Biotechnology

News & Analysis as of

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

White House Announces Plans To Revise the Coordinated Framework for the Regulation of Biotechnology

The White House, through the Office of Science and Technology Policy (OSTP), announced a major initiative to overhaul the regulation of biotechnology products (OSTP Memo), which are products developed through genetic...more

Biotechnology: White House Announces Effort to Modernize the Regulatory System for Biotechnology Products

In a bit of a surprise announcement, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality released...more

What Constitutes Patentable Subject Matter in Biotechnology? New Federal Circuit Decision Says “Even Less Than You Thought!”

With its recent (June 12, 2015) decision in Ariosa v. Sequenom, the Court of Appeals for the Federal Circuit affirmed the Northern District of California’s broad interpretation of the U.S. Supreme Court’s Prometheus v. Mayo...more

Biotechnology: White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology

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

Crowdfunding and IP in Health and Biotech Start-ups (Part 2): The JOBS Act

Crowd Funding ImageThis is the second in a 3-part series about the use of crowdfunding in health and biotech start-ups. We started with the story of a tech start-up which set records for funding through a Kickstarter...more

Venture Capital Coast to Coast – June 2015

As we reported in January 2015, 2014 was a banner year for venture capital on all fronts, from fundraising, to investment and exits – save, however, for the small drop in the number of deals versus the largest aggregate...more

Crowdfunding and IP in Health and Biotech Start-ups (Part 1): The Beginning

Crowd Funding ImageThis is the first in a 3-part series about the use of crowdfunding in health and biotech start-ups. We start with the story of a tech start-up which set records for funding through a Kickstarter campaign,...more

Patent for Technology that “Revolutionized Prenatal Care” Nonetheless Invalid as Patent Ineligible

The Federal Circuit Friday held in Ariosa Diagnostics, Inc. v. Sequenom, Inc. that Sequenom’s patent directed toward its MaterniT21 test—involving methods of detecting and using cell-free fetal DNA— was invalid for lack of...more

PTAB Grants Fourth Motion to Amend in an IPR Proceeding

For only the fourth time in its history, the Patent Trial and Appeal Board (“PTAB”) has granted a motion to amend in an inter partes review (“IPR”) proceeding, finding all substitute claims proposed by the patent owner...more

Patent Trial and Appeal Board Grants Rare Motion to Amend Claims in Inter Partes Review

On June 5, 2015, a three-judge panel at the Patent Trial and Appeal Board (“PTAB”), granted a motion to amend in an inter partes review (“IPR”) proceeding, ruling that the patentee Neste Oil Oyj (“Neste”) could amend the...more

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