The legal drug and pharmaceutical industry is one of the largest financial interests in the United States. It has seen its fair share of controversy, particularly in recent years, but the development of new drugs remains one of the most critical aspects of modern life. Part of the process of developing drugs is the filing for drug patents, which helps the major pharmaceutical corporations recoup the tremendous expense involved in researching, developing, fielding, and marketing new medications.
Here are five little-known facts about drug patents, which many people entering into medical and pharmacological degree programs aren’t necessarily aware of:
Patent Medicine has a 400 Year History
Patent medicine, the practice of protecting drugs with patents, began in England in the 17th century. At that time, government standards were significantly more lax, and record-keeping was a far more tedious challenge. As such, the prevailing attitude of the day was “buyer beware;” in order to score a patent, a newly manufactured drug had only to be original. There were no standards in place to measure its safety, or whether or not it actually treated any of the conditions connected to its marketing campaign. Early perception of government endorsement, coupled with the guarantee of exclusivity, led to these medications being marketed to treat an astonishing array of dozens of unrelated conditions, ultimately leading to “patent medicines” entering the public lexicon as a disparaging term.
Official Policy Encourages Quick Clinical Trials
Today, we have clinical trials which are meant to ensure the relative safety and effectiveness of a drug, for the purposes for which it is advertised. New drugs must reach a certain point of approval prior to being submitted for clinical trials, however, at which point the clock is ticking for the company to recuperate their losses. They have millions of dollars in expenditures encouraging them to get the drug to market, and government policy which encourages them to go through the trials as quickly as possible while satisfying minimum FDA requirements.
20 Year Patent Protection
Many people believe that new drugs are protected from copycat drugs indefinitely (that generic brands are merely “similar”), or for a period of time equivalent to the protection afforded to books and films. In fact, new drugs are patent-protected for a period of 20 years, after which time other brands are permitted to create generic versions. Prior to that point, it is not unknown for the patent holders to file lawsuits against suspected cases of infringement, which delays the availability of said drugs, regardless of any merit to the claims.
Patent Protection Reduction
As previously mentioned, new drugs are protected by their patents for 20 years, but this amount of time is effectively reduced by the fact that the clock starts immediately. The FDA approval period can take years, however; typically, at least four to six years, with as many as 8-12 years in some cases, particularly if additional or unusual testing is deemed necessary for public safety. This can reduce the 20-year period of exclusivity to anywhere from 8-16 years. Not only does that knock a significant chunk off the amount of time the company has to recover its investment, but it necessitates the expensive process of developing multiple marketing and financial management plans for the drug, based upon different potential windows of exclusivity.
Significant Money is Spent on Litigation
One of the little-understood consequences of unpredictable patent periods is that major drug manufacturers tend to hoard patents, a practice sometimes referred to as “patent trolling.” Through clever wording, patents requested for partial processes, and even patents granted for re-branded medicines, major pharmaceutical manufacturers attempt to prolong the lifespan of their costly, highly-invested products. This leads to significant amounts of litigation by generic drug manufacturers, who often have to resort to filing suit to get their drugs to market. This, in turn, ups the price of some generic drugs, while delaying or shelving others due to the prohibitive costs of litigation.
The practice of patenting drugs may be in need of reform in the United States, but overall it is necessary, to ensure the continuing viability of expensive, research-intensive medications. As the industry grows, new opportunities will continue to be created for researchers, accountants, financial analysts, medical professionals, and other individuals to make their mark in the development of new and innovative drugs for the treatment of a variety of once-problematic illnesses and conditions.
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