Congress has exhibited a strong and ongoing interest in facilitating the development of new, innovative pharmaceuticals for the marketplace while reducing the cost of drugs to consumers. To date, the U.S. system of research, development, and commercialization has had a clear impact on the pharmaceutical and biotechnology industries. Policies pertaining to funding for research and development (R&D), intellectual property protection, and cooperative ventures have played an important role in the economic success of these sectors. Industry-specific legislation, including the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the "Hatch-Waxman Act," also work to encourage innovation in the pharmaceutical sector while facilitating the entry of lower cost generic competition. A critical component of many of these federal efforts concerns patents. Patent ownership can provide an economic incentive for companies to take the results of research and make the often substantial investment necessary to bring new goods and services to the marketplace. The grant of a patent provides the inventor with a mechanism to capture the returns to his invention through exclusive rights on its practice for a limited time. In the pharmaceutical industry, patents are perceived as particularly important to innovation due, in part, to the ease of duplicating the invention. Recently, patents on a significant number of "blockbuster" drugs have expired. At the end of 2011, Lipitor, with 2010 retail sales in the United States of $5.8 billion and the world's best selling medication, lost patent protection. Between 2012 and 2016, branded pharmaceuticals with an estimated $117.2 billion in U.S. sales are expected to go off patent. Once patent protection is lost, these drugs are expected to lose up to 80% of the revenue generated for the innovator companies. "In the case of the top selling drugs, generics are capturing most of the market within weeks of their launch." Innovator companies depend on the funds generated from sales of blockbuster drugs to invest in additional R&D leading to new products that can improve the health and welfare of the public. At the same time, generic versions of these pharmaceuticals benefit the public due to their lower cost and greater availability; according to one estimate, over the 10 years between 2001 and 2010, generic drugs "saved the U.S. health care system more than $931 billion." However, "while consumers and companies [that] provide health benefits could gain from the substantial slashes in costs, big pharma has to look at new ways and strategies to fill the [revenue] gap" created by the unprecedented number of patent expirations on blockbuster drugs. The pharmaceutical industry is highly innovative and "stands as one of our nation's leading industries in high quality job creation ... and global competiveness." American pharmaceutical firms have "consistently maintained a competitive edge in international markets," lead in new drug discoveries, and "hold the intellectual property rights to most new medicines. A review of the 75 best selling drugs in 2009 determined that more than half originated in the United States." In 2011, 8 of the top 20 global drug companies (as measured by worldwide sales) were based in the United States. Estimates of employment in the pharmaceutical sector differ. A study by the Milken Institute found that "private-sector employment in the U.S. biomedical industry in 2009 was 1,219,200," including 283,700 biopharmaceutical jobs and "526,300 in related R&D, testing, and labs." Research by the Battelle Technology Partnership Practice indicated that "the biopharmaceutical sector is responsible for more than four million jobs in the U.S. economy (674,000 direct jobs and an additional 3.4 million indirect and induced jobs) in 2009" which generated "$258 billion in wages and benefits." Despite these different figures, it is clear that the wages paid to pharmaceutical sector employees are significantly higher than in other industries. According to the Milken Institute report, wages in the biomedical sector average 70% more than the national average wage. Battelle found that the average total compensation per employee in the biopharmaceutical sector is more than twice that of the average wage in the U.S. private sector. Estimates on global pharmaceutical 2010 R&D funding range from $120 billion to $133 billion. In the United States, research and development spending by the biopharmaceutical industry totaled between $67.4 billion and $68.0 billion. This U.S. investment in health-related R&D exceeds all other countries and is one reason for the leadership of American pharmaceutical firms. In addition, U.S. companies have demonstrated a pattern of R&D support that has increased at a faster rate than R&D in Europe. In 1990, investments in the European biopharmaceutical industry were 50% above those in the United States; by 2006, investments in the U.S. biopharmaceutical industry were 40% more than in Europe. According to the Pharmaceutical Research and Manufacturers Association (PhRMA), member spending on R&D increased 9.3% between 2009 and 2010 to a record level for the industry. Other analysis revealed that the average annual growth rate in U.S. R&D expenditures between 2000 and 2007 was largest in the pharmaceutical sector when compared to all industries that produce products that can be imported or exported. This R&D support is almost twice as much per employee than the next closest industry included in the study. Similarly, the National Science Foundation found that in 2008, the pharmaceutical and medicine industries invested over twice the amount of funding for R&D ($70 million) than the nearest R&D intensive sector (semiconductor and electronic components). Domestic R&D support by PhRMA members totaled an estimated $37.4 billion in 2010. This figure does not include the 5% reduction in spending by Roche, which ended its membership in PhRMA in 2009. Four of the five PhRMA members with the largest R&D funding increased their spending in 2010. These five companies contributed approximately 56.6% of the $67.4 billion in total pharmaceutical industry R&D support. In 2011, domestic R&D spending for members of PhRMA totaled an estimated $38.5 billion, with 21.1% of domestic sales reinvested in research and development However, other studies indicate that R&D spending is declining. R&D funding by PhRMA member companies dropped an estimated 2.4% in 2011 from the record high spending the previous year. An analysis of the top 50 global pharmaceutical companies (as determined by their 2010 healthcare revenue) found that 18 of these firms, including AstraZeneca and GlaxoSmithKline, decreased their annual R&D spending from the previous year. Similarly, research performed by CMR International noted that "R&D expenditure continued to drop in 2010 to an estimated three year low of $68 billion, which is in stark contrast to the growth rate leading up to 2008." According to one report, the world's largest pharmaceutical company, Pfizer, plans to reduce its R&D funding by 25% between 2010 and 2012 while other firms are expected to make less substantial cuts. Analysis by Battelle indicated that: Some of the largest cuts still coming are from Merck ... , which is closing eight global R&D facilities as part of a larger operational consolidation effort. Pfizer ... is signaling cuts of up to $3 billion in its R&D budget over the next few years. AstraZeneca has announced plans to reduce R&D budgets by $1 billion in the next four years, and Abbott Laboratories ... has announced plans for big cuts in R&D among more than 3,500 job cuts globally. Roche also recently announced plans to cut 4,800 jobs globally. Experts widely believe that patents encourage invention and innovation by simultaneously protecting the inventor and fostering competition. They provide the inventor with a right to exclude others, temporarily, from use of the invention without compensation. Patents give the owner an exclusive right for (typically) 20 years from date of filing to further develop an idea, commercialize a product or process, and potentially realize a return on the initial investment. Concurrently, the process of obtaining a patent places the concept in the public arena. As a disclosure system, the patent can, and often does, stimulate other firms or individuals to invent "around" existing patents to provide for parallel technical developments or meet similar market needs. This may form the basis for technological progress as patents are used to create an environment of competitiveness with multiple sources of innovation. The value of widespread invention is reinforced by research performed by Professors Robert Merges and Richard Nelson which demonstrated that when only "a few organizations controlled the development of a technology, technical advance appeared sluggish." Innovation produces new knowledge but is often costly and resource intensive. One characteristic of this knowledge is that it is a "public good," a good that is not consumed when it is used. If discoveries were universally available without a means for the inventor to realize a return on investment, most commentators are convinced that there would result a "much lower and indeed suboptimal level of innovation." Thus, the patent process is designed to resolve the problem of appropriability; patents permit novel concepts or discoveries to become "property" when reduced to practice and therefore allow for control over their use. Article I, Section 8, Clause 8 of the U.S. Constitution states: "The Congress Shall Have Power ... To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.... " Codified in Title 35 of the United States Code, one who "invents or discovers any new and useful process, machine, manufacture, or any composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title."