{{Short description|Pharmaceutical drugs with patent protections}} '''Proprietary drug''' are chemicals used for medicinal purposes which are formulated or manufactured under a name protected from competition through trademark or patent.<ref>{{Cite web |title=APA Dictionary of Psychology |url=https://dictionary.apa.org/ |access-date=2023-06-23 |website=dictionary.apa.org |language=en |archive-date=2018-04-27 |archive-url=https://web.archive.org/web/20180427011428/https://dictionary.apa.org/ |url-status=live }}</ref> The invented drug is usually still considered proprietary even if the patent expired.<ref>{{Cite web|date=11 May 2011|title=OFFICIAL RECORD OF PROCEEDINGS|url=https://www.legco.gov.hk/yr10-11/english/counmtg/hansard/cm0511-translate-e.pdf|access-date=26 March 2021|website=Hong Kong Legislative Council|archive-date=18 September 2021|archive-url=https://web.archive.org/web/20210918044443/https://www.legco.gov.hk/yr10-11/english/counmtg/hansard/cm0511-translate-e.pdf|url-status=live}}</ref> When a patent expires, generic drugs may be developed and released legally. Some international and national governmental organizations have set up laws to enforce intellectual property to protect proprietary drugs, but some also highlight the importance of public health disregarding legal regulations.<ref name=":22" /><ref name=":23" /> Proprietary drugs affect the world in various aspects including medicine, public health and economy.
Not all proprietary drugs have their generic replacements available. Biologics are often produced by in vivo preparation and direct extraction of substances from living organisms.<ref>{{Cite journal |last=Research |first=Center for Biologics Evaluation and |date=2019-02-28 |title=What Are "Biologics" Questions and Answers |url=https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers |journal=FDA |language=en |access-date=2021-03-15 |archive-date=2022-11-06 |archive-url=https://web.archive.org/web/20221106030726/https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers |url-status=dead }}</ref> Pharma is not extensively involved in searching for ready-to-sell generic biologics due to the complexity of manufacture and hurdles in extraction processes.<ref name=":0">{{Cite web |title=Generic Biologic Drugs - Drugs |url=https://www.msdmanuals.com/home/drugs/brand-name-and-generic-drugs/generic-biologic-drugs |access-date=2023-06-23 |website=MSD Manual Consumer Version |language=en |archive-date=2023-05-10 |archive-url=https://web.archive.org/web/20230510234109/https://www.msdmanuals.com/home/drugs/brand-name-and-generic-drugs/generic-biologic-drugs |url-status=live }}</ref> Besides vaccines, these endogenous origin chemicals are prescribed to patients with severe conditions, such as complications including asthma, rheumatoid arthritis,<ref>{{cite web |title=Updated Guideline for the Management of Rheumatoid Arthritis |url=https://www.rheumatology.org/Portals/0/Files/Rheumatoid-Arthritis-Guideline-Project-Plan.pdf |publisher=American College Of Rheumatology |archive-url=https://web.archive.org/web/20200212124739/https://www.rheumatology.org/Portals/0/Files/Rheumatoid-Arthritis-Guideline-Project-Plan.pdf |archive-date=February 12, 2020 |url-status=deviated}}</ref> or cancer. Patients taking a particular brand of biologics are unable to interchange between one and another to prevent underlying exposure to more side effects and/or suboptimal treatment.<ref name=":0" /> It is believed that generic biopharmaceutical products will not be released in the near future until all technical difficulties are overcome.<ref>{{Cite journal|last1=Calo-Fernández|first1=Bruno|last2=Martínez-Hurtado|first2=Juan Leonardo|date=2012-12-12|title=Biosimilars: Company Strategies to Capture Value from the Biologics Market|journal=Pharmaceuticals|volume=5|issue=12|pages=1393–1408|doi=10.3390/ph5121393|issn=1424-8247|pmc=3816668|pmid=24281342|doi-access=free}}</ref>
