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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A Comprehensive List Of Everything Don Jr. Doesn’t Know About That Infamous Meeting
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
SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs
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
Mixing Things Up: Let’s Talk Recipes, Part Two of a Four-Part Series (Patent)
Discussions about protecting intellectual property often focus on cutting-edge technologies, corporate branding campaigns, and widely distributed artistic works like movies and music. But let’s mix things up a bit. Follow us through this four-part series as we answer a question that is sure to hit home for anyone with taste buds—can you protect a food recipe? In Part 1, here, we examined whether food recipes are eligible for copyright protection. We concluded that, although a recipe itself is not eligible, you can claim copyrights in certain commentary, illustrations, or other expressive elements used to present the recipe. Here, in Part 2, we investigate whether patent protection offers a viable solution for chefs, bakers, restaurateurs, and others hoping to safeguard their culinary creations. Later, in Parts 3 and 4, we will break down whether recipes are eligible for trade secret protection (Part 3) or trademark/trade dress protection (Part … [Read more...] about Mixing Things Up: Let’s Talk Recipes, Part Two of a Four-Part Series (Patent)