Avian influenza, or "bird flu," is a contagious virus that normally infects only birds but occasionally crosses the species barrier to infect humans. In 1997, a particular strain of avian influenza, the H5N1 virus, infected 18 people in Hong Kong, killing 6 of them. Since mid-2003, more than 258 human H5N1 cases have been diagnosed worldwide, causing more than 154 deaths. According to the World Health Organization, of the few avian influenza viruses that have crossed the species barrier to infect humans, the H5N1 virus has caused the largest number of cases of severe disease and death in humans. The H5N1 virus is alarming because, if it mutates into a form that easily infects many humans, it has the potential to cause a deadly "pandemic," or a global disease outbreak in humans. In the 20 th century, there were three pandemics, in 1918, 1957 and 1968, that killed millions of people worldwide. On November 1, 2005, the Bush Administration issued a report entitled the "National Strategy for Pandemic Influenza," which described the federal government's plan to address the potential outbreak of avian influenza. The report explained: It is impossible to know whether the currently circulating H5N1 virus will cause a human pandemic. The widespread nature of H5N1 in birds and the likelihood of mutations over time raise our concerns that the virus will become transmissible between humans, with potentially catastrophic consequences. If this does not happen with the current H5N1 strain, history suggests that a different influenza virus will emerge and result in the next pandemic. This fear of a global flu pandemic has compelled many countries to prepare for the threat by stockpiling antiviral drugs and attempting to develop vaccines against the disease. According to the Bush Administration, these countermeasures are "the foundation of our [influenza virus] infection control strategy." The President's plan proposes to spend $1 billion to build a national reserve of antiviral medications such as Tamiflu and Relenza to help contain or suppress a pandemic outbreak. As of June 2007, the nation's "Strategic National Stockpile" (SNS) contained 36 million courses of antiviral medications, with a goal of having 50 million courses anticipated to be warehoused in the federal stockpile by the end of 2008. The U.S. Department of Health and Human Services (HHS) has worked with state governments to facilitate the purchase of more than 12 million treatment courses by the states as of June 2007, with a goal of obtaining 31 million courses for their respective stockpiles by December 2008. HHS Secretary Michael Leavitt has explained that the "ultimate goal is to stockpile sufficient quantities of antiviral drugs to treat 25% of the U.S. population." In addition to stockpiling existing antiviral drugs, the U.S. government is promoting the development of new antiviral drugs to combat influenza. For example, the federal government in January 2007 awarded a four-year contract of over $100 million for the development of a new influenza antiviral drug that may be quickly administered to treat persons with severe influenza. Oseltamivir phosphate, marketed under the brand name Tamiflu, is a prescription drug manufactured by the Swiss pharmaceutical company Roche, Inc. Tamiflu is not a vaccine, but is perhaps the most efficient antiviral treatment for influenza. The drug eases flu symptoms by preventing the influenza virus from spreading inside the human body. Some research studies have shown that Tamiflu is effective against the H5N1 avian and human virus strains. However, it is unknown how well Tamiflu would work to control a pandemic. Also, the drug must be ingested within 48 hours of the onset of flu symptoms for maximum efficacy. This requirement raises concerns about the utility of Tamiflu, because it is often difficult for patients to realize within such a short amount of time whether their symptoms are caused by the flu or the common cold. In addition, because Tamiflu has a shelf life of five years, a pandemic may not strike during that time period, raising the possibility that stockpiles of the medicine may go unused and become useless. Prior to 2006, Roche was the exclusive manufacturer of Tamiflu and significantly struggled to meet the strong demand for the patented drug. According to the company, manufacturing the drug is complicated, involving ten main steps, and takes a long time, from six to eight months to produce a capsule of Tamiflu once all the raw materials have been sourced. In November 2005, the World Health Organization estimated that, at Roche's then-present manufacturing capacity, "it will take a decade to produce enough oseltamivir [Tamiflu] to treat 20% of the world's population." The Tamiflu production shortage in 2005 prompted both international and domestic pressures on Roche to ease its patent monopoly and permit other companies to manufacture generic versions of the drug. It was believed that such action would help to increase supplies of the flu treatment to meet the backlog of orders, as well as make the drug more affordable. However, one