Pharmaceutical law governs the manufacture, sale, distribution and use of pharmaceutical drugs. Pharmaceutical laws is a combination of different federal legislation, state laws, and court decisions relating to pharmaceutical drugs. Included in the area of pharmaceutical law is intellectual property law in relation to the protection of a pharmaceutical's research, standards, marketing restrictions and drug prescription and distribution.
One of the most important aspect of pharmaceutical law is intellectual property. The development of a new drug or treatment is project that could earn billions. It is for this reason that pharmaceutical companies are zealous in obtaining intellectual property rights of new drugs and treatments. The U.S. Patent Office, together with the U.S. Food and Drug Administration, govern the granting of exclusivity rights for all pharmaceutical discoveries, inventions and innovations. The FDA is strict in pursuing companies who are manufacturing or selling pharmaceutical products that have not obtained the proper patent coverage. There is stiff competition in the application for patent rights. This is the reason why pharmaceutical companies have a retinue of pharmaceutical law attorneys doing research and drafting documentation for IP application with the Patent Office and exclusivity application with the FDA. In order to acquire exclusivity in the United States, the applicant must comply with requirements laid out by the FDA and the Patent Office. The FDA and the Patent Office have different requirements for application of patent and exclusivity. To be safe, pharmaceutical companies must obtain the two prior to manufacturing a drug, although an FDA exclusivity can be granted without first obtaining a patent.
The FDA gives a five-year exclusivity period for a new chemical entity, which means no other company can file an Abbreviated New Drug Application for the same NCE. Exclusivity application with the FDA can be costly, and, like pharmaceutical research, exclusivity application research is also thorough. The FDA exclusivity occurs regardless of whether or not the Patent Office has issued a patent. If a patent has already been obtained, the pharmaceutical company still cannot legally use any NCE without first obtaining exclusivity from the FDA. The patent must be listed with the so-called FDA Orange Book in order for the patent to work like an exclusivity. Other companies can challenge the validity of patents or a new drug application. Pharmaceutical law attorneys defend defend companies from these challenges as these acts turn really messy especially because of the millions that might be at stake, in terms of lost revenues and profits. These suits are complicated and are thus best left with expert attorneys.
In addition to intellectual property, product safety and marketing is also another important aspect of pharmaceutical law. The FDA has stringent testing on food and drugs before they can be sold in the market in order to protect consumers. Because drugs have the tendency to be abused or misused, the FDA also regulates the kind of marketing for drugs in order for consumers not to file misleading claims. Other laws are also in place that require immediate recall of products that are considered not safe. Product safety and marketing is a subject in numerous class action lawsuits across the country. These suits often seek multi-million dollars in damages. It is therefore a good idea for pharmaceutical companies to hire lawyers to make sure they are in compliance with product safety and marketing laws and defend them when facing complaints on product safety and marketing.