We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico. The latest version of our chart can be dowloaded here. As with the laws we’ve seen before, both the Iowa and Montana biosimilar amendments mirror the state’s existing generic drug substitution laws. More specifically, they amend state pharmacy laws to allow, and in some situations require, the substitution of interchangeable biosimilars. Iowa Substitution Law Is a Bit Different, but Fundamental Challenges Remain Interestingly, the Iowa law is the first law we’ve seen to make a distinction between Medicaid and non-Medicaid patients for purposes of a biosimilar substitution. The law requires pharmacists to substitute an interchangeable biosimilar for Medicaid patients, but provides pharmacists with discretion for non-Medicaid patients. … [Read more...] about New State Substitution Laws, and a Busy Spring for Biosimilars
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POLITICS 05/18/2018 05:45 am ET All 216 things. By Ashley Feinberg The Senate Judiciary Committee on Wednesday released more than 2,500 pages of documents from its inquiry into the now-infamous Trump Tower meeting on June 9, 2016. One of the bigger, more troubling revelations from that release is the fact that, at least by the evidence of his five hours of interviews, Donald Trump Jr. seems to have lived his entire adult life in a coma. How else to explain all the things Don Jr. does not know about his business or even his own daily life? According to his testimony, he doesn’t know his own home phone number. He doesn’t know who at his company does background checks. Was he the guy passing along certain well wishes to his father? “I don’t know that I was ever the person,” he said. The fact that he manages to go even a day without getting both feet stuck in paint cans and falling down a well should be applauded. … [Read more...] about A Comprehensive List Of Everything Don Jr. Doesn’t Know About That Infamous Meeting
The human senses have the powerful ability to trigger memories and help retain information. The tune of “Twinkle, Twinkle, Little Star” helps millions of kids learn the alphabet every year, and even adults retain that tune when they have to recite the ABCs. The smell of freshly baked cookies can transport us back to memories of youth helping bake in grandma’s kitchen.Is it possible to harness these powerful sensory triggers to promote a company’s brand? The answer is yes!The Lanham Act defines “trademark” in broad terms. Under Lanham Act § 45, 15 U.S.C. § 1127, a trademark is “any word, name, symbol, or device, or any combination thereof” used to “identify and distinguish [a person’s] goods, including a unique product, from those manufactured or sold by others and to indicate the source of the goods.”Under this broad definition, a trademark can be anything that can be detected … [Read more...] about Embracing Nontraditional Trademarks: Expand Your Brand Through All the Senses!
On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral arguments on the last day of the Court’s October 2016 Term. With respect to both of the significant issues presented, the Justices unanimously reversed the Federal Circuit Court of Appeals split opinion and remanded for further consideration of questions related to State law.Although our intellectual property colleagues have separately analyzed the “Patent Dance” implications of the Court’s decision in Amgen v. Sandoz (see here), the second issue presented in the case related to the proper interpretation of the 180-day notice provision of the Biologics Price Competition and Innovation Act (“BPCIA”). The Federal Circuit had held that such notice by the biosimilar applicant can only … [Read more...] about SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs
On November 18, 2014, the U.S. Government Accountability Office (“GAO”) published its Annual Report to Congress (B-158766, November 18, 2014), which contains the statistics for bid protests filed at GAO in FY 2014. Frankly, it’s a mixed bag – protests are up, sustained protests are down, but the overall “effectiveness rate” (where the agency grants some type of remedy or corrective action for a protestor) remains flat. Because there are many who think that the bid protest process is broken, it might be worth a closer look at some of the statistics to see if bid protests are being abused (as some in Government might claim) or if the process is working.Here are the statistics taken from the report (along with those for FYs 2010-2013): FY 2014FY 2013FY 2012FY 2011FY 2010 Cases Filed2,561(up 5%)2,429(down 2%)2,475(up 5%)2,353(up 2%)2,299(up 16%) Cases Closed2,4582,5382,4952,2922,226 Merit (Sustain + Deny) … [Read more...] about Protests Up & Sustains Down – A Brief Review of GAO’s FY 2014 Bid Protest Stats