20:
2014 about $ 140 Billion is spent on research and development of pharmaceuticals which produces 25–35 new drugs annually. Technology, which is transforming science, medicine, and research tools has increased the speed at which we can analyze data but we currently still must test the products which is a lengthy process. Differences in the performance of medical care may be due to variation in the introduction and circulation of pharmaceutical innovations.
57:. The MPP aims to improve access to appropriate, affordable HIV medicines and technologies for people living with HIV in developing countries. Working in partnership with a range of stakeholders, the MPP opens the door to generic low-cost production of key HIV therapies as well as fixed-dose combinations and paediatric formulations by creating a pool of relevant patents for sub-licensing and product development.
336:? How many people could have been spared death by skin cancer if human breast milk could be used topically to eliminate cancerous cells? We cannot know. We just know that research and clinical trial money was not put into unpatentable targets at the same rate and volume that it was for patentable ones.
261:
As much money as has been put into HAMLET... it is remarkable that no money has been put into the use of actual Human Breast Milk as a medical product that could fight cancer. Again, Human Breast milk is not patentable, thus investing into clinical trials for its use as a medical product means that
19:
are currently guided by a patent system, the patent system protects the innovator of medicines for a period of time. The patent system does not currently stimulate innovation or pricing that provides access to medicine for those who need it the most, It provides for profitable innovation. As of
328:
It is impossible to quantify something that does not happen. We can count how much money got put into research by companies that rely on patents and we can estimate how much a process for a clinical trial costs, but it is impossible to define how much money SHOULD have been spent just like it is
247:
6) A patent for making HAMLET through combining alpha-lactalbumin with oleic acid was granted in 2008 (expired 2018). A patent for recombinant HAMLET was presented in 2010 (expires 2030). This can be viewed as HAMLET 2.0. Peptides for second generation use were patented in 2011. Use of HAMLET as
102:) is a proposed pay-for-performance mechanism that would provide a market-based solution to problems concerning the development and distribution of medicines globally. It would incentivize the research and development of new pharmaceutical products that make substantial reductions in the global
23:
Pharmaceutical innovation may not apply the same definition of "initiative" as other industries because while a product might use a new molecule or formula, that by itself holds very little value. For people that need the product the health benefits that were not previously achievable may be a
39:
The FDA has implemented the
Breakthrough Therapy Designation which should help bring new needed products to the market faster. One of the key concerns in the current patent system is that an innovation patent is overly generous given that it has a very low inventiveness threshold.
138:
for the patent holder. In health-care pharmaceuticals this advantage has proven to be highly profitable, driving over $ 83 billion dollars investment into
Research and Development by the pharmaceutical industry in 2019. This focus on the profits of
289:
Research suggests that aloe gel, applied in the morning and evening in addition to the use of the topical prescription acne medicine tretinoin (Retin-A, Atralin, others), might be more effective in reducing acne than using a topical prescription
150:. These can be quite expensive, sometimes costing into the billions of dollars. That elevated cost makes it a bad investment to pay for a medicine to be approved that does not guarantee years of profits to those that put up the money.
298:
Aloe extract cream might reduce redness, scaling, itching and inflammation caused by mild to moderate psoriasis. You might need to use the cream several times a day for a month or more to see improvements in your
160:
ruled that isolation by itself is not sufficient for something to be deemed inventive subject matter, and thus patentable. As a rule, raw natural material is generally rejected for patent approval by the
265:
There are many naturally occurring plants and compounds that have medicinal properties. An example of a plant that holds multiple properties, but that has not had money put into clinical trials, is
964:
463:
Westerling, Ragnar; Westin, Marcus; McKee, Martin; Hoffmann, Rasmus; Plug, Iris; Rey, Grégoire; Jougla, Eric; Lang, Katrin; Pärna, Kersti; Alfonso, José L.; MacKenbach, Johan P. (2014).
