WEBVTT Kind: captions Language: en 00:00:28.170 --> 00:00:29.790 So, welcome back. 00:00:29.790 --> 00:00:36.520 So, we were discussing regarding the Patentability issues in biotechnology continuing that. 00:00:36.520 --> 00:00:44.180 So, now the patenting challenges with respect to patenting the organism or the genes or 00:00:44.180 --> 00:00:52.290 the cell or the cell lines basically remains in deciding whether or not that article would 00:00:52.290 --> 00:00:57.430 be considered as an invention under the purview of the patent act or it is mere discovery 00:00:57.430 --> 00:01:05.550 and if it is an invention whether it is like meeting the other criterias or not . 00:01:05.550 --> 00:01:10.659 In general patent law across the country do not allow discovery to be patented. 00:01:10.659 --> 00:01:15.920 So, discovery is something which is already present in the earth and you are just taking 00:01:15.920 --> 00:01:23.570 it out and invention is that where you with the help of the human endeavours you are imparting 00:01:23.570 --> 00:01:29.159 a certain new form or new quality or at least some new properties to the original product 00:01:29.159 --> 00:01:31.100 which is existing in the nature. 00:01:31.100 --> 00:01:37.880 So, that human interventions makes the discovery into a patentable subject matter. 00:01:37.880 --> 00:01:44.490 Mere the originally existing microorganisms suppose some microorganisms are present in 00:01:44.490 --> 00:01:47.920 the earth crust or in the sea or the ocean beds. 00:01:47.920 --> 00:01:54.880 So, isolation of those microorganism and or particularly you cannot claim those microorganisms 00:01:54.880 --> 00:01:56.250 as a patent subject matter. 00:01:56.250 --> 00:02:01.240 You can claim isolation methods where you have tried certain new techniques to isolate 00:02:01.240 --> 00:02:07.610 those things from the nature that may be patent eligible provided that meets the different 00:02:07.610 --> 00:02:13.230 criteria, but when is when it is about the microorganism which is already known or which 00:02:13.230 --> 00:02:22.020 is already they existed in in the earth cannot be considered for a patentable subject matter. 00:02:22.020 --> 00:02:30.220 And the controversy regarding that was like is was solved like whether or or what kind 00:02:30.220 --> 00:02:37.290 of microorganism is patentable or not patentable it was basically decided through a landmark 00:02:37.290 --> 00:02:42.709 case which is known as the Diamond versus Chakrabarty case of 1980 and it from after 00:02:42.709 --> 00:02:50.670 this case it basically clarified that modified microorganisms can be patent eligible or can 00:02:50.670 --> 00:02:59.140 be patented and that had prompted the formations of many companies where they have started 00:02:59.140 --> 00:03:02.180 developing the bio-engineered products. 00:03:02.180 --> 00:03:08.540 To just give you briefly the facts about this Diamond versus Chakrabarty case. 00:03:08.540 --> 00:03:15.709 So, basically micro biologist Professor Ananda Chakrabarty he filed a patent application 00:03:15.709 --> 00:03:21.909 related to an invention for the treatment of the oil spills in the year 1972. 00:03:21.909 --> 00:03:28.910 So, that patent basically what he did was that he isolated certain strains of the pseudomonas 00:03:28.910 --> 00:03:36.909 bacterium and which had the capability to degrade the fatty acids or hydrocarbon compounds 00:03:36.909 --> 00:03:45.409 which they use as an energy source and he tried to form a mixture of the different types 00:03:45.409 --> 00:03:51.939 of the pseudomonas strains which has the ability to degrade various types of hydrocarbons and 00:03:51.939 --> 00:03:55.000 with that mixture he tried to treat the oil spills. 00:03:55.000 --> 00:04:01.200 So, if when he made a consortium with that with different strains of the microorganism 00:04:01.200 --> 00:04:05.190 of the pseudomonas that was not effective. 00:04:05.190 --> 00:04:13.129 So, what he did he the then his he then understood that the plasmids carried certain genes which 00:04:13.129 --> 00:04:18.340 is responsible for the degradation of the hydrocarbons and then he tried to make a new 00:04:18.340 --> 00:04:27.650 strain where he like basically put all those as hydrocarbon degrading genes together and 00:04:27.650 --> 00:04:33.030 made a new strain of pseudomonas which is which has a high efficiency in degrading that 00:04:33.030 --> 00:04:35.130 hydrocarbon or the oil spill. 