STAT+: U.S. Patent Office software mistakes extend patent life for drugs and need to be fixed, researchers say

Amid concerns that the pharmaceutical industry abuses the U.S. patent system, a new paper suggests one way to crack down on the problem — amend a little-known method for correcting mistakes that lengthen the life of a patent and, consequently, can greatly add to the cost of medicines.

The idea is to improve the way administrative delays are handled at the U.S. Patent & Trademark Office. Sometimes, a delay is caused by a patent review, so the PTO will compensate the pharmaceutical company by extending the life of the patent by the number of days caused by the delay. Conversely, if a company was slow to respond to requests, the time is subtracted from the patent life.

The process for handling delays is called a patent term adjustment. The process was created as part of a federal law called the American Inventors Protection Act of 1999 and was seen as a way to compensate patent applicants when the PTO failed to act on applications within specified time limits. And to get it right, the PTO relies on automated software.

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