Supreme Court issues ‘pay-for-delay’ ruling
NEW YORK — Patent settlements between brand and generic drug makers commonly referred to as "pay-for-delay" settlements are not necessarily against the law, the Supreme Court ruled Monday.
In a 5-3 ruling in the case of Federal Trade Commission v. Actavis — Samuel Alito did not take part in the case — the court ruled that courts reviewing such settlements should take a "rule of reason" approach rather than a "quick look" approach; the latter approach would presume that the settlements are unlawful, while the former holds that the plaintiff must prove they are on a case-by-case basis.
The high court also reversed the ruling by the U.S. Court of Appeals for the Eleventh Circuit, which had affirmed a lower court’s ruling granting drug maker Actavis’ motion to dismiss the FTC’s suit.
"We are pleased that the court rejected the FTC’s proposed ‘quick look’ test and did not rule that settlement agreements are presumptively unlawful," Actavis president and CEO Paul Bisaro said. "Rather, the court has established that the ‘rule of reason’ be applied and left it to the lower courts to determine if the benefits of the settlement outweigh harm to consumers."
The ruling means that the FTC can still challenge patent settlements between branded and generic drug companies, which have become controversial in recent years.
In a typical case, a generic drug maker will file an application with the Food and Drug Administration challenging the patent on a branded drug with the goal of becoming the first to market the generic. The branded drug’s manufacturer will respond with a patent-infringement lawsuit that will put an automatic stay of final FDA approval for up to two-and-a-half years. Rather than going to court, however, most cases are settled.
The settlements that become a problem for the FTC and many patient-advocacy groups are those in which the generic company agrees to hold off launch of the generic in exchange for a "reverse payment." The payment can involve money or a promise by the brand drug maker not to launch an "authorized generic" — essentially the branded drug marketed under its generic name at a discounted price, usually through a third-party company — and is called a "reverse payment" because it involves the patent holder paying the alleged infringer, rather than the other way around. Still, generic drug companies maintain that regardless of delays, the deals still get generic drugs into the hands of consumers months or years ahead of patent expiration, and that withholding launch beyond patent expiration would be illegal.
In the current case, Actavis predecessor Watson Pharmaceuticals entered a deal with Solvay Pharmaceuticals, now owned by AbbVie, in 2009, in which Watson, Par Pharmaceuticals and Paddock Labs agreed to delay launching generic versions of the topical testosterone ointment AndroGel for a share of profits on the drug. The FTC sued, alleging an antitrust violation.
Reckitt Benckiser partners with Save the Children to lower global death rate from diarrhea
PARSIPANNY, N.J. — Reckitt Benckiser, whose portfolio includes such brands as Clearasil, Mucinex and Lysol, is partnering with Save the Children to help drastically lower the global death rate of children younger than 5 years from diarrhea, a preventable illness, by 2020.
The "Healthier kids, Happier homes" global partnership, with an initial funding of $35.5 million, will combine RB’s expertise in hygiene and health, innovative technology and consumer communication capabilities with Save the Children’s expertise in delivering life-saving treatment.
Globally, diarrhea remains the second leading cause of death from a preventable disease among children younger than 5 years, behind pneumoniai. Nearly 1-in-10 child deaths — approximately 800,000 each year — is due to diarrhea caused by poor home environments, inadequate personal hygiene and lack of access to essential services, such as healthcare, sanitation, clean water and basic nutrition.
By developing new, innovative products, for example a low cost "de-germer," RB aims to support mass reach hand-hygiene campaigns and create safer home environments for babies and children, helping families to live healthier and happier lives. In addition to providing expertise, RB is committing to a multimillion dollar investment to achieve its vision by 2020, and involving its 36,000 employees around the world in the initiative.
"At an unacceptable rate, children in the developing world are dying from completely preventable diseases, like diarrhea. We have already made dramatic progress in reducing the number of children dying, but there is still much more that needs to be done. Through this exciting partnership with RB, we can combine our skills and transform the lives of thousands of the world’s most vulnerable children," said Justin Forsyth, chief executive of Save the Children.
The "Healthier kids, Happier homes" global partnership will launch with two pilot projects in Nigeria and Pakistan, looking at embedding best behaviors and attitudes to health and hygiene, and to educate. This new phase of the global partnership continues to build on the ground-breaking projects already underway around the world. Since the partnership began in 2003, RB has helped Save the Children reach more than 1 million children.
Bio Follicle introduces new lavender shampoo, conditioner
NEW YORK — Bio Follicle has announced the launch of its 100% vegan plant-derived sulfate- and cruelty-free aromatherapy lavender shampoo and conditioner.
This hair care duo promises to provide hair and scalp with the benefits of natural botanicals and a pH-balanced formula. The shampoo is a gentle, plant-derived formula that thoroughly cleanses hair while restoring its natural balance, body and shine, the company stated. The conditioner contains an antioxidant-rich herbal blend of therapeutic lavender oil and rich plant-based moisturizers.
The shampoo is priced at $22. The conditioner is priced at $25.