On May 9, 2023, a Delaware federal jury ruled in favor of Gilead in a first-of-its-kind lawsuit filed by the United States. Filed in 2019, the US Health and Human Services Department sued the biopharmaceutical company in assertion of the government's patent rights. The federal government alleged that Gilead's drugs Truvada and Descovy infringed upon patents for pre-exposure prophylaxis (PrEP), a drug regimen developed decades earlier by the Centers for Disease Control and Prevention (CDC) as a means of preventing HIV infections, to the tune of billions of dollars. The US asserted it had received no royalties and was seeking $1 billion from Gilead. Intellectual Property partner Steve Moore told Bloomberg Law that the lawsuit was "very novel and disconcerting to the industry," adding "if I was in-house again I'd be pretty worried about, 'Should we continue to keep working with the government?'" While the outcome was favorable to Gilead, the filing itself no doubt struck fear into the hearts of many organizations willing to collaborate with the federal government. Discussing the case with The Global Legal Post, Steve suggested that similar cases in the future could seriously impact the inclination of companies to work alongside government agencies and that "this would not benefit the public."
Ultimately, the jury invalidated the federal government's three patents in question and also determined that Gilead's drugs would not have infringed upon those patents regardless of their validity. Steve told BioWorld that he was unsurprised by the verdict: "I don't think it was a great case for them [the government] to be doing this. But they did it." He also pointed to a lesson for the government in the jury's decision: Agencies shouldn't file patents on drugs owned by a company they're working with and then not tell the company about the patent filing for years while they continue the collaboration.
Steve provided his thoughts on the case to The Global Legal Post: "The long period of time over which Gilead dealt with the government in respect of the dispute without backing away from any of their positions, its earlier win at the Court of Federal Claims on contract claims, the manner in which the provisional patent applications were filed and belatedly disclosed to Gilead, as well as the large number of counsel that Gilead employed at trial in the dispute, all suggested that Gilead had a very strong case."
Steve said that while he didn't expect the jury verdict to be upended by the district court judge, the federal government is likely to appeal the adverse ruling. "From what I have seen, I believe the verdict will ultimately be upheld at the appellate level."
"If this case teaches the government a lesson," he continued, "it is to only bring cases wherein the background of the case indicates that the government agency was completely squeaky-clean in its dealings with the company that collaborated with it. Just because certain public forces push for a case, does not mean it should be taken irrespective of the factual background."
You can read more at the following links. Please note that a subscription may be required:
- 'Gilead prevails against US government in billion-dollar patent trial,' The Global Legal Post - May 11, 2023, quoted
- 'Jury: Gilead not on the hook for $1B in PrEP royalties,' BioWorld - May 9, 2023, quoted
- 'Gilead Beats US in Billion-Dollar Trial on Anti-HIV Patents,' Bloomberg Law - May 9, 2023, quoted
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