Inequitable Conduct and Invalidation of Patents Related to Food and Drug Administration–Regulated Products

Median brand-name drug launch prices increased from $2115 in 2008 to $180 007 in 2021. An important factor allowing drug manufacturers to sustain high prices is market exclusivity, length of which is usually defined by drug patents. Therefore, ensuring that patents are obtained legitimately from the US Patent and Trademark Office (USPTO) without misrepresenting or omitting information is important. Inequitable conduct is a legal claim that can be brought to invalidate patents acquired by fraud or deceit, such as intentionally withholding or misrepresenting material information. Fraudulently granted patents could increase patient and health care system costs by enabling extended periods of monopoly pricing.

Read more here.