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Pfizer Wins RAPAMUNE Patent Case Against Watson

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Pfizer Inc. (NYSE: PFE) said today that the United States District Court for the District of Delaware ruled that Pfizer's patent covering a method for using sirolimus, the active ingredient in RAPAMUNE®, for the inhibition of organ transplant rejection is valid and infringed. The company brought a patent infringement action in April 2010 against the generic company Watson Laboratories, Inc—Florida (now known as Actavis) and three other Watson entities after Watson applied to the FDA to market a generic version of RAPAMUNE®. The Court's decision prevents Watson from marketing its generic version of RAPAMUNE® in the U.S. before Pfizer's patent expires, pending a possible appeal by Watson.

The patent at issue in the lawsuit is U.S. Patent No. 5,100,899, which including pediatric exclusivity, expires January 7, 2014. In response to the decision, Amy Schulman, Executive Vice President and General Counsel for Pfizer, said, “We are pleased with the Court's decision, recognizing the validity of our patent."

In the United States, RAPAMUNE® is indicated for the prevention of organ transplant rejection in kidney transplant patients aged 13 years and older.

Important Safety Information

* There is an increased risk of developing infections or certain cancers, especially lymphoma and skin cancers. Rapamune has not been shown to be safe and effective in people who have had liver or lung transplants. Serious complications and death may happen in people who take Rapamune after a liver or lung transplant. You should not take Rapamune if you have had a liver or lung transplant without talking with your doctor. * Do not take Rapamune if you know you are allergic to sirolimus or any of the other ingredients in Rapamune. Symptoms of an allergic reaction include swelling of your face, eyes, or mouth; trouble breathing or wheezing; throat tightness; chest pain or tightness; feeling dizzy or faint; and rash or peeling of your skin. * Before taking Rapamune, tell your doctor if you have liver problems, skin cancer or it runs in your family, high cholesterol or triglycerides, are breastfeeding or plan to breastfeed, and are pregnant or plan to become pregnant. Women of childbearing potential should use effective birth control before therapy, during therapy, and for 12 weeks after Rapamune therapy has been stopped. Rapamune may interact with other medicines. Make sure that your doctor is aware of all prescription and over-the-counter drugs that you are taking, including vitamins, herbs, and nutritional supplements. * Rapamune may cause swelling in your hands, feet, and in various tissues of your body. Call your doctor if you have trouble breathing. * Rapamune may cause your wounds to heal slowly or not heal well resulting in redness, drainage, or opening of the wound. * Rapamune may increase the levels of cholesterol and triglycerides (lipids or fat) in your blood. Your doctor should do blood tests to check your lipids during treatment with Rapamune. Your doctor may recommend treatment if your lipid levels become too high. Your lipid levels may remain high even if you follow your prescribed treatment plan. * In patients taking Rapamune with cyclosporine, decreased kidney function has been observed. Your doctor will regularly check your kidney function. * Rapamune may increase protein in your urine. Your doctor may monitor you for abnormal protein in your urine from time to time. * Rapamune may increase your risk for viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak. One of these viruses, BK virus, can affect how your kidney works and cause your transplanted kidney to fail. A certain virus can cause a rare serious brain infection called Progressive Multifocal Leukoencephalopathy causing death or severe disability. * Rapamune may cause potentially life-threatening lung or breathing problems. Symptoms may include coughing, shortness of breath, or difficulty breathing. * When Rapamune is taken with cyclosporine or tacrolimus, you may develop a blood clotting problem resulting in unexplained bleeding or bruising. * Common side effects associated with Rapamune include high blood pressure, pain (including stomach and joint pain), diarrhea, headache, fever, urinary tract infection, low red blood cell count (anemia), nausea, and low platelet count (cells that help blood to clot). If you experience any side effects, contact your doctor.

Posted-In: News FDA

 

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