WEBVTT Kind: captions Language: en 00:00:28.560 --> 00:00:30.699 Hello all. 00:00:30.699 --> 00:00:38.230 So, in the previous classes I have been telling about certain incentives which are given for 00:00:38.230 --> 00:00:43.590 the biopharmaceutical manufacturers as well as bio similar or bio generic manufacturers 00:00:43.590 --> 00:00:50.030 like which is known as the data exclusivity or patent term extension, so in this topic, 00:00:50.030 --> 00:00:57.050 in this lecture, I would like you to give certain more information regarding these beneficial 00:00:57.050 --> 00:01:00.030 provisions of with respect to the biopharmaceutical. 00:01:00.030 --> 00:01:08.210 So, here in this lecture we will cover the terms like data exclusivity, patent term extension, 00:01:08.210 --> 00:01:14.560 and supplementary protection certifications, and we will see how these are helping this 00:01:14.560 --> 00:01:16.280 biopharmaceutical industry to grow further. 00:01:16.280 --> 00:01:18.100 So, data exclusivity. 00:01:18.100 --> 00:01:24.920 In earlier classes also I mentioned for the biopharmaceuticals as well as for the new 00:01:24.920 --> 00:01:27.700 drug molecules data exclusivity are given. 00:01:27.700 --> 00:01:34.079 So, what is this data exclusivity, how it is relevant for the biopharmaceutical industry 00:01:34.079 --> 00:01:35.729 or any industry per se. 00:01:35.729 --> 00:01:43.030 So, if you see data exclusivity or exclusivity is generally something which basically refers 00:01:43.030 --> 00:01:50.770 to delays in approval or certain prohibition for the approval of a competitor drug product 00:01:50.770 --> 00:01:53.490 which is available under the statute. 00:01:53.490 --> 00:01:59.430 And basically when the approval of a drug product is dependent on certain prior information 00:01:59.430 --> 00:02:05.899 or prior data submitted by another or original drug product develop original drug developer, 00:02:05.899 --> 00:02:13.069 then there is a certain time period or limitation between which it may not be allowed. 00:02:13.069 --> 00:02:22.600 So, if we go by the definition, the data exclusivity or exclusivity of the registration of the 00:02:22.600 --> 00:02:28.569 data is the period of the non-reliance and non-disclosure which is provided to the new 00:02:28.569 --> 00:02:34.740 chemical entities, or any pharmaceutical compositions, or any agronomical registration or any test 00:02:34.740 --> 00:02:35.740 data. 00:02:35.740 --> 00:02:44.239 So, this test data or the data generated for the submission procedure or approval procedure 00:02:44.239 --> 00:02:50.040 are regarded as very critical information and they are a part of intellectual property 00:02:50.040 --> 00:02:51.319 law. 00:02:51.319 --> 00:02:57.379 Like the TRIPs agreement under Article 37 like this undisclosed information is a kind 00:02:57.379 --> 00:03:02.489 of a trade secret because it has said this undisclosed information which keeps certain 00:03:02.489 --> 00:03:09.819 commercial advantage to the competitors or rivals may be regarded as a trade secret which 00:03:09.819 --> 00:03:11.860 is of high value. 00:03:11.860 --> 00:03:18.739 So, what happens in the pharmaceuticals segment or even in the agro chemical segment or normal 00:03:18.739 --> 00:03:25.760 chemical segment because the test data is essential for giving the marketing approval 00:03:25.760 --> 00:03:29.900 for such products to access their safety. 00:03:29.900 --> 00:03:33.140 So, the manufacturer has to submit those test data. 00:03:33.140 --> 00:03:39.390 And based on the test data, the drug regulator or the other agencies they generally approve 00:03:39.390 --> 00:03:41.900 those substances. 00:03:41.900 --> 00:03:46.550 And unless and until it is a public emergency, they are not supposed to reveal this test 00:03:46.550 --> 00:03:48.469 information, test data. 00:03:48.469 --> 00:03:53.540 And this test data are now covered by various provisions as per the different countries 00:03:53.540 --> 00:04:00.110 legislation, but in the developing country understand developed nation by understanding 00:04:00.110 --> 00:04:07.129 the importance of such test data or the clinical submission in case of the drug substances, 00:04:07.129 --> 00:04:15.640 they have given certain exclusive period during which those test data cannot be rebuilt to 00:04:15.640 --> 00:04:16.640 the competitors. 