Appeals court upholds decision to OK ‘pay-for-delay’ deals
NEW YORK The federal government got a kick in the face Thursday as an appeals court ruled in favor of patent litigation settlements between branded and generic drug companies.
The U.S. Second Circuit Court of Appeals in New York decided not to reconsider a ruling it made earlier this year in the case of Arkansas Carpenters Health and Welfare Fund vs. Bayer AG. The case concerned the legality of a settlement between Bayer and Teva Pharmaceutical Industries subsidiary Barr Labs over the anthrax treatment Cipro (ciprofloxacin), but the court ruled that the deal between the two companies did not violate antitrust laws.
The appeals court’s decision is a major setback for the efforts of the Federal Trade Commission and members of Congress who have sought to ban such settlements.
In most cases, a generic drug company that wishes to market its version of a drug before the branded drug company’s patents expire will file an approval application with the Food and Drug Administration with a paragraph IV certification, a legal assertion that the patents covering the branded drug are invalid, unenforceable or won’t be infringed by the generic drug. In response, the branded drug company usually will sue, but cases frequently result in settlements whereby the generic drug company agrees to hold off launching its drug in exchange for payment of some sort by the branded drug company.
This often comes in the form of an agreement not to use an authorized generic, essentially the branded drug marketed under its generic name, to compete with the generic drug company during its customary six-month market exclusivity period. Legally, the generic company must launch before the patents expire or as soon as they do, and delaying launch after patent expiry would be illegal, though critics such as the FTC and The New York Times’ editorial board have often derided the settlements as “pay-for-delay” deals, with the FTC contending that they cost consumers billions of dollars a year. Nevertheless, most cases that are settled result in launch of the generic drug ahead of patent expiry. In the case of Bayer and Barr, Bayer paid Barr $400 million to hold off launching its version of Cipro.
“Patents, issued by the government, are given the presumption of validity,” read a statement from the Generic Pharmaceutical Association, the generic drug industry’s main lobby. “Any market entry of a generic drug before the brand patent expires –– whether as the result of a finding that the generic product does not infringe the patent, that the patent is not enforceable or through a patent settlement agreement with the brand company –– is a positive, cost-saving event for consumers.”
Kiwi Shoe Care goes back to basics with new ad campaign
EXTON, Pa. Sara Lee’s Kiwi Shoe Care is looking to educate consumers on how to care for their shoes with a back-to-basics approach.
Kiwi’s new campaign focuses on taking care of what consumers already have without breaking the bank, the company said.
"Our new ads will take a unique approach to drive home the concept of caring for one’s shoes and demonstrate the value and savings it can bring to one’s household," said Bob Clark, marketing director of Kiwi Shoe Care.
Kiwi’s line of products include shoe inserts, boot and suede protectors, shine sponges and women’s comfort cushions.
HHS launches CuidadoDeSalud.gov
WASHINGTON The Department of Health and Human Services on Sept. 8 unveiled CuidadoDeSalud.gov, a website designed to help Hispanic consumers take control of their health care by connecting them to new information and resources that will help them access quality, affordable healthcare coverage.
Consistent with the mandate in the Affordable Care Act to provide consumers with information and resources to make informed healthcare decisions, CuidadoDeSalud.gov is the partner site of HealthCare.gov, which was launched in July 2010.
"CuidadoDeSalud.gov, like HealthCare.gov, is an unprecedented website that provides consumers with the power of information at their fingertips," stated HHS secretary Kathleen Sebelius. "Individuals, families and small businesses will be able to easily compare both public and private health coverage options tailored specifically for their needs … [by providing] better information about the choices they have, how much they cost and what they can expect from their doctor — specific to their life situation and local community."
In addition, the website is a one-stop shop for information about the implementation of the Affordable Care Act, as well as other healthcare resources. The website connects consumers to quality rankings for local healthcare providers, as well as preventive services.
The initiative is particularly important for Latinos, HHS stated, as that demographic has the highest rates of uninsurance in the nation — more than 1-in-3 Latinos are uninsured. Latinos only are half as likely to have a usual source of primary care, and half of Latinos do not have a regular doctor. As many as 20% of low-income Latino youth have gone a year without a healthcare visit –– a rate three times higher than that of high-income whites.
In addition, HHS noted that Latinos disproportionately suffer from such chronic health diseases as diabetes and cardiovascular disease, and that Latinas have disproportionate rates of cervical cancer, which they contract at twice the rate of white women.
In October 2010, CuidadoDeSalud.gov will include price estimates for health insurance plans. In the weeks and months ahead, new information on preventing disease and illness and improving the quality of health care for all Americans will also be posted.