Patents exclusivity period

Qther interesting features of the Canadian system include its 1998 mutual recognition agreement with the EU, prohibition of prescription drug advertising to consumers, a 20-year patent exclusivity period, and the establishment of the PMPRB to ensure fair pricing of medications. ... 

Although it was open to Member States to decide not to allow an exclusivity period to run beyond patent expiry. 

A third basic option available in the case of some therapeutic categories is to develop an over-the-counter version of a product subject to patent expiration. The strategy has been employed for example for anti-inflammatory pain relievers such as Motrin and Naprosyn, anti-ulcer therapies such as the H2 blockers Tagamet and Zantac, proton pump inhibitors such as Prilosec, and in several other therapeutic categories. However, a shift to OTC status requires approval by the FDA that the drug is safe for self-medication (Juhl 2000 McCarran 1991 Schweitzer 1997). A company will normally need to submit new clinical trial evidence to that effect. If approved by the FDA, the company receives a three-year exclusivity period for its OTC product in recognition for the new clinical trial work. 

When a new indication is approved, only that indication receives three years of additional exclusivity under the Act. However, there is no effective way to prevent a less expensive generic firm from being used for all indications during this three-year exclusivity period, since physicians do not specify an indication when they write a prescription. This will be the case unless the brand firm utilizes an alternative delivery system or formulation that has exclusivity or patent protection. 

ROYALTY TERM shall mean, with respect to each country in which Product is sold the period of time equal to the longer of (i) ten (10) years from the date of first sale of the Product in such country, (ii) the expiration of the last-to-expire Licensed Patent listed in EXHIBIT A in such country that claims such Product, or (iii) the period of time equal to the Data Exclusivity Period in such country. 

III) Amendment of certification. The first applicant amends or withdraws the certification for all of the patents with respect to which that applicant submitted a certification qualifying the applicant for the 180-day exclusivity period. 

VI) Expiration of all patents. All of the patents as to which the applicant submitted a certification qualifying it for the 180-day exclusivity period have expired. 

As presented in Table 2, many of these early biotechnology products have reached the end of their period of patent exclusivity [4-9], Thus, it is appropriate to now consider the next steps in the life cycle of these products as potential generic drugs. 

For Generic Companies The act provided access to certain innovator information without the threat of legal action via patent infringement suits (safe harbor provisions), allowing generics the opportunity to prepare for market introduction prior to the expiration of patent/exclusivity terms. This effectively limited the period of innovator exclusivity to the statutory timelines. 

The relevant data exclusivity periods for each approved drug product, as well as any applicable patents on the product or its use, are listed in the Orange Book , which is published by the FDA and also available electronically on the FDA s web site. 

Companies use the terms of the provision to extend the effective exclusivity period by managing the introduction of new dosage forms to coincide with the expiration of the patent on earlier generations of the compound. Physicians almost always prefer extended-release dosage forms because they increase patients adherence to the prescription. Increasing company incentives to develop products with these benefits is the rationale for the 3-year exclusivity provision in... 

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