00:04:16.640 --> 00:04:23.540 Because I said the generic companies can use the original company in clinical trial data 00:04:23.540 --> 00:04:29.140 and they have to prove the bio equivalency only, and they can apply for the abbreviated 00:04:29.140 --> 00:04:30.140 new drug application. 00:04:30.140 --> 00:04:37.530 Even in the biopharmaceutical also bio similar company can use certain reference data, and 00:04:37.530 --> 00:04:39.930 then give the application. 00:04:39.930 --> 00:04:46.590 But again because high cost is involved, time is involved, and the manufacturer original 00:04:46.590 --> 00:04:54.160 manufacturer has to get certain incentive to again get back those costs incurred 00:04:54.160 --> 00:04:59.210 as well as to have some profit, so these provision has been introduced. 00:04:59.210 --> 00:05:05.580 So, basically what happens, during the data exclusivity period the drug regulatory authorities 00:05:05.580 --> 00:05:12.900 do not allow the test data of the original company to be used by the genetic company. 00:05:12.900 --> 00:05:23.310 And this is a provision by which there is an endeavour to create a balance between the 00:05:23.310 --> 00:05:28.990 new drug innovation and the greater public access to the drugs that is resulting from 00:05:28.990 --> 00:05:30.430 the generic drug competition. 00:05:30.430 --> 00:05:36.419 So, in both means you are also giving certain incentive to the innovator by giving them 00:05:36.419 --> 00:05:37.650 the exclusivity period. 00:05:37.650 --> 00:05:40.940 And after that also you are allowing the genetic companies to proliferate. 00:05:40.940 --> 00:05:48.090 So, both the way it is trying to create a balance. 00:05:48.090 --> 00:05:55.009 And this data exclusivity should not be confused with any of the intellectual property right 00:05:55.009 --> 00:05:56.699 like patents or other things. 00:05:56.699 --> 00:06:04.400 It is definitely the test data is a confidential information and may be regarded as an asset 00:06:04.400 --> 00:06:06.270 or a trade secret. 00:06:06.270 --> 00:06:11.680 But again it should not be confused with something which is related to the patenting of the drugs. 00:06:11.680 --> 00:06:19.630 And the drug exclusivity, data exclusivity period as well as the patent term of the drug 00:06:19.630 --> 00:06:22.780 product may run differently as well as concurrent. 00:06:22.780 --> 00:06:26.979 So, there is no correlation between these two concepts as such. 00:06:26.979 --> 00:06:33.710 Like a patent is generally filed at the initial stage like suppose when a company is already 00:06:33.710 --> 00:06:39.750 having certain clue regarding certain entities which can be used for certain indications. 00:06:39.750 --> 00:06:47.199 In that case, when they have some information on some R and D data, so they can file for 00:06:47.199 --> 00:06:48.949 the patent application. 00:06:48.949 --> 00:06:56.190 And it is generally advisable that the patent application must be filed as early as possible. 00:06:56.190 --> 00:07:02.069 Once they are convinced that, now this drug product is going to have this new invention 00:07:02.069 --> 00:07:04.970 for the treatment of certain disease or indication. 00:07:04.970 --> 00:07:12.569 And the patent tenure starts from the date of filing to the 20 years time period, next 00:07:12.569 --> 00:07:16.639 20 years time periods once it is granted. 00:07:16.639 --> 00:07:23.759 So, what happens many a time as I said it is a long process, biopharmaceutical development 00:07:23.759 --> 00:07:24.949 is a long process. 00:07:24.949 --> 00:07:31.930 So, even though you have a patent from 10 years, last 10 years it possible that your 00:07:31.930 --> 00:07:37.509 drug product is still not have not entered into the market because you know development, 00:07:37.509 --> 00:07:42.990 the clinical trials, then the regulatory approval all these processes takes certain time period. 00:07:42.990 --> 00:07:46.190 So, it may vary from 10 to 12 years. 00:07:46.190 --> 00:07:52.600 So, the effective time period which remains after the drug approval or after the marketing 00:07:52.600 --> 00:07:59.729 authorization is sometimes very less maybe 7 years, maybe 5 years or sometimes like maybe 00:07:59.729 --> 00:08:01.139 10 years. 