FDA Delays Hand Roche Extra Year of Drug Patent Protection
Published Date: 12/10/2025
Notice
Summary
Hoffman-La Roche just scored a one-year extra patent life for their drug Bitopertin because the FDA’s approval process is still underway. This means the company keeps exclusive rights to sell Bitopertin oral tablets until December 17, 2026, giving them more time to make money before others can copy it. If the FDA takes longer, they can get up to five one-year extensions, so the clock keeps ticking in their favor!
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Up to Five One-Year Extensions Possible
Under 35 U.S.C. 156(d)(5), the term of a patent may be extended for no more than five interim periods of up to one year each if the Food and Drug Administration approval phase is expected to extend beyond the patent's expiration. This means the patent owner may seek up to five separate one-year interim extensions if the FDA approval phase continues to delay beyond expiry.
One-Year Patent Extension Granted
The U.S. Patent and Trademark Office granted a one-year interim extension of U.S. Patent No. 7,319,099 for the drug Bitopertin (GlyT1 inhibitor) oral tablets. The patent's original expiration date of December 17, 2025 is extended by one year to December 17, 2026.
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