With nuanced ruling on ‘pay for delay,’ Supreme Court hands generics partial resolution
Half a loaf, the saying goes, is better than none. For the generic drug industry, that means that the Supreme Court handed it a partial victory Monday by ruling that “pay for delay” patent settlements between brand name and generic drug companies aren’t necessarily illegal and should be considered on a case-by-case, “rule of reason” approach by the Federal Trade Commission, which staunchly opposes the practice.
The high court’s decision, reported June 17 by Drug Store News, means that pioneer and copycat pharmaceutical makers are free to continue pursuing the controversial legal settlements of patent-infringement lawsuits that can delay the introduction of generic versions of some big-selling branded drugs in return for a cash payment or other compensation. Those agreements often involve “reverse payments” to the generic company — or an agreement by the brand company not to launch its own “authorized generic” version of the drug in question — in exchange for the generic company’s agreement to delay launch of its first-to-market version of the drug. Such settlements are not “presumptively unlawful,” the Supreme Court ruled in a 5-3 decision (Justice Samuel Alito didn’t participate in the ruling).
But the court’s ruling doesn’t really settle much. Justices essentially threw the legal uncertainties and antitrust questions surrounding reverse payments and pay-for-delay back to the lower courts.
In an online report Monday, the Los Angeles Times called the court’s decision “a middle-ground position” that leaves the door open for the FTC to challenge in court any settlement between branded and generic drug makers that involves a lot of money changing hands. To wit: “A ‘large and unjustified’ payment to settle a patent dispute can trigger an antitrust claim against the brand-maker,” the Times noted.
The issue is far from simple or black-and-white. The FTC, not to mention some retail pharmacy groups and the American Medical Association, argue that pay-for-delay settlements violate antitrust laws and end up costing consumers and health plans billions of dollars in higher drug costs by delaying generic competition. But industry trade groups like the Generic Pharmaceutical Association and the Pharmaceutical Research and Manufacturers of America — not to mention the big health research firm IMS Health — say the practice actually gets many copycat drugs to market sooner and helps lower overall spending for pharmaceuticals.
“Over the past 10 years, patent settlements have enabled dozens of first-time generics to come to market many months before patents on the counterpart brand drugs expired, including the top-selling medicines Lipitor, Effexor and Lamictal,” says GPhA’s Ralph Neas, president and CEO.
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Study: Eating peanut butter, peanuts at breakfast can help control hunger all day
ALBANY, Ga. — A new study, released in the current British Journal of Nutrition, showed that consuming peanut butter or peanuts for breakfast can control blood-sugar throughout most of the day, even after eating a high-carbohydrate lunch. In addition to this "second meal effect," peanuts and peanut butter caused a significant reduction in the desire to eat for up to 12 hours and a significant increase in the secretion of the hormone PYY that promotes satiety and feelings of fullness.
The study, "Acute and second-meal effects of peanuts on glycaemic response and appetite in obese women with Type 2 diabetes risk: A randomized cross-over clinical trial," was conducted jointly by Purdue University and the Federal University of Vicosa in Brazil. The principal investigator, Dr. Richard Mattes of Purdue University, explained, "If you include peanut butter or peanuts at breakfast, you not only diminish the rise in blood-sugar at breakfast but also again after lunch, helping to reduce blood sugar over a very large portion of the day."
During three phases of the study, 1.5 oz. of peanuts, 3 Tbs of peanut butter or no peanuts or peanut butter were consumed with a breakfast consisting of orange juice and cream of wheat, followed by a lunch consisting of white bread and strawberry jam. Blood samples and appetite ratings were taken over a series of three hours following breakfast and again after lunch to assess glucose control and satiety; participants were also asked to keep a food diary for the remainder of the day after leaving the testing site.
Results showed that peanut butter or peanuts included with breakfast promotes secretion of the appetite-suppressing hormone peptide YY (PYY). In addition, participants who consumed peanut butter or peanuts with breakfast reported a lower desire to eat for up to 8 to 12 hours later and maintained lower blood-sugar following a high carbohydrate lunch compared to participants that did not include peanut butter or peanuts. Peanut butter had a slightly stronger effect, possibly because the cell walls of the peanut are ruptured during processing and may help slow the rate that carbohydrates are absorbed from the gut, resulting in a lower glycaemic response in the blood.
The researchers suggest that it is the synergy of components in peanuts, including the high protein, high fiber and healthy oils, that help to maintain blood-sugar control, as well as contribute to feelings of fullness. According to the latest USDA National Nutrient Database, peanuts contain more protein than any other nut, with about 8g of protein per 1-oz. portion, and they are also a good source of fiber with about 2.5 g of fiber per 1-oz. serving.
"Combined with findings from other work, this new research provides additional reasons to start your day with peanut butter and include a snack of peanuts in the late afternoon if you want to control your appetite and blood sugar, too," said Pat Kearney, MEd, RD, program director for The Peanut Institute.
Peanut butter and peanuts are an easy, cost-effective way to add more nutrition to breakfast or snacks every day. Try pairing a whole grain bagel with peanut butter instead of butter or cream cheese, or add a handful of peanuts to oatmeal for a great, high fiber, high protein meal option that will keep you feeling fuller longer.
The Peanut Institute is a non-profit organization that supports nutrition research and develops educational programs to encourage healthful lifestyles. Learn more about peanuts and health at www.peanut-institute.org.
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Teva to acquire MicroDose for up to $165 million
JERUSALEM — Teva Pharmaceutical Industries will spend up to $165 million to buy a company developing a drug to prevent viral respiratory infections.
Teva said it would acquire MicroDose Therapeutx for $40 million, plus up to $125 million in milestone payments and sales milestones and royalties from its lead product, MDT-637, an inhaled treatment for respiratory syncytial virus, or RSV.
"I am thrilled tha tTeva can now count the exciting MicroDose products and technologies amongst our growing respiratory portfolio," Teva chief scientific officer and president for global research and development Michael Hayden said. "The MicroDose platform is both simple and attractive, and their addition will help us to address the unmet needs of the youngest and oldest patients, who have a requirement for a better way of taking the medicines they rely upon."