793:
763:
1181:
Pettersson-Kastberg J, Aits S, Gustafsson L, Mossberg A, Storm P, Trulsson M, Persson F, Mok KH, Svanborg C (2009). "Can misfolded proteins be beneficial? The HAMLET case".
940:
657:
315:
Research suggests that twice-daily application of aloe gel for eight weeks might help reduce symptoms of this inflammatory condition that affects the inside of the mouth.
622:
375:
323:
Whether oral use of aloe latex is effective at treating constipation is unclear. While it acts as a laxative, aloe latex can also cause abdominal cramps and diarrhea.
24:
deciding factor as to whether or not it is initiative. While a pharmaceutical company may view a product that fills a niche as innovative if it can produce a profit.
187:
3) If the verified characteristic is deemed interesting, further experiments are made that attempt to isolate the compound that causes the interesting behavior.
437:
126:
An unintended but real consequence of the influence of a patent-heavy industry is that money is not put into unpatentable elements with the same fervor. A
708:
693:
332:
How much money could have been saved world-wide if doctors were allowed to prescribe medicine that many people can grow at home at a very low cost, like
281:
Application of aloe gel appears to shorten the duration of wound healing for first- and second-degree burns. Aloe gel might also promote wound healing.
162:
65:
Kristopher J. Hult has proposed a new measurement based on novel and incremental innovation. The model predicts a decline of 40% for the 2010s.
241:
5) Alpha-lactalbumin was partially unfolded to allow for release of the calcium ion and replacement with an oleic acid molecule, this enabled
189:
4) Once isolated, the compound is again subject to experimentation to verify that it is, indeed, the one that causes the interesting behavior.
554:
388:
894:
Dimasi, Joseph A; Grabowski, Henry G; Hansen, Ronald W (2016). "Innovation in the pharmaceutical industry: New estimates of R&D costs".
771:
157:
248:
prophylaxis (preventive was) patented in 2013 (expires 2033). The use of HAMLET for
Papilloma was patented in 2013 (expires 2023).
668:
213:
1) In 1995 Human Breast milk was observed that Human Breast Milk killed cancerous human cells while leaving healthy cells intact.
191:
5) In order to be able to patent, efforts are then made to try and modify the original substance in a way that differentiates it.
633:
394:
166:
734:
193:
6) Once the original substance has been successfully modified, a patent application is presented for the new substance.
84:
Regulatory uncertainty is one area that stifles innovation. The approval processes are becoming increasingly complex.
1286:
207:
345:
176:
69:
118:
economist Aidan Hollis, and is promoted by the non-profit organization
Incentives for Global Health (IGH).
1291:
135:
115:
45:
579:
Scannell, JW; Blanckley, A; Boldon, H; Warrington, B (2012). "Eroom's Law in pharmaceutical R&D".
1094:
1006:
412:
130:
gives its owner the legal right to exclude others from making, using, or selling an invention for a
1140:
Gustafsson L, Hallgren O, Mossberg AK, Pettersson J, Fischer W, Aronsson A, Svanborg C (May 2005).
1250:
1206:
604:
94:
172:
The current patent structure lays incentives in a pattern that has been observed several times:
231:
4) In 2000 an active compound for tumericidal activity was found to be a complex that involved
146:
The process of having something be deemed usable as a medical product involves going through a
1198:
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1024:
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903:
841:
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588:
525:
484:
476:
438:"MedidataVoice: The Next Wave Of Pharmaceutical Innovation: An Interview With Bernard Munos"
143:
leaves a downside where investment money is not going, that is, into unpatentable research.
350:
1098:
1010:
846:
821:
530:
513:
489:
464:
255:
251:
196:
147:
131:
103:
28:
465:"The timing of introduction of pharmaceutical innovations in seven European countries"
156:
are subject for debate and can vary from jurisdiction to jurisdiction. As of 2013 the
1280:
1117:
1082:
1029:
994:
140:
1210:
1142:"HAMLET kills tumor cells by apoptosis: structure, cellular mechanisms, and therapy"
709:"Medicines Patent Pool Aims To Increase Access To HIV Drugs In Developing Countries"
907:
608:
355:
242:
111:
1225:
195:
7) If the patent is granted the new pharmaceutical candidate can then be taken to
49:(MPP), is a United Nations-backed organisation founded in July 2010 and based in
742:
203:
76:
used the method to measure 2012 and found that the rate fell from 7.7% to 7.2%.
