Patent-term restoration

Other expansions of FDA s authority include the Dmg Price Competition and Patent Term Restoration Act of 1984, commonly known as the 1984 Amendments or the Waxman-Hatch Act, which was passed to attain quicker marketing of safe, effective, and less expensive generic dmgs and the Safe Medical Device Amendments of 1990, which was passed to correct perceived weaknesses in the implementation of the 1976 Device Amendments. Congress further expanded FDA authority over nutrition labeling and health and nutrient content claims on food labels with the Nutrition Labeling and Education Act of 1990. 

Drug price competition and patent term restoration act of 1984, Public 98-417, 98 Stat. 1585-1605, Sept. 24, 1984. 

Drug metabolite production, microbial biotransformations for, 16 398-399 Drug Price Competition and Patent Term Restoration, 15 686 Drug products... 

Drag Price Competition and Patent Term Restoration Act intended to allow... 

Fines Enhancement Laws of 1984 and 1987 increase penalties for all federal crimes, with double fines for corporations. The Drug Price Competition and Patent Term Restoration Act expedites the availability of less-costly generic drugs by permitting FDA to approve generics without repeating the safety and effectiveness research. 

Thus, Hatch-Waxman balanced an expedited FDA approval process to speed generic entry with patent term restoration to... 

One district court explicitly has held that a brand-name company may not list a metabolite patent in the Orange Book, because the metabolite patent does not claim the drug, as required by the listing statute. " The court looked to the precedent, Hoechst-Roussel Pharms., Inc. v. Lehman, which interpreted the term claims in the Patent Term Restoration portion of the Hatch-Waxman Amendments at 35 U.S.C. 156(a) and concluded that a metabolite patent does not claim the approved dmg product. 

As indicated above, the status of generic versions of both pre-1962 and post-1962 new drugs was settled by Congress in the Drug Price Competition and Patent Term Restoration Act of 1984. That statute will be discussed in greater detail below. 

The vast bulk of prescription drugs on the market today are subject to the requirement for some form of an approved NDA. Following enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, there are now three clearly established types of NDA a full NDA, a paper NDA [now called a Section 505(b)(2) NDA, after the provision in the FD C Act that created it], and an abbreviated NDA. Each of these is discussed in the sections that follow. 

The ffatch-Waxman Act, or the Drug Price Competition and Patent Term Restoration Act, makes it easier for generic drugs to get approval from the FDA but also allows drug companies to extend their patents when the FDA approval process delays the sales of patented drugs. 

The pharmaceutical marketplace has also become more crowded as innovative pharmaceutical firms compete with a growing number of generic producers as well as their own products via parallel importation. The passage of the 1984 Drug Price Competition and Patent Term Restoration Act (The Hatch-Waxman Act) intensified... 

Marketing of less-costly generic drugs is expedited with congressional passage of the Dmg Price Competition and Patent Term Restoration Act. Under the new regulations, the FDA could approve applications for... 

Patent Term Restoration Act (commonly referred to as the Waxman-Hatch Amendments or the 1984 Amendments) amended the FDC act by establishing a statutory ANDA procedure for duplicate and related versions of human drugs approvedunder section 505(b) of the FDA Act [69]. 

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