What does the Hatch-Waxman Act do?
The Drug Price Competition and Patent Term Restoration Act, better known as the Hatch-Waxman Act, is a comprehensive legal framework enacted by Congress in 1984 to streamline the process for generic pharmaceutical approvals and preserve incentives for innovation, including the creation of a procedure for patent …
What is Hatch-Waxman protection?
Formally known as the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. Patent litigation that may be triggered when a generic drug applicant files an ANDA with certain certifications concerning patents covering the relevant reference drug, usually a branded drug. …
What is patent safe harbor?
Safe Harbor Patent Terms This safe harbor provision allows a generic company to perform experiments needed to obtain regulatory approval prior to the expiration of the patents covering the drug product.
What is an ANDA case?
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
What is 180 day exclusivity period?
The premise of the 180-day exclusivity under the Hatch-Waxman Act is that the “First Applicant” to challenge a drug patent is entitled to 180 days of exclusivity against subsequent generic applicants.
Where is Hatch-Waxman codified?
The Hatch-Waxman Act created a statutory exemption from certain claims of patent infringement. As codified in 35 U.S.C. §271(e)(1), this provision mandates: “It shall not be an infringement to make, use, offer to sell, or sell within the United States a patented invention …
What is the Bolar exemption?
The Bolar provision is a defence for patent infringement wherein a patented invention (that is due to expire in the next three years) can be exploited by a third party solely for research and development purposes and to obtain the required regulatory approvals, while the patent is still valid.
What provides a safe harbor for the inventor and the product developer?
The Hatch-Waxman Act § 271(e), that provides “safe harbor” from infringement for pharmaceutical companies using patented inventions in their drug research and development operations.
What is a Inda?
Investigational new drug application abbreviated as INDA is a mandatory requirement filed with the FDA in order to seek permission for administering a new drug under investigation to Human subjects after completion of the preclinical studies on it.
What is the difference between NCE and NME?
The main difference between NCE and NME is that NCE does not have any FDA authorised active ingredient, although NME has an FDA approved active moiety which has not been previously approved. The terms NCE and NME are used for drug categorisation based on whether active moieties are present or not.