00:08:01.139 --> 00:08:08.680 So, sometimes the so it is believed that because the complexity of the process the patent, 00:08:08.680 --> 00:08:17.490 the patent monopoly right is not that effective or not enjoyed to the full extent by the innovators. 00:08:17.490 --> 00:08:24.590 So, therefore, other provisions are there which again links the patent as well as the 00:08:24.590 --> 00:08:30.060 drug marketing authorization or we will see all these things. 00:08:30.060 --> 00:08:34.930 So, coming back again to drug exclusive data exclusivity. 00:08:34.930 --> 00:08:40.919 So, there are different exclusivity period for different kinds of the drug. 00:08:40.919 --> 00:08:46.610 For example, there is a category of the drug known as the orphan drug like a drug which 00:08:46.610 --> 00:08:51.680 is generally developed for a rare disease, again the definition of the rare disease varies 00:08:51.680 --> 00:08:56.860 like it may be one patient in per 5 lakhs of population. 00:08:56.860 --> 00:09:03.410 So, depending on the country the definition of the orphan drug changes. 00:09:03.410 --> 00:09:11.800 And once the company develops any orphan drug, so 7 years of data exclusive period is given 00:09:11.800 --> 00:09:18.130 means within that 7 years, no competitor company would be allowed to use those information. 00:09:18.130 --> 00:09:25.720 Again we have this New Chemical entity Exclusivity for 5 years as we saw in Hatch-Waxman Act. 00:09:25.720 --> 00:09:32.090 Then we have Generating Antibiotic Incentive that is a gain exclusivity for 5 years, then 00:09:32.090 --> 00:09:39.410 New Clinical investigation exclusivity for 3 years, Pediatric Exclusivity, it is again 00:09:39.410 --> 00:09:41.960 6, 6 months are added to the existing exclusivity. 00:09:41.960 --> 00:09:49.800 Suppose, a medicine is generally available for any indication, and we have given a 5 00:09:49.800 --> 00:09:56.070 year exclusivity; and further it has been proved found to be effective against the for 00:09:56.070 --> 00:10:02.160 the like in case of pediatric patients, then 6 months are also extra is added means 5 plus 00:10:02.160 --> 00:10:03.160 6 months. 00:10:03.160 --> 00:10:07.990 If it is a new chemical entity and then it is again used for certain pediatrics purpose 00:10:07.990 --> 00:10:10.840 then 6 months exclusivity is added. 00:10:10.840 --> 00:10:18.180 Like we saw Para IV certification or in abbreviated new drug application 180 days of exclusivity 00:10:18.180 --> 00:10:24.910 is given for the the first company who has applied for this ANDA after that starts from 00:10:24.910 --> 00:10:30.440 the date on which it gets the marketing. 00:10:30.440 --> 00:10:34.420 Then competitive generic therapy again 180 days of exclusivity is given. 00:10:34.420 --> 00:10:39.570 So, depending on the nature of the drug molecule, different drug exclusivity period has been 00:10:39.570 --> 00:10:44.050 mentioned in this is about the United States. 00:10:44.050 --> 00:10:51.090 And as again in India, we really do not have any formal drug exclusivity period, but for 00:10:51.090 --> 00:10:56.190 the first 4 years generally no generic companies are allowed to use the test data, so that 00:10:56.190 --> 00:11:00.560 4 years may be considered as a exclusive period for the manufacturers. 00:11:00.560 --> 00:11:07.110 But we do not have any co-regulation upon that. 00:11:07.110 --> 00:11:10.940 And coming to the data exclusivity of the biologicals. 00:11:10.940 --> 00:11:18.370 So, we saw under the Public Health Safety Act, United states, they have provided certain 00:11:18.370 --> 00:11:19.691 data exclusivity for the biologics. 00:11:19.691 --> 00:11:26.850 For example, the reference drug receives twelve years of exclusivity period before the first 00:11:26.850 --> 00:11:31.460 bio similar can be approved means the first drug gets twelve years of exclusivity. 00:11:31.460 --> 00:11:37.440 So, that is quite a long than compared to the generic versus like 5 years and this is 00:11:37.440 --> 00:11:38.930 twelve years. 00:11:38.930 --> 00:11:44.660 And in the twelve years, first four years of data exclusivity in which the bio similar 00:11:44.660 --> 00:11:48.019 applications cannot be filed. 