Biotechnology

News & Analysis as of

Biotech Industry Supports Cert in Sequenom to Avert “Crisis of Patent Law and Medical Innovation”

The biotechnology and life sciences community has voiced broad support for Sequenom’s recent request that the Supreme Court review the Federal Circuit’s decision holding Sequenom’s diagnostic fetal DNA patent ineligible under...more

To be prepared is half the victory

In the second in our series of alerts relating to drug pricing, we identify several considerations and potential actions that a pharmaceutical or biotechnology company can take to address the current headwinds impacting...more

California Sues Mendota Bioenergy LLC Over $1.7 Million In Misspent Public Money

On April 8, 2016, the California State Energy Resources Conservation and Development Commission (Commission) sued Mendota Bioenergy LLC, claiming it improperly spent public money targeted for equipment purchases....more

DOE's Biotechnology Office To Announce Funding Opportunity For Bio Manufacturing

On April 15, 2016, DOE's Office of Energy Efficiency and Renewable Energy (EERE) announced a Notice of Intent (NOI) to issue a Funding Opportunity Announcement (FOA) entitled "Project Definition for Pilot and Demonstration...more

BRAG, B&C, and Industrial Biotechnology Host Bioeconomy Leaders Reception During BIO World Congress 2016

Scientists, executives, investors, and media representatives gathered in San Diego, California on Monday evening for a fascinating and wide-ranging panel discussion on current issues facing bioeconomy leaders and innovators....more

DOE Announces Upcoming International Energy Agency Webinar On Climate Impacts Of Bioenergy

On April 21, 2016, DOE and IEA Bioenergy (IEA) presented a webinar, Bioenergy - Is It Good for the Climate?, which discussed the climate benefits of bioenergy and the impact of bioenergy on atmospheric CO2 levels....more

Court Report - April 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Teva Pharmaceuticals USA Inc. et al. v. Biocon Ltd. et al. 1:16-cv-00278; filed April 19, 2015 in the District Court of...more

AGG Food and Drug Newsletter - April 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

Legislative Developments in Post-Grant Proceedings

Amidst a spate of high-profile IPR filings in the life sciences space by hedge fund financiers, the biotechnology industry has mobilized behind two chief legislative strategies designed to limit or eliminate its exposure to...more

Plastics Industry Trade Association Releases Report Simplifying Bioplastics

On April 1, 2016, The Plastics Industry Trade Association's SPI Bioplastics Division released a new report explaining and defining bioplastics....more

PTAB Statistics From Spring BIO IPCC Meeting

At the end of March, the Intellectual Property Counsels' Committee (IPCC) of the Biotechnology Innovation Organization (BIO) held its Spring meeting, convening in-house counsel and outside counsel involved in patenting the...more

DOE Announces Date Of Algal Biology Toolbox Workshop

On April 8, 2016, the U.S. Department of Energy (DOE) announced a Save the Date for the upcoming Algal Biology Toolbox Workshop. ...more

Supreme Court Asked to Clarify Limits on Diagnostic Method Patents

Arguing that the current state of the law weakens the patent system and poses a danger to life science innovators, biotechnology company, Sequenom, Inc., has filed a writ of certiorari with the U.S. Supreme Court, asking the...more

Can Science be Copyrighted? You Might be Surprised…

Biotechnology. For many, the mere mention of the word stirs up a thought of people in white lab coats working in underground bunkers trying to create superhuman mutant weapons, with beakers of green goo bubbling in the...more

3D Printing and the Renaissance of Local Economies

The rise of 3D printing holds tremendous potential to impact the economy from the local to the national level. Although it is still an estimated five to 10 years away from mainstream consumer adoption, we are already seeing...more

BETO Presents The 2016 Multi-Year Program Plan With A Focus On The Bioeconomy And Algae

On March 28, 2016, the U.S. Department of Energy's (DOE) Bioenergy Technologies Office (BETO) announced the 2016 update of the BETO Multi-Year Program Plan (MYPP). ...more

Another Diagnostic Patent Falls Under 101

In Genetic Techs Ltd v Merial LLC (Fed. Cir., April 8, 2016), the Federal Circuit invalidated yet another diagnostic patent for failing to satisfy 35 U.S.C. § 101 on the ground that the claims recite nothing more than a law...more

Methods Exploiting Junk DNA May Be Useful But Lack Patent Eligibility

Striking another blow against patent eligibility in the field of biotechnology, the Federal Circuit agreed with the district court that methods that use “junk DNA” to detect genetic variations lack patent eligibility under 35...more

SEC Charges Biotech Company and Its Officers with Misleading Investors by Failing to Disclose FDA Concerns and Recommendations

On March 29, 2016, the Securities and Exchange Commission (SEC) announced charges against a biotech company and three of its officers for securities fraud. The company has agreed to pay $4 million to resolve the charges...more

Court Report - April 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Unimed Pharmaceuticals, LLC et al. v. Amneal Pharmaceuticals, LLC 1:15-cv-00964; filed October 22, 2016 in the District...more

NAS Releases Agenda for First Future Biotechnology Products and Regulatory System Committee Meeting

On April 5, 2016, the National Academies of Science, Engineering, and Medicine (NAS) posted the Agenda for the first open session of its committee on “Future Biotechnology Products and Opportunities to Enhance Capabilities of...more

Solazyme Becomes TerraVia, Shifts Focus To Food And Specialty Ingredients

On March 11, 2016, Solazyme announced a name change to reflect a new focus on food, nutrition, and specialty ingredients instead of biofuels. TerraVia™ (TerraVia), as Solazyme is now known, will create value in plant-based...more

Iowa Senate Approves Renewable Chemical Production Tax Credit Legislation

On March 17, 2016, the Iowa State Senate voted 46-3 to approve Senate File 2300, a bill creating a production tax credit for renewable chemicals. The legislation was created to attract investment in renewable chemical...more

[Webinar] Avoiding Drug Substance Patents and Exclusivities: Prodrugs, Deuterated Drugs, and 505(b)(2) - April 14th, 9:00am...

Join Kurt Karst (Hyman, Phelps & McNamara, P.C.) (coauthor, "The FDA Blog") and Jeffrey Hovden (Robins Kaplan LLP) (coauthor, Generically Speaking) for a collaborative webinar. For generic drug companies, the biggest and...more

Sign Up For The Third And Final Public Meeting On Modernizing The Regulatory System For Biotechnology Products

On July 2, 2015, the 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 jointly issued Modernizing the Regulatory...more

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