00:04:35.130 --> 00:04:42.561 So, that patent included 36 claims related to the modified bacterium where different 00:04:42.561 --> 00:04:48.340 hydro carbon degrading genes in terms of plasmid has been incorporated. 00:04:48.340 --> 00:04:53.420 The method of producing the bacterial strain which is basically a process claim and the 00:04:53.420 --> 00:04:58.330 inoculum which compose the bacterium and the carrier material like the straws which allowed 00:04:58.330 --> 00:05:02.630 the inoculum to float on the surface of the water again which was a process claim. 00:05:02.630 --> 00:05:08.470 So, the patent examiner only approved the process claim, but he rejected the modified 00:05:08.470 --> 00:05:17.350 bacterium on the grounds that no living organisms cannot be no living organisms can be patented 00:05:17.350 --> 00:05:23.200 under the Section 101 of the US patent Act or 35 U.S.C.. 00:05:23.200 --> 00:05:28.810 And this was further challenged into so, the Dr Chakrabarty challenge this verdict of the 00:05:28.810 --> 00:05:30.930 patent examiner. 00:05:30.930 --> 00:05:38.520 And then it was it was it was a long battle and it went till the Supreme Court and so 00:05:38.520 --> 00:05:45.210 the major issue was whether a modified bacterium would constitute an article or an subject 00:05:45.210 --> 00:05:47.150 method for the patent or not. 00:05:47.150 --> 00:05:54.300 So, the modified bacterium whether or not it is a product of nature so; however, the 00:05:54.300 --> 00:06:00.160 supreme court ruled in favor of Dr Chakrabarty and finally, the patent was granted by the 00:06:00.160 --> 00:06:10.690 United States Patent Office on 31st of March 1981 and there the bench the jury they cited 00:06:10.690 --> 00:06:14.740 thing anything under this sun that is made by man is patentable . 00:06:14.740 --> 00:06:20.080 So, that became very popular that does not mean anything it was related to the bacterium 00:06:20.080 --> 00:06:21.240 strain. 00:06:21.240 --> 00:06:29.030 Basically what the jury considered is that even though the pseudomonas strains were isolated 00:06:29.030 --> 00:06:36.090 or they were present differently in the nature, but the the strain which Dr Chakrabarty created 00:06:36.090 --> 00:06:38.890 was not originally present it has been created. 00:06:38.890 --> 00:06:44.660 A person did not included the core biotechnology or the recombinant DNA part, but still by 00:06:44.660 --> 00:06:48.040 human interventions he had tried to made make a modified bacterium. 00:06:48.040 --> 00:06:57.040 So, modified bacterium can be a patent eligible subject matter under this Section 101 35 USC 00:06:57.040 --> 00:06:58.040 101. 00:06:58.040 --> 00:07:04.240 So, this was the landmark case after which lot of companies have started patenting different 00:07:04.240 --> 00:07:09.770 modified strains of the bacteria or the microorganisms and try to develop new process. 00:07:09.770 --> 00:07:15.270 So, this is one of the very important decisions in the history of the United States that has 00:07:15.270 --> 00:07:23.750 favored the biotech industry . Similarly, of when we talk about the patentability 00:07:23.750 --> 00:07:32.440 of the genes so we have again two views there, because you know our the human cells or any 00:07:32.440 --> 00:07:35.750 animal cell is composed of certain nucleic nuclear material. 00:07:35.750 --> 00:07:42.490 So, the nuclear material may be in the form of the DNA or the RNA and each of this DNA 00:07:42.490 --> 00:07:45.820 has certain character which they express. 00:07:45.820 --> 00:07:50.610 So, these are the basic units of the life which is known as the again genes 00:07:50.610 --> 00:07:56.060 So, the genes are present naturally in the living organism. 00:07:56.060 --> 00:08:02.210 So, those who oppose this view the gene should be patented because they oppose it because 00:08:02.210 --> 00:08:05.520 of the fact that gene sequences are already present there. 00:08:05.520 --> 00:08:07.290 So, it is not a new. 00:08:07.290 --> 00:08:13.460 So, you have just identified the genes, which is already present in the body of certain 00:08:13.460 --> 00:08:14.670 living organism. 