00:11:48.019 --> 00:11:53.110 And the first interchangeable receives an exclusivity period ranging from the twelve 00:11:53.110 --> 00:11:54.110 to forty-two months. 00:11:54.110 --> 00:11:57.740 So, this is given in the different legislation of the corresponding countries. 00:11:57.740 --> 00:12:06.100 So, now as I mentioned this data exclusivity and other terms are not specific or are not 00:12:06.100 --> 00:12:08.089 common for all the countries. 00:12:08.089 --> 00:12:13.430 Developed nations have adopted those principles to promote more and more and more innovation 00:12:13.430 --> 00:12:16.690 in this area of drug development or biopharmaceutical development. 00:12:16.690 --> 00:12:20.589 So, they are known by different terminologies in different countries. 00:12:20.589 --> 00:12:27.610 So, we now talked about the data exclusivity there is something called the market exclusivity 00:12:27.610 --> 00:12:35.810 in the Data exclusivity is like that information of the test data cannot be used by the competitor. 00:12:35.810 --> 00:12:40.800 Market exclusivity is that nobody apart from the one which has been given the marketing 00:12:40.800 --> 00:12:47.000 authorization can enter into the market, maybe the application process is under thing they 00:12:47.000 --> 00:12:50.089 have applied, but they are not allowed to market. 00:12:50.089 --> 00:12:59.589 So, the marketic exclusivity, is a term which is defined in which a bio similar manufacturers 00:12:59.589 --> 00:13:06.500 will not receive an approval from the respective authority, even though he may have requested 00:13:06.500 --> 00:13:13.399 for such approval and presented the necessary data already and if the data has been taken 00:13:13.399 --> 00:13:15.920 from the authorization of the innovator. 00:13:15.920 --> 00:13:21.440 So, even though the application is pending, but they will not get the marketing authorization, 00:13:21.440 --> 00:13:27.209 so that period is known as the market exclusivity. 00:13:27.209 --> 00:13:32.100 And so this marketing exclusive, market exclusivity is used mostly in the European Union. 00:13:32.100 --> 00:13:37.589 So, if you see in the European Union, the data exclusivity and the marketing exclusivity 00:13:37.589 --> 00:13:40.209 are to be used together. 00:13:40.209 --> 00:13:45.000 So, that is known as 8 plus 2 plus 1 formula. 00:13:45.000 --> 00:13:49.970 And this has been set under the regulation 626 upon 2004. 00:13:49.970 --> 00:13:57.900 So, according to which an eight years of data exclusivity term is provided, and these term 00:13:57.900 --> 00:14:02.699 begins with the marketing authorization of the original drug. 00:14:02.699 --> 00:14:07.731 So, once the marketing authorization has been given, so till next eight years, the data 00:14:07.731 --> 00:14:10.180 exclusivity period remains. 00:14:10.180 --> 00:14:17.490 And under that condition that any new indication with the significance clinical benefit is 00:14:17.490 --> 00:14:20.610 available that will be provided. 00:14:20.610 --> 00:14:29.000 Then additional two years marketing exclusivity is provided if for the same product, one and 00:14:29.000 --> 00:14:33.290 more new therapeutic indications are filed during that period. 00:14:33.290 --> 00:14:40.529 And this is applicable to all the biopharmaceutical products which are approved after 31st October, 00:14:40.529 --> 00:14:41.740 2005. 00:14:41.740 --> 00:14:48.449 And all the drug products which have been approved before 2005, a drug exclusive period 00:14:48.449 --> 00:14:51.160 of 10 years is applied. 00:14:51.160 --> 00:14:58.460 And then a few of the European Union countries member countries they have been mutual recognition 00:14:58.460 --> 00:15:02.980 among themselves, and for them and it is 6 years. 00:15:02.980 --> 00:15:09.920 So, as I said there is no fixed formula or fixed definition or a fixed rule for this 00:15:09.920 --> 00:15:15.399 marketing exclusivity or the data exclusivity under the different national legislation. 00:15:15.399 --> 00:15:25.050 Now, coming back to the relation of the intellectual property like patent with the drug marketing 00:15:25.050 --> 00:15:32.910 and other process or drug approval process, there are again a lot of debate. 