shutterstock_1569359980_sundry-photography
shutterstock_1569359980_Sundry Photography
18 May 2023Big PharmaMuireann Bolger

US govt seeks new trial in Gilead HIV drug patent case

The government lost its high stakes and unusual royalties dispute with the big pharma firm | New status report claims that the court should have allowed the jury to take four inter partes petitions into account.

The US government is attempting to secure a new trial in its royalties dispute with  Gilead Sciences, marking the latest twist in the high-profile case concerning a HIV prevention drug.

Earlier this month, a Delaware jury handed a win to Gilead in its unusual lawsuit, resulting in the firm avoiding a potential billion-dollar payout over HIV drugs  Truvada and  Descovy.

The government argued that it was owed up to $691 million in damages from Truvada sales and $311 million from Descovy.

But after a five-day trial, the jury in Delaware found that Gilead had not infringed the trio of patents in the dispute—US patent numbers 9,579,333 and 9,937,191 and 10,335,423. All three were found to be invalid as anticipated and obvious, and the ‘423 was additionally held to be invalid as not enabled.

Bid for renewed motion

According to a joint status report filed on May 16 at the US District Court for the District of Delaware, the government wants a renewed motion for judgments on the infringement and validity issues at the heart of the feud.

The case emerged in 2019, when the US government sued the drugmaker in a development thought to be the first time the government has filed a patent infringement case against a company.

Gilead countered by filing its own lawsuit against the US in 2020, on the grounds of breached research agreements—a case that the California-based drugmaker also won.

The case centres on research carried out between Gilead and the government agency, the  Centers for Disease Control and Prevention (CDC), into methods for preventing HIV infection known as pre-exposure prophylaxis, or PrEP. This involved testing whether Truvada could prevent infection by the virus as well as treating it.

‘Exaggeration’ of role

After gaining patents for the treatments, the government accused Gilead of “exaggerating”  its role in developing PrEP and refused to license the patents.

In August 2019, Gilead asked the US Patent and Trademark Office (USPTO)  to review the patents granted to the government.

The joint order filed this week outlines that the government’s motion for a new trial will cite issues of induced infringement, damages, the court’s exclusion of evidence from the jury trial regarding Gilead’s four inter partes petitions, as well as the court’s failure to exclude from the jury trial evidence related to transfer agreements and their IP provisions.

Gilead has said in the joint status report that it does not intend to pursue any further relief beyond denial of the government’s motions.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk


More on this story

Big Pharma
4 July 2023   Verdict confirms legality of 2014 patent settlement, dismissing allegations of anti competitive practices.
Big Pharma
23 February 2023   Gilead, Johnson & Johnson and others will face trial in May | Class-action suit involves allegations of anticompetitive practices.
Americas
16 January 2020   Gilead and its alleged co-conspirators Bristol-Myers Squibb, Japan Tobacco, and Johnson & Johnson have been accused of engaging in a long-running scheme to suppress competition in the market for HIV prevention therapies.

More on this story

Big Pharma
4 July 2023   Verdict confirms legality of 2014 patent settlement, dismissing allegations of anti competitive practices.
Big Pharma
23 February 2023   Gilead, Johnson & Johnson and others will face trial in May | Class-action suit involves allegations of anticompetitive practices.
Americas
16 January 2020   Gilead and its alleged co-conspirators Bristol-Myers Squibb, Japan Tobacco, and Johnson & Johnson have been accused of engaging in a long-running scheme to suppress competition in the market for HIV prevention therapies.

More on this story

Big Pharma
4 July 2023   Verdict confirms legality of 2014 patent settlement, dismissing allegations of anti competitive practices.
Big Pharma
23 February 2023   Gilead, Johnson & Johnson and others will face trial in May | Class-action suit involves allegations of anticompetitive practices.
Americas
16 January 2020   Gilead and its alleged co-conspirators Bristol-Myers Squibb, Japan Tobacco, and Johnson & Johnson have been accused of engaging in a long-running scheme to suppress competition in the market for HIV prevention therapies.