00:08:14.670 --> 00:08:20.310 So, that may not be may not come under the purview of an invention. 00:08:20.310 --> 00:08:25.780 You may say it discovery where you have isolated or you are just taking out or telling that 00:08:25.780 --> 00:08:30.280 sequence of the gene, but it is there, it is there is no change in that gene. 00:08:30.280 --> 00:08:35.360 So, it should not come under the purview of the invention. 00:08:35.360 --> 00:08:41.399 The second group they propose that the genes or the DNA sequences are useful in the various 00:08:41.399 --> 00:08:42.399 application. 00:08:42.399 --> 00:08:47.750 For example, the diagnosis where you can check for various genetic diseases or it may be 00:08:47.750 --> 00:08:49.970 useful for the gene therapy. 00:08:49.970 --> 00:08:57.910 So, the so, when the isolated gene are used for various purposes and meeting the industrial 00:08:57.910 --> 00:09:02.120 industrial applicability requirement so, it should be patentable. 00:09:02.120 --> 00:09:05.360 . So, there again lot of controversies regarding 00:09:05.360 --> 00:09:06.500 this. 00:09:06.500 --> 00:09:09.940 So, if we again go back to little bit of history. 00:09:09.940 --> 00:09:16.470 So, we will found that when the human genome project has started and like scientist have 00:09:16.470 --> 00:09:19.390 started decoding the human genes. 00:09:19.390 --> 00:09:23.850 So, now, lot of information were available. 00:09:23.850 --> 00:09:32.610 So, in the year 1991 the then NIH National Institute of Health director Bernadine Healy. 00:09:32.610 --> 00:09:40.300 So, he thought ok with these kind of discoveries or the invention where the human genes has 00:09:40.300 --> 00:09:47.079 been decoded we can develop number of products which will be helpful for disease treatment 00:09:47.079 --> 00:09:57.660 and that is why he filed around 2750 expression sequence tags from the human genome and it 00:09:57.660 --> 00:10:03.660 also included around 600 protein coding ESTs from the human brain, which would be which 00:10:03.660 --> 00:10:09.350 can be potentially useful for developing diagnostic kits. 00:10:09.350 --> 00:10:15.350 And they have applied patents in Europe, America and as well as Australia and Italy. 00:10:15.350 --> 00:10:21.180 So, there are the application has been filed in many countries; however, it drew a lot 00:10:21.180 --> 00:10:23.200 of controversy. 00:10:23.200 --> 00:10:32.999 So, finally, in the year 1994 the NIHEST s patents were withdrawn, one reason was that 00:10:32.999 --> 00:10:38.180 the patent was not granted in Europe we will come to that in Europe again the criteria 00:10:38.180 --> 00:10:44.600 of patentability is quite strict compare to the American or United States of America. 00:10:44.600 --> 00:10:52.779 So, the the question was the the next director of the NIH they have consulted with the US 00:10:52.779 --> 00:10:57.889 patent office to understand whether or not the patents in this area should be pursued 00:10:57.889 --> 00:10:59.610 or not. 00:10:59.610 --> 00:11:06.449 So, with the their advice was that the patent should be pursued only if it would advance 00:11:06.449 --> 00:11:12.610 the commercialization and it should not hinder the scientific development, but by patenting 00:11:12.610 --> 00:11:20.670 this expression sequence tag it may raise the competition among the private players 00:11:20.670 --> 00:11:23.670 and it would be basically because patent is a monopoly right. 00:11:23.670 --> 00:11:28.699 So, it may hinder the development of the science rather than promoting the commercialization. 00:11:28.699 --> 00:11:36.249 So, for that reason they withdrew the patents , but; however, once this process has started 00:11:36.249 --> 00:11:41.920 and where number of venture capitalist they started exploring business possibility in 00:11:41.920 --> 00:11:48.439 the area of the genomics and the many private enterprises entered into the sequencing of 00:11:48.439 --> 00:11:52.300 the genes or the nucleotide product. 00:11:52.300 --> 00:12:01.810 So, this was the first where the use usefulness of the genes or the ESTs were seen or you 00:12:01.810 --> 00:12:10.519 have had apply had been had been applied as a patentable substance. 