News & Analysis as of

Precision Medicine - Even Medicare Will Pay for It!

President Barack Obama announced in his 2015 State of the Union address that he was introducing a new Precision Medicine Initiative, supported with over $200 million in the proposed 2016 federal budget. "Precision Medicine"...more

Wrap-Up of Federal and State Chemical Regulatory Developments, September 2015

EPA Releases TSCA Assessment Documents For Flame Retardant Chemicals: On August 18, 2014, the U.S. Environmental Protection Agency (EPA) released for public comment three Problem Formulation and Initial Assessment documents...more

Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: BIO and PhRMA

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted...more

Strong Support for Sequenom’s Petition for Rehearing En Banc

In Ariosa Diagnostics Inc. v. Sequenom Inc., 788 F.3d 1371 (Fed. Cir. 2015), a Federal Circuit panel held that Sequenom Inc.’s prenatal diagnosis patent claims patent ineligible subject matter under the two-step test of Mayo...more

3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles

This white paper – 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles – explores the legal ramifications and risks of the rapidly increasing use of 3D printing of medical devices. 3D...more

EPA To Hold Public Meeting on Biotechnology Algae

On August 25, 2015, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing a Public Meeting and Opportunity for Public Comment on Considerations for Risk Assessment of Genetically...more

Kyle Bass Loses Round 1 of IPR Attack Against Pharma/Biotech Patents

On August 24, 2015, the Patent Trial and Appeal Board (PTAB) declined institution of two petitions filed by Coalition For Affordable Drugs for Inter Partes Reviews (IPRs) of Acorda’s patents (U.S. Patent Nos: 8,007,826,...more

EPA Schedules Workshop on Considerations for Risk Assessment of Biotechnology Algae

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the August 25, 2015, Federal Register announcing a public meeting on September 30, 2015, to receive public input and comments on EPA's data...more

BESC Announces Microbe That Significantly Improves Isobutanol Yields

On August 14, 2015, the Department of Energy's (DOE) BioEnergy Science Center (BESC) announced the creation of a microbe that increases isobutanol yields by a factor of ten. The study, published in Metabolic Engineering,...more

Court Report - August 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Reckitt Benckiser LLC v. Dr. Reddys Laboratories, Inc. et al. 1:15-cv-04524; filed June 26, 2015 in the District Court of...more

Federal Circuit Expands Direct Divided Infringement

In an en banc, per curiam decision in Akamai Technologies, Inc. v. Limelight Networks, Inc., on remand from the Supreme Court, the Federal Circuit broadened the circumstances under which a party can be liable for direct...more

Expansion of Direct Infringement in Federal Circuit’s Akamai Decision a Big Win for Patent Holders

In a victory for holders of method patents, the Federal Circuit issued an en banc decision yesterday expanding the scope of direct infringement when multiple parties perform different steps of an invention. In its unanimous...more

The Defend Trade Secrets Act of 2015: Proposed Legislation Would Open the Federal Courthouse Door for Trade Secret...

In an era where bipartisanship is rarely on display, a group of Senators and members of the House of Representatives from both parties recently joined together to propose the Defend Trade Secrets Act of 2015 (S. 1890, H.R....more

Healthcare & Life Sciences Private Equity Deal Tracker: Metacrine Secures $36 Million in Financing

Metacrine, based in San Diego, Calif., is a biotechnology company focused on advancing research in nuclear hormone receptors for treatment of metabolic diseases originated at the Salk Institute for Biological Studies....more

Tax Credits For Renewable Chemical Production Introduced In The House

On July 29, 2015, a bill to amend the Internal Revenue Code of 1986 to provide credits for the production of renewable chemicals and investments in renewable chemical production facilities, and for other purposes (H.R. 3390)...more

EPA Posts Information on GM/Synbio Algae Project

The U.S. Environmental Protection Agency (EPA) announced last week that it is developing a project intended to support public dialog concerning the development and use of synthetic biology (synbio). EPA has oversight...more

The Upcoming Implementation of the Italian Patent Box Regime

Several press articles in recent weeks have anticipated the upcoming enactment of the Ministerial Decree which will eventually implement the Italian Patent Box regime. The Ministry of Economics and Finance announced on 29...more

Biotech-specific Subject Matter Eligibility Materials Delayed

Pursuant to the Notice published in the Federal Register today, the U.S. Patent and Trademark Office provided additional materials related to the Office's interpretation of what does (and what does not) satisfy the subject...more

Sanofi Seeks IPR of Cabilly Patent

On July 27, 2015, Sanofi-aventis U.S. LLC and Regeneron Pharmaceuticals, Inc. filed a petition for Inter Partes Review (IPR) of the “Cabilly II” patent, U.S. Patent No. 6,331,415. The Cabilly II patent granted shortly after I...more

Healthcare & Life Sciences Private Equity Deal Tracker: Oncobiologics Secures $31 Million in Financing

Oncobiologics, based in Cranbury, N.J., is a biopharmaceutical company focused on developing and commercializing monoclonal antibody biosimilar therapeutics....more

Federal Circuit Review | July 2015

Nunc Pro Tunc Assignments Insufficient To Confer Retroactive Standing - In ALPS SOUTH, LLC v. OHIO WILLOW WOOD CO., Appeal Nos. 2013-1452, 2013-1488, 2014-1147, and 2014-1426, the Federal Circuit reversed the denial of a...more

Kaneka v. Xiamen Kingdomway Group: Implicit Order Read into Method Steps of Industrial Biotechnology Patent

The Federal Circuit’s recent decision in Kaneka Corp. v. Xiamen Kingdomway Group Co. (Fed. Cir. 2015) serves as a reminder that courts may implicitly read an order into a patent’s method claim steps, even if the applicant did...more

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

Modernizing and Coordinating the Regulatory System of Biotechnology Products

On July 2, 2015, the U.S. Office of Science and Technology Policy (OSTP) of the Office of the President issued a memorandum to initiate a process to coordinate, update and modernize the federal regulatory system governing...more

How an Insufficiently Detailed Provisional Patent Application Can Hurt You

A well-intentioned decision to reduce expenses can result in a poorly written provisional patent application that actually destroys an institution’s future patent rights in an important technology. In today’s world,...more

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