DIFFERENTIAL TREATMENT OF BIOTECHNOLOGY INVENTIONS AND THE ETHICAL SAFEGUARDS IN PATENT ACT, 1970
Volume 2Issue I Year 2023
Bilal A. Nazeer
Research Scholar, Inter University Centre for IPR Studies, Cochin University of Science and Technology, Kochi -22
nazeer.bilal1@gmail.com
Dr. I. G Rathish
Assistant Professor, Inter University Centre for IPR Studies, Cochin University of Science and Technology, Kochi -22
rathish.ig@cusat.ac.in
Table of Contents
Bilal A. Nazeer
Research Scholar, Inter University Centre for IPR Studies, Cochin University of Science and Technology, Kochi -22
nazeer.bilal1@gmail.com
Dr. I. G Rathish
Assistant Professor, Inter University Centre for IPR Studies, Cochin University of Science and Technology, Kochi -22
rathish.ig@cusat.ac.in
CRISPR- Biotechnology- TRIPS- Discrimination- Subject Matter
1. Art. 27.3(b), Art.3, TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994)
2. 563 F.2d 1031 (C.C.P.A. 1977).
3. Patents Act, 1970, s.3(b), No. 39, Acts of Parliament, 1970 (India).
4. UNCTAD, https://unctad.org/data-visualization/now-8-billion-and-counting-where-worlds-population-has-grown-most-and-why, (last visited July 25, 2023).
5. Anton-Hermann Chroust & David L. Osborn, Aristotles Conception of Justice, 17 Notre Dame L. Rev. 129, 130 (1942).
6. Id. at 136
7. Id. at 137.
8. Id.
9. Art.3, TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994)
10. Id. at Art 4.
11. Id. at Art 27.1
12. Id. at Ar. 3.
13. Id. at Art 4
14. Id. at Art. 27.1
15. Canada-Patent Protection of Pharmaceutical Products, Report of the Panel, WTO, WT/DS114/R (2000).
16. Id.
17. Id. at p 171.
18. Art 31, United Nations,Vienna Convention on the Law of Treaties, 23 May 1969,United Nations, Treaty Series, vol. 1155, p. 331 reads as A treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of a treaty in their context and in the light of its object and purpose.
19. TRIPS Agreement, Supra note 8, Art 7 reads as The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.
20. Bruce Alberts et. al., Molecular Biology of The Cell, 95-100 (4th ed. 2002).
21. Patents Act, 1970 s. 53 reads as Subject to the provisions of this Act, the term of every patent granted, after the commencement of the Patents (Amendment) Act, 2002, and the term of every patent which has not expired and has not ceased to have effect, on the date of such commencement, under this Act, shall be twenty years from the date of filing of the application for the patent
22. Canada-Patent Protection of Pharmaceutical Products, Report of the Panel, WTO, WT/DS114/R (2000).
23. The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations
24. In Re Bell 991 F.2d 781 (Fed. Cir. 1993) and In Re Deuel 51 F.3d 1552 (Fed. Cir. 1995). (while in Deuel only partial amino acid sequence was disclosed in prior art, the complete amino acid sequence was part of the prior art in Bell)
25. Tetsch L., The adaptive bacterial immune system CRISPR-Cas and its therapeutic potential, 40(1) Med Monatsschr Pharm. 17-23, 2017.
26. Id at 18.
27. Id at 18.
28. The Broad Institute, Inc. v. The Regents of the University of California, No. 106,048 (P.T.A.B. 2017); Regents of the University of California v. Broad Institute, Inc., 2018 U.S. App. LEXIS 25535 (Fed. Cir. 2018); U.S. Patent No. (filed Oct. 13, 2013); U.S. Patent App. No. 20140068797 (filed Mar. 15, 2013).
29. O.O. Abudayyeh, J.S. Gootenberg, P. Essletzbichler, S. Han, J. Joung, J.J. Belanto, et al., RNA targeting with CRISPRCas13, 550Nature, 280284 (2017).
30. Carolyn Brokowski, Mazhar Adli, CRISPR Ethics: Moral Considerations for Applications of a Powerful Tool, 431(1) Journal of Molecular Biology, 88-101 (2019).
31. Id.
32. K.A. Schaefer, W.H. Wu, D.F. Colgan, S.H. Tsang, A.G. Bassuk, V.B. Mahajan, Unexpected mutations after CRISPRCas9 editing in vivo, 14Nat. Methods, 547548 (2017).
33. Carolyn, Supra note 27, at p 90.
34. Id.
35. Diamond v. Chakrabarty 563 F.2d 1031 (C.C.P.A. 1977).
36. John M. Conley, Gene Patents and the Product of Nature Doctrine, 84Chi.-Kent. L. Rev.109 (2009).
37. Id.
38. U.S. Patent No. 4,736,866.
39. T315/03, 2004.
40. Harvard Coll. v. Canada (Commissioner of Patents), [2002] 4 S.C.R. 45, 46, 122 (Can.).
41. Patents Act, 1970, s.3(b), No. 39, Acts of Parliament, 1970 (India).
42. Id.
43. Cyranoski D, The CRISPR baby scandal: What's next for human gene editing, Nature (July 25, 2023, 10.30 am.), available at https://www.nature.com/articles/d41586-019-00673-1
44. Guidelines for Examination of Biotechnology Applications for Patent, Office of the Controller General of Patents, Designs and Trademarks, 2013.
