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Biden administration acts to promote competition and lower drug prices for all Americans

Common blog of Kathi Vidal, Under Secretary of Commerce for Intellectual Property and Director of the USPTO, and Robert M. Califf, Commissioner of the FDA

President Biden is helping Americans protect and preserve their health and live with the dignity of knowing they can take care of themselves and their loved ones, in part by making the cost of prescription drugs more reasonable. The President outlined a multi-pronged plan to increase access and reduce the cost of prescription drugs in his July 2021 Executive Order Promoting Competition in the U.S. Economy. This plan included a call to the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) to leverage our collective expertise in promoting innovation, competition and of approving and regulating safe and effective drugs to help bring relief to American families at the pharmacy.

The Biden administration, including the USPTO and FDA, recognizes the important contributions and lifesaving treatments developed by the pharmaceutical industry, a primary force in the discovery and development of drugs and vaccines that have completely or nearly eradicated diseases. deadly diseases like smallpox, poliomyelitis, measles, diphtheria, hepatitis B and meningitis, as well as highly effective treatments for various cancers and other chronic diseases.

This work, and the billions of dollars spent on laboratory research and clinical trials, are made possible in part by our patent laws. The foundations of these laws were enshrined in the US Constitution by our country’s founders, and pharmaceutical companies can use the patents granted for a limited time to recoup and benefit from their investments.

Our laws also allow and encourage generic drug manufacturers to enter the market to increase competition and lower prices. This delicate balance rewards and incentivizes those who put in the work to create original lifesaving medicines, as well as those who enter the market later to find and provide access to more affordable alternatives. These laws contribute to the fact that thirteen of the twenty most innovative and inventive pharmaceutical companies of 2021 are headquartered in the United States. The American pharmaceutical industry offers enormous benefits to Americans when more drugs and treatment options are available to treat a wide range of illnesses.

But more needs to be done. As President Biden noted in the executive order almost exactly a year ago, while issuing strong and reliable patents to encourage pharmaceutical innovations is essential, our patent system must not be used to unduly delay generic drugs and competition from biosimilars beyond what is reasonably contemplated by law. .

To further the goals of this executive order, the USPTO and the FDA recently entered into an exchange of letters outlining numerous initiatives to be executed on the President’s agenda. These initiatives will strengthen our relationship and expand the resources available to assess patentability and address instances of patent misuse to delay competition.

Through these initiatives, the USPTO will protect against patenting incremental and obvious changes to existing drugs that do not qualify for patents. This effort can lead to lower drug prices because drug companies will not be able to unduly delay generic competition based on insignificant changes to a drug.

The USPTO will ensure that patent examiners have the time and resources they need to conduct thorough examinations of patent applications for pharmaceutical inventions. The FDA will help the USPTO provide patent examiners with training on the state of the art in the pharmaceutical and biological fields, and the USPTO will provide new tools for patent examiners to search huge global databases and increasing amounts of technical information, including publicly available sources. maintained by the FDA – to determine if similar innovations already exist.

The USPTO and FDA will work together more to develop policies to protect and promote American innovation while advancing competition that can lower drug prices for all Americans. We invite the public to participate in this process through upcoming outreach events and listening sessions.

Our intention is to ensure that our government’s innovation system strikes the right balance, encouraging meaningful innovation in drug development without unduly delaying competition that relieves high drug costs.

For more information on the Biden administration’s initiative to reduce drug prices, please visit the White House website. For more information on planned FDA and USPTO initiatives, please visit the USPTO website.