Monday, June 17, 2013

Lower BAC/ Equal Pay/ Generic Drugs


As described in chapter 4, laboratory studies have shown that driving-related performance is degraded at BAC levels as low as 0.01, and epidemiological studies employing crash data have shown significantly elevated crash risk at BAC levels near 0.05. Lowering per se BAC limits has been associated with reductions in impaired driving crashes and fatalities. For example, 14 independent studies conducted in the United States found that lowering the BAC limit from 0.10 to 0.08 resulted in reductions in alcohol-related crashes, fatalities, or injuries of 5–16 percent (Fell and Voas 2006, 233–43). Other studies have found similar results (for example, Dee 2001, 111–28; Shults and others 2001, 66–88; Voas, Tippetts, and Fell 2000, 483–92). In 2012, the CDC listed 0.08 per se BAC laws among the “top 20 violence and injury practice innovations since 1992” (Kress and others 2012, 257–63).27


“Respondent Solvay Pharmaceuticals obtained a patent for its approved brand-name drug AndroGel. Subsequently, respondents Actavis and Paddock filed applications for generic drugs modeled afterAndroGel and certified under paragraph IV that Solvay’s patent was invalid and that their drugs did not infringe it. Solvay sued Actavis and Paddock, claiming patent infringement. See 35 U. S. C. §271(e)(2)(A). The FDA eventually approved Actavis’ generic product, but instead of bringing its drug to market, Actavis entered into a “reverse payment” settlement agreement with Solvay, agreeing not to bring its generic to market for a specified number of years and agreeing to promote AndroGel to doctors in exchange for millions of dollars. Paddock made a similar agreement with Solvay, as did respondent Par, another manufacturer aligned in the patent litigationwith Paddock.”

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