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In re BRCA1- and BRCA2-based Hereditary Cancer Test Patent Litigation (Fed. Cir. 2014)

In a decision that will surprise no one (written by Judge Dyk, which made the conclusions foregone from the first page of the opinion), the Federal Circuit today affirmed the Utah District Court's decision denying Myriad...more

12/18/2014 - Multidistrict Litigation Myriad Patent Litigation Patents Popular Preliminary Injunctions

Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y....

Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more

12/15/2014 - Biologics Biologics Price Competition and Innovation Act of 2009 Biosimilars FDA Intellectual Property Litigation Life Sciences Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Prescription Drugs

Japanese Foundation for Cancer Research v. Lee (Fed. Cir. 2014) - When you file a disclaimer, you'd better mean it

The Federal Circuit reversed a District Court decision this week in a case involving an improperly filed statutory (terminal) disclaimer, in Japanese Foundation for Cancer Research v. Lee. Caught between miscommunication...more

12/12/2014 - Patents Terminal Disclaimer

Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc. (Fed. Cir. 2014)

That it is more difficult today to be a patentee able to defend her patent rights than any time since the 1940's is nicely illustrated by the Federal Circuit's decision in Par Pharmaceutical, Inc. v. TWI Pharmaceuticals,...more

12/4/2014 - ANDA Par Pharmaceutical Patent Litigation Patents Pharmaceutical Manufacturers Pharmaceutical Patents

How the Kirtsaeng Decision Could Ruin the U.S. Branded Drug Industry

The Constitution gives Congress the power to grant copyright and patent protection in the same part of Article I, specifically in Section 8, Clause 8...more

11/26/2014 - Books Canada Copyright Copyright Infringement DOHA Exports FDA First Sale Doctrine Generic Drugs Imports International Treaties Medicaid Medicare Patents Pharmaceutical Patents Popular WTO

Genetic Technologies Ltd. v. Laboratory Corp. of America Holdings (D. Del. 2014)

Another district court (actually, a magistrate judge) has succumbed to the siren song, or drank the Kool-Aid, or (fill in your favorite Apocalyptic metaphor here) of applying the Supreme Court's Mayo v. Prometheus decision in...more

11/25/2014 - CLS Bank v Alice Corp Mayo v. Prometheus Patent Litigation Patent-Eligible Subject Matter Patents Section 101

Ariosa v. Sequenom -- Ariosa's Responsive Brief

The Federal Circuit heard oral argument in the Ariosa v. Sequenom case last Friday, and a discussion of that argument will be posted in due course. Having posted on Sequenom's opening brief and the amicus brief filed by BIO,...more

11/12/2014 - AMP v Myriad DNA Genetic Materials Patent Infringement Patent Litigation Patents Sequenom

Lex Machina Looks at ANDA Cases

Lex Machina, a commercial venture spinning out of the "quantitative statistics" trend in patent scholarship popularized by Mark Lemley, Kimberly Moore, David Schwartz, and others, has released a Report on ANDA litigation that...more

11/6/2014 - ANDA FDA Generic Drugs Information Reports Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents

President and Fellows of Harvard College v. Lee (Fed. Cir. 2014)

One of the most iconic inventions of the biotechnology era is the "Harvard Oncomouse" invented by Philip Leder and Timothy Stewart in the early 1980's. One of the first transgenic mice transformed with DNA encoding something...more

10/30/2014 - Biotechnology Harvard University Inter Partes Reexamination Patent Infringement Patent Litigation Patents Pharmaceutical Patents

GPhA Issues Statement Regarding Proposed IP Provisions of Trans-Pacific Partnership Agreement

The Generic Pharmaceutical Association (GPhA) issued a statement today regarding ongoing talks between major Pacific Rim countries (including the U.S.) related to the proposed Trans-Pacific Partnership Agreement. This trade...more

10/24/2014 - Distributors Drug Distribution Generic Drugs Manufacturers Patents Pharmaceutical Manufacturers Pharmaceutical Patents Trans-Pacific Partnership

The Indefiniteness of What is "Routine, Well-understood and Conventional" in Assessing Patent Eligibility of Diagnostic Method...

Castigating the Supreme Court, at least in patent circles, has become as prevalent as the Court's forays into patent law have been to overrule the Federal Circuit. While even those who give the Court the benefit of the doubt...more

10/21/2014 - Diagnostic Method Patent Infringement Patent Litigation Patent-Eligible Subject Matter Patents

Amgen Poised to Enter Biosimilars Market

As reported in Fierce Biotech earlier today, Amgen announced the results of a Phase III clinical trial of its biosimilar drug (designated ABP 501) for moderate-to-sever plaque psoriasis conducted in comparison with adalimumab...more

10/9/2014 - Amgen Biosimilars Biotechnology Patent Litigation Patents

Federal Circuit Argument in Myriad Appeal Scheduled

The Federal Circuit has scheduled oral argument in Myriad Genetics' appeal of denial earlier this year by the Utah District Court of its motion for preliminary injunction against Ambry Genetics....more

