The U.S. Food and Drug Administration (FDA) and the E.U. European Medicines Agency (EMA) announced that Slovakia has beeen added to a mutual recognition agreement (MRA) regarding good manufacturing practice (GMP) inspections in the European Union. Slovakia was the last of the 28 member states of the European Union to be recognized as capable of
Many factors contribute to the price that consumers pay for prescription drugs and biologics. These factors include research and development costs, manufacturing costs, terms negotiated by insurance plans, supply and demand, and intellectual property rights. Intellectual property rights are often viewed as one of the most significant factors driving high drug and biologic prices. In
Prior to 1994, the term of a U.S. patent was 17 years from the date of issuance. When the Uruguay Round Agreements Act (“URAA”) changed the term to 20 years from the earliest nonprovisional priority date, it appeared that unpatentability due to obviousness type double patenting (“ODP”) would no longer be relevant since the patent
Lately, it has been very difficult to get diagnostic claims allowed without limiting the method steps to very specific components (e.g. reagents, devices, assays, samples, etc.). However, a recent Federal Circuit case suggests that there may be hope for broader diagnostic claims in the future. In Exergen Corp. v. Kaz USA, Inc., Appeal No. 2016-2315,
Sandoz’s request for inter partes review (“IPR”) of U.S. Patent Numbers 9,512,216 (“the ’216 patent”) and 8,802,100 (“the ’100 patent”) was denied by the Patent Trial and Appeal Board (“the Board”) on the grounds that Sandoz did not show that the patents were likely unpatentable. The decisions not to institute an IPR of either patent