[[File:Viagra in Pack.jpg|thumb|Viagra, a famous example of proprietary drug on the market]] The table below shows some examples of pharma and their past/current proprietary medications: {| class="wikitable" !Pharma !Proprietary medications |- |Pfizer |Viagra (sildenafil),<ref>{{Cite web |last=Wilson |first=Jacque |date=2013-03-27 |title=Viagra: The little blue pill that could |url=https://www.cnn.com/2013/03/27/health/viagra-anniversary-timeline/index.html |access-date=2023-06-23 |website=CNN |language=en |archive-date=2023-03-25 |archive-url=https://web.archive.org/web/20230325173030/https://www.cnn.com/2013/03/27/health/viagra-anniversary-timeline/index.html |url-status=live }}</ref> Comirnaty (tozinameran, co-op with BioNTech)<ref>{{Cite web |last=Browne |first=Ryan |date=2020-11-11 |title=What you need to know about BioNTech — the European company behind Pfizer's Covid-19 vaccine |url=https://www.cnbc.com/2020/11/11/biontech-the-european-company-behind-pfizers-covid-19-vaccine.html |access-date=2023-06-23 |website=CNBC |language=en |archive-date=2021-03-04 |archive-url=https://web.archive.org/web/20210304192058/https://www.cnbc.com/2020/11/11/biontech-the-european-company-behind-pfizers-covid-19-vaccine.html |url-status=live }}</ref> |- |GlaxoSmithKline |Amoxil (amoxicillin),<ref>{{Cite web |title=Espacenet – search results |url=https://worldwide.espacenet.com/patent/search/family/027257367/publication/GB978178A?q=pn=GB978178A |access-date=2023-06-23 |website=worldwide.espacenet.com}}</ref> Ventolin (salbutamol)<ref>{{Cite web |title=Sir David Jack |url=https://www.telegraph.co.uk/news/obituaries/finance-obituaries/8897458/Sir-David-Jack.html |access-date=2023-06-23 |website=www.telegraph.co.uk |archive-date=2011-11-25 |archive-url=https://web.archive.org/web/20111125011155/http://www.telegraph.co.uk/news/obituaries/finance-obituaries/8897458/Sir-David-Jack.html |url-status=live }}</ref> |- |Sanofi |Dupixent (dupilumab, co-op with Regeneron Pharmaceutical),<ref>{{Cite web |title=Document |url=https://www.sec.gov/Archives/edgar/data/872589/000153217617000027/regn-063017x10q.htm |access-date=2023-06-23 |website=www.sec.gov |archive-date=2017-10-21 |archive-url=https://web.archive.org/web/20171021004232/https://www.sec.gov/Archives/edgar/data/872589/000153217617000027/regn-063017x10q.htm |url-status=live }}</ref> Lantus (insulin glargine)<ref>{{Cite web |title=Long Acting Insulin For Diabetes {{!}} Lantus® (insulin glargine injection) 100 Units/mL |url=https://www.lantus.com/ |access-date=2023-06-23 |website=www.lantus.com |language=en-US |archive-date=2024-07-12 |archive-url=https://web.archive.org/web/20240712030227/https://www.lantus.com/ |url-status=live }}</ref> |}
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== Terminology ==
=== Brand name drugs === [[File:Panadol.jpg|thumb|100px|Panadol, one of the branded version of paracetamol]]Broadly defined as drugs that are marketed under trade names and have patents,<ref>{{Cite web |title=Brand name (drugs) - Glossary |url=https://www.healthcare.gov/glossary/brand-name-drugs |access-date=2023-06-23 |website=HealthCare.gov |language=en |archive-date=2023-06-23 |archive-url=https://web.archive.org/web/20230623084229/https://www.healthcare.gov/glossary/brand-name-drugs/ |url-status=live }}</ref> which can be a synonym of proprietary drugs in daily use. Strictly speaking, every drug with a trade name is a brand name drug,<ref>Organisation for Economic Co-operation and Development; 2020. http://stats.oecd.org/wbos/fileview2.aspx?IDFile=4c170032-1dcd-4324-a541-dcba0ac7ec38 {{Webarchive|url=https://web.archive.org/web/20240712030225/http://stats.oecd.org/wbos/fileview2.aspx?IDFile=4c170032-1dcd-4324-a541-dcba0ac7ec38 |date=2024-07-12 }}. Accessed March 14, 2021.</ref> such as Panadol, a GSK branded paracetamol.
=== Generic drugs === [[File:Albert Heijn Paracetamol, Winschoten (2020) 01.jpg|thumb|100px|generic form of paracetamol]]Generic drugs are drugs that have the same active ingredient with a patent-expired drug, and are virtually bio-equivalent. The official names are often used to market these drugs, which are called unbranded generic drug,<ref>{{Cite web |title=Overview of Generic Drugs and Drug Naming - Drugs |url=https://www.msdmanuals.com/home/drugs/brand-name-and-generic-drugs/overview-of-generic-drugs-and-drug-naming |access-date=2023-06-23 |website=MSD Manual Consumer Version |language=en |archive-date=2023-06-01 |archive-url=https://web.archive.org/web/20230601074412/https://www.msdmanuals.com/home/drugs/brand-name-and-generic-drugs/overview-of-generic-drugs-and-drug-naming |url-status=live }}</ref> such as Panamax, a generic form of paracetamol.
