A recent filing in the Eastern District of Texas highlights the importance of investigating patent ownership issues before initiating a lawsuit or as part of defending against a lawsuit. Earlier this month, accused infringer Eli Lilly filed a motion to dismiss for lack of subject-matter jurisdiction under Fed. R. Civ. P. 12(b)(1), contending that Plaintiff…
Last week the Second Circuit upheld an injunction blocking Forest Laboratories (“Forest”) from removing immediate-release Namenda (“Namenda IR”) from the market. The decision prevents Forest from effectuating a so-called “product-hopping” strategy under which it planned to stop selling Namenda IR and switch patients to its newer extended-release product, Namenda XR, prior to entry of a…
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…
A district court found that a defective complaint still a triggers 30-month stay. The District of Delaware recently issued an opinion holding that a defective complaint in which the plaintiff did not have standing could still trigger a thirty-month stay. The case arose out of Mylan’s ANDA seeking approval to manufacture a generic version of…
Every Paragraph IV certification is a potential trial. But this simple fact is often ignored until just before trial, when the attorneys rush to figure out how to present the case. The most effective and efficiently runs case, however, is one in which every aspect of the case—from beginning to end—revolves around a case story.…
The Federal Circuit recently heard oral arguments in Allergan’s appeal of its second patent infringement action seeking to preclude Apotex from launching a generic version of Zymar, a pinkeye treatment. Allergan initially sued Apotex back in 2007 under the Hatch-Waxman Act. Apotex prevailed in that action, with the District Court finding that the asserted claims…
The Supreme Court will hear oral arguments next month in Association for Molecular Pathology v. Myriad Genetics, Inc. and will consider whether to permit isolated human genes patents. Much has been written about the Myriad case, but little attention has been paid to the potential international consequences of the decision. Dissimilarities in patent rights in…