Slugfest Over Hep C Drug Gets Its Day in Court

     SAN JOSE, Calif. (CN) – The patent battle between two titans of the pharmaceutical industry vying for proprietary interest in a revolutionary hepatitis C drug therapy kicked off with opening statements on Monday.
     Gilead Sciences sued its competitor Merck & Co. in 2013, in quest of a ruling that it did not infringe Merck patents when it brought the drugs Solvaldi and Harvoni to market in recent years.
     The medicine underlying these pharmaceutical brands is sofosbuvir, a chemical compound called a nucleotide that prevents the hepatitis C virus from replicating in the human liver.
     Hepatitis C can end in death as the virus attacks cells in the liver, eventually causing scarring or cirrhosis, liver cancer or liver failure. Previous treatments have proven only partially effective, with cure rates hovering at 50 percent, and also take several months accompanied by significant side effects.
     Sofosbuvir provides a higher cure rate more quickly while producing far less adverse side effects.
     At issue between the two companies are two patents taken out by Merck, one dubbed the ‘499 patent issued in 2006 and the second called the ‘712 patent issued in 2013.
     Merck claims these patents represent it staking a claim over a certain class of nucleotides that could potentially prove effective at treating hepatitis C due to their fundamental composition.
     “That class of compounds had never been found before,” Merck attorney Bruce Genderson said. “Merck found them and claimed them in a patent application.”
     Merck further contends that Gilead’s supposed breakthrough actually came from this class of compounds and owes Merck a royalty for using its discovery.
     Gilead contends the asserted patents do not include the particular breakthrough that eventually became sofosbuvir. Instead, they say the discovery was made by a scientist working for Pharmasset, a small company Gilead acquired for $11 billion in 2011 for the express purpose of bringing the medicine to market.
     Gilead’s lawyers argued that Merck never truly thought Pharmasset was infringing its intellectually property, since Merck had attempted to buy the small company itself.
     “Why would you try and buy something you believe you already own?” Juanita Brooks, attorney for Gilead, asked the jury.
     Instead, Brooks argued Merck is trying to retroactively claim Gilead’s invention as its own.
     Interestingly, Gilead brought the original suit asking the courts to settle the patents at issue. Merck then filed a counterclaim, asking for damages for what it claims is an infringement of its intellectual property.
     In Gilead’s 2013 complaint, the company claims it proactively filed suit because Merck requested Gilead take out licenses on the two patents in the case at a 10 percent royalty.
     “A 10 percent royalty on products containing sofosbuvir is a prohibitive demand,” the complaint says. “On information and belief, Merck understands that its license demand is prohibitive and instead is meant to threaten Gilead, on the eve of approval of sofosbuvir, with the prospect of an infringement suit and a substantial claim for damages.”
     Merck said it was forced to counterclaim for royalties because of the lawsuit and the company’s request for royalties was and remains reasonable.
     “Merck will vigorously defend its intellectual property rights at trial,” Merck representative Lainie Keller said in a statement emailed to Courthouse News on Monday afternoon. “The compounds and methods at issue in this case facilitated significant advances in the treatment of individuals with hepatitis C and were appropriately granted patent protection. Achieving these advancements required many years of research and significant investment by Merck and its partners.”
     Gilead continues to assert Merck’s patents are irrelevant to their particular drug.
     “We strongly believe that Merck’s patents on sofosbuvir are invalid and we will continue to take measures to protect sofosbuvir’s intellectual property,” Michelle Rest, director of public affairs for Gilead Sciences, said in a statement emailed to Courthouse News on Monday afternoon.

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