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The United States’ First-Ever Biosimilar Reaches the Market

Today, Sandoz (a Novartis subsidiary) launched the first biosimilar approved under the BPCIA: the cancer drug Zarxio (filgrastim-sndz), which is a biosimilar version of Amgen’s Neupogen. The launch follows the Federal...more

Recent Cases Consider Patent Eligibility Under Mayo/Alice “Two-Step” Test: Invoking Routine and Conventional Elements Is Not...

In a series of cases addressing whether inventions are eligible for patent protection under 35 U.S.C. § 101, the U.S. Supreme Court has adopted a two-step analysis. Two recent decisions by the U.S. Court of Appeals for the...more

Federal Circuit Finds Revolutionary Non-Invasive Fetal DNA Test Method Unpatentable Under Mayo

On June 12, 2015, in Ariosa Diagnostics, Inc. et. al. v. Sequenom, Inc. et. al., the Court of Appeals for the Federal Circuit invalidated claims in U.S. Patent 6,258,540 directed to methods for detecting paternally inherited...more

U.S. Appeals Court Finds Prenatal DNA Test Unpatentable

The United States Court of Appeal for the Federal Circuit in the District of Columbia came down with another blow for the patentability of biotech testing products on Friday, June 12, 2015. The Court affirmed the 2013...more

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

IP Newsflash - June 2015

FEDERAL CIRCUIT CASES - CAFC: If (No Factual Findings), Then (No Deference) - Two days ago, on remand from the U.S. Supreme Court, the Federal Circuit in Shire v. Watson again affirmed its reversal of the...more

North Carolina Business Court Holds Pleading Stage Too Early to Dismiss Broad Non-compete

On May 7, 2015, Judge Gregory McGuire of the North Carolina Business Court denied defendants’ motion to dismiss a claim that a physician’s assistant breached non-competition and non-solicitation provisions in her employment...more

Biosimilar Makers Turn to IPRs before Litigation under the BPCIA

A number of biosimilar makers have turned to inter partes review (IPR) proceedings in order to litigate the validity of patents that cover their proposed products prior to submission of their biosimilar applications to FDA. ...more

Amgen Wins Injunction against Neupogen® Biosimilar Pending Appeal

The Federal Circuit has granted Amgen’s emergency motion for an injunction against Sandoz, preventing that company from marketing, selling, offering for sale, or importing into the United States its FDA-approved ZARXIO®...more

Federal Circuit Grants Injunction Keeping Sandoz’s Biosimilar Version of Neupogen Off Market Until Appeal Decided

The Federal Circuit yesterday granted Amgen’s motion for a preliminary injunction to keep Sandoz’s biosimilar form of Neupogen off the market until the Court renders its decision on the merits of the appeal. The parties had...more

Otsuka’s Orphan Drug Exclusivity Claims: FDA Rips Off the Band-Aid Early

On April 20, 2015, FDA filed a brief in Opposition to Plaintiff’s Motion for Temporary Restraining Order (“TRO”) or Preliminary Injunction (“PI”), addressed how Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical...more

Amicus Briefs on Biosimilar Patent Litigation

Amgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. The appeal is on an expedited briefing schedule at the Federal...more

In Non-precedential Case, Third Circuit Affirms Fracking Trade Secrets Trump Physician’s Right to Know, Absent Actual Harm

Fracking in Pennsylvania continues to create work for the courts. On March 16, 2015, in a non-precedential opinion in Rodriguez v. Secretary of Pennsylvania Environmental Protection of PA et al., the Third Circuit issued a...more

N.D. Cal Interprets the Biological Price Competition Act

Amgen Inc., et al. v. Sandoz Inc., et al., No. 14-cv-04741RS - On March 19, the Northern District of California became the first court to interpret two key provisions of the Biological Price Competition Act: whether...more

Biosimilars in the US: still at the starting line?

Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2009 to create a framework for the introduction of biosimilar and interchangeable drugs into the US market. Like the predecessor Hatch-Waxman Act,...more

Can Digital Healthcare Innovation Be Patented? Eligibility of Digital Healthcare Technologies Under the New USPTO Eligibility...

Digital healthcare, the confluence of digital technology with medical and other biological fields, has become an ever-increasing presence in our daily lives. Ideas that seemed nearly impossible just a few years ago (such as...more

News from Abroad: Research Exemptions and Active Ingredient Manufacture

After a series of papers, reports and consultations on the scope of the research exemptions to patent infringement stretching over 10 years, section 60 of the Patents Act 1977 was finally amended on 1 October 2014 by the...more

Another Patent Challenge for Personalized Medicine

The U.S. Supreme Court’s recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles...more

Dr. Reddy’s Laboratories Settles on Eve of Trial – Agrees to Cooperate with Plaintiffs

Much has happened since our last post on the Nexium “pay for delay” class action lawsuit. Jury selection began in the District of Massachusetts on Monday, October 20, 2014. The day prior, one of the generic drug makers, Dr....more

Beginning the Patent Process

The second step in bringing your medical device to market is to understand whether you can protect your invention. This article is part two of a series that presents the three big issues in intellectual property: Do...more

Patent-Eligibility of Stem Cells Under New USPTO "Myriad-Mayo" Guidance

In March, the U.S. Patent and Trademark Office (USPTO) implemented new procedures to address whether inventions that relate in whole or in part to laws of nature and naturally occurring products are patent-eligibility in...more

Mayo, Myriad, and Multi-factor balancing tests

Updated subject matter eligibility guidance from the USPTO - On the same day that the Supreme Court’s opinion was handed down in Assoc. for Mol. Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), the U.S. Patent...more

Genentech’s Distribution of Prescribing Information to Physicians is Alleged to Infringe Method Patent

On January 31, 2014, Phigenix, Inc. (“Phigenix”) filed a lawsuit in federal district court in Georgia alleging that the sale and use of the drug Kadcyla by Genentech, Inc. (“Genentech”) infringed U.S. Patent No. 8,080,534B2,...more

Computer-Aided Selection Method Fails Patent-Eligibility

In SmartGene, Inc. v. Advanced Biological Labs., S.A., No. 2013-1186 (Fed. Cir., Jan. 24, 2014), the Federal Circuit held that a patent claiming the use of a computer to implement routine mental information-comparison and...more

News from Down Under -- High Court of Australia Confirms That Claims to Methods of Medical Treatment Are Patentable in Australia

In the decision of Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50 (order), the High Court of Australia, Australia's supreme court, confirmed that methods of medical treatment are a "manner of manufacture" and...more

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