Tag: pharmaceutical

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K&L Gates releases 2017/18 Patents Year in Review – Second Edition
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Federal Circuit Holds That an Offer to Sell a Drug Product Was a Patent-Invalidating Offer for Sale under Pre-AIA § 102(b) Even Though the Offer Lacked “Safety and Liability Terms”

K&L Gates releases 2017/18 Patents Year in Review – Second Edition

2017/18 was an intriguing 12 months in the Australian patent landscape, with Courts being called upon to deliver decisions in relation to a number of issues that have not previously been judicially considered. The judgments delivered in this period have dealt with the patentability of methods claims deploying genetic information, patent term extensions for “Swiss-style” claims and whether applying to list a product on the Pharmaceutical Benefits Scheme constitutes an act of patent infringement.

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Federal Circuit Holds That an Offer to Sell a Drug Product Was a Patent-Invalidating Offer for Sale under Pre-AIA § 102(b) Even Though the Offer Lacked “Safety and Liability Terms”

On May 13, 2016, the Federal Circuit determined that Merck’s crystalline calcium salt of tetrahydrofolic acid (“MTHF”) had been the subject of a commercial offer for sale, and held Merck’s MTHF claim in U.S. Patent No. 6,441,168 is invalid under the on-sale bar provision of pre-AIA § 102(b).  Specifically, the Federal Circuit held that Merck made an invalidating offer to sell MTHF when it sent a fax that included price, quantity, and delivery terms, and rejected the district court’s determination that additional, industry standard “safety and liability terms” were required for there to have been an “offer for sale.”

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Trevor M. Gates, Theodore J. Angelis, Peter Giunta

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