00:12:10.519 --> 00:12:16.139 And finally,at the time in 2001 the United States Patent Office they had also given certain 00:12:16.139 --> 00:12:23.290 examination guidelines means what if a patent has been applied for a gene related product 00:12:23.290 --> 00:12:28.079 then what can be considered as a patent eligible and what may be rejected. 00:12:28.079 --> 00:12:35.509 So, if a patent claim directed to a isolated to an isolated or the purified DNA molecule 00:12:35.509 --> 00:12:41.819 like it may be it may cover the gene excise from the natural chromosome or a synthesized 00:12:41.819 --> 00:12:44.059 DNA molecule. 00:12:44.059 --> 00:12:50.100 And so in this case the isolated DNA molecules were allowed as a patentable because it is 00:12:50.100 --> 00:12:54.449 isolated and so it was not found in the isolated form. 00:12:54.449 --> 00:13:00.059 So, if someone is isolating a gene means the human intervention is made and the the that 00:13:00.059 --> 00:13:03.670 is the reason it was allowed as a patent at that point of the time. 00:13:03.670 --> 00:13:08.970 And further if the isolated and the purified DNA molecule has the same sequence as the 00:13:08.970 --> 00:13:16.810 natural occurring gene it may make them patent eligible, because it it acts like a composition 00:13:16.810 --> 00:13:22.300 of the matter and as it is not naturally occurring in that form. 00:13:22.300 --> 00:13:30.949 And the the synthetic DNAs if if it is synthetic DNA it may be patent eligible because again 00:13:30.949 --> 00:13:36.620 it is not available in the purified form and it is different from the naturally occurring 00:13:36.620 --> 00:13:37.620 compounds. 00:13:37.620 --> 00:13:44.370 And further the the Nuffield Council of the bioethics they distinguished different application 00:13:44.370 --> 00:13:48.309 of the DNA sequences which can be related to the patent claims. 00:13:48.309 --> 00:13:53.439 For example there may be sequences which are used for the diagnostic testing and there 00:13:53.439 --> 00:13:59.699 may be sequences which are used for the research tools; like if there are genes sequence which 00:13:59.699 --> 00:14:04.529 can be helpful in the identification of the potential targets for the new drugs and the 00:14:04.529 --> 00:14:08.120 vaccines that is useful so that can also be patented. 00:14:08.120 --> 00:14:14.879 Sequences sometimes may be used in the gene therapy, where a faulty gene is removed in 00:14:14.879 --> 00:14:21.230 place of the and in that place a normal gene is inserted and then there are different sequences 00:14:21.230 --> 00:14:26.980 which are used in the production of the therapeutic proteins which are used as the medicine. 00:14:26.980 --> 00:14:36.850 So, depending on the use of the substances the in some cases we patent on the genes are 00:14:36.850 --> 00:14:43.660 allowed and if you again there is another landmark case of Association of Molecular 00:14:43.660 --> 00:14:50.279 Pathology versus Myriad Genetics in 2013 which has again changed the landscape with respect 00:14:50.279 --> 00:14:52.059 to the gene sequence. 00:14:52.059 --> 00:14:57.819 So, just to again give you brief facts of the case the Myriad Genetics which is a startup 00:14:57.819 --> 00:15:01.769 company founded in 1991 out of the University of the Utha. 00:15:01.769 --> 00:15:06.899 So, they along with the National Institute of Environmental Health Sciences of University 00:15:06.899 --> 00:15:14.569 Utha they filed a patent for a for BRCA 1 gene or the BRCA gene which is popularly known 00:15:14.569 --> 00:15:17.220 BRCA 1 and BRCA 2. 00:15:17.220 --> 00:15:24.029 So, basically these genes are the genes which were helpful in identifying whether a woman 00:15:24.029 --> 00:15:28.209 can developed develop breast cancer or not. 00:15:28.209 --> 00:15:36.259 So, in 1996 the Myriad Genetics they launched a diagnostic product known as the "BRAC Analysis" 00:15:36.259 --> 00:15:43.310 which is basically a thing which detected mutation in these two genes BRCA and BRCA 00:15:43.310 --> 00:15:51.089 2 and it identified like which women is at a higher risk of developing the cancer, breast 00:15:51.089 --> 00:15:52.990 cancer and the ovarian cancer. 00:15:52.990 --> 00:15:59.329 So, once this technique was out lot of other companies they also started using the technology 00:15:59.329 --> 00:16:01.410 without the permission of the Myriad Genetics. 00:16:01.410 --> 00:16:06.269 So, since Myriad has the patent on the BRCA 1 and BRCA 2. 