00:15:32.910 --> 00:15:39.630 Keeping in the view like same thing like the feeling that the biological drug development 00:15:39.630 --> 00:15:46.060 is a long process and the innovators are not getting sufficient not enjoying to the full 00:15:46.060 --> 00:15:51.530 time period of 20 years for their drug and effective patent term remains very low for 00:15:51.530 --> 00:15:56.690 most of the biopharmaceuticals, this provision known as the patent term extension has been 00:15:56.690 --> 00:16:00.420 introduced in many developed nations. 00:16:00.420 --> 00:16:05.040 And particularly this is known as the Patent Term Extension or the PTE. 00:16:05.040 --> 00:16:10.589 And this doctrine PTE doctrine comes from the Title II of the Drug Price Competition 00:16:10.589 --> 00:16:15.759 and Patent Term Restoration Act of 1984 or the Hatch-Waxman Act. 00:16:15.759 --> 00:16:20.880 And the purpose being the same that you have to encourage new drug research and you have 00:16:20.880 --> 00:16:29.779 to compensate some way by compensate the reduction in the effective patent term by some way. 00:16:29.779 --> 00:16:38.490 So, like we have to one here more to understand one thing patent approval process is a different 00:16:38.490 --> 00:16:43.420 process, it is controlled by the USPTO - United States Patent and Trademark Office. 00:16:43.420 --> 00:16:49.339 And drug approval process is guided by the USFDA - United States Food and Drug Approval 00:16:49.339 --> 00:16:50.720 Agency. 00:16:50.720 --> 00:16:53.649 So, these are two different agencies. 00:16:53.649 --> 00:16:59.520 So, there might be if there is no coordination between these two agencies, so there might 00:16:59.520 --> 00:17:03.770 be a chance where there might be questions of patent infringement if the generic drug 00:17:03.770 --> 00:17:04.770 has been approved earlier. 00:17:04.770 --> 00:17:09.459 So, you are not effective 20 years time period has been realized by them. 00:17:09.459 --> 00:17:14.120 So, they have tried to coordinates two agencies. 00:17:14.120 --> 00:17:21.340 So, in this patent term extension, so the information from the patent agency and information 00:17:21.340 --> 00:17:27.319 by the regulatory agency is combined together, and additional time period is given to the 00:17:27.319 --> 00:17:33.690 manufacturer company, so that they can enjoy the patent rights for a sub substantive time 00:17:33.690 --> 00:17:34.710 period. 00:17:34.710 --> 00:17:43.270 In this under first during the Hatch-Waxman Act, the part of the time spent while seeking 00:17:43.270 --> 00:17:51.231 the regulatory approval was regained by lengthening the patent term for an eligible patent in 00:17:51.231 --> 00:17:53.880 order to compensate the type of the delay. 00:17:53.880 --> 00:17:59.260 So, for note for every patent, this can be given you have to now cite an eligible potent 00:17:59.260 --> 00:18:04.470 patent means maybe the patent over the active ingredient or the main patent related to the 00:18:04.470 --> 00:18:06.190 drug molecule. 00:18:06.190 --> 00:18:11.180 And under this Hatch-Waxman Act, this patent term extension provisions were available to 00:18:11.180 --> 00:18:16.750 the eligible patents, and covers human drug products, veterinary drug products, and as 00:18:16.750 --> 00:18:18.970 well as the medical devices. 00:18:18.970 --> 00:18:25.140 And they have a defined set of rules which determines the eligibility for the patent 00:18:25.140 --> 00:18:27.110 term extension of the drug products. 00:18:27.110 --> 00:18:33.430 And what kind of the claims or patent can be covered under this patent term extension. 00:18:33.430 --> 00:18:39.040 And both the Patent and Trademark Office as well as the Food Drug Agency participate in 00:18:39.040 --> 00:18:42.790 calculating and determining the patent term extensions. 00:18:42.790 --> 00:18:48.510 But again this is the Patent Office which makes the final determination on the patent 00:18:48.510 --> 00:18:53.680 eligibility means they have to again see which patent has to be given this extension. 00:18:53.680 --> 00:18:58.630 They cannot give, so there might be 10 patents over a single molecule - single drug product, 00:18:58.630 --> 00:19:02.650 but again one eligible patent can be given the extension. 