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In an ANDA case, Watson contended that claim 4 of the Merck’s patent was invalid under the on sale bar of Section 102(b).  The district court held that claim 4 was not invalid, because the September 9, 1998 fax from Merck was not sufficiently definite to qualify as a commercial offer, because it did not include “important safety and liability terms.” 

On appeal, the Federal Circuit reversed, because the fax in question contained all of the required elements to qualify as a commercial offer for sale as it had the essential price of the product and the delivery and payment terms.  There were no qualifications to the offer, as even Merck’s employee assured the potential buyer that he would “arrange everything.”  Further, the fact that the actual sale was never consummated was not relevant.  As to the district court’s rationale, the court found that there was no evidence that safety and liability provisions would likely be required in a standard industry offer to sell, rather than an actual sale.  The testimony of witnesses as of the time frame of the lawsuit was further insufficient to overcome the contemporaneous documentary evidence.

Merck & Cie v. Watson Laboratories, Inc., Case Nos. 2015-2063, -2064 (May 13, 2016); Opinion by: Mayer, joined by Dyk and Hughes; Appealed From: United States District Court for the District of Delaware, Andrews, J. Read the full opinion here.

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