00:16:06.269 --> 00:16:10.699 So, they have the monopoly about that and no one is suppose to use those things, but 00:16:10.699 --> 00:16:12.660 other company started using that. 00:16:12.660 --> 00:16:20.499 So, as a preventing measure in 1998 Myriad issued cease and desist letters basis which 00:16:20.499 --> 00:16:26.069 is basically citing that it is a kind of a patent infringement activity which the other 00:16:26.069 --> 00:16:27.519 companies were doing. 00:16:27.519 --> 00:16:34.629 So, they sent notices to different companies or the University of Pennsylvania to stop 00:16:34.629 --> 00:16:40.130 these tastings of the patients sample using this BRCA. 00:16:40.130 --> 00:16:46.839 But again since this was a naturally occurring gene BRCA gene though so the association of 00:16:46.839 --> 00:16:51.949 molecular pathology along with the researchers of the University of Pennsylvania, Colombia, 00:16:51.949 --> 00:16:58.350 Yale, Emory and the New York University they built a case challenging the validity validity 00:16:58.350 --> 00:17:01.690 of such kind of the patent. 00:17:01.690 --> 00:17:07.600 And specifically the use of the genes sequence to diagnose the propensity of the cancer. 00:17:07.600 --> 00:17:14.880 So, initially the district court as well as the federal circuit court held that the isolated 00:17:14.880 --> 00:17:20.770 DNA does not exist in nature and there should be patentable, but to this decision the association 00:17:20.770 --> 00:17:24.850 of molecular pathology they appeal to the Supreme Court. 00:17:24.850 --> 00:17:32.640 And in the Supreme Court the court basically looked into, how much modification would we 00:17:32.640 --> 00:17:37.780 be looking into a gene product or into the extraction product that would make a gene 00:17:37.780 --> 00:17:40.760 as an patent eligible subject matter? 00:17:40.760 --> 00:17:46.340 And and what are the factors we should taking into account to while we consider that this 00:17:46.340 --> 00:17:54.200 cut DNA or the isolated gene DNA is considered as an invention ? Will it be the new function 00:17:54.200 --> 00:18:00.520 or how different the DNA from the inside the DNA which is existing outside and which is 00:18:00.520 --> 00:18:01.600 there in the body? 00:18:01.600 --> 00:18:08.780 So, all and how this complimentary DNA how we can compare the complimentary DNA with 00:18:08.780 --> 00:18:10.340 a genetic DNA? 00:18:10.340 --> 00:18:16.220 And if we stop this kind of the patenting then, what incentive would remain for the 00:18:16.220 --> 00:18:18.090 companies to go for new discoveries? 00:18:18.090 --> 00:18:23.100 If they are not assured patent protection these are the few questions they considered 00:18:23.100 --> 00:18:29.800 and finally, the verdict of the Supreme Court was that merely isolating genes that are found 00:18:29.800 --> 00:18:33.220 in nature, but does does not make them patentable. 00:18:33.220 --> 00:18:40.080 So, the Myriad does not Myriad did not create or alter the genetic information encoded in 00:18:40.080 --> 00:18:45.090 the BRCA and BRCA 2 genes and the genetic structure of the DNA. 00:18:45.090 --> 00:18:49.570 So, the isolated BRCA 1, BRCA should not be given patent. 00:18:49.570 --> 00:18:56.440 However, the complimentary DNA which is again a changed version of the DNA was not something 00:18:56.440 --> 00:18:59.870 which occurred naturally and again it is useful for the diagnostic purpose. 00:18:59.870 --> 00:19:04.820 So, that complementary DNA is patentable, but not the BRCA and BRCA. 00:19:04.820 --> 00:19:12.780 So, after this decision in 2013 mere isolation of the gene was again not held patentable. 00:19:12.780 --> 00:19:18.810 So, it has changed the whole landscape of the gene patenting provisions in the United 00:19:18.810 --> 00:19:19.810 States. 00:19:19.810 --> 00:19:24.890 And also in the Australia later on there are DNC there are cases which also in the in the 00:19:24.890 --> 00:19:31.480 same way did not allow the mere isolation of the genetic sequence from the human genes. 