We don’t yet know how bad the coronavirus outbreak will be in America. But we do know that the virus is likely to have a major impact on Americans’ access to medication. Currently, 80% of the active ingredients found in the drugs Americans take are made in China, and the virus has disrupted China’s ability ... Is it time for a new approach to generic drugs?
A pending case in the U.S. Court of Appeals for the 3rd Circuit has raised several interesting questions about the FTC enforcement approach and patent litigation in the pharmaceutical industry. The case, FTC v. AbbVie, involves allegations that AbbVie (and Besins) filed sham patent infringement cases against generic manufacturer Teva (and Perrigo) for the purpose ... FTC v. AbbVie – Questioning the Agency’s Enforcement Authority
Last week the Senate Judiciary Committee held a hearing, Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition, that explored whether changes to the pharmaceutical patent process could help lower drug prices. The committee’s goal was to evaluate various legislative proposals that might facilitate the entry of cheaper generic drugs, while also ... Balancing competition and innovation in the drug industry: An evaluation of current proposals.
Longtime TOTM blogger, Paul Rubin, has a new book now available for preorder on Amazon. The book’s description reads: In spite of its numerous obvious failures, many presidential candidates and voters are in favor of a socialist system for the United States. Socialism is consistent with our primitive evolved preferences, but not with a modern ... Paul Rubin’s new book: The Capitalism Paradox: How Cooperation Enables Free Market Competition
On March 14, the Federal Circuit will hear oral arguments in the case of BTG International v. Amneal Pharmaceuticals that could dramatically influence the future of duplicative patent litigation in the pharmaceutical industry. The court will determine whether the America Invents Act (AIA) bars patent challengers that succeed in invalidating patents in inter partes review ... Reducing Duplicative Patent Challenges in the Drug Industry
Drug makers recently announced their 2019 price increases on over 250 prescription drugs. As examples, AbbVie Inc. increased the price of the world’s top-selling drug Humira by 6.2 percent, and Hikma Pharmaceuticals increased the price of blood-pressure medication Enalaprilat by more than 30 percent. Allergan reported an average increase across its portfolio of drugs of 3.5 percent; ... Drug Prices and Distortions in the Pharmaceutical Market
Last week, Senator Orrin Hatch, Senator Thom Tillis, and Representative Bill Flores introduced the Hatch-Waxman Integrity Act of 2018 (HWIA) in both the Senate and the House of Representatives. If enacted, the HWIA would help to ensure that the unbalanced inter partes review (IPR) process does not stifle innovation in the drug industry and jeopardize ... The Hatch-Waxman Integrity Act of 2018—Reestablishing Balance in the Drug Industry
The two-year budget plan passed last week makes important changes to payment obligations in the Medicare Part D coverage gap, also known as the donut hole. While the new plan produces a one-year benefit for seniors by reducing what they pay a year earlier than was already mandated, it permanently shifts much of the drug ... A Windfall for Insurers in the Medicare Part D Coverage Gap
Last week, several major drug makers marked the new year by announcing annual increases on list prices. In addition to drug maker Allergan—which pledged last year to confine price increases below 10 percent and, true to its word, reported 2018 price increases of 9.5 percent—several other companies also stuck to single-digit increases. Although list or “sticker” ... The year ahead in drug pricing.
It’s been six weeks since drug maker Allergan announced that it had assigned to the Saint Regis Mohawk Tribe the patents on Restasis, an Allergan drug challenged both in IPR proceedings and in Hatch-Waxman proceedings in federal district court. The unorthodox agreement was intended to shield the patents from IPR proceedings (and thus restrict the ... Inter Partes Review Jeopardizes the Social Contract between Drug Makers and Patients
Last Friday, drug maker Allergan and the Saint Regis Mohawk Tribe announced that they had reached an agreement under which Allergan assigned the patents on its top-selling drug Restasis to the tribe and, in return, Allergan was given the exclusive license on the Restasis patents so that it can continue producing and distributing the drug. ... The Allergan-Mohawk deal: An ingenious strategy to avoid an unbalanced IPR process
Today, the Senate Committee on Health, Education, Labor, and Pensions (HELP) enters the drug pricing debate with a hearing on “The Cost of Prescription Drugs: How the Drug Delivery System Affects What Patients Pay.” By questioning the role of the drug delivery system in pricing, the hearing goes beyond the more narrow focus of recent hearings that ... Voluntary pricing restraints in the drug industry