Posts Tagged: "Gilead"

CAFC Says University of Minnesota Patent Fails Written Description Test

In a precedential decision published Monday, the United States Court of Appeals for the Federal Circuit (CAFC) affirmed the Patent Trial and Appeal Board’s (PTAB) decision to invalidate a pharmaceutical patent owned by the University of Minnesota. Gilead Sciences filed an inter partes review (IPR) in 2017 challenging the claims of the university’s  U.S. Patent 8,815,830 as unpatentable. The ‘830 patent covers chemical compounds that prevent the reproduction of viruses or the growth of cancerous tumors. The PTAB found that the University of Minnesota failed to provide a sufficient written description that supported the patent’s priority claim. The Board thus concluded that the patent would not guide a skilled artisan to the patent’s claims. The CAFC agreed with the PTAB’s decision and with the ruling that a 2010 patent application publication filed by Gilead was “prior art” over the university’s patent.

Unsealed Court Documents Reveal Scale of Counterfeit Gilead HIV Drugs Scam

The U.S. District Court for the Eastern District of New York unsealed multiple documents last week that named the kingpins behind an alleged counterfeit HIV medication conspiracy. An unsealed amended complaint filed in late September names the two alleged kingpins as Lazaro Roberto Hernandez and Armando Herrera, both of Florida. The two “kingpin defendants” are accused of being “at the head of the conspiracy” and “career criminals who organized the conspiracy and controlled the flow of the counterfeits, all while operating from the shadows and using extensive measures to conceal their identities.” Hernandez was identified by basic geolocation data associated with burner phones used to communicate details about the conspiracy.

EPO Opposition Division Upholds NuCana Patent on Gilead’s Sovaldi, Highlighting Potential Flaws of CAFC Ruling in Gilead/Idenix

On April 7, 2021, the European Patent Office (EPO) Opposition Division (OD) issued a comprehensive written decision in the Opposition by Gilead Sciences, Inc. against NuCana plc’s European Patent No. B-2 955 190, upholding amended compound claims that include Gilead’s blockbuster hepatitis C drug, Sovaldi (sofosbuvir). The claims were upheld over various arguments made by Gilead, including an assertion that the NuCana patent did not teach the skilled worker how to make the nucleoside component of Sovaldi (which is a nucleotide phosphoramidate). Gilead alleged, as it did in the myriad of global Idenix litigation cases, that a skilled person in 2003 who tried to make the nucleoside of Sovaldi “would be required to undertake extensive experimentation, if indeed he would be able to succeed at all. This represented an undue burden.”

Property Rights and State AGs’ Assault on Remdesivir: A Conservative Perspective

By now, everyone in the IP arena has heard about the demands of more than 30 state and territorial attorneys general (AGs) regarding the promising COVID treatment remdesivir. These AGs seem to disrespect the exclusive rights of limited duration that patents afford. California Attorney General Xavier Becerra (D) and Louisiana Attorney General Jeff Landry (R) led a bipartisan effort getting colleagues to write the U.S. Department of Health and Human Services and call for what’s tantamount to eminent domain on intellectual property. To a conservative who works on IP matters, this demand in and of itself is troubling. Bedrock conservative principles include property rights, free enterprise and the rule of law. The AGs advocate government’s abrogation of all three of these foundational principles.

No, You Can’t March in On Remdesivir

One thing you should never say in 2020 is: “Well, at least things can’t get any worse.” They can and often do. The latest exhibit—in the intellectual property space at least—is a letter to Health and Human Services (HHS) Secretary Azar, National Institutes of Health (NIH) Director Collins and Food and Drug Administration (FDA) Commissioner Hahn authored by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry. It’s also signed by 32 other state attorneys general, along with those representing the District of Columbia, Guam and American Samoa. They are demanding that the government use its authorities under the Bayh-Dole Act to march in against Gilead Sciences, the maker of the COVID-19-fighting drug remdesivir, so that it can be made more widely available at a lower cost.