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Cooley LLP

Janssen v. Teva: Federal Circuit Upholds Claims to Pharmaceutical Dosing Regimen, Clarifies Presumption of Obviousness for...

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On July 8, the US Court of Appeals for the Federal Circuit issued a precedential opinion in Janssen Pharmaceuticals, Inc. et al. v. Teva Pharmaceuticals USA, Inc. affirming the district court’s finding that patent claims to a...more

DLA Piper

The Federal Circuit Widens The ITC as a Venue for Life Sciences

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Federal Circuit reshapes foundational requirements for viability of a case in the ITC - Pharmaceutical and life sciences companies have historically been rare participants before the International Trade Commission (ITC) – in...more

Fish & Richardson

Federal Circuit Evaluates Enablement for Antibody Claims for the First Time Since Amgen v. Sanofi in Baxalta Inc. et al. v....

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On May 18, 2023, the Supreme Court in Amgen Inc. v. Sanofi unanimously affirmed the Federal Circuit’s holding that U.S. Patent Nos. 8,829,165 and 8,859,741 did not enable certain functional genus claims describing a class of...more

A&O Shearman

Half an hour for a bifurcation: UPC Central Division rejects preliminary objection after first oral hearing

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The decision concerns the time of filing and admissibility of a revocation action at the Central Division when a parallel infringement action is filed at a local division (Art. 33(4) UPCA). Art 33(4) UPCA states that...more

McDonnell Boehnen Hulbert & Berghoff LLP

IBSA Institut Biochimique, S.A. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2020)

The Federal Circuit has spent the past few years applying the Supreme Court's most recent precedent, Nautilus, Inc. v. Biosig Instruments, Inc., on the indefiniteness standards in the patent statute.  35 U.S.C. § 112(b).  The...more

Goodwin

Federal Circuit Hears Oral Argument in Bevacizumab Preliminary Injunction Appeal

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Today, a panel of the Federal Circuit (Judges Moore, O’Malley, and Hughes) heard oral argument in Genentech v. Amgen. The case is on appeal from the District of Delaware, where the court denied Genentech’s motion for...more

Smart & Biggar

Federal Court dismisses ViiV’s action for patent infringement re: Gilead’s BIKTARVY following summary trial on claim construction

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Update: see our article here regarding the dismissal of ViiV’s appeal. On April 6, 2020, the Federal Court granted Gilead’s motion for summary trial and dismissed ViiV’s action: ViiV Healthcare Company v Gilead Sciences...more

Smart & Biggar

First decision under amended PMNOC Regulations: Federal Court finds Amgen’s filgrastim patent obvious

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UPDATE: On November 3, 2020, the Federal Court of Appeal dismissed Amgen’s appeal. See our article here. On April 16, 2020, Justice Southcott of the Federal Court issued the first decision under the amended Patented...more

Goodwin

Federal Circuit Finds Pfizer’s RUXIENCE Plans Insufficient to Establish Standing to Appeal IPR

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On April 27, 2020, the Federal Circuit issued a non-precedential opinion ruling that Pfizer failed to establish Article III standing in a pair of IPR appeals.  At the PTAB, Pfizer had challenged the validity of Chugai’s...more

Smart & Biggar

Federal Court of Appeal dismisses Pfizer’s appeal of interlocutory decision in pregabalin section 8 case: infringement not a...

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UPDATE: On December 10, 2020, the Supreme Court of Canada dismissed Pfizer’s application for leave to appeal (Docket No. 39150)... As previously reported, Justice O’Reilly of the Federal Court granted Pharmascience’s...more

McDonnell Boehnen Hulbert & Berghoff LLP

Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020)

The latest Federal Circuit decision on subject matter eligibility in the life sciences came down (by a divided court) in favor of eligibility, in Illumina, Inc. v. Ariosa Diagnostics, Inc.  The claims at issue fell into the...more

Goodwin

BREAKING NEWS: Federal Circuit Rejects Genentech’s Bid to Block Sales of Amgen’s Trastuzumab Biosimilar

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Following the oral argument two days ago, the U.S. Court of Appeals for the Federal Circuit today affirmed the lower court’s denial of Genentech’s motion for a preliminary injunction to enjoin sales of Amgen’s KANJINTI...more

Smart & Biggar

Federal Court maintains $100M+ award in cefaclor infringement damages reconsideration decision

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On November 20, 2019, the Federal Court (FC) issued its reconsideration decision on the quantum of damages owed by Apotex for its infringement of eight Eli Lilly process patents related to the antibiotic cefaclor:  Eli Lilly...more

Goodwin

Biosimilar Appellate Update: Genentech v. Immunex, Genentech v. Amgen, Janssen v. Celltrion

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Below we provide an update on some recent developments from several biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Immunex Rhode Island, Fed. Cir. Case No. 19-2155 – briefing complete in...more

WilmerHale

Unprecedented State Law on Pharmaceutical “Reverse Payments” Goes Into Effect

WilmerHale on

A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...more

Goodwin

BREAKING NEWS: Federal Circuit Affirms Amgen’s $70 Million Damages Award Against Pfizer Unit

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This morning, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit issued a 24-page opinion affirming the district court’s judgment in favor of Amgen in its four-year long BPCIA patent ligation against...more

Smart & Biggar

Federal Court of Appeal confirms obviousness finding in section 8 bortezomib action against Teva

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As previously reported, the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of Compliance) Regulations relating to Teva’s bortezomib product (Janssen markets bortezomib as...more

Goodwin

Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

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On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen.  The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more

Smart & Biggar

Amgen not precluded by invalidity decision under pre-amended PMNOC Regulations from litigating same patent under amended...

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On October 4, 2019, the Federal Court of Appeal dismissed Pfizer’s appeal of its failed motion to dismiss Amgen’s action under section 6 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for a...more

McCarter & English, LLP

License To Sell Kills Patent: Supreme Court Holds Confidential Sales May Invalidate Patents In Helsinn Healthcare S.A. V. Teva...

Can a confidential agreement between a pharmaceutical company and a distributor constitute a patent-invalidating offer for sale of a pharmaceutical product, even if information about the product is never revealed to the...more

Knobbe Martens

Ranbaxy and AstraZeneca Prevail in Nexium® Pay-For-Delay Case

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On November 21, 2016, the U.S. Court of Appeals for the First Circuit upheld a 2014 jury verdict for AstraZeneca (AZ) and Ranbaxy regarding a 2012 payment of $700 million from AstraZeneca for Ranbaxy to abandon its challenge...more

Patterson Belknap Webb & Tyler LLP

Biosimilar Litigation Update

With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent...more

Patterson Belknap Webb & Tyler LLP

Amgen’s Federal Circuit Appeal: the Importance of Manufacturing Information to Biosimilar Litigation

Amgen has filed its appeal brief in Amgen v. Hospira, following the Federal Circuit’s denial of Hospira’s motion to dismiss the appeal for lack of jurisdiction. The appeal presents an important question for biosimilar...more

Patterson Belknap Webb & Tyler LLP

Amgen Appeals Ruling on Requirement to Produce Manufacturing Information for a Biosimilar Product under Amgen v. Sandoz

Amgen has appealed a partial denial of its motion to compel in Amgen v. Hospira, No. 15-cv-839, currently pending in the District of Delaware. The case, filed last September, concerns Hospira’s proposed biosimilar of Amgen’s...more

McDonnell Boehnen Hulbert & Berghoff LLP

MBHB Snippets: A review of developments in Intellectual Property Law - Volume 14, Issue 2 (Spring 2016)

Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more

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