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 […]
This week, the Federal Circuit confirmed that a strong affirmative case of obviousness can overcome unexpected results in Allergan, Inc. v. Sandoz, Inc. The case involved a number of patents covering Combigan®, a combination eye-drop solution for indicated for glaucoma containing 0.2% brimonidine, an α2-agonist, and 0.5% timolol, a beta-blocker, along with benzalkonium chloride preservative, including a formulation […]
On Friday April 19 the Federal Circuit, in a divided decision, emphasized the importance of adhering to the appeal rules by establishing that if a patent infringer does not appeal a trial court’s validity decision, then that infringer/defendant cannot challenge the validity of the claims on subsequent appeals. On its face, this seems quite logical; […]
The United States Supreme Court heard oral arguments yesterday in one of the most anticipated and potentially influential biotechnology cases in decades: Ass’n for Molecular Pathology et al. v. Myriad Genetics, Inc. et al. In simple terms, at issue is whether human genes are patentable. The dispute began in 2009, when various non-profit research organizations and […]