Patents extensions

Maximum patent extension 15 from first marketing approval 14 from marketing approval... 

Companies would thus be practising cross-subsidies between products under patent and products whose patent has expired, in order to maintain their overall income. Other strategic responses are patent extension, the creation of second brands and subsidiaries of generics and the differentiation of the brand product through marginal innovations and promotion campaigns. 

In Chapter 4 Aidan Hollis examines three proposals in considerable detail. The first is an Advanced Purchase Commitment by sponsors, who offer an explicit subsidy in advance for innovative products. The subsidy offer includes a fixed-dollar amount per unit as well as a commitment to purchase a specific number of units at that price. The second proposal is that sponsors pay annual rewards based on the therapeutic effectiveness of innovative drugs. The third approach is to offer a patent extension on patented products to pharmaceutical companies if they successfully developed a vaccine for a disease such as HIV/AIDS that is highly prevalent, particularly in some low-income countries. Hollis concludes that the third approach is an extremely inefficient way to reward innovation. By contrast, the second approach could correct the market failure directly by rewarding innovative drugs according to their therapeutic effectiveness, which is measurable by cost-effectiveness analysis, a topic discussed later in greater detail in Chapters 10 and 11. 

The Project BioShield II Act of 2005, introduced to the U.S. Senate in April 2005, contains a proposal for so-called Transferable Intellectual Property Rights, in which a firm that developed a vaccine for a disease such as AIDS would obtain a wildcard patent extension that could be applied to a drug of its choice in the United States. The proposal has received the endorsement of the International AIDS Vaccine Initiative, which sees any proposal to increase research into AIDS vaccines positively. This is therefore a proposal that deserves serious scrutiny. 

There are at least three very important flaws in the basic mechanism proposed by Project BioShield II (and Transferable Intellectual Property Rights in general). First, the way the reward for the innovator is financed through a patent extension is inefficient and inequitable. Second, the incentive mechanism is poorly defined, and does not offer a clear methodology to determine how large a reward to pay for a given innovation. Third, the mechanism discriminates against small firms. 

First, then, consider the way that financing is raised for this mechanism. Essentially, Transferable Intellectual Property Rights offer a way of providing an off-the-books financial reward to companies that develop some socially desirable innovation, such as a vaccine for HIV/AIDS. Ignoring the effect on innovation for the moment, consider how this financial reward is obtained. The innovator is rewarded with a wildcard patent extension of, say, two years... 

Patent extension for a useful agent not different from citalopram Patient/Famiiy Education... 

SPC (Supplementary Protection of Certification) Allows for a patent extension of approximately 5 years or longer... 

DELAY OF EFFECTIVE DATE FOR CERTAIN APPLICATION. If the Secretary determines that the acceptance or approval of an application under section 505(b)(2) or 505(j) for a new drug may occur after submission of reports of pediatric studies under this section, which were submitted prior to the expiration of the patent (including any patent extension) or the applicable period under clauses (ii) through (iv) of section 505(c)(3)(D) or clauses (ii) through (iv) of section 505(j)(5)(F), but before the Secretary has determined whether the requirements of subsection (d) have been satisfied, the Secretary shall delay the acceptance or approval under section 505(b)(2) or 505(j) until the determination under subsection (d) is made, but any such delay shall not exceed 90 days. In the event that requirements of this section are satisfied, the applicable six month period under subsection (b) or (c) shall be deemed to have been running during the period of delay. 

Before 1980, in some countries, mainly those that were formerly part of the British Commonwealth, patent extensions were obtainable on petition at the end of the patent life. For a petition to be granted, the patent owner was required to show inability during the normal life of the patent to receive sufficient remuneration from the use of the patented invention. Under this system, patent extensions of 4 to 10 years could be obtained based on the evidence presented. 

The transformation of the anhydrous sodium warfarin, an amorphous substance, into the solvate, which is crystalline, demonstrates the utilization of technology for some commercial advantages. The amorphous sodium warfarin is crystallized from isopropanol to form a clathrate with a molecular ratio of 2 1. This formation was awarded a patent extension because of the material crystallized out of the solution, resulting in purity improvement. " ... 

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