What did the Hatch-Waxman Act do?

The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the …

What provisions of the Hatch-Waxman Act have been the most beneficial to drug research companies and why?

“By streamlining the approval process for a generic drug form, the Hatch-Waxman Act reduced the average delay between patent expiration and generic entry into the consumer market from greater than three years to less than three months for top-selling drugs.”13 In cases where the generic manufacturer is the patent …

What is patent certification under 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 the purpose of Bolar exception in relation to a patented drug?

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.

Why was the Hatch-Waxman Act passed?

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 are the amendments of Hatch-Waxman Act?

The “Drug Price Competition and Patent Term Restoration Act of 1984,” also known as the Hatch-Waxman Amendments, established the approval pathway for generic drug products, under which applicants can submit an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C …

Who regulates prescription advertising?

The FDA
The Federal Trade Commission (FTC) is responsible for regulating OTC drug ads. The FDA regulates advertising only for prescription drugs. We also oversee the advertising for certain kinds of medical devices, such as hearing aids, the lasers used in LASIK procedures, and contact lenses.

How does patent term extension work?

The Act allows the extension of the term of a patent claiming a product that requires regulatory approval prior to being sold, or a method of using or manufacturing the product. Such products include human and veterinary pharmaceuticals, food additives, color additives and medical devices.

What is a paragraph 4 filing?

A paragraph IV filing is a subset of an ANDA application, specifically covering a filing where the generic applicant is asserting that the patent they are targeting is i) invalid, ii) not infringed by their product or iii) not enforceable as written.

What is a paragraph IV challenge?

In these so-called Paragraph IV challenges, the generic drug manufacturer files an abbreviated new drug application with the Food and Drug Administration certifying that its drug either does not infringe the brand drug patents or that those patents are not enforceable.

What is the principle of IPR?

In light of the universality and hierarchy of legal principle, the principles of the international protection system of intellectual property rights (IPR) can be divided into the following two types: one is the fundamental principles applied to the what, why and how a legal system shall be constructed, such as …

What are the conditions for revocation of patents?

A patent may be revoked for non-working as per section 85 of Patents Act, 1970, if even after two year from the date of grant of first compulsory license, the patented invention has not worked in the territory of India; or. the reasonable requirement of the public has not been met; or.

Are there any exemptions to the Hatch-Waxman Act?

The two exemptions are (1) a judicially created exemption developed through case law and (2) an exemption created by the Hatch–Waxman Act (the “safe harbor” provision).

When did the safe harbor exemption come into effect?

The statutory exemption, that is, the safe harbor provision, was created by Congress in 1983 as part of the Hatch–Waxman Act.

Are there any exemptions for research and development?

The law exempts certain experimental activities during research and development that would normally be considered patent infringement.