Showing archive for: “Pharmaceutical Industry”
The year ahead in drug pricing.
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.
Inter Partes Review Jeopardizes the Social Contract between Drug Makers and Patients
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
The Allergan-Mohawk deal: An ingenious strategy to avoid an unbalanced IPR process
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
How a Patent Office Agency Undermines Patent Rights and Cripples Innovation – and What Can Be Done About It
On August 14, the Federalist Society’s Regulatory Transparency Project released a report detailing the harm imposed on innovation and property rights by the Patent Trial and Appeals Board, a Patent and Trademark Office patent review agency created by the infelicitously-named “America Invents Act” of 2011. As the report’s abstract explains: Patents are property rights secured ... How a Patent Office Agency Undermines Patent Rights and Cripples Innovation – and What Can Be Done About It
Voluntary pricing restraints in the drug industry
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
Understanding innovation markets in antitrust analysis
Today, three of the largest proposed mergers — Bayer/Monsanto, Dow/Dupont, and ChemChina/Syngenta — face scrutiny in both the U.S. and Europe over concerns that the mergers will slow innovation in crop biotechnology and crop protection. The incorporation of innovation effects in the antitrust analysis of these agricultural/biotech mergers is quickly becoming more mainstream in both the U.S. ... Understanding innovation markets in antitrust analysis
ABA Antitrust Section Transition Report: A Respectful Critique
The American Bar Association Antitrust Section’s Presidential Transition Report (“Report”), released on January 24, provides a helpful practitioners’ perspective on the state of federal antitrust and consumer protection enforcement, and propounds a variety of useful recommendations for marginal improvements in agency practices, particularly with respect to improving enforcement transparency and reducing enforcement-related costs. It also ... ABA Antitrust Section Transition Report: A Respectful Critique
Understanding government negotiation of Medicare drug prices
In a weekend interview with the Washington Post, Donald Trump vowed to force drug companies to negotiate directly with the government on prices in Medicare and Medicaid. It’s unclear what, if anything, Trump intends for Medicaid; drug makers are already required to sell drugs to Medicaid at the lowest price they negotiate with any other buyer. ... Understanding government negotiation of Medicare drug prices
What’s next for the pharmaceutical industry?
On November 9, pharmaceutical stocks soared as Donald Trump’s election victory eased concerns about government intervention in drug pricing. Shares of Pfizer rose 8.5%, Allergan PLC was up 8%, and biotech Celgene jumped 10.4%. Drug distributors also gained, with McKesson up 6.4% and Express Scripts climbing 3.4%. Throughout the campaign, Clinton had vowed to take on ... What’s next for the pharmaceutical industry?
A “social contract” for the drug industry
Mylan Pharmaceuticals recently reinvigorated the public outcry over pharmaceutical price increases when news surfaced that the company had raised the price of EpiPens by more than 500% over the past decade and, purportedly, had plans to increase the price even more. The Mylan controversy comes on the heels of several notorious pricing scandals last year. Recall ... A “social contract” for the drug industry
U.S. Food and Drug Administration (FDA) Reforms Needed to Promote Path-Breaking Biopharmaceutical Innovation
Yesterday the Heritage Foundation published a Legal Memorandum, in which I explain the need for the reform of U.S. Food and Drug Administration (FDA) regulation, in order to promote path-breaking biopharmaceutical innovation. Highlights of this Legal Memorandum are set forth below. In recent decades, U.S. and foreign biopharmaceutical companies (makers of drugs that are based ... U.S. Food and Drug Administration (FDA) Reforms Needed to Promote Path-Breaking Biopharmaceutical Innovation
Time to Confront Bias Against Patent Owners in Patent “Reform” Legislation like the VENUE Act
Last March, I published an op ed in the the Washington Times on the proposed VENUE Act, a recently introduced bill taken wholesale from a portion of HR 9 (the tendentiously titled “Innovation Act”). HR 9 has rightly stalled given its widespread and radical changes to the patent system that weaken and dilute all property rights ... Time to Confront Bias Against Patent Owners in Patent “Reform” Legislation like the VENUE Act
