What follows below is a review of some of the biotech and pharma news stories that caught my attention during the month of January 2014. Please also see Protecting IP is NOT ‘Satanic Genocide’, written by Dr. Kristina Lybecker.
All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C Genotype 1
On January 31, 2014, AbbVie (NYSE: ABBV) announced the completion of its phase III clinical program and released results of four additional studies designed to assess AbbVie’s investigational all-oral, interferon-free therapy with and without ribavirin (RBV) in patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. These results described below confirm previously reported AbbVie data and further demonstrate high sustained virologic response rates 12 weeks post treatment (SVR12) and tolerability in these GT1 patients. Even in difficult-to-treat patients (cirrhotic patients) achieved 92-96 percent SVR(12) rates.
The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg), dosed once daily, and ABT-333 (250mg) with or without ribavirin (weight-based), dosed twice daily. The combination of three different mechanisms of action interrupts the HCV replication process with the goal of optimizing SVR rates across different patient populations.
The Federal Trade Commission has extended the deadline for public comments on its proposed study of patent assertion entities (PAEs), which it announced on September 27. To provide additional time for interested parties to submit comments on the proposed study, the deadline has been extended throughDecember 16, 2013. The Commission will not consider requests for further extension. Comments can be submitted electronically.
PAEs are firms with a business model based primarily on buying patents and then attempting to generate revenue by asserting the intellectual property against persons who are already practicing the patented technologies. The FTC is conducting the study in order to further one of the agency’s key missions — to examine cutting-edge competition and consumer protection topics that may have a significant effect on the U.S. economy.
In testimony presented to a U.S. House of Representatives Judiciary subcommittee the Federal Trade Commission described its ongoing efforts to protect competition and consumers in many important sectors of the economy, including health care, pharmaceuticals, and technology.
Testifying on behalf of the FTC before the Subcommittee on Regulatory Reform, Commercial and Antitrust Laws, Chairwoman Edith Ramirez said that, “In an effort to be most effective with limited resources, we pay particular attention to sectors where our action will provide the greatest benefit to the largest number of consumers. Chief among those are health care and the technology sector.”
The testimony outlines the FTC’s critical work promoting competition in health care markets, noting that health care consolidation can threaten to undermine efforts to control rising health care costs. Examples of FTC actions to prevent anticompetitive health care mergers include litigation involving proposed hospital mergers that threaten higher prices and lower quality of care, as well as divestitures in pharmaceutical mergers to preserve competition and maintain competitive pricing for needed medications.
Following a public comment period, the Federal Trade Commission has approved final consent orders in three cases involving allegedly deceptive environmental claims for mattresses. The FTC’s complaints, first announced in July, 2013, against Relief-Mart, Inc.; Esssentia Natural Memory Foam Company, Inc.; and Ecobaby Organics, Inc., charged the companies with making unsupported claims that the mattresses they sell are free of harmful volatile organic compounds (VOCs).
The FTC also charged that two of the companies made unsupported claims that their mattresses were chemical-free and odorless. The FTC also challenged one company’s claim that its mattresses are made from 100 percent natural materials, and another company’s claim that its mattresses were certified by an organic mattress organization.
In settling the Commission’s charges, the companies have agreed not to make similar claims in the future, unless they have competent and reliable scientific evidence to prove they are true. In addition, Ecobaby is barred from making misrepresentations about certifications.
The Federal Trade Commission today announced six enforcement actions, including one that imposes a $450,000 civil penalty and five that for the first time address biodegradable plastic claims, as part of the agency’s ongoing crackdown on false and misleading environmental claims.
The plastic cases include a complaint against a company that markets an additive it claims makes plastic products biodegradable and four complaints and proposed consent orders against companies that marketed various plastics with allegedly false and unsupported claims that their products were biodegradable. In the civil penalty case, the FTC filed a complaint and consent order against a company for violating a 1994 FTC order that prohibited it from making unsupported green claims for its paper plates and bags.
All of these cases are part of the FTC’s program to ensure compliance with the agency’s recently revised Green Guides. The Commission publishes the Guides to help businesses market their products accurately, providing guidance as to what constitutes deceptive and non-deceptive environmental claims.
How to Write a Patent Application is a must own for patent attorneys, patent agents and law students alike. A crucial hands-on resource that walks you through every aspect of preparing and filing a patent application, from working with an inventor to patent searches, preparing the patent application, drafting claims and more.
Without hesitation I recommend One Simple Idea and think it should be required reading for any motivated inventor. There is so much to like about the book and so much that I think author Stephen Key nails dead on accurate. The book is educational, information and inspirational. For the $14 cover price it is essential reading.
Typically blog roll links are not helpful to a website's rank. To give some additional "link love" to those we think you might be interested in reading we have moved our blog roll and links to a dedicated page. Go to IPWatchdog Blog Roll & Links.