PHARMACY

District court rules against Lilly in Strattera patent suit

BY Alaric DeArment

INDIANAPOLIS The U.S. District Court for the District of New Jersey has ruled against drug maker Eli Lilly in its patent infringement case against generic drug maker Actavis regarding a drug used to treat attention deficit hyperactivity disorder, Lilly said.

The court ruled that a method-of-use patent covering the drug, Strattera (atomoxetine), was invalid. The patent was set to expire in May 2017.

Lilly said it would appeal, but expects a generic version of Strattera to enter the market in the near term as a result of the decision.

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PHARMACY

GPhA: Banning patent settlements will cost money, not save it

BY Alaric DeArment

WASHINGTON The main lobbying group for the generic drug industry said federal authorities erred in projecting savings from a proposed ban on patent litigation settlements between branded and generic drug companies.

The Generic Pharmaceutical Association said the Federal Trade Commission and the Congressional Budget Office used faulty assumptions to support legislation against the settlements, based on an analysis led by former Clinton administration official Jonathan Orszag.

“Making drug patent litigation settlements presumptively unlawful will cost, not save, money for the government and consumers,” a statement by the GPhA read. “There are no examples of patent settlements that have delayed generic market entry beyond the date of the patent expiration. But there are many examples of settlements that have proven to be pro-competitive and pro-consumer by making lower-cost generics available months and even years before patents have expired.”

In many such lawsuits, a generic drug company will file for regulatory approval of its version of a branded drug before patent expiration. In response, the branded drug company will file a patent infringement lawsuit, placing a stay on Food and Drug Administration approval of the generic. Often, the two companies will reach a settlement whereby the generic company will agree to hold off launching its version of the drug in exchange for “payment” from the branded drug company, usually in the form of the branded drug company agreeing not to launch an “authorized generic” –– essentially the branded drug marketed under its generic name at a discount –– to compete with the generic.

Critics of the deals have derided them as “pay-for-delay” deals, though by law, the generic drug maker is forbidden from delaying launch beyond patent expiration, and launch often occurs ahead of expiration.

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Text messages may aid medication adherence for teen diabetics

BY Allison Cerra

COLUMBUS, Ohio A pilot study conducted by an endocrinologist at Nationwide Children’s Hospital is looking to increase medication adherence among adolescent diabetic patients with text message alerts.

Doctor Jennifer Dyer found that a simple reminder, in the form of a text message, can be sent to her teenage patients to improve their medication adherence. During the study, she sent personalized questions and reminders specific to diabetes adherence activities, in addition to friendly, supportive messages to her patients. Dyer also applied for an internal grant in order to test an iPhone application that she has developed. This application will allow endocrinologists to send personalized, yet automated texts to multiple patients at a specific time.

“If adolescent diabetes patients do not adhere to their treatment and medication plans, it can result in difficulty concentrating in school or functioning throughout the day,” said Dyer, who also is an assistant professor of pediatrics at The Ohio State University College of Medicine. “Excellent control and treatment can have a long-term, positive effect on a patient with diabetes. This form of communication allows for real-time health management, which is extremely valuable for patients that suffer from a chronic illness like diabetes.”

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