Drug Patent Transparency: Faster Access to Affordable Generic Medications.
This law mandates that pharmaceutical companies must provide consistent and complete patent information for drugs and biological products to both the FDA and the Patent Office. The goal is to prevent companies from improperly extending their drug monopolies, which should speed up the availability of cheaper generic alternatives for consumers. Non-compliance can lead to the denial of drug approval or weaken patent protection in court.
Key points
Drug companies must certify that patent data submitted to the FDA matches the data given to the Patent Office, ensuring full transparency.
Failure to disclose required patent information can result in the FDA denying approval for the drug application.
If a company hides information, generic manufacturers can use this failure as a legal defense against patent infringement claims, potentially lowering drug costs sooner.
Expired
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