=== Off-patent drugs === A term specifically used to describe past proprietary drugs by referring to their off-patent status.<ref>{{Cite journal|last=Research|first=Center for Drug Evaluation and|date=2020-12-15|title=List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic|url=https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/list-patent-exclusivity-drugs-without-approved-generic|journal=FDA|language=en|access-date=2021-03-26|archive-date=2021-04-10|archive-url=https://web.archive.org/web/20210410234859/https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/list-patent-exclusivity-drugs-without-approved-generic|url-status=live}}</ref>
== Regulations == To support scientific investigation and protect intellectual properties, patents are granted to companies and individuals who invented the drug.<ref>{{Cite web|title=General information concerning patents|url=https://www.uspto.gov/patents/basics|access-date=2021-03-26|website=www.uspto.gov|language=en-US|archive-date=2021-03-28|archive-url=https://web.archive.org/web/20210328134854/https://www.uspto.gov/patents/basics|url-status=live}}</ref> Most entities in the world have established corresponding agendas legally. Global and regional governmental organizations have various extents of advancements and approaches in their intellectual property rights protection laws. Below are some examples for comparison:
=== World Trade Organization (WTO) ===
==== TRIPS Agreement ==== The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement)<ref>{{Cite web |title=>WTO {{!}} Intellectual property (TRIPS) - gateway |url=https://www.wto.org/english/tratop_e/trips_e/trips_e.htm |access-date=2023-06-23 |website=www.wto.org |language=en |archive-date=2016-10-12 |archive-url=https://web.archive.org/web/20161012015531/https://www.wto.org/english/tratop_e/trips_e/trips_e.htm |url-status=live }}</ref> set up in 1994 suggested a standard on Intellectual Property Rights, which proprietary drug, a type of pharmaceutical and scientific inventions, is covered in this agreement. Basic principles such as the minimal duration of patent and part of the exclusive rights of patent owners are included by WTO member states in their respective national regulations. By 5 years and 10 years after the effectiveness of TRIPS Agreement, developed countries and developing countries were required to comply with it.<ref name="unaids.org">TRIPS transition period extensions for least-developed countries. 2013. https://www.unaids.org/sites/default/files/media_asset/JC2474_TRIPS-transition-period-extensions_en_0.pdf {{Webarchive|url=https://web.archive.org/web/20210118040249/https://www.unaids.org/sites/default/files/media_asset/JC2474_TRIPS-transition-period-extensions_en_0.pdf |date=2021-01-18 }}. Accessed March 14, 2021.</ref>
==== Doha Declaration ==== Trying to alleviate worldwide divide in accessibility of medical resources, members from the WTO endorsed the Doha Declaration on the TRIPS Agreement and Public Health in 2001. The basics of this Declaration is that "the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health".<ref name=":23">{{Cite web|title=WHO {{!}} THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH|url=http://www.who.int/medicines/areas/policy/doha_declaration/en/|archive-url=https://web.archive.org/web/20080220041511/http://www.who.int/medicines/areas/policy/doha_declaration/en/|url-status=dead|archive-date=February 20, 2008|access-date=2021-03-15|website=WHO}}</ref> It legalized the participating members to ignore the restriction from the patent of the proprietary medicine when they are controlling a significant public health crisis, namely human immunodeficiency virus (HIV), malaria and tuberculosis. Thus, affordable generic medicine can be provided for the populations in the developing countries in emergency situations.
=== United States === In the United States, proprietary drugs are associated with two status: patent and exclusivity. Patent is managed by the United States Patent and Trademark Office,<ref name=":22">{{Cite web |title=Patent Basics |url=https://www.uspto.gov/patents/basics |access-date=2023-06-23 |website=www.uspto.gov |language=en-US |archive-date=2023-06-18 |archive-url=https://web.archive.org/web/20230618175134/https://www.uspto.gov/patents/basics |url-status=live }}</ref> granting inventors of new drugs rights for 20 years.<ref name="unaids.org"/> It is open to all drugs, regardless of its research or commercialization status.<ref>{{Cite web |title=WTO {{!}} 2015 News items - WTO members agree to extend drug patent exemption for poorest members |url=https://www.wto.org/english/news_e/news15_e/trip_06nov15_e.htm |access-date=2023-06-23 |website=www.wto.org |archive-date=2023-06-13 |archive-url=https://web.archive.org/web/20230613003223/https://www.wto.org/english/news_e/news15_e/trip_06nov15_e.htm |url-status=live }}</ref> To enjoy the benefits brought by patenting, pharmaceutical companies are obliged to disclose all research data on that drug to the public for further progression.