00:19:31.480 --> 00:19:37.410 Only and if the genetic sequences altered or it had sufficient function to attach to 00:19:37.410 --> 00:19:41.220 it it may be diagnosis, it may be treatment or development of any therapeutic purpose 00:19:41.220 --> 00:19:46.420 then only it was held patentable and. 00:19:46.420 --> 00:19:55.610 Similarly, there is another case Ariosa Diagnostic versus Sequenom in 2015 where this Sequenom 00:19:55.610 --> 00:20:02.010 Company held the patent for this NIPT which is basically a method for detection of the 00:20:02.010 --> 00:20:10.590 down syndrome and it it included a provision where the plasma sample from a pregnant female 00:20:10.590 --> 00:20:18.910 was taken were collected and then the presence of the nucleic acid of the fetal origin was 00:20:18.910 --> 00:20:21.570 tested with respect to the paternal DNA. 00:20:21.570 --> 00:20:28.780 So, this method had many advantage with respect to the earlier available method which was 00:20:28.780 --> 00:20:32.560 more invasive and which may cost miscarriages. 00:20:32.560 --> 00:20:37.780 So, this was given patent to the Sequenom. 00:20:37.780 --> 00:20:42.430 Again so, after this Sequenom launch this diagnostic method in the market, number of 00:20:42.430 --> 00:20:50.550 other companies started using the same and then this Sequenom filed a cease and desist 00:20:50.550 --> 00:20:55.140 or patent infringement thing against those company. 00:20:55.140 --> 00:20:59.280 So, the other companies again they challenge the patent. 00:20:59.280 --> 00:21:05.390 So, the district court in this case held that the claims are patent ineligible on the grounds 00:21:05.390 --> 00:21:12.490 that, "the claims atthe issue pose a substantial risk of preempting the natural phenomena of 00:21:12.490 --> 00:21:17.290 paternally inherited fetal DNA" and it again. 00:21:17.290 --> 00:21:22.390 So, this Sequenom Company appeal to the Federal Circuit, but; however, the Federal Circuit 00:21:22.390 --> 00:21:27.630 again affirmed the judgment of the district code and held that the claims which the Sequenom 00:21:27.630 --> 00:21:35.330 had are "directed to the patent ineligible concept" as the claimed method did not transfer 00:21:35.330 --> 00:21:39.960 the claimed naturally occurring phenomena into patent eligible for phenomenon because 00:21:39.960 --> 00:21:42.040 that paternal DNA is existing in there. 00:21:42.040 --> 00:21:49.300 So, by just taking that concept and developing a diagnostic kit would not be a provision 00:21:49.300 --> 00:21:52.660 and you cannot debar others from using that technology. 00:21:52.660 --> 00:22:00.380 So, these are the issues which has or these are the cases which has led a change in the 00:22:00.380 --> 00:22:04.920 total outlook in which the patenting of the genes has been looked in the United States. 00:22:04.920 --> 00:22:11.730 So, finally, when we see the current provisions the patenting of the genes and the DNA sequences 00:22:11.730 --> 00:22:20.470 is allowed if again the if the DNA sequences are not similar to the living organism and 00:22:20.470 --> 00:22:23.660 or those complimentary DNA is patentable. 00:22:23.660 --> 00:22:27.480 Sequences which can be used as a research tools say for example, the expression sequence 00:22:27.480 --> 00:22:33.040 tag or SNPs are not patentable if the utility is not substantial. 00:22:33.040 --> 00:22:40.540 So, you have to show substantial credible and specific utility to show that the thing 00:22:40.540 --> 00:22:43.640 or the sequences are useful. 00:22:43.640 --> 00:22:50.410 And sequences used in the gene therapy actually is rarely permitted because you know if a 00:22:50.410 --> 00:22:54.600 gene is faulty the definite way out is to replace it with the natural occurring gene 00:22:54.600 --> 00:22:55.660 or the good gene. 00:22:55.660 --> 00:23:02.160 So, it is it should not be given patent and yes sequences used in the production of the 00:23:02.160 --> 00:23:08.010 therapeutic proteins are mostly patented and it is very much helpful for the development 00:23:08.010 --> 00:23:12.840 of the new therapeutics as well as it acts as an incentive for the companies. 00:23:12.840 --> 00:23:17.220 So, this is with respect to the gene patenting . 00:23:17.220 --> 00:23:25.130 The third issue with respect to the patenting of the cells and the cell lines is that in 00:23:25.130 --> 00:23:30.520 United States the isolated cells were patentable only if they were significantly different 00:23:30.520 --> 00:23:32.890 from the naturally occurring genes. 