REGENTS OF THE UNIVERSITY OF MINNESOTA V. GILEAD SCIENCES, INC. Before Lourie, Dyk, and Stoll. Appeal from the Patent Trial and Appeal Board. Summary: For drug patents, adequate written description of a broad genus...more
What You Need to Know About Kidney Damage and Bone Loss Claims - For individuals who either live with or are at risk of contracting HIV, a medication that provides both (partial) treatment of HIV symptoms and pre-exposure...more
In Washington: After several consecutive days of talks between House Speaker Nancy Pelosi (D-CA) and Treasury Secretary Steven Mnuchin it appears increasingly likely that Congress will have to wait to consider any COVID-19...more
In Washington - Senate Majority Leader Mitch McConnell (R-KY) and Republicans released the text of their “skinny” or “targeted” coronavirus relief bill. McConnell said a vote to proceed to the bill is expected Thursday....more
In Washington: The House is set to vote on the two high-profile policy issues before leaving town for the two-week July 4 recess, however, neither of the measures is likely to be taken up in the GOP-controlled Senate,...more
On November 6, 2019, the bonds between the U.S. government and pharmaceutical companies were stretched when the U.S. Department of Health and Human Services (“HHS”) filed a patent infringement lawsuit against Gilead Sciences...more
When Big Pharma insists its sky-high prices are justified, patients may want to keep in mind key findings just revealed about prescription drugs and their makers...more
An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more
Case Name: Idenix Pharms. LLC v. Gilead Sciences, Inc., Civ. No. 14-846, 2018 U.S. Dist. LEXIS 25663 (D. Del. Feb. 16, 2018) (Stark, J.)....more
Gilead prevails in SOVALDI appeal - The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). In the trial decision, as previously reported, the...more
Last year in Universal Health Services, Inc. v. United States ex rel. Escobar et al. the Supreme Court reminded litigants that the False Claims Act “is not an all-purpose antifraud statute.” In that case, the Court expanded...more
On July 7, 2017, the Ninth Circuit Court of Appeals issued an opinion in United States ex rel. Campie v. Gilead Sciences, Inc., holding that violations of Food and Drug Administration (FDA) regulations could create liability...more
On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that...more
Charitable organizations can easily become enmeshed in Justice Department enforcement issues. We have seen charities used in FCPA cases as a means to funnel bribes to government officials, spouses or family members....more
Those working in the pharmaceutical space are used to hearing complaints about the high costs of drugs, and patents often are blamed for allowing pharmaceutical companies to charge “too much” for their products. But are drug...more
The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more
Last week, in a letter addressed to the Secretary of the U.S. Department of Veteran Affairs, Senator Bernard Sanders (I-VT) urged Secretary Robert McDonald to use his authority as Secretary "to break the patents on Hepatitis...more
The battle over the rising costs of drugs, fueled by Gilead’s Hepatitis C drug Sovaldi that costs $84,000 for a 12 week treatment regimen, intensified this week. Critics of the cost have taken to referring to the drug as the...more
Gilead Sciences, Inc. (Gilead) owns United States Patent No. 5,763,483 and United States Patent No. 5,952,375. The patents feature common inventors and disclose similar material in the field of anti-viral compounds. Natco...more