Pharmaceutical Law

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.

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Estate Planning Law - Legal Information and Resources

Estate Planning Law

Estate planning law governs the laws and procedures involved in the administration of an individual's estate while still alive and the process by which the estate will be distributed in the event the individual becomes incapacitated or when the individual is deceased. An estate consists of all of the individual's property, including house and other real estate; and tangible and intangible property. Estate planning also takes into consideration taxes to be paid during the distribution of assets and the selection of appropriate heirs.

The Uniform Probate Code seeks to clarify, unify and modernize estate planning laws throughout the United States and Washington, D.C.; however, only 30% of the states have completely adopted the Code, while the remaining 70% of states adopted only a portion of the Code. Thus, estate planning law vary greatly from state to state.

An estate plan must include the following: (1) a will; (2) assignment of power of attorney; (3) a living will or health-care proxy; and (4) for some people, a trust. Estate planning is for everyone, not just for the wealthy. Estate planning is for anyone who has property, regardless of whether it is in millions or in hundreds. Estate planning is also not just for older people because time will never tell when an individual will be incapacitated or will die. Estate planning is straightening an individual's life so that when that person can no longer make sane decisions, he or she will continue to live his or her life according to how he or she wants to live.

Drafting estate planning documents is relatively easy and may be completed without the guidance of an attorney. However, there may be unknown complicating issues that need legal advice. Thus it is advisable to have an expert estate planning attorney run through the documents. In addition, there is the issue on probate, the court process to determine whether a will is valid or not. A will is not a guarantee that the probate process will be easy. Probate is usually a lengthy and expensive process, which may involve different courts. If an individual has numerous properties in different states, each property may have to go through probate in accordance with the laws of the state where it is located. State laws on estate planning differ greatly, thus, an attorney who is knowledgeable on the myriad of laws involved in estate planning need to be retained.

Another area in estate planning that would require the expertise of an attorney would be the drafting of a trust. Trusts are draft to mainly avoid probate. An expert on estate planning would know other ways to avoid probate, aside from the drafting of a trust. Probate can be avoided when the property is jointly owned, in the case of spouses, or when the property is life insurance, annuities, or retirement plans.

An estate planning law attorney can greatly help in making sure that all properties are accounted for, the applicable taxes are taken into consideration, and all appropriate heirs are include to cut short the lengthy and expensive probate.

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