Intellectual property (IP) is a category of property that includes intangible creations of the human intellect. There are many types of intellectual property,and some countries recognize more than others. The best-known types are patents,copyrights,trademarks,and trade secrets. The modern concept of intellectual property developed in England in the 17th and 18th centuries. The term "intellectual property" began to be used in the 19th century,though it was not until the late 20th century that intellectual property became commonplace in most of the world's legal systems.
A patent is a type of intellectual property that gives its owner the legal right to exclude others from making,using,or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention. In most countries,patent rights fall under private law and the patent holder must sue someone infringing the patent in order to enforce their rights. In some industries patents are an essential form of competitive advantage;in others they are irrelevant.
A chemical patent,pharmaceutical patent or drug patent is a patent for an invention in the chemical or pharmaceuticals industry. Strictly speaking,in most jurisdictions,there are essentially no differences between the legal requirements to obtain a patent for an invention in the chemical or pharmaceutical fields,in comparison to obtaining a patent in the other fields,such as in the mechanical field. A chemical patent or a pharmaceutical patent is therefore not a sui generis right,i.e. a special legal type of patent.
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same,the medical profile of generics is equivalent in performance. A generic drug has the same active pharmaceutical ingredient (API) as the original,but it may differ in some characteristics such as the manufacturing process,formulation,excipients,color,taste,and packaging.
Patents are legal instruments intended to encourage innovation by providing a limited monopoly to the inventor in return for the disclosure of the invention. The underlying assumption is that innovation is encouraged because an inventor can secure exclusive rights and,therefore,a higher probability of financial rewards for their product in the marketplace or the opportunity to profit from licensing the rights to others. The publication of the invention is mandatory to get a patent. Keeping the same invention as a trade secret rather than disclosing it in a patent publication,for some inventions,could prove valuable well beyond the limited time of any patent term but at the risk of unpermitted disclosure or congenial invention by a third party.
Test data exclusivity refers to protection of clinical trial data required to be submitted to a regulatory agency to prove safety and efficacy of a new drug,and prevention of generic drug manufacturers from relying on this data in their own applications. It provides a form of market exclusivity outside that provided by patent rights.
The pharmaceutical industry is one of the leading industries in the People's Republic of China,covering synthetic chemicals and drugs,prepared Chinese medicines,medical devices,apparatus and instruments,hygiene materials,packing materials,and pharmaceutical machinery. China has the second-largest pharmaceutical market in the world as of 2017 which is worth US$110 billion. China accounts for 20% of the world's population but only a small fraction of the global drug market. China's changing health-care environment is designed to extend basic health insurance to a larger portion of the population and give individuals greater access to products and services. Following the period of change,the pharmaceutical industry is expected to continue its expansion.
The pharmaceutical industry in India was valued at an estimated US$42 billion in 2021. India is the world's largest provider of generic medicines by volume,with a 20% share of total global pharmaceutical exports. It is also the largest vaccine supplier in the world by volume,accounting for more than 50% of all vaccines manufactured in the world. With industry standards compliant mega production capabilities and large number of skilled domestic workforce,Indian exports meet the standards and requirements of highly regulated markets of USA,UK,European Union and Canada. According to the Department of Pharmaceuticals,Ministry of Chemicals and Fertilizers,domestic pharmaceutical market turnover reached Rs 129,015 crore in 2018,growing 9.4 per cent year-on-year and exports revenue was US$17.28 billion in FY18 and US$19.14 billion in FY19.
James Packard Love is the director of Knowledge Ecology International,formerly known as the Consumer Project on Technology,a non-governmental organization with offices in Washington,D.C. and Geneva,that works mainly on matters concerning knowledge management and governance,including intellectual property policy and practice and innovation policy,particularly as they relate to health care and access to knowledge.
The pharmaceutical lobby refers to the representatives of pharmaceutical drug and biomedicine companies who engage in lobbying in favour of pharmaceutical companies and their products.
Evergreening is any of various legal,business,and technological strategies by which producers extend the lifetime of their patents that are about to expire in order to retain revenues from them. Often the practice includes taking out new patents,or by buying out or frustrating competitors,for longer periods of time than would normally be permissible under the law. Robin Feldman,a law professor at UC Law SF and a leading researcher in intellectual property and patents,defines evergreening as "artificially extending the life of a patent or other exclusivity by obtaining additional protections to extend the monopoly period."
A patent thicket is "an overlapping set of patent rights" which requires innovators to reach licensing deals for multiple patents. This concept is associated with negative connotations and has been described as "a dense web of overlapping intellectual property rights that a company must hack its way through in order to actually commercialize new technology".
Legal scholars,economists,activists,policymakers,industries,and trade organizations have held differing views on patents and engaged in contentious debates on the subject. Critical perspectives emerged in the nineteenth century that were especially based on the principles of free trade. Contemporary criticisms have echoed those arguments,claiming that patents block innovation and waste resources that could otherwise be used productively,and also block access to an increasingly important "commons" of enabling technologies,apply a "one size fits all" model to industries with differing needs,that is especially unproductive for industries other than chemicals and pharmaceuticals and especially unproductive for the software industry. Enforcement by patent trolls of poor quality patents has led to criticism of the patent office as well as the system itself. Patents on pharmaceuticals have also been a particular focus of criticism,as the high prices they enable puts life-saving drugs out of reach of many people. Alternatives to patents have been proposed,such Joseph Stiglitz's suggestion of providing "prize money" as a substitute for the lost profits associated with abstaining from the monopoly given by a patent.
Mark A. Lemley is currently the William H. Neukom Professor of Law at Stanford Law School and the Director of the Stanford Law School Program in Law,Science &Technology,as well as a founding partner of the law firm of Durie Tangri LLP,which he has been practicing with since 2009.
Some authors advocating patent reform have proposed the use of prizes as an alternative to patents. Critics of the current patent system,such as Joseph E. Stiglitz,say that patents fail to provide incentives for innovations which are not commercially marketable. Stiglitz provides the idea of prizes instead of patents to be awarded in order to further advance solutions to global problems such as AIDS.
LifeArc is a British life science medical research charity. It was established in 2000 as MRC Technology to translate the work of UK Medical Research Council (MRC) research scientists.
The Medicines Patent Pool (MPP) is a Unitaid-backed international organisation founded in July 2010,based in Geneva,Switzerland. Its public health driven business model aims to lower the prices of HIV,tuberculosis and hepatitis C medicines and facilitate the development of better-adapted HIV treatments through voluntary licensing and patent pooling. Its goal is to improve access to affordable and appropriate HIV,hepatitis C and tuberculosis medicines in low- and middle-income countries (LMIC). In May 2020,the MPP become an implementing partner of the WHO's Covid-19 Technology Access Pool (C-TAP).
An FDA citizen petition is a process provided by the United States Food and Drug Administration (FDA) for individuals and community organizations to make requests to the FDA for changes to health policy. It is described in Title 21 of the Code of Federal Regulations.
Dan L. Burk is Chancellor's Professor of Law at the University of California,Irvine School of Law and is a founding member of the law faculty. His areas of expertise include intellectual property,gene patenting,digital copyright,electronic commerce and computer trespass.
Proprietary drug are chemicals used for medicinal purposes which are formulated or manufactured under a name protected from competition through trademark or patent. The invented drug is usually still considered proprietary even if the patent expired. 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. Proprietary drugs affect the world in various aspects including medicine,public health and economy.
