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Cialis generic for sale in the UK, company recently announced that it is seeking a patent on several "new mechanisms" for drug administration. These mechanisms include a new means of packaging treatment (previously, the package was a foil), new ways of measuring drug dosage, and a new way of measuring drug effectiveness. These cialis generic best price innovations could lead pharmaceutical companies to develop new, better drug formulations that can be more closely analyzed and approved.
As this patent battle unfolds, drug regulators in India and elsewhere are also examining how their policies might affect development and marketing of new medicines. If these changes cause other countries to adopt the Indian approach pricing, result will be increased prices and shortages, as many drugs sold illegally in Indian markets have not yet seen the light of day.
The stakes in case are high. The FDA currently regulates only drugs in the United States with a net profit of more than $5 million per year, a level that has been maintained over time, and one at which only a handful of drugs are actually approved. However, the agency could soon be asked to review the price of all new drugs sold in the country. This could prove difficult, given the FDA's recent willingness to regulate prices for "disease-related" drugs with potentially significant benefits versus risks. And it's not clear which drugs are most at risk of being forced onto the market under new policy, which could increase prices for those with preexisting conditions.
The FDA hasn't yet decided how it will respond, and has not provided comment generic drug approval process in canada to Vox. That said, if it decides to impose a new policy, it could spark a backlash. While the agency usually doesn't respond directly to patent challenges, it can make exceptions under certain circumstances. It has the power to lower threshold for patentability, instance, so that it can rule a drug patentable even if its effects are minimal and drug does no better than existing treatments.
The new policy could also open the door to new claims of patent infringement. In November 2011, for example, doctors in Pakistan filed a petition on behalf of the All Drugs Foundation to take the FDA court seeking to invalidate the current policy, citing several aspects of it that they claim are unconstitutional. The U.S. Supreme Court is expected to decide whether hear the case later this year. In the meantime, fight over pricing and how drug price changes are measured could lead to more costly legal challenges — and potentially to more costlier lawsuits from generic companies, or perhaps even worse: The FDA could decide against making changes but nonetheless rule in the company's favor.
This story has been updated to reflect subsequent reporting that suggested it was the generic drug manufacturers that filed the patent challenge.
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