Posts Tagged: "hhs"

HHS Denies Appeal of Xtandi March-In Petition as Comments Close on Proposed Framework

One day before comments closed on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, published by the National Institute of Standards & Technology (NIST) and the Department of Commerce last month, the Department of Health and Human Services (HHS) denied an appeal of a decision not to march in on the blockbuster prostate cancer drug, Xtandi®.

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.

Uncle Sam the Patent Troll Sues to Stop Generic HIV Drug

HHS is suing a defendant that merely wants to market a generic version of a drug that is used to treat patients with human immunodeficiency virus (HIV). Not only is the United States government a patent troll, but the government is also trying to deprive patients who need live saving HIV drugs an affordable generic version. Egad!

High Noon for Bayh-Dole

Senate Judiciary Committee Chairman Patrick Leahy (D-VT) asked NIH in a July 12 letter to force compulsory licensing of Myriad’s BRCA breast and ovarian cancer genetic test under the “march-in rights” provision of the Bayh-Dole Act. Myriad received an exclusive license to develop the test from universities operating under Bayh-Dole Act. The law allows nonprofit institutions receiving federal R&D funds to own and license resulting inventions so they can be commercialized for use by the public. Critics of Bayh-Dole have long sought to reinterpret its statutory standards under which the government can compel universities to issue compulsory licenses as a weapon to control prices. This was not the intent of the law.

US, Europe Debate Embryonic Stem Cell Patents and Research

Earlier today the United States Court of Appeals for the District of Columbia vacated the preliminary injunction issued by the United States District Court for the District of Columbia preventing the federal government from funding stem cell research. Meanwhile, the patenting of stem cells is also currently under attack in Europe. According to European Union Advocate General M. Yves Bot, stem cells have the capacity to evolve into a complete human being and, therefore, must be legally classified as human embryos and must be excluded from patentability on moral grounds. But is it really moral not to perform research that many believe could hold promising cures for such diseases as Parkinson’s and Alzheimer’s?

Time for Congress to Fund Embryonic Stem Cell Research

I understand the objections to embryonic stem cell research, but I simply cannot understand anyone that has a moral objection to embryonic stem cell research. How is it moral to watch those with crippling diseases agonize without trying to do everything we possibly can to find cures and treatments? Simply put, there is nothing moral about watching the suffering of another human being and doing nothing.

Minority Report: Task Force on IP & Genetic Testing

Yesterday, the Task Force on IP and Genetic Testing submitted its Final Draft Report (titled Final Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests) to the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS). SACGHS, in turn, voted to accept the recommendations, which will be passed on to Secretary Sebelius,…

HHS Assault on Gene Patents and Diagnostic Methods

UPDATED: 7:19pm on 10/8/2009 Today the Task Force on IP and Genetic Testing submitted its Final Draft Report (titled Final Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests) to the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS). SACGHS, in turn, voted to accept the recommendations, which will be passed…