. Iss. 7.
Saw Lim C. Whither Gene Patenting and the Patenting of Diagnostic Methods Post-
Mayo and Myriad? The Need for Certainty in Navigating the High Seas of Policy //
Singapore Management University School of Law Research Paper No. 4/2017.
Sterckx S. Some Ethically Problematic Aspects of the Proposal for a Directive on
the Legal Protection of Biotechnological Inventions // European Intellectual Property
Review. 1998. Vol. 20. Iss. 4.
Storz U. CRISPR Cas9 – Licensing What Can’t Be Licensed // https://www.kiip.
re.kr/webzine/1807/resource/file/Library08.pdf.
Torrance A. Metaphysics and Patenting Life // University of Missouri-Kansas
City Law Review. 2007. Vol. 76. Iss. 2.
Van Zimmeren G., Van Overwalle G. A Paper Tiger? Compulsory License Regimes
for Public Health in Europe // International Review of Intellectual Property and
Competition Law. 2011. Vol. 42. Iss. 1.


Information about the author

Vorozhevich A.S. (Moscow, Russia) – PhD in Law, Assistant of the Department of Civil Law of the Faculty of Law of the Lomonosov Moscow State University (1 Leninskie Gory, Bldg. 13 (4th education building), GSP-1, Moscow, 119991, Russia; e-mail: arinavorozhevich@yandex.ru).

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