00:23:32.890 --> 00:23:42.240 So, as we saw till 2013 and when the Myriad decisions were not given the USPTO granted 00:23:42.240 --> 00:23:47.280 patents with respect to the human pluripotent cells as well as the human embryonic stem 00:23:47.280 --> 00:23:48.550 cell lines. 00:23:48.550 --> 00:23:56.590 However, after the subsequent decision by the Supreme Court it has changed and in 2014 00:23:56.590 --> 00:24:00.460 the USPTO further issued certain guidelines. 00:24:00.460 --> 00:24:08.370 So, "isolated" from the natural "human induced" environments, were not considered as naturally 00:24:08.370 --> 00:24:09.770 occurring. 00:24:09.770 --> 00:24:15.950 And a cell can be considered to be patentable if it is "significantly different" in the 00:24:15.950 --> 00:24:18.200 structure, functions and other aspect of the natural cells. 00:24:18.200 --> 00:24:24.750 So, those were the recent changes after 2014 to the human embryonic stem cell research 00:24:24.750 --> 00:24:30.160 in the United States unless and until it is substantially different the it is was not 00:24:30.160 --> 00:24:40.660 held patentable there . And if we come to the so far we have discussed 00:24:40.660 --> 00:24:46.500 about the United States, but if we become little bit to the European Union. 00:24:46.500 --> 00:24:51.290 So, and in Europe the things are taken little bit differently. 00:24:51.290 --> 00:24:57.170 So, they the public order modality concept or the particularly patent with respect to 00:24:57.170 --> 00:25:01.250 biotechnological invention is considered as a serious matter there. 00:25:01.250 --> 00:25:09.010 So, they have a particular directive which is known as the biotechnology directive 98/44 00:25:09.010 --> 00:25:13.670 EC which was adopted in 98 in the year 1998. 00:25:13.670 --> 00:25:19.020 So, the directive gives a lot of guidelines what aspect of the biotechnology could be 00:25:19.020 --> 00:25:20.770 patented. 00:25:20.770 --> 00:25:25.530 For example, this Article 4 of the Directive finds that the "plants and the animal varieties" 00:25:25.530 --> 00:25:30.840 and other "essential biological processes for the production of the plants and animals" 00:25:30.840 --> 00:25:32.250 are not patentable. 00:25:32.250 --> 00:25:37.780 And Article 2 of the directive establishes that the, "biological material which is isolated 00:25:37.780 --> 00:25:43.570 from the natural environment are produced by means of the technical process may be the 00:25:43.570 --> 00:25:47.570 subject of invention even though it is previously occurring in nature." 00:25:47.570 --> 00:25:56.530 But the important issue was considered is that any invention the invention should not 00:25:56.530 --> 00:25:59.860 be contrary to the public order or the morality. 00:25:59.860 --> 00:26:07.580 For example, so, in the human embryonic stem cell research or the process of cloning of 00:26:07.580 --> 00:26:14.420 human beings or process of modifying the germ line in the modify the germ lines which basically 00:26:14.420 --> 00:26:21.530 changing the genetic identity of the human beings huge use of human embryos for the commercial 00:26:21.530 --> 00:26:28.470 purposes and process for modifying the genetic identity of the animals which may cause them 00:26:28.470 --> 00:26:35.680 suffering without any substantial medical benefit to the man or the animals and animals 00:26:35.680 --> 00:26:41.470 resulting from those process were not patentable because it is something which is considered 00:26:41.470 --> 00:26:44.130 as against the public order. 00:26:44.130 --> 00:26:51.490 So, the main important provision which the EU directive belives is that the patent laws 00:26:51.490 --> 00:26:57.590 must be applied to respect the dignity and integrity of a person. 00:26:57.590 --> 00:27:02.470 So, if you are destroying a human embryo so; that means, that you are destroying the human 00:27:02.470 --> 00:27:07.220 dignity because they consider the human embryo to be equivalent as a living organism. 00:27:07.220 --> 00:27:15.210 So, the principle with that the human body at any stage in its formation or development 00:27:15.210 --> 00:27:21.920 including the germ cells or the discovery of the any any element of the cells or the 00:27:21.920 --> 00:27:24.830 partial sequence of the genes cannot be patented there. 