<ref name="stopfakes.gov">{{Cite web |title=How Long Does Patent, Trademark or Copyright Protection Last? {{!}} STOPfakes.gov - Intellectual Property Rights Resources and Assistance |url=https://www.stopfakes.gov/article?id=How-Long-Does-Patent-Trademark-or-Copyright-Protection-Last |access-date=2023-06-23 |website=www.stopfakes.gov |language=en |archive-date=2024-07-12 |archive-url=https://web.archive.org/web/20240712030228/https://www.stopfakes.gov/article?id=How-Long-Does-Patent-Trademark-or-Copyright-Protection-Last |url-status=live }}</ref> Exclusivity, given by the U.S. Food and Drug Association (FDA), means a period of time in which no other competitor drugs can be approved.<ref name="stopfakes.gov"/> Commercialized and clinically used drugs are the targets of exclusivity. The length of exclusivity depends on the nature of application, and ranges from one to seven years.<ref name="stopfakes.gov"/> Practically exclusivity is granted for proprietary drugs that have been granted with patents, but it is not mandatory. Legalwise, generic counterparts have to wait for at least 2 decades for patent expiration to sell a copy . This system is said to aim for a balance between gaining public access to generic drugs and encouraging drug research and development.<ref name="stopfakes.gov"/>
==== Litigation ==== Despite the US having a legal system regarding to drug patenting, litigation have taken place. In the past, it is common for drug manufacturers challenging the validity of patents.<ref name=":13" /> In 2018, Mylan attempted to revoke the patent of Symbicort owned by AstraZeneca through the court.<ref name=":1">{{Cite web|last=Media|first=Newton|title=AstraZeneca prevails in inhaler dispute|url=https://www.lifesciencesipreview.com/news/astrazeneca-prevails-in-inhaler-dispute-4390|access-date=2021-03-30|website=Life Sciences IP Review|language=en|archive-date=2024-07-12|archive-url=https://web.archive.org/web/20240712030240/https://www.lifesciencesipreview.com/americas/astrazeneca-prevails-in-inhaler-dispute-4390|url-status=live}}</ref> Now pharma suing on deliberately infringing generic drugs has become more prominent.<ref name=":13">{{Cite web|date=June 2014|title=Pharma and Biotech Patent Litigation|url=https://media.crai.com/sites/default/files/publications/Pharma-and-biotech-patent-litigation.pdf|access-date=30 March 2021|website=Charles River Associates}}</ref> AstraZeneca then took follow-up actions against Mylan for premature submission of Abbreviated New Drug Application (ANDA) for generic Symbicort and won the lawsuit.<ref name=":1" /> The introduction of biopharmaceuticals and the subsequent establishment of new drug laws may also bring more litigation.<ref name=":1" />
=== India === According to the Patent Law in India, drug can apply for a patent since 2005.<ref name=":12">{{Citation|last=He|first=Juan|title=Indian Patent Law and Its Impact on the Pharmaceutical Industry: What Can China Learn from India?|date=2019|work=Innovation, Economic Development, and Intellectual Property in India and China|series=ARCIALA Series on Intellectual Assets and Law in Asia|pages=251–269|place=Singapore|publisher=Springer Singapore|doi=10.1007/978-981-13-8102-7_11|isbn=978-981-13-8101-0|doi-access=free}}</ref> Registering a drug for patents in India is more limiting than developed countries. India was removed from the least developed member states list of the WTO and is therefore no longer eligible for the waiver,<ref>{{Cite web |title=WTO {{!}} Understanding the WTO - least-developed countries |url=https://www.wto.org/english/thewto_e/whatis_e/tif_e/org7_e.htm |access-date=2023-06-23 |website=www.wto.org |language=en |archive-date=2019-01-17 |archive-url=https://web.archive.org/web/20190117185840/https://www.wto.org/english/thewto_e/whatis_e/tif_e/org7_e.htm |url-status=live }}</ref> it has modified its patent law<ref name=":12" /> to satisfy TRIPS Agreement with its intellectual property rights legal system. An Indian patent lasts for 20 years.<ref>Section 27(a) of ''the Patents (Amendment) Act'', 2002. Accessed 30 March 2021</ref> To ensure the interest of public, a compulsory license can be issued by the government if a pharma is suspected for violating the public health principles.<ref name=":12" />
==== Litigation ==== Introducing new drug patenting regulations after 35 years<ref>{{Cite web|title=Patents And The Indian Pharmaceutical Industry - Intellectual Property - India|url=https://www.mondaq.com/india/patent/865888/patents-and-the-indian-pharmaceutical-industry|access-date=2021-03-30|website=www.mondaq.com|archive-date=2021-04-28|archive-url=https://web.archive.org/web/20210428054912/https://www.mondaq.com/india/patent/865888/patents-and-the-indian-pharmaceutical-industry|url-status=live}}</ref> could possibly lead to today's disputes, such as the Novartis v. Union of India incident. Generic Gleevec, a formulation that can substitute Glivec, were distributed in the local market since 1993.