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Fosamax patent regainedDespite mounting lawsuits and ongoing troubles with its osteoporosis drug Fosamax, Merck received some good news in March 2007 when its European patents were reinstated. The patent initially expired in 2004, but due to a loophole the wording of the drug’s purpose was changed slightly prompting the European Patent Office to make the extremely rare move of reinstating Merck’s patents. The company now has the sole monopoly on marketing alendronate (the chemical name of Fosamax) in 23 European companies until 2018. The main exception to the reinstatement is the United Kingdom, where Merck has lost patent protection.
The company has stated quite publicly that it will “enforce our rights where the patent is valid” against pharmaceutical companies that have already started to sell the generic form of Fosamax.
However this does raise many questions since most drug plans in Europe are handled at the government level, not the private level. Some national programs may not be able to afford the pricey Fosamax, so it may not be as easy as switching from the generic form of the drug back to Merck’s patented drug. The company said that it will be willing to “work with authorities” to continue the supply of the drug while maintaining its intellectual property rights. There was not any mention during these negotiations, however, about the possible side effects of Fosamax. The drug has been associated with osteonecrosis of the jaw (ONJ), a condition where bone simply dies and falls apart. This painful illness has no cure except for surgery to remove the dead and/or dying bone, a traumatic and disfiguring solution for those unfortunate patients who get it.
The real tragedy is that doctors, dentists, and researchers have suspected a connection between Fosamax and ONJ since 2001. Still, the Food and Drug Administration (FDA) did not release any warnings about the possible side effects until September 2004. The official Fosamax labeling in the United States was not changed to reflect this major side effect until July 2005. During that time, there were an estimated 2,400 cases of ONJ associated with Fosamax.
If you or a loved one has developed ONJ while taking Fosamax, or experienced any other serious or life-threatening drug side effects, contact Jim S. Adler & Associates for a professional medical legal perspective. The firm has more than 30 years of litigation experience in Texas and may be able to help you get the compensation you deserve to reimburse you for your medical bills, lost wages and mental anguish. Call today for a free case review, or submit the details of your Fosamax side effects via our online form and one of our associates will contact you. |