In letters to the U.S. Patent and Trademark Office (USPTO) in September 2021, FDA acting Commissioner Janet Woodcock, MD, as well as Sens. Patrick Leahy, D-Vermont, and Thom Tillis, R-North Carolina, of the Senate Judiciary Subcommittee on Intellectual Property, suggested ways the office could potentially reduce drug monopolies. In an effort to reduce the price of medications, the FDA and Senate are both exploring methods of limiting pharmaceutical companies' abilities to extend drug monopolies by leveraging patent strategies.

In July 2021, President Biden issued an executive order that called for federal agencies to create policies promoting increased competition in the U.S., including the goal of lowering prescription medication costs by increasing competition through better access to generic and biosimilar drugs.

As a result, the patenting process for therapeutics is under examination. Some suggestions from the FDA and Senate on how the USPTO can better screen patent applications include avoiding practices...

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