<ref name=":14">{{Cite web|date=2013-04-04|title=The Judgment In Novartis v. India: What The Supreme Court Of India Said|url=https://www.ip-watch.org/2013/04/04/the-judgment-in-novartis-v-india-what-the-supreme-court-of-india-said/|access-date=2021-03-30|website=Intellectual Property Watch|language=en-US|archive-date=2021-04-14|archive-url=https://web.archive.org/web/20210414235140/http://www.ip-watch.org/2013/04/04/the-judgment-in-novartis-v-india-what-the-supreme-court-of-india-said/|url-status=live}}</ref> Novartis had filed a patent for Glivec in 1997.<ref name=":14" /> An exclusive marketing right was also granted for Novartis in 2003 and the application were approved in 2005 .<ref name=":14" /> In 2013, the Supreme Court of India upheld the rejection of the patent application of Glivec by Novartis,<ref name=":9">file:///Users/spencer/Downloads/1744-8603-10-3.pdf</ref> ending the 10-years battle between the proprietary drug tycoon and the local patent law. Since 1993, Novartis has started to register patent for Glivec and its active ingredients worldwide without defeats.<ref name=":9" /> However, the Supreme Court of India rejected the patent registration of Glivec on 2006<ref name=":9" /> according to the interpretations on the patent law and TRIPS agreement by the Court. By then, the local generic drugs in India are protected.<ref name=":9" /> This incident is referred as a challenge to the intellectual property laws.<ref name=":9" />
== Patent cliff == Patent cliff refers to a dramatic dip in the revenue of a merchandise upon patent expiry.<ref>{{Cite web|last=Hayes|first=Adam|title=Patent Cliff Definition|url=https://www.investopedia.com/terms/p/patent-cliff.asp|access-date=2021-03-15|website=Investopedia|language=en|archive-date=2021-02-27|archive-url=https://web.archive.org/web/20210227013651/https://www.investopedia.com/terms/p/patent-cliff.asp|url-status=live}}</ref> It is a prominent phenomenon in the proprietary drug industry due to the vast gap of prices between the proprietary drug and the generic drug.<ref name=":18" /> Since 2010, numerous pharmaceutical board busters have started to become off-patent.<ref name=":10">{{Cite web|author1=Jack DeRuiter|author2=Pamela L. Holston|title=Drug Patent Expirations and the "Patent Cliff"|url=https://www.uspharmacist.com/article/drug-patent-expirations-and-the-patent-cliff|access-date=2021-03-29|website=www.uspharmacist.com|language=en|archive-date=2024-07-12|archive-url=https://web.archive.org/web/20240712030232/https://www.uspharmacist.com/article/drug-patent-expirations-and-the-patent-cliff|url-status=live}}</ref> As seen in the figure below, the top five off-patent proprietary drug before 2017 have a combined lifetime sale of around US$588.4 Billion,<ref name=":2">{{Cite web|title=The decade's top 10 patent losses, worth a whopping $915B in lifetime sales|url=https://www.fiercepharma.com/pharma/decade-s-top-10-patent-losses-featuring-seismic-sales-shifts|access-date=2021-03-15|website=FiercePharma|date=17 August 2017|language=en|archive-date=2021-01-24|archive-url=https://web.archive.org/web/20210124222801/https://www.fiercepharma.com/pharma/decade-s-top-10-patent-losses-featuring-seismic-sales-shifts|url-status=live}}</ref> which is enormous enough to surpass the bottom 5% countries' GDP in 2020.<ref>{{Cite web|title=GDP by Country - Worldometer|url=https://www.worldometers.info/gdp/gdp-by-country/|access-date=2021-03-15|website=www.worldometers.info|language=en|archive-date=2021-03-17|archive-url=https://web.archive.org/web/20210317044530/https://www.worldometers.info/gdp/gdp-by-country/|url-status=live}}</ref>
{| class="wikitable" |Expired proprietary drug |Expiry year |Worldwide total lifetime sale (Billion US dollars) |- |Humira |2016 |179.4 |- |Lipitor |2011 |149.4 |- |Advair |2016 |108.3 |- |Lantus |2015 |81.8 |- |Nexium |2015 |69.5 |} '''Figure 1: Five best-selling proprietary drug which lost their patents before 2017<ref name=":2" />'''
Proprietary drug is a substantial business protected by its respective patent. They are usually sold at a higher price, to compensate for the clinical trial cost and sometimes for the manufacturing of new technology.<ref name=":16">{{Cite journal |last=Research |first=Center for Drug Evaluation and |date=2021-03-16 |title=Generic Drugs: Questions & Answers |url=https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/generic-drugs-questions-answers |journal=FDA |language=en |access-date=2024-07-12 |archive-date=2024-06-29 |archive-url=https://web.archive.org/web/20240629083114/https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/generic-drugs-questions-answers |url-status=live }}</ref> For example, an widely used average proprietary drug is 18 times more expensive than a common generic drug.