P sued D for infringement of the '552 patent. The invention is a prosthetic device called a 'transcatheter heart valve.' The valve is mounted on a stent and implanted in the heart by catheter, thereby avoiding open-heart surgery and its associated risks. The trial was to a jury, and the verdict was that the '552 patent is valid, that D's infringement was willful. The jury awarded damages of $72,645,555 in lost profits and $1,284,861 as a reasonable royalty. P requested entry of an injunction against future infringement and cited several equitable considerations, including the importance of establishing customer relationships, and the fact that D, a large medical device manufacturer, could overwhelm the much smaller P. The court denied an injunction. The district court responded to P's argument that without exclusivity it would lose first-mover advantage and market share and reputation, by stating that these had already been lost - although P states that this is incorrect, for sales in the United States had not yet been authorized by the FDA, as to either P or D's product. The district court also stated that Edwards had given up exclusivity by licensing the '552 patent to another competitor. The court placed significant weight on D's statements that it was immediately moving this manufacturing operation to Mexico, and thus that infringement would terminate. The court also stated that P can always bring another suit against D if D should renew its manufacturing in the U.S. Both parties appealed. P states on appeal that D never stopped its infringing manufacture in California and that P never licensed to a competitor.