And. . . Just For General Background -- The Original 2013 Gilead Sovaldi® Patent Complaint

I'll not comment on Gilead's narrative below, in any more detail at this point. [Do remember Merck would tell a rather differing account. In fact it has. That post, tomorrow, time permitting.] Here it is -- a PDF file. [Recall that this suit was filed before Gilead had an FDA approved drug -- and that Gilead acquired these patent rights from Pharmasset.]

In general, just see my other posts about this next gen Hep C patent spat -- by searching the term "Idenix", here. From the PDF, then -- some background, according to Gilead:

. . . .Traditionally, chronic HCV infection has been treated with a combination of antiviral medicines—ribavirin, interferons, and, more recently, protease inhibitors. In addition to relatively limited efficacy, these available treatments have frequent and, at times, permanent side effects including flu-like symptoms, serious hemolytic anemia, worsening of cardiac disease, weight loss, skin rashes, hair loss, muscle or bone pain, diarrhea, and vomiting. Moreover, these treatments must be taken for prolonged periods—24 to 48 weeks—thereby exacerbating the physical and emotional toll on the infected individuals and their families, which can lead to patient discontinuation of treatment. While liver transplantation can be life-saving for HCV-infected individuals in end-stage liver disease, transplantation presents significant risks and is not a readily available option for patients due to donor shortages and potential organ rejection. Even when available, transplantation is costly and requires ongoing post-procedure care, and for HCVpositive transplant recipients, reinfection is almost universal.

Gilead has developed a new, orally administered prescription drug for treatment of chronic HCV infection called sofosbuvir that shortens HCV therapy to no more than 12 to 16 weeks. Invented by Pharmasset, sofosbuvir is a nucleotide analogue NS5B polymerase inhibitor for the treatment of chronic HCV infection. Ultimately, it combats the disease by suppressing the replication of viral RNA and directly interfering with the HCV life cycle.

Sofosbuvir is an all-oral treatment that sets a new standard of care for treating chronic HCV infection. Because of this, sofosbuvir [is] a revolution in hepatitis C treatment. . . . the Sofosbuvir NDA drug product. . . compete[s] against Merck’s Victrelis^® product in the HCV market. . . .

On information and belief, during prosecution of the ’499 patent, Merck amended its pending claims in an attempt to cover compounds useful for treating HCV infection and/or methods of treating HCV infection that were the subject of pending Pharmasset patent applications so as to obtain patent rights to attempt to exclude Pharmasset from the market or extract royalty payments in relation to potential future Pharmasset products. . . .

On information and belief, during prosecution of the ’712 patent, Merck became aware of compounds in Pharmasset’s pipeline, including PSI-7977, that were experimental treatments for HCV infection. . . .

On information and belief, during prosecution of the ’712 patent, Merck amended its pending claims in an attempt to cover compounds related to PSI-7977 so as to obtain patent rights to attempt to exclude from the market or extract royalty payments for sofosbuvir. . . .

Word -- to Whitehouse Station: Keep calm. And. Carry on.

I will say that a running 10 per cent royalty on all Sovaldi^® sales is a pretty. . . outsized. . . demand, on these facts.