1. Before a drug becomes generic, the patent holder seeks FDA approval to sell a version of the drug directly to consumers. 2. A host of major patent holders, including the Massachusetts Institute of Technology, urged the Supreme Court to overturn that decision. 3. But because the approval process can take much longer, opponents of the new regulations say that many patent holders will now be effectively short-changed. 4. But even a patent on the process of cloning humans could give the patent holder some rights over people, some lawyers said. 5. But rulings in favor of generic drug makers in other cases have opened the way for class action lawsuits that charge the patent holders with antitrust law violations. 6. But the patent holder has a virtual monopoly and can protect the patent in court. 7. Congress needs to close these patent loopholes to maintain intellectual property rights for the patent holders but also to allow generics to become available, as the law intended. 8. For the most part, that also meant serving institutional inventors and corporate patent holders. 9. For example, countries can force patent holders to license their patents to others, like generic manufacturers. 10. Gene patent holders avoid that prohibition because genes must be isolated, cloned or otherwise changed to be studied. |
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