A 3-judge panel of the Federal Circuit (Federal Circuit Judges Timothy Dyk, Kathleen O’Malley and Evan Wallach) affirmed an appeal of a Southern District of Florida decision from Watson Pharmaceuticals, Inc. The per curiam order affirmed a 2011 decision that found valid Valeant’s four patents covering a particular salt formation of the antidepressant bupropion. No. 10-20526,…
The Federal Circuit recently issued an opinion that reminds us of the importance of being consistent in our statements to the FDA and in patent matters. What matters for the sake of infringement analysis is the product specified in the ANDA filing. The case, Sunovion Pharmaceuticals., Inc. v. Teva Pharmaceuticals USA, Inc. et al. (Fed.…
In Leo Pharmaceutical Products, Ltd. v. Rea (Fed. Cir. Aug. 12, 2013), the Federal Circuit by Judge Rader, with Judges O’Malley and Reyna, found Patent No. 6,753,013 non-obvious, reversing a decision by the Board of Patent Appeals and Interferences. Significantly, the opinion implies that prior art loses its significance for obviousness determinations with time. The…
Everyone who works in the pharmaceutical area has heard of the patent cliff for blockbuster pharmaceuticals. The patent cliff has caused generic pharmaceutical companies to re-think how they approach litigation. With potential profits being less, generic pharmaceutical companies are looking for ways to save costs. One key cost of a generic drug entry is the…
The federal government recently filed its amicus brief with the United States Supreme Court in Medtronic, Inc. v. Boston Sci. Corp. At issue is who should bear the burden of proof when a licensee says it does not infringe a licensed patent and, therefore, no royalties are due to the licensor. The Federal Circuit (Judges…
The Federal Circuit recently expanded the role of secondary considerations, or objective indicia, of non-obviousness in the obviousness calculus. In Plantronics, Inc. v. Aliph, Inc., the district court held claims directed to a headset stabilizer invalid as obvious. No. C09-1714, 2012 U.S. Dist. LEXIS 40172 (N.D. Cal. Mar. 23, 2012). On appeal, the Federal Circuit…
A Massachusetts district court has granted summary judgment in favor of defendants Amphastar and Teva in a suit over a quality-control method patent for manufacture of the anticoagulant enoxaparin. The two related suits were filed by plaintiff Momenta Pharmaceuticals, the first generic manufacturer of enoxaparin. Momenta Pharm., Inc. v. Amphastar Pharm., Inc., No. 11-11681 (D.…
In an earlier post [see previous post] we discussed the Supreme Court’s ruling that reverse payments between brand and generic pharmaceutical companies could violate anti-trust laws. On July 11, 2013, in the wake of that ruling, Bayer agreed to pay $74 million to settle a California consumer class action suit involving reverse payments. The case…
In early June, the Supreme Court ruled that Myriad Genetics Inc.’s patents on isolated BRCA genes (useful for predicting an increased risk of breast and ovarian cancer) are invalid, and that isolated genes are not patentable subject matter [see previous post]. The Supreme Court made two other rulings in that case. First, the Court affirmed…
On February 26, 2013, we analyzed Cephalon, Inc. et al. v. Watson Pharmaceuticals, Inc., where the Federal Circuit held that proving lack of enablement requires more than an expert saying it would be “complex” or “difficult.” The Federal Circuit’s unanimous decision in Wyeth v. Abbott Laboratories further clarified the enablement requirement and affirmed a lower…