00:19:02.650 --> 00:19:11.160 So,in the United States the maximum term extension is 5 years provided the extension does not 00:19:11.160 --> 00:19:16.140 result in the total remaining patent term more than 14 years. 00:19:16.140 --> 00:19:22.450 That means, like 5 years additional patent term give can be given that may be 20 plus 00:19:22.450 --> 00:19:29.740 5, that means, 25 maybe, but again we have to calculate after the marketing authorization 00:19:29.740 --> 00:19:34.270 means once the marketing authorization has been granted means it has been approved for 00:19:34.270 --> 00:19:38.280 entering into the market from that it would be calculated. 00:19:38.280 --> 00:19:45.150 So, after marketing authorization maximum 14 years should be the remaining patent term. 00:19:45.150 --> 00:19:50.250 So, it accordingly maximum patent term extension is given 5 years. 00:19:50.250 --> 00:19:58.640 For example, if like when a marketing author marketing authorization has been granted for 00:19:58.640 --> 00:20:05.310 a drug molecule, the remaining patent term is suppose 5 years, then additional 5 years 00:20:05.310 --> 00:20:10.350 would be given, so that means, 10 years of patent term would be the after patent term 00:20:10.350 --> 00:20:15.730 extension the effective patent protection would be 10 years, even though it has like 00:20:15.730 --> 00:20:17.600 15 years has been passed by. 00:20:17.600 --> 00:20:25.730 But if the remaining term is already suppose 13 year when the marketing authorization is 00:20:25.730 --> 00:20:32.450 granted, and they have remaining 13 years of time period to enjoy the patent then only 00:20:32.450 --> 00:20:37.290 1 year extension might be given because it should be maximum of 14 years after the marketing 00:20:37.290 --> 00:20:38.290 authorization. 00:20:38.290 --> 00:20:43.900 So, that is the calculation which is made by the PTO as well as the FTO. 00:20:43.900 --> 00:20:49.880 So, the 14 year period is measured from the date of the drug product received the regulatory 00:20:49.880 --> 00:20:54.120 approval up to the date of the patent expiration. 00:20:54.120 --> 00:21:00.620 And any term extend extension granted under this statute is applied from the original 00:21:00.620 --> 00:21:05.000 expiration date of the patent including the patent term like PTA. 00:21:05.000 --> 00:21:12.790 So, patent term edition that is another patent term addition is another concept which is 00:21:12.790 --> 00:21:19.440 again individually done by the USPTO - Patent Office means if during the patent prosecution 00:21:19.440 --> 00:21:23.340 or the patent approval due to certain process the process has been delayed. 00:21:23.340 --> 00:21:24.750 So, they adjust the term. 00:21:24.750 --> 00:21:28.000 And it is only found in the United States only. 00:21:28.000 --> 00:21:34.750 So, if you ever get a chance to see any patent document, you might see there is a patent 00:21:34.750 --> 00:21:36.470 term adjustment. 00:21:36.470 --> 00:21:43.070 So, this patent term adjustment like few days or depending on the nature of the process, 00:21:43.070 --> 00:21:46.730 so that some time period has been adjusted. 00:21:46.730 --> 00:21:50.280 And accordingly they decide the date of expiration of the patent. 00:21:50.280 --> 00:21:57.870 And at that date would be taken into consideration while calculating the patent term extension. 00:21:57.870 --> 00:22:02.790 So, again as I mentioned there should be set of rules which guides which patent must be 00:22:02.790 --> 00:22:03.790 eligible. 00:22:03.790 --> 00:22:10.690 So, a patent will only be eligible for the extension if it includes at least one claim 00:22:10.690 --> 00:22:16.280 covering the approved drug products or its approved method of use or method of manufacturing 00:22:16.280 --> 00:22:17.280 it. 00:22:17.280 --> 00:22:21.220 So, like a patent is generally given for an invention. 00:22:21.220 --> 00:22:27.710 So, in a patent document generally the inventor specifies certain claims means on which aspect 00:22:27.710 --> 00:22:31.090 of the patent you want to have the patent. 00:22:31.090 --> 00:22:32.330 Those are known as the claims. 00:22:32.330 --> 00:22:37.240 So, claims are the basic they are the main thing of a patent. 