Pharma Corner

We have approached the pharmaceutical industry from virtually every angle: working for brands, for generics, for classes and for regulators. We have worked on drugs in development, drugs facing generic entry, and drugs replaced by follow-on products. We are endlessly fascinated by the rapid evolution of this unique industry, and we make it a point to stay abreast of recent developments. Our occasional blog, Phama Corner, offers reflections on just a few of these topics.

The Cost of Opioid Abuse: A Review of Recent Estimates

It is well known that the United States is staggering under the burden of an opioids epidemic. This has led to several efforts over the last 20 years to quantify the overall cost of opioid addiction and abuse. The various estimates agree that the cost is extremely high, but there are important differences—in some cases dramatic ones—between the estimates. The sources of these differences lie in methodological choices.

The IMS-Quintiles Merger: A Window into the Future of Pharmaceutical R&D

In October 2016, IMS Health, the dominant provider of pharmaceutical market data, merged with Quintiles to form QuintilesIMS, subsequently renamed IQVIA (pronounced “I-Q-via,” with emphasis on the “Q”). This merger is notable because Quintiles, the company acquired by IMS, was not a data company, but a contract research organization (CRO).

Patent Proliferation: A 30-year increase in the number of patents per drug

September 12, 2016 Over the past 30 years, there has been a marked increase in the average number of patents covering a single drug. Will it change the way pharmaceutical patents are litigated? It was once common wisdom about the pharmaceutical industry that a single product was normally covered by a single patent.[1] This one-product one-patent…

Biologics Exclusivity and the TPP: An International Balancing Act

October 6, 2015 With sufficient participation, trade pacts have the potential to set international standards that eventually become global norms. This is exactly what opponents on both sides of the Trans-Pacific Partnership (TPP) agreement fear will happen when it comes to biosimilar drug development. The deal, announced October 5, 2015, would apparently commit the 12…

Biosimilar Conversion: How Slippery is the Slope?

August 21, 2015 There is no doubt that massive capital has lined up behind biosimilar drug development. Many of the top biologics will be losing patent protection over the next decade or have already lost it. And the Biologics Price Competition and Innovation Act (BPCIA) of 2010 has finally defined the pathway for biosimilars to…

Amgen v. Sandoz – Let’s Just Agree to Disagree

July 22, 2015 Yesterday ended the long wait for the first appellate court interpretation of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). A 3-judge panel of the Federal Circuit (Lourie, Newman and Chen) struggled with arguably inconsistent language in the Act, which Judge Lourie described as “a riddle wrapped in an enigma.” Ultimately,…