Patent, term

The life of a trade secret may extend indefinitely if the owner of the secret has taken the proper steps to safeguard the iavention, in contrast to a 17-yr patent term, after which time the iavention is in the pubHc domain. TraditionaHy, trade secrets have been protected by confidentiaHty agreements, nondisclosure agreements, and employment agreements. 

In addition to utiHty patents, some countries pubHsh patent documents under different or less stringent standards for patentabiHty and with shorter patent terms. For example, plant patents cover asexually reproduced plants. Design patents cover the decorative aspects of a product. UtiHty models and petty patents cover products with differences from the prior art that need not meet the nonobviousness standards set for utiHty patents. 

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... 

F 3 years, 6 months 17 months after date of agreement. Between 100 and 250 million A royalty pajment of 7.5% of the generic company s net sales for months 21 through 15 prior to expiration of patents, 5% royalty of net sales for months 14 through 8, and 2.5% of net sales for months 7 through end of patent term. 

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. 

At the same time. Congress recognised that the effective patent term of pioneer drugs was dramatically reduced because of the time required for drug development by the FDA IND/NDA requirements prior to marketing. On average, the... 

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. 

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