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Federal court issues rulings in favor of Teva in MS drug case

BY Alaric DeArment

JERUSALEM — A federal court has acted in favor of Teva Pharmaceutical Industries in the drug maker’s patent infringement case against several generic drug companies seeking to market versions of its multiple sclerosis drug.

Teva said the U.S. District Court for the Southern District of New York issued a set of claim construction rulings in its patent infringement case against Sandoz and Momenta Pharmaceuticals, and Mylan and Natco regarding the drug Copaxone (glatiramer acetate) that favored Teva; the two parties are each seeking to market generic versions of the drug. A claim construction decision is when a U.S. District Court examines evidence from all parties on the meanings of relevant words used in a patent claim; the court’s interpretation of those words affects how it assesses patent infringement and validity.

The trial is set to begin on Sept. 7.

What sets the case apart from typical patent-infringement cases involving branded and generic drug makers is the nature of Copaxone. Though approved as a pharmaceutical drug, its molecular complexity places it more in league with biotech drugs, which makes the development of a generic version more challenging.

A similar case was that of Sanofi’s blood-thinning drug Lovenox (enoxaparin sodium), also a complex molecule approved as a pharmaceutical; Sandoz now markets a generic version of that drug. According to some analysts, such cases could help shape the Food and Drug Administration’s regulations concerning follow-on biologics, now that the agency must draft them thanks to the regulatory approval pathway created by the Patient Protection and Affordable Care Act.

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Study examines effects of dietary weight loss, exercise on insulin resistance among postmenopausal women

BY Allison Cerra

NEW YORK — A new study that is slated to appear in the October issue of the American Journal of Preventive Medicine found that postmenopausal women may improve their insulin sensitivity through such interventions as diet, exercise, or a combination of the two.

The subjects, which were inactive, overweight/obese postmenopausal women between the ages of 50 and 70 years, were assigned to one of the following groups during the study: dietary weight-loss program (118 subjects); exercise program (117 subjects); a combined program of exercise and diet (117 subjects); or control (87 subjects). The diet intervention was a group-based reduced-calorie program with a 10% weight-loss goal, while the exercise intervention was 45 min/day, 5 days/week of moderate-to-vigorous intensity aerobic activity, the researchers said.

The research, which was conducted between 2005 and 2009 and analyzed in 2010, found that the diet and diet/exercise combination programs garnered the best results, with insulin resistance decreasing by 24% and 26%, respectively. Groups in the exercise and control groups only saw respective decreases of 9% and 2%. These effects were similar in middle-aged (ages 50 to 60 years) and older women (ages 60 to 75 years).

This study was supported by a grant from the National Cancer Institute at the National Institutes of Health.

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Report: Mylan temporarily banned from launching generic acne drug

BY Alaric DeArment

NEW YORK — Mylan will be banned temporarily from launching a generic drug for acne pending a federal court’s decision whether or not to bar it, according to published reports.

According to Bloomberg, the U.S. District Court for the District of Delaware ruled that Mylan violated 1-of-4 patents covering the acne drug Oracea (doxycycline), sold by Galderma Labs. Galderma, New York University and the Research Foundation of the State University of New York sued Mylan for patent infringement related to the drug in 2009. The court will wait to decide whether to bar Mylan from launching.

Patents covering Oracea are scheduled to expire between Aug. 30, 2016, and Dec. 19, 2027, according to Food and Drug Administration records.

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