<ref name=":18">{{Cite web |last= |date=2019-04-04 |title=Average Brand-Name Drug Price Now Over 18 Times Higher Than Average Generic Drug Price, New AARP Report Shows |url=https://states.aarp.org/new-hampshire/average-brand-name-drug-price-now-over-18-times-higher-than-average-generic-drug-price-new-aarp-report-shows |access-date=2023-06-23 |website=New Hampshire |language=english |archive-date=2021-07-22 |archive-url=https://web.archive.org/web/20210722191548/https://states.aarp.org/new-hampshire/average-brand-name-drug-price-now-over-18-times-higher-than-average-generic-drug-price-new-aarp-report-shows |url-status=live }}</ref> Lyrica, a recent off-patent painkiller for nervous systems, had a sale of 5B USD in 2019,<ref>{{Cite web |last=Team |first=Trefis |title=Pfizer's Lyrica In the Anti-Epileptic Drugs Market |url=https://www.forbes.com/sites/greatspeculations/2019/10/07/pfizers-lyrica-in-the-anti-epileptic-drugs-market/ |access-date=2023-06-23 |website=Forbes |language=en |archive-date=2022-05-23 |archive-url=https://web.archive.org/web/20220523223949/https://www.forbes.com/sites/greatspeculations/2019/10/07/pfizers-lyrica-in-the-anti-epileptic-drugs-market/ |url-status=live }}</ref> out of the 51.8B USD annual sale of the corresponding company.<ref>Pfizer Reports Fourth-quarter And Full-Year 2019 Results. Pfizer Inc. - Investors Overview. https://investors.pfizer.com/investor-news/press-release-details/2020/PFIZER-REPORTS-FOURTH-QUARTER-AND-FULL-YEAR-2019-RESULTS/default.aspx {{Webarchive|url=https://web.archive.org/web/20210301074037/https://investors.pfizer.com/investor-news/press-release-details/2020/PFIZER-REPORTS-FOURTH-QUARTER-AND-FULL-YEAR-2019-RESULTS/default.aspx |date=2021-03-01 }}. Published January 28, 2020. Accessed March 14, 2021.</ref>
However, once the proprietary drug become off-patent, there will soon be immense competition from the generic drugs produced by their business rivals.<ref name=":3">{{Cite journal|last1=Song|first1=Chie Hoon|last2=Han|first2=Jeung-Whan|date=2016-05-23|title=Patent cliff and strategic switch: exploring strategic design possibilities in the pharmaceutical industry|journal=SpringerPlus|volume=5|issue=1|pages=692|doi=10.1186/s40064-016-2323-1|issn=2193-1801|pmc=4899342|pmid=27347468 |doi-access=free }}</ref> As cheaper pharmaceutical alternatives are launched, the surge in supply disrupts the market supply-and-demand status.<ref name=":10" /> The declining dependence on the original proprietary drug will cause its sales decreases. On top of that, the original company usually will have their prices tuned down for improving competitiveness.<ref name=":10" /> Resulting in a significant drop of revenue of the proprietary drug.<ref name=":3" />
Below showed the graph which represented the yearly revenue of Lipitor, a proprietary drug which lost its patent on 2011.<ref name=":11" /> As it can be seen, a significant patent cliff happened from 2011 to 2012(58.8% drop in yearly revenue) and it is very possibly due to its newly off-patent status.<ref name=":10" /><graph>{"version":2,"width":521,"height":223,"data":[{"name":"table","values":[{"x":2004,"y":10862},{"x":2005,"y":12187},{"x":2006,"y":12886},{"x":2007,"y":12675},{"x":2008,"y":12401},{"x":2009,"y":11434},{"x":2010,"y":10733},{"x":2011,"y":9577},{"x":2012,"y":3948},{"x":2013,"y":2315},{"x":2014,"y":2061},{"x":2015,"y":1860},{"x":2016,"y":1758},{"x":2017,"y":1915},{"x":2018,"y":2062},{"x":2019,"y":1973}]}],"scales":[{"name":"x","type":"linear","range":"width","zero":false,"domain":{"data":"table","field":"x"}},{"name":"y","type":"linear","range":"height","nice":true,"domain":{"data":"table","field":"y"}}],"axes":[{"type":"x","scale":"x"},{"type":"y","scale":"y"}],"marks":[{"type":"line","from":{"data":"table"},"properties":{"enter":{"x":{"scale":"x","field":"x"},"y":{"scale":"y","field":"y"},"y2":{"scale":"y","value":0},"interpolate":{"value":"monotone"},"stroke":{"value":"steelblue"},"strokeWidth":{"value":3}}}}]}</graph> '''Figure 2: The yearly revenue of Lipitor by Pfizer (million US dollars) from 2004 to 2019<ref name=":11">{{Cite web|title=Pfizer: global Lipitor revenue 2003-2019|url=https://www.statista.com/statistics/254341/pfizers-worldwide-viagra-revenues-since-2003/|access-date=2021-03-15|website=Statista|language=en|archive-date=2021-04-18|archive-url=https://web.archive.org/web/20210418165213/https://www.statista.com/statistics/254341/pfizers-worldwide-viagra-revenues-since-2003/|url-status=live}}</ref>'''
== Benefits ==
=== Promoting influx of income to pharmaceutical research industry === Proprietary drug market is protected by its patent. As a result, its market exclusivity basis allows proprietary drugs to be highly profitable and commercially successful.<ref name=":4">{{Cite journal|last1=Grabowski|first1=Henry G.|last2=DiMasi|first2=Joseph A.|last3=Long|first3=Genia|date=2015-02-01|title=The Roles Of Patents And Research And Development Incentives In Biopharmaceutical Innovation|url=https://www.healthaffairs.org/doi/10.1377/hlthaff.2014.1047|journal=Health Affairs|volume=34|issue=2|pages=302–310|doi=10.1377/hlthaff.2014.1047|pmid=25646111|issn=0278-2715|hdl=10161/12744|hdl-access=free|access-date=2021-03-15|archive-date=2021-05-16|archive-url=https://web.archive.org/web/20210516203746/https://www.healthaffairs.org/doi/10.1377/hlthaff.2014.1047|url-status=live|url-access=subscription}}</ref> Usually, pharmaceutical research is a lengthy, highly demanding, rarely successful, costly and risky investment.