Recent Posts
- Hikma v. Vanda: Oral Argument Recap
- Teva v. Lilly should not be read as creating a new 112 rule for method of use claims
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- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: Patent Term Extension
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Somerset Pharmaceuticals v. Dudas, No. 2007-1447 (Fed. Cir. 2007) The Federal Circuit decided an unusual case yesterday respecting Somerset Pharmaceuticals’ application for an interim patent term extension for U.S. Reissue Patent No. RE 34,579. The ‘579 patent covers a method of treating depression using Emsam, a transdermal patch that includes selegiline as the active ingredient.…
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Merck & Co. v. Hi-Tech Pharmacal, No. 06-1401 (Fed. Cir. 2007) 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 that is subject to a terminal disclaimer under 35 USC 253, handing a victory to Merck in its…
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It has always been assumed the answer is "yes." Now the Federal Circuit will answer the question directly in Merck v. Hi-Tech Pharma., which concerns Hi-Tech’s ANDAs for generic versions of Merck’s Trusopt and Cosopt prescription eye drops. The case was argued in December and a decision could come at any time. Merck owns U.S.…
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After a Massachusetts drug company missed–by a single day–a non-extendable deadline for filing for a patent term extension, H.R. 5120 was recently proposed in the U.S. House of Representatives to amend 35 U.S.C. 156, the statute governing patent term extensions based on regulatory review delay. Some people are calling H.R. 5120 the "Dog Ate My…
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