• Regulatory NewsRegulatory News

    How a Fax Caused the Federal Circuit to Invalidate a Patent for Two Bayer Oral Contraceptives

    The US Court of Appeals for the Federal Circuit on Friday ruled that a Merck KGaA patent - linked to two of Bayer’s oral contraceptives, Safyral and Beyaz - is invalid because ingredients in the drug were offered for sale before the filing of the patent. The reversal of the lower court decision could mean a loss of patent protection and the launch of new Safyral and Beyaz generics before the patent expires in April 2020. The story and patent claim on the contraceptives...
  • New Safety Warning Issued For Popular Birth Control Product, Potentially Rekindling Controversy

    The US Food and Drug Administration (FDA) issued an updated safety warning 10 April about birth control products containing drospirenone-a synthetic version of the hormone progesterone-saying the hormone may be associated with a higher risk for blood clots than other progesterone-based pills. Some studies highlighted by FDA showed a three-fold increase in the risk of developing a blood clot, though FDA admitted "it is unclear whether the increased risk seen for blood clo...