Search Results for keywords:"U.S. Patent and Trademark Office"

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Search Results: keywords:"U.S. Patent and Trademark Office"

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  • 2024-31276 — Determination of Regulatory Review Period for Purposes of Patent Extension; ROCTAVIAN
    Type:Notice
    Citation:89 FR 106505
    Reading Time:about 7 minutes

    The Food and Drug Administration (FDA) has calculated the regulatory review period for the human biological product ROCTAVIAN. This action is in relation to a request for patent term extension submitted to the U.S. Patent and Trademark Office by BioMarin Pharmaceutical, Inc. The total review period is 2,101 days, divided into 816 days for testing and 1,285 days for approval. The FDA encourages anyone who believes the dates are incorrect to submit comments or petitions by specified deadlines for consideration.

    Simple Explanation

    The FDA looked at how long it took to check if a medicine called ROCTAVIAN is safe to use and found it took 2,101 days. They are letting people who think the timeline is wrong say so, but the rules for saying this are a bit complicated.

  • 2024-29966 — Determination of Regulatory Review Period for Purposes of Patent Extension; BYLVAY
    Type:Notice
    Citation:89 FR 102916
    Reading Time:about 7 minutes

    The Food and Drug Administration (FDA) has announced its determination of the regulatory review period for the human drug BYLVAY. The FDA made this determination following a request from the U.S. Patent and Trademark Office for information related to patent term restoration. BYLVAY, approved for treating pruritis in patients aged 3 months and older with progressive familial intrahepatic cholestasis, underwent 1,868 days of regulatory review, including a testing phase of 1,625 days and an approval phase of 243 days. This notice invites anyone with information suggesting that these dates might be incorrect to submit their comments for consideration.

    Simple Explanation

    The FDA checked how long they tested and reviewed a medicine called BYLVAY before deciding it was safe for people to use, and they are letting others know how they calculated this time. If anyone thinks they made a mistake with these dates, they can say so, and the FDA will look into it.

  • 2024-29964 — Determination of Regulatory Review Period for Purposes of Patent Extension; SOHONOS
    Type:Notice
    Citation:89 FR 102912
    Reading Time:about 7 minutes

    The Food and Drug Administration (FDA) announced the determination of the regulatory review period for the drug SOHONOS, which is used to treat fibrodysplasia ossificans progressiva in certain children and adults. This determination is related to a patent extension application made to the U.S. Patent and Trademark Office (USPTO). FDA found that the drug underwent a lengthy review process, including 6,657 days of testing and 869 days of approval proceedings. People who believe any of the review dates are incorrect can submit comments to FDA, and petitioners can also request a review of the applicant's diligence during this period.

    Simple Explanation

    The FDA looked at how long it took to check if a special medicine for a rare bone problem was safe and worked well, and they found that it took a very long time. Now, people can say if they think any of the times were counted wrong.

  • 2024-31269 — Determination of Regulatory Review Period for Purposes of Patent Extension; VEOZAH
    Type:Notice
    Citation:89 FR 106496
    Reading Time:about 7 minutes

    The Food and Drug Administration (FDA) has calculated the regulatory review period for the human drug product VEOZAH, which is used to treat menopause-related symptoms. This review period consists of 2,573 days, split between the drug testing phase (2,248 days) and the approval phase (325 days). The announcement is necessary due to requests for patent term extensions filed with the U.S. Patent and Trademark Office. The FDA invites comments and petitions regarding the accuracy of these dates and the diligence of the applicant during the review process.

    Simple Explanation

    The government checked how long it took to test and approve a medicine called VEOZAH, and they say it took a little over seven years. They're letting people know because there are some questions about how much extra time the medicine's special rules should last, and they want people to tell them if they agree or not.