00:22:37.240 --> 00:22:45.780 So, the claim must cover the like approved drug product, or method of use, or how they 00:22:45.780 --> 00:22:47.580 are manufacturing it. 00:22:47.580 --> 00:22:53.220 And they have to also satisfy few conditions like the patent should not have expired; the 00:22:53.220 --> 00:22:58.940 term of the patent has never been extended before; the patent owner or its agent submitted 00:22:58.940 --> 00:23:04.060 a complete and timely application for the extension; and the product has been subjected 00:23:04.060 --> 00:23:10.040 to the regulatory review period before it is commercial marketing or the use; and the 00:23:10.040 --> 00:23:15.570 permission for the commercial marketing or use is first permitted accepted patents claiming 00:23:15.570 --> 00:23:22.720 a method of making a product primarily using the recombinant DNA technology were different. 00:23:22.720 --> 00:23:27.650 So, these rules, so they they are there are set of rules which has to be followed. 00:23:27.650 --> 00:23:33.130 And the patent has to be like found eligible for giving the patent term extension. 00:23:33.130 --> 00:23:37.000 And this patent term extension why it is necessary, so what benefit will you give? 00:23:37.000 --> 00:23:41.600 So, it increases their profitability means till the time the patent is alive nobody is 00:23:41.600 --> 00:23:43.430 allowed to copy that product. 00:23:43.430 --> 00:23:47.870 So, you have the monopoly for additional 5 years of time period in the United States. 00:23:47.870 --> 00:23:49.580 So, that is the advantage. 00:23:49.580 --> 00:23:55.100 Like there was an example of Prozac by Emily Lee. 00:23:55.100 --> 00:24:05.170 So, like when the patent for that drug molecule expired that drug Prozac it next 5 years benefit 00:24:05.170 --> 00:24:10.030 was the highest among whole of whole of its life term. 00:24:10.030 --> 00:24:15.080 So, you may understand how this patent term extension gives the commercial advantage to 00:24:15.080 --> 00:24:17.830 any company who is marketing their drugs. 00:24:17.830 --> 00:24:24.860 So, that is the way the patent term extension is being helpful. 00:24:24.860 --> 00:24:34.640 Now, in the European Union, we do not call this patent term extension as PTE rather it 00:24:34.640 --> 00:24:39.380 is known as the Supplementary Protection Certificate or the SPC. 00:24:39.380 --> 00:24:45.540 So, in the EU the SPC or the supplementary protection certificate is a sui generis or 00:24:45.540 --> 00:24:50.370 a specific extension of the patent under a specific set of rights. 00:24:50.370 --> 00:24:55.300 And it is available for the drug products, medicinal products, plant protection products 00:24:55.300 --> 00:24:58.880 like insecticides and herbicides as well. 00:24:58.880 --> 00:25:05.250 And again this is in the same way has been introduced to compensate the long time period 00:25:05.250 --> 00:25:07.460 needed to obtain the regulatory approval. 00:25:07.460 --> 00:25:16.590 And so that the profit for the manufacturers is generally higher, and they they incur more 00:25:16.590 --> 00:25:22.000 profit and the loss is compensated in some way. 00:25:22.000 --> 00:25:29.920 And again the product has to satisfy few conditions like first for which you are giving a patent 00:25:29.920 --> 00:25:31.200 extension or the SPC. 00:25:31.200 --> 00:25:35.511 The product is protected by a basic patent which is in force; the product should be a 00:25:35.511 --> 00:25:40.801 medicinal product, which has been granted the marketing authorization; and the product 00:25:40.801 --> 00:25:46.510 has not already been subjected to certificates; and the marketing authorization is the first 00:25:46.510 --> 00:25:50.020 authorization to place the product on the market as a medicinal product. 00:25:50.020 --> 00:25:55.550 So, there are a few condition which has to be met in European, Indian as well, so that 00:25:55.550 --> 00:26:01.380 the supplementary protection certificate can be granted. 00:26:01.380 --> 00:26:07.720 And this supplementary protection certificate again it is not related to patent directly 00:26:07.720 --> 00:26:10.540 in European Union, it is a supplementary certificate. 00:26:10.540 --> 00:26:14.480 So, it starts only after the patent expires. 00:26:14.480 --> 00:26:19.090 And as in the same way like United States, the supplementary protection certificate has 00:26:19.090 --> 00:26:21.450 a maximum life of 5 years. 