Written Description: A License To Hunt Or A Wild Goose Chase?

Order Denying Gilead's Motion for Summary Judgment and Granting Merck's Motion for Summary Judgment, Gilead Sciences, Inc. v. Merck & Co., Inc. et al., Case No. 5:13-cv-04057 (Judge Beth Freeman)

Gilead sued Merck on August 30, 2013, seeking a declaratory judgment that Gilead's drugs Sovaldi and Harvoni, do not infringe Merck's U.S. Patent Nos. 7,105,499 ("the '499 Patent") and 8,481,712 ("the '712 Patent"). Sovaldi and Harvoni are the brand names of sofosbuvir, an RNA polymerase inhibitor used to treat Hepatitis C therapeutically. The patents-in-suit claim a Hepatitis C treatment using sofosbuvir, and the question raised by Gilead's motion for summary judgment was whether the patents-in-suit provided adequate written description to practice the claimed methods as of the 2002 filing date of the patents.

In moving for summary judgment, Gilead relied on the seminal Supreme Court decision, Brenner v. Mason, 383 U.S. 519, 536 (1966), which famously stated, "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion." For the purposes of the Section 112 written description analysis, the patent specifications (which are not identical) were treated the same way.

Under Brenner's guidance, Gilead argued that a person having ordinary skill in the art (PHOSITA) would not have had understood the practical utility of Merck's patent because, when Merck filed the first of the patents in 2002, using nucleosides to treat the Hepatitis C virus (HCV) was a newly developing practice for which there was a lack of reliable data. Gilead explained, "the activity of nucleoside derivatives against HCV was, and is, an unpredictable field in which small changes to a molecule can cause large changes...