Federal Circuit Extends Biologic Exclusivity by 180 Days Gives Biosimilars A Choice Whether to Disclose Product Information Required by the BPCIA

Declaratory Judgement, FDA

The Federal Circuit handed down a decision interpreting the Biologics Price Competition and Innovation Act (BPCIA) in a way that effectively grants branded biologics an additional six months of exclusivity.  However, in a win for biosimilar applicants, the Federal Circuit also held that the statutory directive to disclose abbreviated application and manufacturing information to the…

Federal Circuit Narrows “Factual Findings” Requiring Deference During Claim Construction

Claim Construction, Uncategorized

The Disposition:  On remand from the Supreme Court, the Federal Circuit affirmed its earlier decision finding the claims of Teva’s Orange Book patent for Copaxone invalid as indefinite.  See Teva Pharmaceuticals USA, Inc. et al. v. Sandoz, Inc. et al., No. 12-1567 (June 18, 2015). Case History.  In its initial review, the Federal Circuit reversed…

Patent Eligible Subject Matter After Mayo: Federal Circuit Invalidates Diagnostic Test Patent

Declaratory Judgement, Uncategorized

Last week, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a district court finding that the asserted claims of a prenatal diagnostic testing method patent are not directed to patent eligible subject matter and are therefore invalid under § 101. The Patent. The patent at issue (the ‘540 patent) involves a technology…

Federal Circuit Finds a Role for Extrinsic Evidence Post-Teva

Claim Construction, Invalidity, Non-infringement, Uncategorized

Last week, in Virginia Innovation Sciences (“VIS”) v. Samsung, the Federal Circuit provided some indication of the circumstances under which it would defer to a district court’s evaluation of extrinsic evidence in the post-Teva world.  We have previously written about the Supreme Court’s 2015 Teva v. Sandoz opinion, which overturned long-standing precedent, holding that while…

Supreme Court Holds Good-Faith Belief of Invalidity Not a Defense to Induced Infringement

Inducement, Infringement, Invalidity, Supreme Court

The Ruling. In a 6-2 decision issued Tuesday, the Supreme Court once again disagreed with the Federal Circuit and held that a defendant’s good-faith (but incorrect) belief that a patent is invalid is not a defense to an induced infringement claim. Commil USA, LLC v. Cisco Sys., Inc., No. 13-896. The Court also affirmed that induced…

Second Circuit Addresses Product-Hopping and Requires Branded Company to Continue Selling Product with Expiring Patent Protection

Strategy, Uncategorized

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…

Federal Circuit Clarifies Scope of § 271(e) Safe Harbor in Classen v. Elan

ANDA Litigation, Appeal, FDA, Non-infringement

In Classen Immunotherapies, Inc. v. Elan Pharms., Inc., the Federal Circuit determined that an NDA-holder’s post-approval activities fall within the scope of the § 271(e) safe harbor.  2015 U.S. App. LEXIS 7854 (Fed. Circ. May 13, 2015).  Specifically, 35 U.S.C. § 271(e)(1) exempts activities reasonably relating to developing clinical data on an approved drug and submitting that…

Federal Circuit Discounts Commercial Success Evidence Even Though Alleged Invention Helped Secure Regulatory Approval

ANDA Litigation, Obviousness

Last Thursday, in its decision in AstraZeneca LP v Breath Ltd., the Federal Circuit affirmed Breath Ltd.’s Paragraph IV ANDA challenge of AstraZeneca’s Orange Book patent covering sterile budesonide compositions.  It was undisputed that those of ordinary skill in the art would have been motivated to pursue a sterile budesonide composition, limiting the obviousness dispute…

Court Permits FDA to Carve Out Indications, Despite Brand Name’s Orphan Drug Status

ANDA Litigation, FDA

A United States District Court has decided generic versions of aripiprazole (Abilify®) may proceed to market despite the brand name drug’s orphan drug status.  On April 28, 2015, the FDA approved four generic versions of aripiprazole (Abilify®), which is marketed and sold by Otsuka America Pharmaceutical, Inc.  Otsuka sought a temporary restraining order that would…