9/26/2014 - Ambry Appeals Myriad Myriad v Ambry Patent Infringement Patent Litigation Patents

In re Lipitor Antitrust Litigation (D.N.J. 2014)

In the lastest instance of a plaintiff attempting to extend the Supreme Court's holding in FTC v. Actavis that "reverse payment" settlement agreements in ANDA litigation could be anticompetitive and violate the antitrust...more

9/25/2014 - ANDA Antitrust Investigations Antitrust Provisions Class Action Complex Litigation Generic Drugs Motion to Dismiss Patent Litigation Patents Pfizer Pharmaceutical Pharmaceutical Patents Settlement Sherman Act

PTAB Decides Inter Partes Review of Patent at Issue in Ariosa v. Sequenom

On September 2nd, the Patent Trial and Appeals Board (PTAB) entered judgment in an inter partes review styled Ariosa Diagnostics v. Isis Innovation Ltd. (IPR 2012-00022). The Board found that Ariosa demonstrated, by a...more

9/16/2014 - Inter Partes Review Proceedings Patent Infringement Patent Litigation Patent Trial and Appeal Board Patents USPTO

Federal Trade Commission "Meets the Press"

Federal Trade Commission Chairwoman Edith Ramirez and Debbie Feinstein, Director of the Commission's Bureau of Competition, held a thirty-minute press conference on Monday to discuss the latest foray in the Commission's...more

9/10/2014 - AbbVie Federal Trade Commission Act FTC FTC v Actavis Generic Drugs Media Pharmaceutical Pharmaceutical Manufacturers SCOTUS Teva Pharmaceuticals

Ferring B.V. v. Watson Laboratories, Inc. (II) (Fed. Cir. 2014)

In the second of a pair of decisions issued last Friday, styled Ferring B.V. v. Watson Laboratories, Inc., the Federal Circuit affirmed a finding by the District Court that the generic ANDA challenger had not shown the...more

9/2/2014 - ANDA Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Patents

Ferring B.V. v. Watson Laboratories, Inc. (I) (Fed. Cir. 2014)

In the first of a pair of decisions issued last Friday, Ferring B.V. v. Watson Laboratories, Inc., the Federal Circuit affirmed a finding by the District Court that a generic company could moot ANDA litigation by amending its...more

8/29/2014 - ANDA Generic Drugs Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents

MBHB Snippets: Review of Developments in Intellectual Property Law - Summer 2014 - Vol. 12, Issue 3

In This Issue: - The Analysis for Design Patent Infringement Post-Egyptian Goddess - Supreme Court Issues Decision in Alice Corp. v. CLS Bank - Capitol Records, LLC v. Pandora Media, Inc.: Future of...more

8/27/2014 - Capitol Records CLS Bank v Alice Corp Copyright Design Patent Digital Media Music Industry Pandora Patent Infringement Patent Litigation Patents Prior Art SCOTUS

Supreme Court Issues Decision in Alice Corp. v. CLS Bank

There's an old saying that “bad facts make bad law,” acknowledging that a court's decisions regarding extreme cases can result in law poorly adapted to less extreme cases. The Supreme Court's recent trio of 35 U.S.C. § 101...more

8/25/2014 - Alice Corporation CLS Bank CLS Bank v Alice Corp Kappos Mayo v. Prometheus Patent Infringement Patent Litigation Patents SCOTUS

Top NIH-funded U.S. Universities 2014

On Monday, Genetic Engineering and Biotechnology News (GEN) published a list of the Top 50 NIH-funded U.S. universities in fiscal year October 1st – September 30th. Geographically, California leads the list of most Federal...more

8/22/2014 - Federal Funding NIH Research Funding Universities

Domestic Cat Genome Sequenced

Earlier this month, an international effort* led by Stephen J. O'Brien at the Oceanographic Center, Nova Southeastern University, Ft. Lauderdale, Florida reported the complete genomic sequencing of the domestic cat, Felix...more

8/21/2014 - DNA Genetic Materials

Apotex Inc. v. UCB, Inc. (Fed. Cir. 2014)

Last week, the Federal Circuit affirmed a finding of inequitable conduct in Apotex v. USB, a relatively rare occurrence in the years after the Federal Circuit's decision in Therasense v. Becton, Dickenson. In the Therasense...more

8/20/2014 - En Banc Review Inequitable Conduct Patent Litigation Patents Pharmaceutical Pharmaceutical Patents USPTO

FDA Releases Another Prospective Guidance

On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first...more

8/14/2014 - Biologics Biosimilars Biotechnology FDA Pharmaceutical PHSA Prescription Drugs

How to Protect a Product of Nature

"The more things change . . ." is the beginning of an old saw, and that saying has particular relevance just days after the USPTO stopped accepted comments on its Subject Matter Eligibility Guidance. After all, this isn't...more

8/4/2014 - DNA Patent-Eligible Subject Matter Patents Roslin USPTO

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