In the U.S., the promotion of nearly all consumer products and services is regulated by the Federal Trade Commission (FTC). In addition to the FTC regulations on advertising, in Title 16 of the Code of Federal Regulations, the Commission has issued numerous Guides, which are not binding law, but which do reflect enforcement policy. Complaints and investigations by the FTC can result in fines in the millions of dollars, charged against principals of the erring company as well as to the corporation itself. In addition, each state has its own False Advertising regulations, usually under the heading of Business Codes; and recently, state Attorney Generals have been extremely active in prosecuting false, deceptive, and unsupported advertising.The FTC has broad powers to regulate and monitor all advertisements for goods and services (with the exception of a few industries such as pharmaceuticals and aviation). This purview includes advertisements in any medium whatsoever, including … [Read more...] about 13 Questions to Ask Yourself About Marketing Claims to Help Avoid an FTC Enforcement Action
I ph 5 s price
In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit found that a publicly-announced “Supply and Purchase” agreement triggered the on-sale bar under pre-AIA 35 USC § 102(b) and under AIA 35 USC § 102(a)(1). With this case, the court offered its first interpretation of the on-sale bar of the America Invents Act. Although the court did not address whether an entirely secret sale would qualify as prior art under the AIA, it decided that where the existence of the sale was made known to the public, the sale constitutes prior art even if the public disclosure did not reveal the invention. The Patents At IssueThe patents before the court included three pre-AIA patents and one AIA patent. The pre-AIA patents were U.S. Patent Nos. 7,947,724, 7,947,725, and 7,960,424. The Court identified claim 2 of the ’725 patent as representative of the group.A pharmaceutically stable solution for … [Read more...] about Are Secret Sales Prior Art Under The AIA?
In the few weeks since I first wrote about Kyle Bass and the Coalition for Affordable Drugs he formed to challenge Orange Book-listed patents that he believes “have little value other than to drive up prescription drug prices,” he has been busy. Here, I review the patents he has challenged with Inter Partes Review (IPR) petitions, and identify whether there are other Orange Book-listed patents for the pharmaceutical product at issue.IPRs Against Ampyra® PatentsIn February, the Coalition filed IPRs against two Orange Book-listed patents for Ampyra®: 8,663,685 and 8,007,826.Claim 1 of the ‘685 patent recites:1. A method of improving walking in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a time period of at least two weeks, wherein the sustained release composition further comprises one or more pharmaceutically acceptable … [Read more...] about Keeping Up With Kyle Bass: Pharma Patents Post
This month, FDA issued its final guidance on Nonproprietary Naming of Biological Products (Naming Guidance). The Naming Guidance represents a new framework for the entire category of biological products, including biosimilars. Instead of using nearly identical labeling for a biosimilar and its reference product, FDA now is requiring the use of a proper nonproprietary name (proper name) for each originator biological product, related biological and biosimilar product. The Proper Name will be a combination of a “core name” and a distinguishing suffix for each product which is composed of four lowercase letters devoid of any meaning. (Naming Guidance at 1.)Notably, all previously licensed biologics under section 351(a) or 351(k) of the Public Health Service (PHS) Act will be renamed with a new suffix. (Id.) Also, the new requirement does not address how to designate interchangeability of biosimilars for which FDA is still considering the appropriate format. (Id.) FDA believes … [Read more...] about New Approach for Biologic and Biosimilar Names
It was a Perry Mason moment.The witness, an old man dying of lung cancer, had just finished telling the jury why he could be so sure that Kent was the brand of cigarette he had switched to as a young man almost a half century earlier.The man was the plaintiff in a closely watched 1995 product liability suit against the tobacco industry. He had been diagnosed with mesothelioma, a rare but deadly form of lung cancer caused primarily by exposure to asbestos. And he blamed his disease on a filter containing asbestos used in Kent cigarettes over a four-year period in the mid-1950s.The witness said he took up smoking during World War II and that he clearly remembered switching from an unfiltered brand to Kent shortly after it came on the market in the spring of 1952.Since there was no evidence to support his testimony, his credibility was key.It was an important time in his life, he told the jury on direct examination. He had just finished school in Kansas and gotten a job as a clinical … [Read more...] about Shook Hardy Smokes ‘Em