00:27:24.830 --> 00:27:32.600 So, here it is in Europe compared to US it they adopt a stricter guideline or stricter 00:27:32.600 --> 00:27:36.480 provision in patenting the human cells or human genes. 00:27:36.480 --> 00:27:42.280 So, there are again little bit changes recently there have been certain changes to this aspect. 00:27:42.280 --> 00:27:47.020 So, in the International Stem Cell Corporation versus the Comptroller General of the Patents 00:27:47.020 --> 00:27:55.390 are case in the the European court of justice the the court lifted the formal ban on the 00:27:55.390 --> 00:27:59.590 patentability of the parthenogenetic stem cell technique. 00:27:59.590 --> 00:28:04.990 So, any intervention on the human embryonic stem cell is strictly forbidden because it 00:28:04.990 --> 00:28:08.180 considers the human embryo to be a living organism. 00:28:08.180 --> 00:28:15.530 But when the stem cells were developed from the parthenogenesis process that is the human 00:28:15.530 --> 00:28:21.720 induced pluripotent stem cells or human parthenogenetic embryonic stem cell that is somatic cell is 00:28:21.720 --> 00:28:32.060 confirm somatic cell is transferred into pluripotent cells or like the like the process of parthenogenesis 00:28:32.060 --> 00:28:34.060 cell has been changed. 00:28:34.060 --> 00:28:39.840 So, this gave a little bit relaxation to the earlier strict criteria. 00:28:39.840 --> 00:28:45.640 Although the court confirm that the human body or the embryo at any stage of the development 00:28:45.640 --> 00:28:53.300 cannot be patented it gave a little bit provision that organisms incapable of developing into 00:28:53.300 --> 00:28:56.750 the human beings should be patentable under the European law. 00:28:56.750 --> 00:29:03.070 So, it is now considered a little bit of relaxation or break through which the court has given 00:29:03.070 --> 00:29:09.800 like in the earlier Bristle case, it banned all the intellectual property rights of the 00:29:09.800 --> 00:29:15.490 embryonic stem cell technique means no inventions related to the embryonic stem cell development 00:29:15.490 --> 00:29:18.120 or associated techniques would be patentable. 00:29:18.120 --> 00:29:23.330 However, in after this case it gave a relaxation that ok human embryonic stem cell cannot be 00:29:23.330 --> 00:29:30.170 patented, but the associated techniques can be allowed to be patented. 00:29:30.170 --> 00:29:43.770 So, like in the Bristle case in 2011 it basically excluded all the human embryonic stem cells 00:29:43.770 --> 00:29:51.980 and the patentability of the other techniques if it results in 'the prior destruction of 00:29:51.980 --> 00:29:57.340 the embryo or they are used as a based material, whatever the stage at which it take at which 00:29:57.340 --> 00:29:58.420 it takes place.' 00:29:58.420 --> 00:30:05.660 So, no process in around the embryonic stem cells were allowed and,but there were again 00:30:05.660 --> 00:30:13.650 debate over how do you define the embryo like at what stage you are saying that the human 00:30:13.650 --> 00:30:16.940 embryo is equivalent to the living organism? 00:30:16.940 --> 00:30:21.550 Whether the concept of totipotency is considered into factor or not? 00:30:21.550 --> 00:30:27.810 Or whether we consider a plutipotency stem cells as same as a totipotent stem cell? 00:30:27.810 --> 00:30:33.630 So, thereby debates, anyway the crux of the matter is that human embryonic interventions 00:30:33.630 --> 00:30:36.330 on human embryonic stem cells as such is not patentable. 00:30:36.330 --> 00:30:41.810 But yes, associated technique which may result in other developments may be allowed as a 00:30:41.810 --> 00:30:42.970 patentable subject matter. 00:30:42.970 --> 00:30:49.930 So, this is the controversy regarding the cell and the cell lines across US and EU and 00:30:49.930 --> 00:30:51.140 India as we said. 00:30:51.140 --> 00:30:58.480 So, in India also we do not allow patent on the human embryonic stem cells and isolated 00:30:58.480 --> 00:31:06.850 gene sequence are also patentable, but again if it has it is changed and again it is substantial 00:31:06.850 --> 00:31:09.930 utilities also observed in case of the India as well. 00:31:09.930 --> 00:31:16.300 So, this is for this lecture we have discussed we will discuss more about the other issues 00:31:16.300 --> 00:31:17.540 in the upcoming lectures. 00:31:17.540 --> 00:31:18.460 Thank you so much.