Showing archive for: “Pharmaceutical Industry”
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
Innovation trends in agriculture and their implications for M&A analysis
The US agriculture sector has been experiencing consolidation at all levels for decades, even as the global ag economy has been growing and becoming more diverse. Much of this consolidation has been driven by technological changes that created economies of scale, both at the farm level and beyond. Likewise, the role of technology has changed ... Innovation trends in agriculture and their implications for M&A analysis
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
Significant Impediment To Industry Innovation: A novel theory of harm in EU merger policy?
In Brussels, the talk of the town is that the European Commission (“Commission”) is casting a new eye on the old antitrust conjecture that prophesizes a negative relationship between industry concentration and innovation. This issue arises in the context of the review of several mega-mergers in the pharmaceutical and AgTech (i.e., seed genomics, biochemicals, “precision ... Significant Impediment To Industry Innovation: A novel theory of harm in EU merger policy?
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
Senate Bill Provides Remedy for Regulatory Abuse Keeping Generics Off the Market
I’d like to begin by discussing Geoff’s post on the pending legislative proposals designed to combat strategic abuse of drug safety regulations to prevent generic competition. Specifically, I’d like to address the economic incentive structure that is in effect in this highly regulated market. Like many others, I first noticed the abuse of drug safety ... Senate Bill Provides Remedy for Regulatory Abuse Keeping Generics Off the Market
Senator Lee’s prescription for regulatory failure in the generic drug market
Brand drug manufacturers are no strangers to antitrust accusations when it comes to their complicated relationship with generic competitors — most obviously with respect to reverse payment settlements. But the massive and massively complex regulatory scheme under which drugs are regulated has provided other opportunities for regulatory legerdemain with potentially anticompetitive effect, as well. In ... Senator Lee’s prescription for regulatory failure in the generic drug market
