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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.
Chemical patent claims often use generic, Markush structures contained within them, named after the inventor Eugene Markush who won a lawsuit in the US in 1925 to allow such structures to be used in patent claims. These generic structures are used to make the patent claim as broad as possible.
In the United States, patents on pharmaceuticals were considered unethical by the medical profession during most of the nineteenth-century. [1] Drug patent terms in the US were extended from 17 to 20 years in 1994. [2]
Pharmaceutical patents are typically more valuable than any other type of patents, and thus play an essential role in the pharmaceutical industry. There are several reasons for this peculiarity: [3] [4] [5]
A 2021 analysis [7] of the most valuable US pharmaceutical patents published in the Orange Book between 2000 and 2018 showed that ca. 25% of these patents end up litigated in courts, but only 26% of these litigated patents are invalidated, well below the overall patent invalidation rate of 43%. 94% of these invalidated patents are not the highly innovative “primary’ patents on the active ingredient, but weaker follow-on patents (that claim changes in formulation, dissolution profile, new use), that should have not been allowed by examiners in the first place. Remarkably, the prosecution histories of most of these invalidated patents share striking similarity in having the same assignees, the same prosecuting attorneys, and the same examiners. Examiners approve litigated patents after having issued fewer office actions than they do with unlitigated patents. For litigated patents it takes approximately five office actions before allowance. In contrast, for the average, it takes approximately eight office actions before an allowance.
The main reason for invalidating these weak follow-up patents in courts is obviousness in view of the prior art, which was not considered by the examiner. Nevertheless, the authors conclude, that "having examiners spend more time on the important patents ... is not likely to help much; examiners who get more time to work on important cases now do not do more work, but instead cut and paste their existing work from prior cases." As a better alternative, the authors suggests, that the patent owners identify in advance, which patents they intend to list in the Orange Book, and have these patents examined by USPTO's Central Reexamination Unit with a higher level of scrutiny than regular examiners do.
Pharmacology is the science of drugs and medications, including a substance's origin, composition, pharmacokinetics, pharmacodynamics, therapeutic use, and toxicology. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function. If substances have medicinal properties, they are considered pharmaceuticals.
A medication is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management.
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 compared to their performance at the time when they were patented drugs. 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.
Prescription drug list prices in the United States continually are among the highest in the world. The high cost of prescription drugs became a major topic of discussion in the 21st century, leading up to the American health care reform debate of 2009, and received renewed attention in 2015. One major reason for high prescription drug prices in the United States relative to other countries is the inability of government-granted monopolies in the American health care sector to use their bargaining power to negotiate lower prices, and the American payer ends up subsidizing the world's R&D spending on drugs.
The pharmaceutical industry is an industry involved in medicine that discovers, develops, produces, and markets pharmaceutical goods for use as drugs that function by being administered to patients using such medications with the goal of curing and/or preventing disease. Pharmaceutical companies may deal in "generic" medications and medical devices without the involvement of intellectual property, in "brand" materials specifically tied to a given company's history, or in both within different contexts. The industry's various subdivisions are all subject to a variety of laws and regulations that govern entire financial processes including the patenting, efficacy testing, safety evaluation, and marketing of these drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020, in total, and this showed a compound annual growth rate (CAGR) of 1.8% given the results of recent events.
A topical medication is a medication that is applied to a particular place on or in the body. Most often topical medication means application to body surfaces such as the skin or mucous membranes to treat ailments via a large range of classes including creams, foams, gels, lotions, and ointments. Many topical medications are epicutaneous, meaning that they are applied directly to the skin. Topical medications may also be inhalational, such as asthma medications, or applied to the surface of tissues other than the skin, such as eye drops applied to the conjunctiva, or ear drops placed in the ear, or medications applied to the surface of a tooth. The word topical derives from Greek τοπικόςtopikos, "of a place".
Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company based in Hyderabad. The company was founded by Kallam Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited. Dr. Reddy manufactures and markets a wide range of pharmaceuticals in India and overseas. The company produces over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology.
