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Reuters General/ - Article, Ter, 17 de Abril de 2012 CLIPPING INTERNACIONAL (Supreme Court) U.S. top court rules for generic drugmaker on patent By Anna Yukhananov and James Vicini WASHINGTON | Tue Apr 17, 2012 3:07pm EDT (Reuters) - The U.S. Supreme Court ruled on Tuesday in favor of a generic drugmaker in a case over how companies can fight brand-name rivals in an effort to get their cheaper medicines to market. The high court unanimously ruled that the generics company, Caraco Pharmaceuticals, could sue a brand-name drugmaker to get it to narrow its patent description with the Food and Drug Administration. The FDA uses this information to decide whether to approve a generic "copycat" version of a medicine before the patent has expired. Caraco, a unit of India's Sun Pharmaceutical Industries, argued that the description of the patent for the diabetes drug, Prandin, was too broad and therefore prevented any generic from entering the market. It raised a "counterclaim" to challenge the description. The U.S. government said generic drugs saved consumers billions of dollars each year, and it opposed a lower court ruling in favor of the brand-name company, Denmark's Novo Nordisk. The justices agreed, and overturned a U.S. appeals court ruling that Caraco could not file a legal counterclaim to challenge the way Novo had described its patent to the FDA. Justice Elena Kagan said in the opinion that when the FDA evaluated an application to market a generic drug, it considered whether the proposed drug would infringe a patent held by the manufacturer of the brand-name version. The FDA requires brand-name manufacturers to submit descriptions of the scope of their patents, known as use codes, and it assumes the information is accurate, she said. "We hold that a generic manufacturer may employ this provision to force correction of a use code that inaccurately describes the brand's patent as covering a particular method of using the drug in question," Kagan concluded. The FDA approved Prandin, known generically as repaglinide, for three separate uses to help patients with Type 2 diabetes to control their blood sugar levels. Novo Nordisk's main patent on the drug already expired, but it has another that covers the use of repaglinide only when it is used in combination with another diabetes drug, metformin. This patent expires in 2018. That means Caraco could get FDA approval to "carve out" two other uses for the drug without infringing on Novo Nordisk's specific patent. But Novo Nordisk, the world's biggest insulin producer, submitted a more general description of its remaining Prandin patent to the FDA, effectively covering all three uses. Novo Nordisk said its description of the patent for Prandin fulfilled FDA requirements and that the "counterclaim" provision was a minor point in the law that was never supposed to fix patent descriptions. But the Supreme Court rejected the company's arguments. The Supreme Court case is Caraco Pharmaceutical Laboratories v. Novo Nordisk, No. 10-844. (Reporting By Anna Yukhananov and James Vicini; Editing by Lisa Von Ahn) 210
Reuters General/ - Article, Ter, 17 de Abril de 2012 CLIPPING INTERNACIONAL (Supreme Court) Florida judge in Trayvon Martin case to decide on recusal By Barbara Liston ORLANDO, Florida | Tue Apr 17, 2012 4:21pm EDT (Reuters) - A Florida judge will decide this week whether to step down from the second-degree murder trial of George Zimmerman, the neighborhood watch volunteer charged in the shooting death of 17-year-old Trayvon Martin. Circuit Judge Jessica Recksiedler disclosed last week that her husband's law partner previously had been contacted by Zimmerman seeking representation. Zimmerman's lawyer, Mark O'Mara, on Monday filed a motion asking Recksiedler to recuse herself. Recksiedler is on temporary assignment from the Florida Supreme Court, hearing oral arguments at the Fifth District Court of Appeal in Daytona Beach, Florida. She will issue a written order by Friday on the recusal motion, according to a court news release issued on Tuesday. A bond hearing is set for Zimmerman on Friday. The court spokesman was unavailable to comment on Tuesday on whether that hearing would go forward as scheduled if another judge takes over the case. In what the court spokesman previously acknowledged was an unusual decision, a different judge at Zimmerman's first appearance on Thursday sealed all court records filed in the case after that date. Martin was killed February 26 after he went to a convenience store to buy snacks before watching the NBA All-Star game on television. As he walked through a gated residential community where he was staying with his father and father's fiancee, Martin, a black teen, was spotted by Zimmerman, a white Hispanic. Prosecutors allege Zimmerman profiled Martin, disregarded police instructions, confronted and then killed Martin with a single gunshot to the chest. Zimmerman has claimed self-defense in the shooting in the central Florida town of Sanford. Police initially failed to arrest him or charge him with any crime because Florida's so-called "Stand Your Ground" law allows individuals who feel threatened in a public place to use lethal force in self-defense. (Editing By Tom Brown and Eric Walsh) 211
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