What does the Waxman Hatch 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 patient …

What is Hatch-Waxman protection?

Formally known as the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. Legislation that amended the Food, Drug, and Cosmetic Act to establish the Food and Drug Administration’s (FDA) generic drug approval process and the patent litigation process for generic drugs. …

What are the patent certifications under Hatch-Waxman Act?

In the US, under the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, a company can seek approval from the FDA to market a generic drug before the expiration of a patent relating to the brand name drug upon which the generic is based.

What is a paragraph IV certification created by the Hatch-Waxman Act?

Paragraph IV Patent Certifications. Under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Amendments, a company can seek FDA approval to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy.

What is Hatch-Waxman Act Slideshare?

CONCLUSION  The hatch-Waxman act provides an expedited USFDA program for speedy generic entry and market exclusivity  The hatch-Waxman act allows for a patent term extension of a maximum of 5 years for the branded drug manufacturer to compensate for the time lost during the NDA approval by the USFDA.

What is orphan drug exclusivity?

Orphan Drug Exclusivity Is Product & Disease Specific It blocks approval of the same product for the same disease. Orphan Exclusivity bars any sponsor from making the same drug for the same disease – even if the sponsor does not rely on the innovator’s data.

Can you petition the FDA?

Citizen petitions are part of the basic law governing everything the FDA does—at any time, any “interested person” can request that the FDA “issue, amend, or revoke a regulation or order,” or “take or refrain from taking any other form of administrative action.”

What is a suitability petition FDA?

A suitability petition is a request by a drug sponsor (called the “petitioner”) to submit an abbreviated new animal drug application (ANADA) for a proposed generic new animal drug that differs from the reference listed new animal drug (RLNAD).

What is para filing?

A paragraph IV filing is a subset of an ANDA application, where the generic applicant is claiming that the patent they are targeting is unenforceable either due to i) invalid or, ii) not infringed or iii) both invalid and non infringed by their product.

What is Bolar provision?

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.