Proprietary drug
Proprietary drug are chemicals used for medicinal purposes which are formulated or manufactured under a name protected from competition through trademark or patent.
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.
[5] Pharma is not extensively involved in searching for ready-to-sell generic biologics due to the complexity of manufacture and hurdles in extraction processes.
[6] Besides vaccines, these endogenous origin chemicals are prescribed to patients with severe conditions, such as complications including asthma, rheumatoid arthritis,[7] 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.
[18] To support scientific investigation and protect intellectual properties, patents are granted to companies and individuals who invented the drug.
Global and regional governmental organizations have various extents of advancements and approaches in their intellectual property rights protection laws.
[21] 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".
[4] 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.
[22] 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.
[24] AstraZeneca then took follow-up actions against Mylan for premature submission of Abbreviated New Drug Application (ANDA) for generic Symbicort and won the lawsuit.
India was removed from the least developed member states list of the WTO and is therefore no longer eligible for the waiver,[27] it has modified its patent law[26] to satisfy TRIPS Agreement with its intellectual property rights legal system.
[26] Introducing new drug patenting regulations after 35 years[29] could possibly lead to today's disputes, such as the Novartis v. Union of India incident.
[34] 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,[35] which is enormous enough to surpass the bottom 5% countries' GDP in 2020.
[41] 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.
[34]Figure 2: The yearly revenue of Lipitor by Pfizer (million US dollars) from 2004 to 2019[41] Proprietary drug market is protected by its patent.
[46] 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.
[37][50] 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.
According to the TRIPS Agreement, the term of patent of the proprietary drug usually can last for 20 years counting from the filing date.
[30][54] 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.