54:
993:
Håkansson A, Zhivotovsky B, Orrenius S, Sabharwal H, Svanborg C (August 1995).
1194:
232:
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329:
impossible to estimate the effect of a process that has not been realized.
1038:
941:"Gene Patents in Europe Relatively Stable Despite Uncertainty in the U.S."
72:, which is used to measure and compare the profitability of investments.
1081:
Svensson M, Håkansson A, Mossberg AK, Linse S, Svanborg C (April 2000).
965:"The Supreme Court Holds Genes Are Patent-Ineligible Products of Nature"
869:
837:
307:
Applying a cream containing aloe extract might help lesions heal sooner.
916:
73:
820:
Hollis, A; Grootendorst, P; Levine, DK; Pogge, T; Edwards, AM (2011).
480:
442:
127:
50:
1056:
592:
1083:"Conversion of alpha-lactalbumin to a protein inducing apoptosis"
107:
106:. The HIF is the creation of a team of researchers led by the
202:
An example of such an occurrence can be seen in the story of
179:
through observation on something that is naturally occurring.
274:"Research on the use of aloe for specific conditions shows:
208:
HAMLET (Human Alpha-lactalbumin Made LEthal to Tumor cells)
794:"measuring the return from pharmaceutical innovation 2014"
764:"Measuring the return from pharmaceutical innovation 2012"
870:"Research and Development in the Pharmaceutical Industry"
27:
A decline in research and development has been coined as
822:"New approaches to rewarding pharmaceutical innovation"
219:
were made and the observed characteristic was verified.
555:"Is Pharmaceutical Productivity In Decline? Maybe Not"
512:
Morgan, Steven; Lopert, Ruth; Greyson, Devon (2008).
514:"Toward a definition of pharmaceutical innovation"
346:Pharmaceutical industry - The cost of innovation
250:7) HAMLET derived drug candidate, Alpha1H is in
739:University of Chicago - Department of Economics
185:are made to verify the observed characteristic.
988:
986:
984:
8:
995:"Apoptosis induced by a human milk protein"
229:(MAL) that caused the interesting behavior.
1050:
1048:
944:Genetic Engineering and Biotechnology News
469:Journal of Evaluation in Clinical Practice
1157:
1116:
1106:
1028:
1018:
915:
845:
529:
488:
163:United States Patent and Trademark Office
623:"Review of the Innovation Patent System"
122:Low investment into unpatentable options
431:
429:
367:
210:, the modified and patented variation.
692:: CS1 maint: archived copy as title (
685:
377:Review of the Innovation Patent System
221:3) Further experiments were made that
175:1) Some interesting characteristic is
7:
826:Canadian Medical Association Journal
707:RUNYOWA, TAVENGWA (10 March 2011).
553:Feyman, Yevgeniy (13 April 2015).
411:Pogge, Thomas (18 December 2011),
245:and stabilization of the molecule.
169:have been patented several times.
68:One current way to measure is the
14:
1261:. Mayo Clinic. 17 September 2017
254:for use with patients that have
939:Sharples, Andrew (2011-03-23).
206:cancer killing properties and
908:10.1016/j.jhealeco.2016.01.012
735:"Kristopher J. Hult: Research"
167:genetically modified organisms
1:
581:Nature Reviews Drug Discovery
1087:Proc. Natl. Acad. Sci. U.S.A
999:Proc. Natl. Acad. Sci. U.S.A
896:Journal of Health Economics
414:Medicine for the 99 percent
1308:
17:Pharmaceutical innovations
1195:10.1080/07853890802502614
225:the compound multimeric
132:a limited period of time
1226:"About Clinical Trials"
1020:10.1073/pnas.92.17.8064
70:Internal rate of return
1108:10.1073/pnas.97.8.4221
262:profit cannot be had.
