Can you imagine having to pay upwards of two dollars or more per pill the next time you have a prescription filled at your local pharmacy? As recently as 2001, patients had to do just that to get BuSpar, an anti-anxiety drug manufactured by the pharmaceutical firm Bristol-Myers Squibb, when they could have saved twenty-five percent or more with generic forms of the drug.

What stopped consumers from using the generic brand was Bristol's efforts to protect its patent on BuSpar and, thus to protect its profits, through charging its generic drug competitors with patent infringement, thereby freezing government approval for cheaper generic versions as required by law when patent-violation accusations are raised [1]. As companies like Bristol-Meyers Squibb and others have demonstrated for several years, the soaring costs of prescription drugs-partly linked to the research and development costs necessary to bring drugs to market-can be attributed in large part to the aggressive business tactics used by pharmaceutical companies to preserve the viability of their products on the market.

Arguably, the most crucial component of these practices is the vigorous pursuit and protection of government-granted patents and market exclusivities, which offer companies protection from competition in selling innovative products for a specific period of time. Since such legally sanctioned financial security is highly desirable to drug firms seeking to maximize their profits on their drugs, many in the pharmaceutical industry will stop at nothing to seek out methods of renewing their drug patents in the hopes of extending the profitability of their products into the future. It is in this light that, in recent times, pharmaceutical companies have discovered, created, and used a wide array of strategies by which they, at their own discretion, have garnered patent protections and extensions.

Background on Patents and Market Exclusivity

Patents are a form of intellectual property protection which give the owner of an idea or invention, or in the case of drug companies, a new chemical formula, the right to exclude others from making, using, or selling it for a specified period of time. Patents in the U.S. are granted by the U.S. Patent and Trademark Office (PTO) and last for twenty years, starting from the date of the patent application.

Market exclusivity, on the other hand, is a protection granted by the Food and Drug Administration (FDA), which obligates the FDA itself to deny public sales approval for any product containing the same active ingredient as the product protected by the exclusivity. There are two different terms of exclusivity: a five year term for entirely new compounds and a three year term for products with chemical modifications, new dosage levels, new drug combinations, and uses.

Although patents and market exclusivities do function similarly in granting virtual monopolies to firms offering treatment-specific drugs in the marketplace, they are legally independent of one another and run on separate, distinct periods of time that may run concurrently with each other [2].

Ideally, patents and grants of market exclusivity are supposed to encourage innovation within the pharmaceutical industry by protecting companies from competitors trying to sell or otherwise exploit their original products and ideas. Once a patent is granted, protected firms are then free to develop their drugs and to carry out any clinical trials required for FDA approval before final release into the market, where the drugs will then enjoy freedom from competition from similar products for the remainder of the exclusivity period [3].

The Case Against Pharmaceuticals

Many drug companies, however, enticed by the potentially inflated profits from patent-protected drugs having little or no competition in the marketplace, do not follow this ideal. Instead, they use a variety of strategies to extend patent life in order to maximize the time their products remain on the market.

The most popular tactics primarily focus on aspects of drug production itself, such as the chemical structure, storage, packaging, usage, and method of administration of a drug [1]. Companies may also elect to use dosage levels and drug combinations, as well as legal and legislative recourse, as a means for requesting new patents for drugs which, although may be used in different ways, are relatively unchanged from their original versions [3].

By far, the most popular method of patent extension is the modification of a drug to the extent that the changes made to the original version merit a new patent; otherwise, the parent drug and the new one are essentially the same. Such drugs, called "line extensions," are generally developed when a parent drug faces inevitable patent expiration [4]. Since making minor alterations to existing drugs is generally cheaper for the drug industry than having to invest in the development of a completely new drug, many companies opt for line extensions if they see that their more popular drugs, also known as "blockbuster drugs," will earn similar profits in the form of "copycat" drugs[3]. Schering Corporation, for instance, used the line-extension strategy to introduce Clarinex, whose parent Claritin, is set to lose its patent this year. As an antihistamine drug similar to Claritin, Clarinex's alleged superiority and improvements over Claritin have recently come under scrutiny in light of the striking chemical similarities between the two drugs and Clarinex's barely-marginal effectiveness in treating allergy symptoms, as compared to placebos in clinical trials. In fact, the apparent similarity between the two drugs has forced international organizations, such as the European Agency for the Evaluation of Medicinal Products (EMEA), to conclude that Clarinex is probably not superior to Claritin, raising questions as to the legitimacy of Clarinex's patent [6].