Note: Register for this month’s CLE, “Legal Fallout from the Financial Crisis,” from 1-2 p.m. ET on Wednesday, Jan. 21.In the game of blame that followed the deepest financial implosion since the Great Depression, bankers and money managers have borne their share of attention. But how much blame should lawyers bear? Plenty.As legislators, they helped remove restrictions on commercial banks that allowed them to get involved with subprime mortgage-backed securities.As regulators, they allowed leverage at investment banks to increase largely unchecked. As judges, they made it harder for shareholders to bring suits to stop the financial shenanigans.As counsel, their legal opinions gave sanction to deals that, in the words of the analysts behind them, “could have been structured by cows.”There were also lawyers who did their jobs, only to find their voices lost in torrents of money, rationalization or plainspoken hostility toward the rule of … [Read more...] about How Lawyers Enabled The Meltdown
While arguments from climate change deniers have subsided, there is still discussion about the cause of climate change—natural or man made? But these arguments are mere time-wasters. Right now it’s critical to put the focus on managing this risk.Insurers have it right. For years they have been pointing to the urgent need to deal with the issues surrounding climate change. Insurers know this global risk needs to be dealt with now—and in the future—and they can’t afford to get it wrong.Johnny Chan, Ph.D., director of the Guy Carpenter Asia-Pacific Climate Impact Center said it best: “The debate on climate change and global warming has been intensely polarized. A great deal of this ‘noise’ has clouded the very real and emerging issues that we as an industry and society need to address. In order to adapt to climate change and the changing risk landscape, it is necessary to cut through this noise and focus on objective decisions to mitigate … [Read more...] about Time to Get Serious About Climate Change Risks
AFAs: WHAT’S THE BIG DEAL?We all know there are dramatic changes occurring in the legal profession. Some changes are the result of economic pressures; others are urged upon lawyers and law firms by the clients they serve. These days, being a lawyer is less about the practice of law and, out of necessity, more about the business of law.At the heart of these changes is a question plaguing managing partners, practice group chairs, CMOs and marketing staff, and every service provider in the law firm – “How do we define and market our value?”Many believe the answer lies in the philosophy and application of alternative fee arrangements (“AFAs”), a topic of much discussion, criticism, and confusion as more corporate counsel seek to hasten the elimination of the billable hour. A comprehensive overview of the most common AFA models is included in the Appendix.AFAs can be a bitter pill for many firms to swallow. Prospectively, firms will have to alter the ways … [Read more...] about Marketing Law Firm Value: Alternative Fee Arrangements
BackgroundIndia is one of the most densely populated countries in the world. According to the World Bank (2012), 1.237 billion people live in India, accounting for about 17.5% of the world’s population. India has risen from the 15 largest pharmaceutical market in 2007 to 12 in 2011 and is expected to become the 8 largest by 2015. In fact, India’s pharmaceutical market has a compound annual growth rate of 12% post price controls. Some of this growth is driven by:1. Increased accessibility and affordability of prescription drugs.2. An increase in the diagnosis and treatment of chronic diseases.3. Mergers, acquisitions and partnerships with big pharma.4. High growth in the hospital sector. Health Insurance and Drug PricingSince its independence, India has struggled to provide its people with universal health care. India’s health industry arose in 1986. However, very few people today have health insurance. As a result, … [Read more...] about An Overview of Biosimilars and the Biosimilar Pathway in India
The Biologics Price Competition and Innovation (BPCI) Act of 2009 was enacted as part of the Patient Protection and Affordable Care Act to establish an abbreviated pathway for the licensure by Food and Drug Administration (FDA) of biological products demonstrated to be biosimilar to or interchangeable with a FDA-licensed reference product. We at the BRIC Wall Blog decided to review the current status of biosimilars in the U.S.FDA GuidancesSince the BPCI Act was signed into law on March 23, 2010, the FDA has issued six guidances relating to biosimilars or reference biological products. These guidances are:1. Guidance for Industry on Biosimilars: Q & A’s Regarding Implementation of the BPCI Act of 2009 – issued February 9, 2012.2. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product – issued February 9, 2012.3. Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product – issued … [Read more...] about A Review of the Status of Biosimilars in the U.S.