Supreme Court Partially Sides with FTC in Ruling that Reverse Payment Settlements in Hatch-Waxman Disputes May Violate Antitrust Laws

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 […]

Allergan, Inc. v. Sandoz, Inc.: An Incongruous Obviousness Decision?

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 […]

Appeal Everything: Remember Invalidity and Infringement are Not the Same Issue

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; […]

“What Exactly Did Myriad Invent?” A gold earring? A baseball bat? Flour? Sap?

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 […]

District Court Finds that a Defective Complaint Still Triggers a 30-Month Stay

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 […]

What’s your story ?…

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. […]

Federal Circuit Hears Argument On Allergan’s Second Attempt To Stop Generic Zymar

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 […]

An International Survey of Gene Patents

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 […]

Will the Supreme Court Review Safe Harbor Provisions for Post-Approval Activity?

Momenta Pharmaceutica and Sandoz recently petitioned the Supreme Court to review the Federal Circuit’s interpretation of the 35 U.S.C. § 271(e)(1) safe harbor provisions. The petition was filed in response to a Federal Circuit decision, issued in August 2012, overturning a Preliminary Injunction that prevented Amphastar from selling its generic version of enoxaparin, a low […]