of the challenges of producing large quantities of Tamiflu is obtaining enough supplies of its key active ingredient, shikimic acid. This acid may be extracted from the pods of a Chinese cooking spice called star anise. Yet there may not be enough star anise in China or elsewhere to produce Tamiflu on a massive scale. To address this shortage, Roche began experimenting with a fermentation process using genetically altered E. coli bacteria to make the shikimic acid. Roche has since declared that the fermentation process is more effective in producing the acid than processing star anise, and that the majority of shikimic acid is now derived from this process. Counterfeit drugs pose public health and safety concerns because they "may closely resemble legitimate drugs yet may contain only inactive ingredients, incorrect ingredients, improper dosages, sub-potent or super-potent ingredients, or be contaminated." The U.S. Federal Food and Drug Administration's Counterfeit Drug Task Force has stated: [W]e believe that counterfeiting is quite rare within the U.S. drug distribution system because of the extensive scheme of federal and state regulatory oversight and the steps taken by drug manufacturers, distributors, and pharmacies, to prevent counterfeit drugs from entering the system. However, we are concerned that the U.S. drug supply is increasingly vulnerable to a variety of increasingly sophisticated threats. We have witnessed an increase in counterfeiting activities and a more sophisticated ability to introduce finished dosage form counterfeits into legitimate drug distribution channels over the years. The rise in global demand for Tamiflu has contributed to the production and sale of illegal, fake Tamiflu. Pills purporting to be Tamiflu, which contain only trace elements of Tamiflu's active ingredient shikimic acid, have been shipped from parts of Asia to the United States after unsuspecting customers had ordered the counterfeit pills via the Internet; however, the U.S. Customs and Border Protection (CBP) agency has been successful in intercepting and seizing counterfeit Tamiflu shipments. Trafficking in counterfeit drugs is potentially punishable under a variety of federal laws, including the mail fraud statute, the Trademark Counterfeiting Act, and the Federal Food, Drug, and Cosmetic Act. However, prosecuting the manufacturers of counterfeit Tamiflu may prove to be challenging if they reside overseas. The cooperation of foreign governments in bringing legal action against these manufacturers may be necessary to prevent the spread of fake versions of Tamiflu within the global medicines market, as well as to impede their entrance into the United States. Roche has issued guidelines to help consumers avoid purchasing counterfeit Tamiflu over the Internet. Among these are the following recommendations: Buying Tamiflu from a website exhibiting the Verified Internet Pharmacy Practice Sites (VIPPS) seal, issued by the National Association of Boards of Pharmacy after a sites's legitimacy has been confirmed. Avoiding Internet pharmacies that do not provide a means of contacting them by telephone Being wary of very low or very high prices for the drug; the average cost for authentic Tamiflu is $80 to $90 for a 10-pill treatment. Avoiding websites selling what they claim is "generic Tamiflu"; there is currently no authorized generic version of Tamiflu. Inspecting the Tamiflu package carefully for any suspicious alterations in the seal, packaging, or label. Genuine Tamiflu is packaged in a white cardboard box with the wording "TAMIFLU Capsules 75 mg" written clearly on the front. The box contains a single blister package containing 10 capsules, which are a yellow and light grey color. Each blister contains one capsule, which can be seen through the transparent outer layer. Each blister is printed on the aluminum foil of the reverse side with the words "TAMIFLU Capsules 75 mg." One of the primary purposes for United States patent law is to provide individuals and institutions with economic incentives to engage in research and development that lead to new products or processes. By granting inventors with a limited monopoly over the use of their discoveries, patent holders will be able to receive a return on investment from their creations. Without patent protection, competitors could "free ride" on the inventor's research and development efforts and easily duplicate or otherwise practice the new inventions without having incurred the costs to develop them. A patent holder has the right to exclude others from making, using, selling, offering to sell, and importing the protected invention. Whoever performs any one of these five acts during the term of the invention's patent, without authorization of the patent holder, is liable for infringement. Note that while the patent holder has the right to exclude others from performing these acts, the conferring of a patent does not automatically allow the invention to be used or marketed in the United States—compliance with other federal laws or regulations may be required in order to do so.