45. Id at p11.
46. Id.
47. Id
48. 161st Report, Review of the Intellectual Property Rights Regime in India, Department Related Parliament Standing Committee on Commerce, Parliament of India, 2021
49. Id at p 46.
50. Id.
References
1. Art. 27.3(b), Art.3, TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994)
2. 563 F.2d 1031 (C.C.P.A. 1977).
3. Patents Act, 1970, s.3(b), No. 39, Acts of Parliament, 1970 (India).
4. UNCTAD, https://unctad.org/data-visualization/now-8-billion-and-counting-where-worlds-population-has-grown-most-and-why, (last visited July 25, 2023).
5. Anton-Hermann Chroust & David L. Osborn, Aristotles Conception of Justice, 17 Notre Dame L. Rev. 129, 130 (1942).
6. Id. at 136
7. Id. at 137.
8. Id.
9. Art.3, TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994)
10. Id. at Art 4.
11. Id. at Art 27.1
12. Id. at Ar. 3.
13. Id. at Art 4
14. Id. at Art. 27.1
15. Canada-Patent Protection of Pharmaceutical Products, Report of the Panel, WTO, WT/DS114/R (2000).
16. Id.
17. Id. at p 171.
18. Art 31, United Nations,Vienna Convention on the Law of Treaties, 23 May 1969,United Nations, Treaty Series, vol. 1155, p. 331 reads as A treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of a treaty in their context and in the light of its object and purpose.
19. TRIPS Agreement, Supra note 8, Art 7 reads as The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.
20. Bruce Alberts et. al., Molecular Biology of The Cell, 95-100 (4th ed. 2002).
21. Patents Act, 1970 s. 53 reads as Subject to the provisions of this Act, the term of every patent granted, after the commencement of the Patents (Amendment) Act, 2002, and the term of every patent which has not expired and has not ceased to have effect, on the date of such commencement, under this Act, shall be twenty years from the date of filing of the application for the patent
22. Canada-Patent Protection of Pharmaceutical Products, Report of the Panel, WTO, WT/DS114/R (2000).
23. The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations
24. In Re Bell 991 F.2d 781 (Fed. Cir. 1993) and In Re Deuel 51 F.3d 1552 (Fed. Cir. 1995). (while in Deuel only partial amino acid sequence was disclosed in prior art, the complete amino acid sequence was part of the prior art in Bell)
25. Tetsch L., The adaptive bacterial immune system CRISPR-Cas and its therapeutic potential, 40(1) Med Monatsschr Pharm. 17-23, 2017.
26. Id at 18.
27. Id at 18.
28. The Broad Institute, Inc. v. The Regents of the University of California, No. 106,048 (P.T.A.B. 2017); Regents of the University of California v. Broad Institute, Inc., 2018 U.S. App. LEXIS 25535 (Fed. Cir. 2018); U.S. Patent No. (filed Oct. 13, 2013); U.S. Patent App. No. 20140068797 (filed Mar. 15, 2013).
29. O.O. Abudayyeh, J.S. Gootenberg, P. Essletzbichler, S. Han, J. Joung, J.J. Belanto, et al., RNA targeting with CRISPRCas13, 550Nature, 280284 (2017).
30. Carolyn Brokowski, Mazhar Adli, CRISPR Ethics: Moral Considerations for Applications of a Powerful Tool, 431(1) Journal of Molecular Biology, 88-101 (2019).
31. Id.
32. K.A. Schaefer, W.H. Wu, D.F. Colgan, S.H. Tsang, A.G. Bassuk, V.B. Mahajan, Unexpected mutations after CRISPRCas9 editing in vivo, 14Nat. Methods, 547548 (2017).
33. Carolyn, Supra note 27, at p 90.
34. Id.
35. Diamond v. Chakrabarty 563 F.2d 1031 (C.C.P.A. 1977).
36. John M. Conley, Gene Patents and the Product of Nature Doctrine, 84Chi.-Kent. L. Rev.109 (2009).
37. Id.
38. U.S. Patent No. 4,736,866.
39. T315/03, 2004.
40. Harvard Coll. v. Canada (Commissioner of Patents), [2002] 4 S.C.R. 45, 46, 122 (Can.).
41. Patents Act, 1970, s.3(b), No. 39, Acts of Parliament, 1970 (India).
42. Id.
43. Cyranoski D, The CRISPR baby scandal: What's next for human gene editing, Nature (July 25, 2023, 10.30 am.), available at https://www.nature.com/articles/d41586-019-00673-1
44. Guidelines for Examination of Biotechnology Applications for Patent, Office of the Controller General of Patents, Designs and Trademarks, 2013.
45. Id at p11.
46. Id.
47. Id
48. 161st Report, Review of the Intellectual Property Rights Regime in India, Department Related Parliament Standing Committee on Commerce, Parliament of India, 2021
49. Id at p 46.
50. Id.