Under United States law, patent protection allows a patent holder the right to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States. Protection typically lasts 20 years, beginning on the date the patent issues and ending twenty years from the filing date of the application.
In certain situations, a patent term may be reduced to be coterminal with a related patent (as in the case of the ‘233 patent), while in other cases the term may be extended to account for delays caused by the PTO during the patent prosecution process.1 This type of patent extension is often referred to as a patent term adjustment. Patent term may also be extended under the Drug Price Competition and Patent Term Restoration Act (commonly known as the Hatch-Waxman Act), because of the time it takes to obtain government premarket approval—such as during FDA review of a new drug or medical device.2
Congress passed the Hatch-Waxman Act in 1984. The patent term restoration portion of this act was designed to compensate patent holders for regulatory delays by creating new incentives for research and development of products subject to government approval. In particular, owners of patents covering certain drugs, medical devices, and food additives may restore to the terms of those patents time lost while awaiting premarket government regulatory approval.
Since inception of the Hatch-Waxman Act, approximately 500 patents have been granted a patent term extension.3 Extensions can range from a few months up to five years, the maximum extension permitted under the law. Thus, for a market dominant product, a patent term extension, even of short duration, can be extremely valuable. The extension allows a patent holder to continue to block competition beyond the normal 20 year monopoly of the patent, thereby potentially gaining millions of dollars in sales revenue for the patent holder.
The majority of patent term extensions are granted for patents covering drugs, including blockbusters such as Viagra, Lipitor, Prozac, and Claritin. Very few have been granted for patents covering medical devices (i.e., less than about 10%).3 Some of these extensions were for devices such as intraocular lenses, orthopedic devices, and cardiac devices—including defibrillators, heart valves, filters, and stents. As medical devices and drugs merge together in combination products, the line between pure drug and pure device blurs, and it is this gray area in which the request of Abbott Cardiovascular Systems for patent term extension falls.
1. 35 USC sect. 154 (2006).
2. Pub. L. No. 98-417 codified at 35 USC sect. 156.
3. “Patent Terms Extended under 35 USC sect. 156” [online] (Washington, DC: U.S. Patent and Trademark Office, 2008 [cited 21 October 2008]); available from Internet: www.uspto.gov/web/offices/pac/dapp/opla/term/156.html.
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