It s Time to Rethink Heart Health
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MISSION, Kan., March 17, 2021 /PRNewswire/ (Family Features) On average, someone in the United States dies from cardiovascular disease (CVD) every 36 seconds, approximately 2,380 deaths each day, according to the American Heart Association. Each day, 405 deaths occur in the U.S. as the result of strokes, an average of one death every 3:33. More people die annually from CVD than from any other cause including cancer, COPD, diabetes, lung infections and the flu, according to the American Heart Association (AHA) 2021 Heart Disease and Stroke Statistics.
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It s Time to Rethink Heart Health
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It s Time to Rethink Heart Health
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On February 11, 2021, Amarin Pharma, Inc. (“Amarin”) filed a petition for a writ of certiorari with the Supreme Court seeking reversal of the Federal Circuit’s decision to affirm a finding that Amarin’s patents are invalid as obvious under 35 U.S.C. § 103.
1 According to Amarin, the district court erred in its analysis because it considered evidence of objective indicia of nonobviousness only after deciding Amarin’s patents were prima facie obvious.
2 In other words, according to Amarin, the court had “relegate[d] objective indicia to second-class status” by using a “prima facie framework,” rather than giving the evidence the “full and fair consideration” it deserved alongside the other Graham factors
The Federal Circuit’s October 2020 split decision in
GSK v. Teva[i] made waves throughout the pharmaceutical industry and among Hatch-Waxman litigators. In the broadest reading, some see the majority opinion as rendering any manufacturer of a marketed “AB‑rated” generic drug liable for induced infringement of patents covering any of the brand products’ FDA‑approved indications – even where the generic’s labeling “carved out” such an indication to escape infringement under the “section viii” provision of Hatch-Waxman.[ii]
GSK v. Teva is now headed to a Federal Circuit panel rehearing (not
en banc review) on February 23, and the industry and practitioners are watching closely. But recent developments suggest that the Federal Circuit might now avoid the hotly-debated legal question of whether a generic with a fully “carved-out” indication might induce infringement solely by touting its “AB-rating.” Rather, there are signs that the majority mi