Pharmaceutical patents are often being challenged in courts or are ignored in certain countries where patent infringement is not punishable. Pharmaceuticals patents can be related to different processes from manufacturing steps to delivery devices. Not all countries abide by the same standards when it comes to patent law protection and intellectual property rights. Naturally, pharmaceutical companies do not get protection for their patents in countries.
Drug patents are necessary because the process for the development of new drugs is very costly, up to $800 million on average. Therefore, the prescription drug industry requires exclusivity for a significant time period to recoup their investment. The process that pharmaceuticals must advance through before they are approved for mass production is extensive. The first step is the discovering of the drug. Pre-clinical trials are next, followed by three phases of clinical trials. The Food and Drug Administration’s approval is next and the final step is production and commercialization. The development and release of pharmaceuticals could take up to 14 years.
While the average patent covers the drug for a period of 20 years, the actual time drug companies realize that exclusivity and profit from the development is closer to 11.5 years. Since there is no way to renew a patent, when the patent expires, pharmaceutical companies must relinquish control of drug production to generic drug producers. Generic drugs however, are popular only because of their affordability. The average consumer or medical professional prefers name brand drugs due to the ease of determining their origination.
The basic types of patents include product patents, which protect new chemical discoveries. There are also products protected by process patents, which protect the manufacturing process. As the name implies, it protects others from using the exact same chemical or manufacturing process to produce a drug. The burden of proof lies on the company accused of infringement. A formulation patent is yet another type of patent pharmaceutical companies may seek. This protects the composition or method of application of a drug or a class of drugs. Examples of this type of patent can be found when examining hypodermic needle inventions of the last decade: the insulin pump or the intradermal needle. A method of use patent can be used to protect using an existing drug for a unique application.
Today many drug companies which have produced drugs with which the public is very familiar, like Plavix®, Lipitor® and Abilify® have patents that have or will expire in the very near future. Their monopoly over the profits from these branded drugs sales is over. This may seem like a fair step in the evolution of the pharmaceutical marketplace, but studies have proven that the innovation that results from patented drugs equals greater proliferation of innovation. Results from companies that can obtain a patent far exceed the innovations generated by generic drug companies. The cost to bring a new drug to the market has more than doubled over the last few decades and there is only one way to recoup the investment, through the use of patents.