Biotechnology

News & Analysis as of

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

Top 5 Patent Red Flags in Life Sciences Due Diligence

Since IP represents 75 to 90% of the value of life science transactions, due diligence is a critical component of the valuation process....more

EMA hosts workshop on adaptive pathways

On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders on the adaptive pathways approach. The aim...more

White House Announces Release of Final Update to the 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...more

The Life Sciences Report - Winter 2017

Consumer Digital Health: Market Shift Is Leading to New Opportunities - The newest wave of consumer digital health investment focuses on applications encouraging consumers to change health-related behaviors, shifting...more

Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2017

Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2017 - 2016 was full of surprises, two of which will drive much of the agenda for OCSPP during 2017. First, Congress...more

White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology

On January 4, 2016, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update). The Update to the Coordinated Framework provides a comprehensive...more

Don’t Miss These 2017 J.P. Morgan Healthcare Conference Events in San Francisco

If your work involves life sciences dealmaking, you know it’s the time of year to start firming up your plans for the week of the J.P. Morgan Healthcare Conference. In the last 10 years, the second week of January in San...more

Who Owns IP Rights in the Age of Artificial Intelligence?

AI raises issues that go to the very foundations of intellectual property law, including the economic incentive to encourage certain activities, and the “moral rights” associating with according credit to authors....more

Biotech Patent Dispute Between Academics That Is Far From Academic

On December 6, 2016, the parties to the complex and soon-to-be departed world of patent interferences orally argued their positions on motions in what has been described as the “biotech trial of the century” and as “the...more

EPO Stays Proceedings Over Patentability Of Plants And Animals

While the U.S. is still sorting out “natural products” jurisprudence under 35 USC § 101, the European Patent Office (EPO) is wrestling with the patentability of plants and animals, and has announced an immediate stay on all...more

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