Biotechnology

News & Analysis as of

National Academies Report Finds Future Biotechnology Products May Overwhelm Agencies

On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a report entitled Preparing for Future Products of Biotechnology, prepared by the Committee on Future...more

Publish or Perish? The Balance Between Public Disclosure and IP Protection in Scientific Research

Public disclosures can destroy intellectual property rights related to the work. Scientists and their attorneys need to strike a delicate balance between competing interests. ...more

Wrap-Up of Federal and State Chemical Regulatory Developments, March 2017

TSCA/FIFRA/NTP - Lynn L. Bergeson, Charles M. Auer, and Carla Hutton, “Practitioner Insights: A Review and Analysis of TSCA Reform Provisions Pertinent to Manufacturers and Processors of Nanoscale Materials,” Bloomberg...more

NAS Issues Report on Preparing for Future Products of Biotechnology

On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) announced the release (pre-publication version) of a new report: Preparing for Future Products of Biotechnology. Pursuant to the White...more

Myths & Misconceptions of Biotech Securities Claims: An Analysis of Motion to Dismiss Results (2005-2016)

There is a common life cycle for Directors and Officers Liability for a publicly-traded biotechnology company bringing its first drug or device to the market. In the early stages, whether pre-clinical or Phase 1, there is...more

DOE Publishes Report On Biorefinery Optimization Workshop

On February 27, 2017, the U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced the publication of the Biorefinery Optimization Workshop Summary Report. The report provides an overview of the...more

Preparing Biotech Patent Applications - Ten Strategies for Success

Obtaining issued patents in the biotechnology space can be a challenge. Here is a list of ten patent strategies we recommend for biotechnology innovators to increase their odds of obtaining valuable intellectual property...more

AkzoNobel Joins Partnership To Develop Wood To Chemicals Biorefinery

On February 9, 2017, Avantium announced a partnership with AkzoNobel (a member of the Biobased and Renewable Products Advocacy Group (BRAG®)), Chemport Europe, RWE Generation, and Staatsbosbeheer to develop a reference plant...more

Relocation of the EU Medicines Agency - The Netherlands: Tulips & EMA, a Gouda combination

The EMA is looking for a new home. According to the Dutch Minister of Foreign Affairs and the Minister of Health, Welfare and Sports' formal bid, this home is where the heart of the Netherlands is. It might not have the food,...more

USDA Extends Comment Period On Biobased Product Categories For Federal Procurement

On February 21, 2017, USDA announced in the Federal Register that the comment period for the Designation of Product Categories for Federal Procurement proposed rule had been extended. The proposed rule aims to amend the...more

Supreme Court Limits Foreign Reach of the U.S. Patent Act

The supply from the United States of a single component of an invention, for assembly of the invention abroad, is not patent infringement under Section 271(f)(1) of the Patent Act. This is according to a unanimous ruling this...more

Advanced Bioeconomy Leadership Conference March 1-3, 2017, Washington D.C.

The Advanced Bioeconomy Leadership Conference 2017 (ABLC 2017) will be held March 1 - 3, 2017, at the Mayflower Hotel in Washington, D.C. ABLC is the gathering point for top leaders in the Advanced Bioeconomy -- bringing...more

Illinois State Senators Introduce Legislation To Boost Biobased Economy

On February 9, 2017, Illinois State Senators Andy Manar and Chapin Rose introduced legislation aimed at growing Illinois’ biobased economy by providing incentives under the Renewable Chemical Production Tax Credit Program...more

BIO World Congress On Industrial Biotechnology, July 23-26, 2017, Montreal, Canada

The BIO World Congress on Industrial Biotechnology brings together business leaders, investors, and policy makers in biofuels, biobased products, and renewable chemicals. The event taking place July 23-26, 2017, at the...more

HHS Overhauls the Common Rule to Enhance Protection for Human Subjects in Research

On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) issued a final rule overhauling the...more

Biotechnology Considerations for the Unitary Patent System in Light of Brexit and Other Current Developments

Written by Daniel A. Kamkar and Eric Furman, Ph.D. After the United Kingdom voted to leave the European Union, dubbed “Brexit” by the press, many have called into question whether the UK would ratify the Unitary Patent...more

AkzoNobel To Produce Biobased Polymers With Itaconix

On January 27, 2017, AkzoNobel, a member of the Biobased and Renewable Products Advocacy Group (BRAG®), signed a framework joint development agreement with Itaconix, a specialty chemicals company and U.S. subsidiary of...more

EMA pilot project on tailored scientific advice to support new biosimilars

In February 2017, the European Medicines Agency (“EMA”) will launch a pilot project to provide tailored scientific advice for the development of new biosimilars, i.e. biological medicinal products that are similar to a...more

AkzoNobel Launches Global Chemicals Start-Up Challenge

On January 16, 2017, AkzoNobel announced the launch of Imagine Chemistry, which provides start-up firms, students, research groups, and career scientists an opportunity to collaborate with AkzoNobel experts to solve real-life...more

EMA Update concerning EU Clinical Trials portal and database

Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was adopted and entered into force in 2014. The...more

White House Releases Updated Coordinated Framework for the Regulation of Biotechnology

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities...more

Your Daily Dose of Financial News

The recent US rejection of the TPP will have wide-reaching effects in Asia. Among them is the strong likelihood of 80s-style trade warring between Japan and the US....more

What Is The Trump Pharmaceutical Policy?

Pharmaceutical stocks took a hit after President-elect Trump criticized the industry during his January 11, 2017 press conference. But he also expressed support for the domestic pharmaceutical industry. What is the Trump...more

Inherent Anticipation for Biotechnology Inventions

Anticipation by inherent disclosure requires that a single prior art reference necessarily includes the unstated limitation. The unpredictable nature of biological processes means that winning summary judgment of invalidity...more

Wrap-Up of Federal and State Chemical Regulatory Developments, January 2017

TSCA/FIFRA/IRIS/NTP/TRI - EPA Promulgates Final TSCA Reporting And Recordkeeping Rule For Nanoscale Materials: After over a decade of effort, the U.S. Environmental Protection Agency (EPA) issued on January 12, 2017, a...more

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