1159:10.1093/jn/135.5.1299
305:Herpes simplex virus.
136:competitive advantage
134:. This can provide a
116:University of Calgary
46:Medicines Patent Pool
1230:www.hamletpharma.com
1061:www.hamletpharma.com
1099:2000PNAS...97.4221S
1011:1995PNAS...92.8064H
838:10.1503/cmaj.100375
383:. 2014. p. 2.
313:Oral lichen planus.
204:Human Breast Milk's
733:Hult, Kristopher.
154:Biological patents
95:Health Impact Fund
801:www2.deloitte.com
481:10.1111/jep.12122
390:978-0-9804542-7-7
279:Burns and wounds.
237:alpha-lactalbumin
227:alpha-lactalbumin
104:burden of disease
1299:
1287:Drug development
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963:Sheehan, Teige.
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774:on 16 April 2015
770:. Archived from
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741:. Archived from
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674:on 23 April 2010
673:
667:. Archived from
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393:. Archived from
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158:US Supreme Court
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1224:HAMLET PHARMA.
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1175:
1152:(5): 1299–303.
1139:
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1055:HAMLET PHARMA.
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658:"Archived copy"
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642:
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630:www.acip.gov.au
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593:10.1038/nrd3681
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351:Chemical patent
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252:clinical trials
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197:clinical trials
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88:Proposed models
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876:. 8 April 2021
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665:www.unitaid.eu
649:
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587:(3): 191–200.
571:
545:
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475:(4): 301–310.
455:
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403:
400:on 2015-02-27.
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256:bladder cancer
148:clinical trial
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62:
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36:
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1292:Patent reform
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745:on 2015-04-16
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639:on 2015-02-27
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321:Constipation.
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235:. as well as
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141:patentability
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35:Current model
34:
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1263:. Retrieved
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1229:
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878:. Retrieved
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800:
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776:. Retrieved
772:the original
767:
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743:the original
738:
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669:the original
664:
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641:. Retrieved
634:the original
629:
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441:
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413:
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395:the original
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356:Generic drug
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243:cytotoxicity
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112:Thomas Pogge
110:philosopher
99:
93:
91:
83:
67:
64:
44:
42:
38:
26:
22:
16:
15:
917:10161/12742
874:www.cbo.gov
524:(1): e4–7.
217:Experiments
183:Experiments
61:Measurement
55:Switzerland
29:Eroom's Law
1281:Categories
1265:21 January
949:2013-06-13
880:2022-01-13
806:2015-04-15
749:2015-04-16
678:25 January
643:2015-04-15
449:2015-04-15
420:2015-04-15
362:References
296:Psoriasis.
233:oleic acid
177:discovered
1257:Aloe vera
1057:"Patents"
902:: 20–33.
334:Aloe vera
268:Aloe vera
1211:31198109
1203:18985467
1183:Ann. Med
1168:15867328
1127:10760289
926:26928437
856:21149519
778:16 April
713:IP Watch
688:cite web
601:22378269
564:16 April
540:21602949
518:Open Med
499:24750393
340:See also
223:isolated
114:and the
80:Barriers
1146:J. Nutr
1095:Bibcode
1039:7644538
1007:Bibcode
973:20 June
847:3071389
768:Reuters
609:3344476
531:3091590
490:4282430
74:Reuters
1235:13 Jan
1209:
1201:
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1066:13 Jan
1037:
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924:
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844:
718:2 June
607:
599:
559:Forbes
538:
528:
497:
487:
443:Forbes
387:
290:alone.
165:, but
128:patent
51:Geneva
1207:S2CID
1118:18203
1030:41287
968:(PDF)
797:(PDF)
672:(PDF)
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