Teva Pharmaceuticals v. Sandoz: availability of generic glatiramer acetate and the impact to patent litigation claim construction

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• Glatiramer is a mixture of polypeptides that range in size from 4,700 – 11,000 Daltons. See, e.g., Ctr. for Drug Evaluation and Research, Food & Drug Admin., Appl. No. NDA 20-622/S-015 Final Printed Labeling (2001)
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• A patent claim is invalid for indefiniteness if its language, when read in light of the specification and prosecution history, “fail[s] to inform, with reasonable certainty, those skilled in the art about the scope of the invention”. Nautilus Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2124 (2014)
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• Rule 52(a)(6) of the Federal Rules of Civil Procedure provides that in matters tried to a district court, the court’s “[f]indings of fact … must not be set aside unless clearly erroneous”
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• The Supreme Court reverses two out of every three cases it chooses to hear. See generally Roy Hofer, Supreme Court Reversal Rates: Evaluating the Federal Courts of Appeals, 2 Landslide (2010) (finding that the Supreme Court affirmed 29 percent of the appeals accepted from 1999-2008). The Supreme Court typically accepts cases that result from a circuit split (where two different circuit courts reach a different conclusion on a legal issue), or when it intends to correct the actions of a lower court. Because appeals in patent law cases are heard by the Federal Circuit, there are no circuit splits in patent law, and so the Supreme Court typically accepts patent cases when it intends to correct law developed by the Federal Circuit. This is apparent in the Supreme Court’s recent opinions. From the October 1996 term up through October 2008, the Supreme Court accepted thirteen patent cases, reversing the Federal Circuit in seven, vacating the decisions in four, and affirming in only two cases, one of which rejected the Federal Circuit’s approach to the legal test at issue. John M. Golden, The Federal Circuit and the D.C. Circuit: Comparative Trials of Two Semi-Specialized Courts, 78 Geo. Wash. L. Rev. 553, 557-558 (2010). Thus, the Supreme Court’s recent trend suggests that the Federal Circuit will once again be reversed in Teva
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• Lighting Ballast Control, 744 F.3d at 1286 (citations omitted)
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