<ref name=":5">{{Cite journal|last1=Crommelin|first1=Daan|last2=Stolk|first2=Pieter|last3=Besançon|first3=Luc|last4=Shah|first4=Vinod|last5=Midha|first5=Kamal|last6=Leufkens|first6=Hubert|date=2010-02-01|title=Pharmaceutical sciences in 2020|url=https://www.nature.com/articles/nrd3087|journal=Nature Reviews Drug Discovery|language=en|volume=9|issue=2|pages=99–100|doi=10.1038/nrd3087|pmid=20118959|s2cid=20558083|issn=1474-1784|access-date=2021-03-15|archive-date=2024-05-08|archive-url=https://web.archive.org/web/20240508110543/https://www.nature.com/articles/nrd3087|url-status=live|url-access=subscription}}</ref> It is usually associated with a disinterested merchandise in the economic world.<ref name=":5" /> However, once a successful experimental drug candidate is registered as a proprietary drug product, the patent legally ensures a long-term dominance in the exclusive market which is free of imitative generic drug. Generating a stable and considerable net income to cover the cost.<ref name=":6">{{Cite journal|doi=10.1001/jama.2020.0442 |title=Profitability of Large Pharmaceutical Companies Compared with Other Large Public Companies |date=2020 |last1=Ledley |first1=Fred D. |last2=McCoy |first2=Sarah Shonka |last3=Vaughan |first3=Gregory |last4=Cleary |first4=Ekaterina Galkina |journal=JAMA |volume=323 |issue=9 |pages=834–843 |pmid=32125401 |pmc=7054843 }}</ref> thumb|256x256px|Patent of the proprietary drug can only be granted after careful approval on its patent registration application.<ref name=":7" /> The huge earning of the proprietary drug can circulate back to fund future medical research. Providing more resources and manpower to the research and development of another drug candidates.<ref name=":4" /> As well as attracting new investments to the pharmaceutical research industry due to its exclusive market potential. They encourage efforts on biopharmaceutical innovations and newborn medical breakthroughs.<ref name=":4" />
=== Guiding future medical progresses by referencing of product knowledge === Being required for successful patent registration, detailed pharmaceutical formulations of the proprietary drug are disclosed on its patent registration application,<ref name=":7">{{cite web |title=Requirements for Content and Format of Patent Applications and Procedure for Filing of Patent Applications with Patent Office |url=https://www.wipo.int/edocs/lexdocs/laws/en/ee/ee077en.pdf |access-date=12 July 2024}}</ref> which promote the spillover of research efforts among the medical world.<ref name=":8">{{Cite journal|last=Rahmah|first=M.|title=Social cost and benefits of patent protection for medicines: Case of Indonesian seaweeds hard capsule invention|url=https://www.redalyc.org/jatsRepo/279/27963185018/html/index.html|journal=Utopía y Praxis Latinoamericana|year=2020|language=en|volume=25|issue=Esp.2|pages=171–178|access-date=2021-03-15|archive-date=2024-07-12|archive-url=https://web.archive.org/web/20240712030235/https://www.redalyc.org/jatsRepo/279/27963185018/html/index.html|url-status=live}}</ref> In order to inspect the safety and efficacy of the proprietary drug candidate, pharmaceutical companies need to list all clinical trial data and formulation method as detailed as possible to prove the drug candidate's validity to the patent registration committee.<ref name=":7" /> Once the patent is rewarded, these data will later be published on medical literature and public domains as common knowledge.<ref name=":8" />
Researchers can capitalise on the previous successes and establish their own project on top of the current statistics. These cooperatively help exploit more unknown drug candidates without repeating previous progresses.<ref name=":8" /> Speeding up future medical advancements.<ref name=":8" />
== Criticisms ==
=== Hindering of equitable access to medicine === According to World Health Organisation(WHO), equitable access to medicines refers to an affordable and reasonable ability for patients to get their required drug to achieve health.<ref name=":17">{{Cite web|title=WHO {{!}} Access to medicines|url=https://www.who.int/mediacentre/news/statements/2009/access-medicines-20090313/en/|archive-url=https://web.archive.org/web/20140307032946/http://www.who.int/mediacentre/news/statements/2009/access-medicines-20090313/en/|url-status=dead|archive-date=March 7, 2014|access-date=2021-03-30|website=WHO}}</ref> WHO member states shall fulfill their moral responsibility to improve the delivery of and access to the needed drugs.<ref name=":17" />
