pharmaceutical patents

Topics: Generic drug, Patent, Pharmacology Pages: 6 (1852 words) Published: August 25, 2014


Patents
A patent is a set of exclusive rights granted by a sovereign state to an inventor or assignee for a limited period of time in exchange for detailed public disclosure of an invention. An invention is a solution to a specific technological problem and is a product or a process. Patents are a form of intellectual property. The procedure for granting patents, requirements placed on the patentee, and the extent of the exclusive rights vary widely between countries according to national laws and international agreements. Typically, however, a granted patent application must include one or more claims that define the invention. A patent may include many claims, each of which defines a specific property right. These claims must meet relevant patentability requirements, such as novelty and non-obviousness. The exclusive right granted to a patentee in most countries is the right to prevent others from commercially making, using, selling, importing, or distributing a patented invention without permission

Pharmaceutical Patents

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. In the pharmaceutical industry, the patent protection of drugs and medicines is accorded a particular importance, because drugs and medicines can easily be copied or imitated (by analyzing a pharmaceutical substance) and because of the significant research and development spending and the high risks associated with the development of a new drug. Chemical patents are different from other sources of technical information because of the generic, Markush structures contained within them, named after the inventor Eugene Markush who won a claim 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.

Drug Patents & Generics
In most cases, the drug patent is awarded for around twenty years in the United States. The lifetime of the patent varies between countries and also between drugs. Since the company applies for a patent long before the clinical trial to assess a drug’s safety and efficacy has commenced, the effective patent period after the drug has finally received approval is often around seven to twelve years. Once the patent has expired, the drug can be manufactured and sold by other companies. At this point, the drug is referred to as a generic drug. According to guidelines in most countries, including those from the US FDA, generic drugs have to be identical to the branded drug in terms of efficacy, safety, usage, route of drug administration, pharmacokinetics and pharmacodynamic. Therefore, a drug can be manufactured as a generic drug when the following apply: Its patent has expired

The company that would manufacture the generic drug certifies that the patents held on the drug are either unenforceable, are invalid or would not be infringed upon There has never been any patents on the drug before

In countries where the drug has no patent protection
Once the generic drug is on the market, the monopoly of the patent holder is removed. This encourages competition and results in a significant drop in drug costs, which ensures that life-saving and important drugs reach the general population at comparative prices. The company holding the initial patent may, however, renews the patent by forming a new version of the drug that is significantly changed compared to the original compound. However, this may require new clinical trials and re-application of the...
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