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…
On June 18, 2013, the Federal Circuit held that Novo Nordisk’s patent covering Prandin, a diabetes treatment, was obvious, and reversed the lower court’s finding of inequitable conduct. Prandin is a Type II diabetes drug therapy that combines repaglinide, an insulin-release stimulator (secretagogue), with metformin, a glucose production suppressant (sensitizer). Novo began experimenting with repaglinide…
Yesterday, the U.S. Supreme Court held that reverse payments in Hatch-Waxman disputes including may violate federal antitrust laws, and that the traditional “rule-of-reason” will govern the determination. In the 5-3 decision, the Court reversed the Eleventh Circuit decision that reverse payments are not subject to federal antitrust laws because they fall within the exclusionary rights…
The day has finally arrived where the full Federal Circuit will reconsider the precedent established in Cybor Corp. v. FAS Technologies Inc. In the 1998 case, the Federal Circuit established that claims construction rulings must be reviewed de novo on appeal and no deference is given to the district court. This might result in a new standard…