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 in biological activity or toxicity,” and thus a PHOSITA in 2002 would have questioned the methods and compounds claimed in Merck’s patents and required additional disclosure to confirm that they were indeed reliable.

Merck responded that a PHOSITA would have found the methods and compounds in its patents adequate because the FDA had approved at least 17 nucleoside analogs for treating viral infections by 2002, including HCV, suggesting that nucleoside production was well understood.

At the December hearing on the motions for summary judgment (Merck also moved for summary judgment of infringement), Judge Freeman reportedly told counsel for Gilead, “I think you’re giving me a strong case.,” while previewing that she still was “not sure it’s strong enough to succeed” on summary judgment.

Ultimately, the court concluded that Merck presented sufficient evidence to create a genuine issue of material fact as to whether a PHOSITA would have “accept[ed] the allegations [in the asserted patents] as obviously correct.”  Judge Freeman accordingly denied Gilead’s motion for summary judgment.  Given that the claims of the Merck patents are directed to sofosbuvir, Merck also won its uncontested summary judgment motion on infringement.