Merck Prevails in Patent Term Extension Case at Federal Circuit
by Aaron F. Barkoff
Orange Book Blog
The U.S. Court of Appeals for the Federal Circuit held today that a patent term extension under 35 USC 156 may be applied to a patent subject to a terminal disclaimer under 35 USC 253, handing a victory to Merck (MRK) in its battle with Hi-Tech Pharmacal over generic Trusopt (dorzolamide HCl opthalmic solution).
Section 156 was enacted as part of the Hatch-Waxman Act in 1984 to allow restoration of part of a pharmaceutical patent's term "lost" due to lengthy FDA review of a new drug application. Section 253, on the other hand, applies to all kinds of patent applications--not only those relating to pharmaceuticals--and allows the filing of a terminal disclaimer to overcome "obviousness-type double patenting" rejections made by the Patent Office.
As we reported last month, a loss for Merck in this case would have had far-reaching effects on pharmaceutical companies and patent owners, since the Patent Office has routinely granted patent term extensions on patents that are subject to a terminal disclaimer. Brand-name drug companies would have lost years of patent protection on some of their best-selling drugs if the Federal Circuit had decided that a terminal disclaimer precludes a patent term extension.
In reaching its decision today, the Federal Circuit properly recognized that "the language of Section 156 is unambiguous and fulfills a purpose unrelated to and not in conflict with that of Section 253."
Source: OrangeBookBlog.com
RELATED READING:
- MarketWatch.com
- Merck Pressured to Halt Gardasil Vaccine Lobbying
- Merck Wants Out of Pfizer's Shadow
- Merck Putting Vioxx Behind It
- Merck Looking To Become RNAi Technology Leader
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Orange Book Blog
The U.S. Court of Appeals for the Federal Circuit held today that a patent term extension under 35 USC 156 may be applied to a patent subject to a terminal disclaimer under 35 USC 253, handing a victory to Merck (MRK) in its battle with Hi-Tech Pharmacal over generic Trusopt (dorzolamide HCl opthalmic solution).
Section 156 was enacted as part of the Hatch-Waxman Act in 1984 to allow restoration of part of a pharmaceutical patent's term "lost" due to lengthy FDA review of a new drug application. Section 253, on the other hand, applies to all kinds of patent applications--not only those relating to pharmaceuticals--and allows the filing of a terminal disclaimer to overcome "obviousness-type double patenting" rejections made by the Patent Office.
As we reported last month, a loss for Merck in this case would have had far-reaching effects on pharmaceutical companies and patent owners, since the Patent Office has routinely granted patent term extensions on patents that are subject to a terminal disclaimer. Brand-name drug companies would have lost years of patent protection on some of their best-selling drugs if the Federal Circuit had decided that a terminal disclaimer precludes a patent term extension.
In reaching its decision today, the Federal Circuit properly recognized that "the language of Section 156 is unambiguous and fulfills a purpose unrelated to and not in conflict with that of Section 253."
Source: OrangeBookBlog.com
RELATED READING:
- MarketWatch.com
- Merck Pressured to Halt Gardasil Vaccine Lobbying
- Merck Wants Out of Pfizer's Shadow
- Merck Putting Vioxx Behind It
- Merck Looking To Become RNAi Technology Leader
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posted by Nico at
9:44 PM
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