Three Sleazy Moves Pharmaceutical Companies Use to Extend Patents

When pharmaceutical companies get a patent on a new molecule, they have 20 years to recoup the cost of developing a drug out of it. Two decades sounds like a long time, but clinical trials eat several of those years, leaving only a handful of years to earn back the money spent bringing the drug to market. So pharmaceutical companies look for loopholes in the law. Here are three shady things these companies do to extend their patents - and rake in more cash from consumers.

Photo by Mircea BEZERGHEANU via Shutterstock.

Once the patent expires, other manufactures can make the medication, and this severely decreases the cost of the pharmaceutical. That's why companies try to extend the time they hold exclusive rights to a drug and can set prices as high as they wish. One common way they do this is to develop new chemical entities - small modifications of existing, often "off-patent molecules" that allow them to get a 5 year extension on the patent. (See our explainer on how this works.)

Here are 3 common methods used to obtain this five year exclusivity period, highlighting some particularly sleazy moves on the part of pharmaceutical manufacturers.

Three Sleazy Moves Pharmaceutical Companies Use to Extend Patents


Method One: The Mashup

This method is simple. Take two existing pharmaceuticals on the market, combine them as a new medication, and bring it to retail. The mashup (known as combination therapy in medical vernacular) is a great way to sell "off-patent" pharmaceuticals under a brand name and charge a higher price.

Pfizer's Caduet is perfect example, a pill for the treatment of heart disease. Caduet is a simple combination of the blood pressure drug amlodipine besylate (marketed as Norvasc) and the cholesterol drug atorvastatin calcium (better known is Lipitor). Pfizer developed both Norvasc and Lipitor, with Lipitor holding the post of top selling pharmaceutical in the world for several years. Pfizer's patent on the molecules behind Norvasc and Lipitor expired in 2007 and 2011, respectively, but due to Pfizer's existing patent on the molecules, no other manufacturers could produce a combination medication containing the molecules. Caduet conveniently entered the market in 2004.

Combination pharmaceuticals are particularly annoying to the consumer, as they increase the co-pay cost or force the patient to pay the full retail cost of the new pharmaceutical. You, as the patient, can always request the drugs separately from your physician, but this cannot be done at the point of the pharmacy.


Three Sleazy Moves Pharmaceutical Companies Use to Extend PatentsMethod Two: The Planned Purification

Research into Lexapro began in 1997, six years before the Danish pharmaceutical company Lundbeck‘s patent on the molecule citalopram, the active component of the anti-depressant Celexa, expired. The pharmaceutical Celexa exists as a mixture of two forms of the same molecule, (R)-citalopram and (S)-citalopram.

Lexapro spent only three and a half years in development, with this short time period due to knowledge that only one of forms of molecule citalopram caused the anti-depressant effects of the drug. Lexapro, the purified replacement, contains only the active form of citalopram, (S)-citalopram. This purified version instantly becomes a new drug in the eyes of the FDA, warranting a five year period of exclusivity as a new chemical entity, and providing an amazing revenue source when Celexa became vulnerable to generics in 2003.

One possible benefit of the purification route is a decrease in side effects associated with the molecule. Users of Lexapro only need to take half the dosage of Celexa, leading many to correlate a decrease in side effects with Lexapro.

Three Sleazy Moves Pharmaceutical Companies Use to Extend Patents

Method Three: Alternate Delivery

The extended release trick! While this method benefits many patients, creating a micro-encapsulated form or a pill with layers that dissolves at different rates and allows for controlled release helps a brand stay on the market.

A great example of patent award via alternative delivery is Intermezzo, a form of the generic drug zolpidem, the molecule active in Ambien. Intermezzo dissolves quickly under the tongue, unlike the pill form of zolpidem, allowing it to be approved as a new chemical entity in November 2011 by the FDA.

Intermezzo also features a lower dosage of zolpidem. The combination of quick onset and low dosage allows for a shorter period of sleep than the 8 hours required for Ambien. Intermezzo features the same active molecule as Ambien (now available as a generic), just a different dosage and method of uptake, yielding five years of patent exclusivity for Transcept Pharmaceuticals to sell Intermezzo.

Be aware and ask questions
These three methods, only a few of the weapons in a pharmaceutical company's patent and marketing arsenal, are some of the most common and clever ones used. Be aware of the alternatives if you take a medication daily for an extended period of time, and ask your physician if a generic form of a prescription drug is available if cost or lack of insurance is an issue for you.

Images from CC sources and Pfizer. Sources cited within the article.