Other companies using similar tactics to extend the shelf life of their drugs include Astra Zeneca for its drug Prilosec [1], Bristol-Meyers Squibb for its products BuSpar [5] and Glucophage [3], and Pfizer Corporation for its epilepsy drug Neurontin [5]. In all these cases, the composition of the pills, not necessarily the active ingredients themselves, were altered to protect the manner in which the body degrades these drugs, thus providing the basis for securing their respective patents.

To extend the profit horizons of their drugs even further, pharmaceutical firms may even find new uses for their drugs while their patents are still active. This practice often results in multiple patents awarded to a company for the exact same drug, but whose uses differ on the basis of the medical treatments the drug manufacturer has claimed that the drug can treat. For example, Merck used the results of its clinical trials on its prostrate drug Proscar to justify to the FDA its use in hair-loss management in men under the new name Propecia. Differing only by their different uses, Proscar and Propecia are essentially the same drug, yet have been awarded separate patents and consequently more years of drug protection for Merck [4]. Similarly, the firm Eli Lilly also found a new use for its antidepressant drug Prozac, whose new name is Sarafem, now a treatment for Premenstrual Dysphoric Disorder (PMDD), extreme cases of Premenstrual Syndrome (PMS) [4].

Since new uses for drugs also include differing combinations of drugs as a treatment for a condition, companies like Merck and Schering Plough used this idea as grounds for a proposed deal in 2000, when the companies considered two different drug combinations of their drugs, one to lower serum levels, the other to treat allergies, designed to win patent renewals for each of the partnered drugs if the companies decided to follow through with their proposal [3].

Many in the pharmaceutical industry have also secured patent and market exclusivity extensions through their abuse of the public trust, mainly through their exploitation of government funding and legal provisions originally meant to accelerate the development of innovative medicines. In most instances, the free accessibility of government and academic scientific resources has encouraged pharmaceutical firms to use academic institutions for both their discoveries and their access to a broad range of human test subjects to help lower their research and development costs and effort. For instance, the anti-cancer drug Taxol, which was first discovered at Florida State University through the help of grants from the National Institutes of Health (NIH), was in the past exclusively licensed to Bristol-Myers Squibb, which lost its status as the sole manufacturer of the drug in April 2002 [3]. Consequent efforts on the part of Bristol to regain its monopoly over Taxol's distribution by patenting it, even though it had already been discovered through public funds, solely on the basis of a different method of delivery into the body have put Bristol on the public spotlight for impropriety. Allegations of foul play took serious form on June 4, 2002, when thirty-two states filed a lawsuit against Bristol on the grounds that it "repeatedly and deliberately misrepresented and concealed" scientific research on Taxol to the PTO, "thereby fraudulently obtaining two patents on methods of administering the drug" [3].

As perhaps the most direct method of patent and exclusivity protection, pharmaceutical companies may use their financial and political sway to influence the implementation of legislation favorable to patent extension. Generally, this type of legislation comes about through the intervention of sympathetic legislators who either attach riders to pieces of legislation or introduce entire bills that sufficiently act to extend patents and exclusivities. For example, the Best Pharmaceuticals for Children Act (BCPA), signed into law on January 4, 2002 by Pres. Bush, gives drug companies the opportunity to extend their market exclusivities for their products by six months by allowing them to shift the target patients of their drugs from adults to children. This pediatric exclusivity gives firms selling a specific medication the exclusive right to sell it as a treatment for children without the threat of competition from other firms having similar products, but which were not able to obtain exclusivity protection under the BCPA.

Essentially, the BCPA provides that the six month grant of market exclusivity for specific therapies be added to the end of the patent period of the product under review, as well as to the end of any existing patents on products owned by a company containing the same active ingredient as the product under pediatric review. Additionally, any cheaper, generic versions of a protected drug waiting for FDA approval during the exclusivity period will not receive approval until after the protection period is over [2]. Under the provisions of the BCPA, a company may obtain market exclusivity even if the pediatric studies it submits to the FDA are not successful; so long as a company submits a pediatric study that follows FDA guidelines, the exclusivity period will be awarded [2]. Examples of drugs that have enjoyed pediatric exclusivity in the past, regardless of whether their pediatric clinical trials were successful, are Schering-Plough's Claritin, Eli Lilly's Prozac, and Bristol-Myers Squibb's Glucophage.

During the six-month pediatric exclusivity periods, additional sales for Claritin, Prozac, and Glucophage were $975 million, $831 million, and $648 million, respectively [2]. As similar sales and profit figures within the pharmaceutical industry continue to grow in the midst of today's legal and economic environment surrounding big firms, patients and their doctors should hope that any future healthcare advancements involve the development of innovative medicines rather than newer, more sophisticated ways of circumventing drug patent expirations.

Ramil is a pre-medical student majoring in biochemistry. Ramil aspires to help those who are unable to afford standard medical care.