The U.S. FTC’s policing of Orange Book patent listings begs the question of when, and whether, the FDA will deliver on its commitment to provide more clarity on the types of device patents that can be listed as covering a “drug product.”
The America Invents Act of 2011 was designed to provide a durable overhaul of the U.S. patent system, but the inter partes review process has drawn fire from inventors as a patent-killing machine. The Senate is considering a new bill to address some of these concerns, but witnesses at a hearing this week were anything but united in their assessment of the status quo, making it difficult to forecast the fate of this latest effort at patent reform.
Carrying through on a policy it adopted a few months ago to crack down on potentially anticompetitive FDA Orange Book listings, the U.S. FTC put 10 drug companies on notice that it’s challenging several of their “improperly or inaccurately listed” patents through the FDA’s regulatory dispute process.
Wading into the “muddied waters” of rounding the numbers used in a range claimed in two drug patents, the U.S. Court of Appeals for the Federal Circuit refused to set a “bright line rule.” Instead, it tossed a lower court win for Actelion Pharmaceuticals Ltd. against Mylan Pharmaceuticals Inc. and sent the case back to that court with instructions to consider the extrinsic evidence and its impact on the claim construction.
U.S. Sen. Bernie Sanders (I-Vt.) is calling for an investigation into the NIH’s proposed grant of an exclusive patent license for a late-stage cervical cancer drug to a small company linked to a former NIH researcher.
In a new report from the U.S. International Trade Commission (USITC), concerns about global inequities accessing diagnostics and medicines for COVID-19 reveal that there are varied and divergent opinions on whether the intellectual property (IP) protections that support the development of new medicines may also act as a barrier to access, particularly in developing countries. In December 2022, U.S. Trade Representative Katherine Tai asked the USITC to respond and identify significant data and information gaps.
With an FDA approval decision on treosulfan possibly more than a year off, the U.S. Patent and Trademark Office granted Medac GmbH a third one-year extension of its method-of-use patent covering the drug, which is being developed as a conditioning agent in allogeneic hematopoietic stem cell transplantation.
The U.S. FTC put brand drug companies on notice Sept. 14 when the commissioners unanimously voted, 3-0, to issue a policy statement recognizing that improperly listed patents in the FDA’s Orange Book “may constitute an unfair method of competition.”
The process of discovery is resource-consuming in any type of litigation, but this is especially the case for patent litigation due to the exceptional importance of attorney-client privilege in patent prosecution. However, a U.S. judicial advisory committee is considering a rewrite of the rules to ease some of this burden in a move that could cut both the expense and time consumed by patent litigation, a development that is sure to draw cheers from across the spectrum of innovators in the life sciences.