However, the monopolisation of some expensive proprietary drug in the market is hindering poor patients' access to their best available medications.<ref name=":15">{{Cite web|date=2016-01-20|title=Inequality Explained: The trouble with pharmaceutical patents|url=https://opencanada.org/inequality-explained-trouble-pharmaceutical-patents/|access-date=2021-03-30|website=Open Canada|archive-date=2021-04-16|archive-url=https://web.archive.org/web/20210416082138/https://opencanada.org/inequality-explained-trouble-pharmaceutical-patents/|url-status=live}}</ref> Leading to suboptimal treatments of diseases and lowering of health standard of these patients.<ref name=":15" /> This phenomenon is very prominent in the underdeveloped countries which usually have a large proportion of underprivileged citizens.<ref name=":15" /><ref>Grover, Anand; Citro, Brian (2011). "India: access to affordable drugs and the right to health". ''The Lancet''. '''377''' (9770): 976–977. doi:10.1016/s0140-6736(10)62042-9. PMID 21227487.</ref> [[File:An overview of the types of gene therapy techniques used in HCC treatment.webp|thumb|State-of-the-art proprietary drugs for gene therapy occupy top rankings in the expensive drug list due to their complex mechanism but superior efficacy in rare disease.]] Some proprietary drugs(mainly speciality proprietary drug) are criticised for their price-gouging commercial tactics.<ref name=":16" /><ref>Weiss, Shira (2017-03-01). "The Ethics of Price Gouging". ''Journal of Religious Ethics''. '''45''' (1): 142–163. doi:10.1111/jore.12171. ISSN 1467-9795.</ref> To illustrate, the world's most expensive drug, Zolgensma, costs over US$2.1 million per year of treatment, which are generally considered as unaffordable.<ref>{{Cite web|title=Top 10 Most Expensive Drugs on the Market|url=https://www.biospace.com/article/gene-therapy-zolgensma-tops-goodrx-list-of-10-most-expensive-drugs/|access-date=2021-03-30|website=BioSpace|language=en-US|archive-date=2021-03-26|archive-url=https://web.archive.org/web/20210326172000/https://www.biospace.com/article/gene-therapy-zolgensma-tops-goodrx-list-of-10-most-expensive-drugs/|url-status=live}}</ref> Since Zolgensma is the only approved drug for curing Spinal Muscular Atrophy in childhood, patients who cannot afford Zolgensma will be physically disabled for the rest of their lives. Creating inequity among patients with varying financial capacitances.
=== Abusing of patent extension system === According to the TRIPS Agreement, the term of patent of the proprietary drug usually can last for 20 years counting from the filing date.<ref name=":19">Article 33 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).</ref> After that, approved generic drugs can enter the market legally with fair competition.<ref name=":19" />
However, in order to achieve longer dominance in the market, pharmaceutical manufacturer (especially big pharma) may apply for patent extension or even new patent registration based on various reasons.<ref name=":21">{{cite web |title=Overpatented, Overpriced: How Excessive Pharmaceutical Patenting is Extending Monopolies and Driving up Drug Prices |url=https://www.i-mak.org/wp-content/uploads/2018/08/I-MAK-Overpatented-Overpriced-Report.pdf |access-date=12 July 2024}}</ref> Including modifying the formulations, dosage form or maneuvering legal system.<ref name=":14" /><ref>{{Cite web|date=2018-09-03|title=Drug Patent Life: How Long Do Drug Patents Last?|url=https://www.drugpatentwatch.com/blog/how-long-do-drug-patents-last/|access-date=2021-04-01|website=DrugPatentWatch - Make Better Decisions|language=en-US|archive-date=2021-04-15|archive-url=https://web.archive.org/web/20210415113509/https://www.drugpatentwatch.com/blog/how-long-do-drug-patents-last/|url-status=live}}</ref> To illustrate, AbbVie, a pharmaceutical tycoon, had attempted 247 proprietary drug patent extension applications for extending their exclusivity for 39 years in the USA on 2018 alone.<ref name=":20">{{Cite web|title=Exploring companies' manipulation of pharma patents|url=https://www.pharmaceutical-technology.com/features/pharma-patents-manpulation/|access-date=2021-03-31|website=www.pharmaceutical-technology.com|date=11 November 2019|archive-date=2021-04-20|archive-url=https://web.archive.org/web/20210420010752/https://www.pharmaceutical-technology.com/features/pharma-patents-manpulation/|url-status=live}}</ref> Among them, 137 applications were successful in extending the patent.
The abusing of patent extension system leads to a much longer terms of patent than that stated in both local regulations and TRIPS Agreement.<ref name=":22" /><ref name=":21" /> Providing a long period of competition-free market to their proprietary drug. It creates an unfair competition environment in the pharmaceutical market.<ref name=":21" /> Since the generic drug companies are excluded from that particular market, they cannot release new pharmaceutical products for public use on the same field.<ref name=":21" /> Resulting enduring monopolisation of proprietary drug market by the big pharma which are already stockpiling proprietary drug.<ref name=":20" />
== See also == * Doha Declaration * Medicines Patent Pool * Generic drug * Generic brand * Intellectual property * ''Novartis v. Union of India & Others incident'' * Patent * Patent Cliff * Pharmaceutical Industry * Trademark * TRIPS agreement
== References == {{Reflist}}
Category:Drugs