Triamterene is a potassium-sparing diuretic often used in combination with thiazide diuretics for the treatment of high blood pressure or swelling. The combination with hydrochlorothiazide, is known as hydrochlorothiazide/triamterene.
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.
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug. The entire process—from concept through preclinical testing in the laboratory to clinical trial development, including Phase I–III trials—to approved vaccine or drug typically takes more than a decade.
The pharmaceutical industry in India was valued at an estimated US$42 billion in 2021 and is estimated to reach $130 billion by 2030. 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 60% of all vaccines manufactured in the world. Indian pharmaceutical products are exported to various regulated markets including the US, UK, European Union and Canada.
In chemistry, fine chemicals are complex, single, pure chemical substances, produced in limited quantities in multipurpose plants by multistep batch chemical or biotechnological processes. They are described by exacting specifications, used for further processing within the chemical industry and sold for more than $10/kg. The class of fine chemicals is subdivided either on the basis of the added value, or the type of business transaction, namely standard or exclusive products.
Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs, biologics, vaccines and natural health 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."
Omega-3-acid ethyl esters are a mixture of ethyl eicosapentaenoic acid and ethyl docosahexaenoic acid, which are ethyl esters of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) found in fish oil. Together with dietary changes, they are used to treat high blood triglycerides which may reduce the risk of pancreatitis. They are generally less preferred than statins, and use is not recommended by NHS Scotland as the evidence does not support a decreased risk of heart disease. Omega-3-acid ethyl esters are taken by mouth.
Medication costs, also known as drug costs are a common health care cost for many people and health care systems. Prescription costs are the costs to the end consumer. Medication costs are influenced by multiple factors such as patents, stakeholder influence, and marketing expenses. A number of countries including Canada, parts of Europe, and Brazil use external reference pricing as a means to compare drug prices and to determine a base price for a particular medication. Other countries use pharmacoeconomics, which looks at the cost/benefit of a product in terms of quality of life, alternative treatments, and cost reduction or avoidance in other parts of the health care system. Structures like the UK's National Institute for Health and Clinical Excellence and to a lesser extent Canada's Common Drug Review evaluate products in this way.
Repros Therapeutics Inc. (Nasdaq: RPRX), was a US-based development stage biopharmaceutical company headquartered in The Woodlands, Texas. Founded in 1987 as Zonagen, it focused on the development of oral small molecule drugs to address major unmet medical needs in male and female health. Joseph S. Podolski was the CEO of this company.
The Food and Drug Administration is a federal agency of the United States, formed in 1930.
The term "me-too drug" or "follow-on drug" refers to a medication that is similar to a pre-existing drug, usually by making minor modifications to the prototype, reflected in slight changes in the profiles of side effects or activity, and used to treat conditions for which drugs already exist. While pharmaceutical companies have justified the development of me-toos as offering incremental improvements in efficacy, side-effects, compliance and cost, critics have questioned the increasing marketing of me-toos, their absorption of research and development resources and their impact on the innovation of new treatments.
Pronova BioPharma is a Norwegian company. In Denmark it is a bulk manufacturer of omega-3 products with a manufacturing plant in Kalundborg. It was acquired by BASF in 2014.
For one, in pharmaceuticals, as in organic and agricultural chemicals, patent claims tend to define products especially precisely. ..." "Second, once a particular molecule is identified as a potentially effective therapeutic medium, it must be carried through expensive clinical trials to prove its safety and efficacy. ..." "Third, absent patent protection or regulatory barriers to imitation, imitators might spend a very few million dollars on product formulation, process development, and clinical trials (typically on 24 human subjects) required to prove therapeutic equivalence and bring their generic substitutes onto the market in competition with the company that has incurred huge discovery and clinical testing costs. ..." "It is for these three reasons together that patents are accorded such high importance by pharmaceutical manufacturers.
patents are key in the pharmaceutical sector, as they allow companies to recoup their often very considerable investments and to be rewarded for their innovative efforts