Biotechnology

News & Analysis as of

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

20th Annual Presidential Green Chemistry Challenge Awards Highlight Biomass- And Waste-To-Resource Technologies

On July 13, 2015, the U.S. Environmental Protection Agency (EPA) announced the winners of the 20th Annual Presidential Green Chemistry Challenge Awards (PGCCA) and honored them at a ceremony at the National Academy of...more

The Patchwork Solidifies: GMO Bill Moves Forward in the House

The proposed Federal regulation of GMOs is proceeding. Following the White House’s recent action on GMOs, Representative Pompeo’s “Safe and Accurate Food Labeling Act” (H.R. 1599) was passed by the House Agriculture Committee...more

White House And Agencies Release Coordinated Biotechnology Regulatory Framework

With little fanfare or advanced notice to the general public, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the...more

GMOs in the Hotseat: White House to Overhaul Regulatory Framework on Biotechnology

Last week, the White House waded into the GMO regulatory fray with the Office of Science and Technology Policy’s (OSTP) announcement of a major overhaul of GMO regulation. In a statement released July 2, OSTP noted that...more

Pharmaceutical IP and Competition Law in Australia: Overview

Conditions and legislation Australian patent law is governed by the Patents act 1990 (Cth) (Patents Act). The Patents Act provides for the grant of two main types of patents in Australia: - Standard, which is...more

Federal Circuit’s Latest Patent Subject Matter Decision in Ariosa v. Sequenom Renders Many Biotech Patents at Risk

On June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., finding that Sequenom’s patent claiming methods of using cell-free fetal DNA (“cffDNA”) for prenatal diagnosis test is...more

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