00:26:21.450 --> 00:26:28.760 And in some cases, it is extendable to 5.5 years when it is related to the human medicinal 00:26:28.760 --> 00:26:35.130 product for which the data from the clinical trials are conducted under the approved pediatric 00:26:35.130 --> 00:26:41.350 investigation plant means if it is a pediatric indication in that case the exclusive the 00:26:41.350 --> 00:26:44.790 extension may be for 5.5years. 00:26:44.790 --> 00:26:50.830 But similarly here like United States the duration of the total market exclusivity of 00:26:50.830 --> 00:26:57.660 the patent and the SPC should not exceed 15 years; in United States like that is 14 years 00:26:57.660 --> 00:26:59.690 and here it is 15 years. 00:26:59.690 --> 00:27:07.800 And however, the grant of this additional 6 months of SPC for the pediatric thing like 00:27:07.800 --> 00:27:14.320 that is again allowed 15.5 years that may be in some cases. 00:27:14.320 --> 00:27:21.890 And so they have specific regulations that is regulation number seven 1768 of 92, and 00:27:21.890 --> 00:27:22.890 1610 of 96. 00:27:22.890 --> 00:27:27.370 So, these are the various regulation which is related to the supplementary protection 00:27:27.370 --> 00:27:28.570 certificate. 00:27:28.570 --> 00:27:36.080 And this is one way through which the companies tried to maximize their profit and monopoly 00:27:36.080 --> 00:27:41.750 over the market that is why patent or intellectual property also plays a crucial role in case 00:27:41.750 --> 00:27:47.400 of the pharmaceutical industry because through which they are getting to or they they can 00:27:47.400 --> 00:27:52.720 extend their life of the market or they get market exclusivity they get other benefits 00:27:52.720 --> 00:27:54.830 from the same. 00:27:54.830 --> 00:28:00.240 But again in India things are a little bit different, we do not have any patent linkage 00:28:00.240 --> 00:28:06.400 provision or patent term extension per say and that is not been recognized in India. 00:28:06.400 --> 00:28:13.250 But in other countries that is one of the way incentives has been given to the pharmaceutical 00:28:13.250 --> 00:28:14.250 companies. 00:28:14.250 --> 00:28:18.960 So, these are the few concepts with respect to pharmaceutical as well as the biopharmaceutical 00:28:18.960 --> 00:28:24.310 in specific which as a student all of us should know. 00:28:24.310 --> 00:28:30.280 And the provisions are also like new new things are coming up as acomplexity of the molecule 00:28:30.280 --> 00:28:33.440 is being resolved the data requirement are also being developed. 00:28:33.440 --> 00:28:39.520 So, if you see the United States FDA, you will see lot of guidance document for monoclonal 00:28:39.520 --> 00:28:45.640 antibody, for normal protein, for any recombinant DNA product, or gene therapy product, or blood 00:28:45.640 --> 00:28:46.640 transfusion product. 00:28:46.640 --> 00:28:52.980 So, because it is so complex, we need to have a specific set for the different set of molecules. 00:28:52.980 --> 00:28:59.090 In India, of course, we are trying to get our regulation in place at par with the other, 00:28:59.090 --> 00:29:04.600 but still there is there are a lot many scope for improvement. 00:29:04.600 --> 00:29:07.970 And also there is one good thing is that there are certain international standards. 00:29:07.970 --> 00:29:13.890 So, we have again ICH - International Standard Council for Harmonization, so that also gives 00:29:13.890 --> 00:29:18.370 certain guidelines regarding this product development, purity safety, and efficacy study. 00:29:18.370 --> 00:29:24.580 So, those are the international standards which can also be adopted by different country 00:29:24.580 --> 00:29:28.280 for making their product at par or of better quality. 00:29:28.280 --> 00:29:31.520 So, these are all different provisions. 00:29:31.520 --> 00:29:36.100 I hope this would be some informative to you all. 00:29:36.100 --> 00:29:39.710 So, keep exploring and keep reading more about this. 00:29:39.710 --> 00:29:41.510 So, that is all for this session. 00:29:41.510 --> 00:29:44.110 So, thank you for being with me. 00:29:44.110 --> 00:29:46.280 So, we will meet in the next module. 00:29:46.280 --> 00:29:47.210 Thank you so much.