Can a drug manufacturer refuse to provide samples of its innovator product under the CREATES Act if it thinks that the requester will not actually use them to develop a biosimilar or generic drug? A recently filed suit in the...more
Enacted in December 2019 as part of the Further Consolidated Appropriations Act of 2020, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (21 USC 355-2) addresses concerns that some brand...more
In late 2019, Congress enacted the “CREATES Act”, which established a private right of action in which generic or biosimilar manufacturers may sue an innovator for an injunction and monetary award for not selling samples of...more
On Friday, July 9, 2021, President Biden released an Executive Order “to promote competition in the American economy” and to “to reduce the trend of corporate consolidation” (the "Order"). As part of this Order, the Biden...more
Innovators in life sciences at companies and universities often collaborate and conduct research under a joint research agreement (JRA). The Cooperative Research and Technology Enhancement Act of 2004 (the “CREATE Act”) was...more
After a turbulent year that roiled the economy, and the health care sector more than most, the Democrats emerged with control of both the White House and Congress for the first time since 2014. Business leaders and in-house...more
The doctrine of obviousness-type double patenting is one of the most complicated and most confounding aspects of U.S. patent law. Although a Terminal Disclaimer can overcome most obviousness-type double patenting rejections,...more
This week, seven top executives from drug manufacturers will testify in a highly anticipated hearing before the Senate Finance Committee. These companies will be questioned regarding rising drug prices, transparency, patent...more
This week, Congress returns to Washington for its lame duck session with uncertain expectations for what gets done between now and the next funding deadline of December 7, 2018. There are a number of legislative items that...more
Welcome to the third week of this four week stretch. This week, the House will continue to vote on a number of proposals to address the opioid crisis. Last week the House passed over 30 bills on opioids, most of which were...more
Welcome back. This week, the Senate Finance Committee will mark up an opioid package. The final text will be important for gauging how close the Senate is to the House package. The House will begin voting on dozens of...more
This week, Congress returns to Washington with 11 days to finalize a government spending bill. House appropriators will be meeting throughout the week to finalize their respective packages which means we should expect to see...more
Congress kicks off this week with three weeks to go before the March 23 omnibus spending deadline. At this point it’s still not entirely clear what will be tacked on to this spending package, but immigration, market...more
Last week, co-sponsors Senators Leahy (D-VT), Grassley (R-IA), Klobucher (D-MN), and Lee (R-UT) introduced a bill (S. 3056), entitled the "Creating and Restoring Equal Access to Equivalent Samples Act of 2016" or the "CREATES...more