News & Analysis as of

Biotechnology

BIO Announces 2017 Rosalind Franklin Award Winner

by Bergeson & Campbell, P.C. on

On June 14, 2017, the Biotechnology Innovation Organization (BIO) announced that biotech industry veteran Vonnie Estes would receive the 4th annual Rosalind Franklin Award for Leadership in Industrial Biotechnology. Estes, an...more

NCGA Launches The “Consider Corn Challenge”

by Bergeson & Campbell, P.C. on

On June 7, 2017, the National Corn Growers Association (NCGA), along with innovation facilitator NineSigma, announced the launch of a global competition to identify new and innovative uses for corn as a renewable feedstock...more

Joint Venture to Open Biosimilar Lab in Brazil

by Goodwin on

PlantForm Corporation, a Canadian biotech firm, has announced that it will begin construction this summer on a new biopharmaceutical lab in Rio de Janeiro with its partner, Brazil-based Axis Biotec Brasil. According to...more

What does Brexit mean for life sciences companies in the EU and UK?

by Hogan Lovells on

Life sciences companies in both the EU and the UK are beginning to speculate on what Brexit will mean for business. In this video, Elisabethann Wright, partner, and Jane Summerfield, counsel, in our European Life Sciences...more

BIO International Convention 2017 Preview

BIO and the Microbiome - The 2017 BIO International Convention begins this week in San Diego. This convention has become an important destination for all organizations working in the biotechnology space, but the large...more

Global Patent Prosecution Newsletter - June 2017

Revocation Proceedings Around the World - Mechanisms to challenge the validity of granted patents are available in many countries throughout the world. The June 2017 issue of Sterne Kessler’s Global Patent Prosecution...more

Humira Patents Invalidated in Inter Partes Reviews

by Morgan Lewis on

AbbVie’s arguments raised in a prior IPR were key to the PTAB’s finding of no commercial success. The Patent Trial and Appeal Board (PTAB) found all of the claims of three AbbVie Biotechnology Ltd. (AbbVie) patents...more

The Age of Competition - The Supreme Court Decides the First BPCIA Case

by King & Spalding on

In a landmark ruling for the biotech and pharmaceutical industries, a unanimous Supreme Court decided Sandoz Inc. v. Amgen Inc., 582 U.S. ____, Nos. 15-1039, 15-1195 (June 12, 2017), its first biosimilar case governed by the...more

Deinove Announces Partnership With Flint Hills Resources For Biobased Animal Feed

by Bergeson & Campbell, P.C. on

On May 31, 2017, Deinove, a biotech company focused on producing high-value compounds from rare bacteria, announced the beginning of the second phase of a project with Flint Hills Resources to develop a nutritional supplement...more

FDA Begins Reorganization that Will Affect How it Regulates Medical Technology

by Hogan Lovells on

What impact will the U.S. Food and Drug Administration’s significant reorganization efforts have on how the agency regulates medical technology? The agency is reorganizing the Office of Regulatory Affairs (ORA) and combining...more

Relocation of the EU Medicines Agency – Spain

by Hogan Lovells on

"Spain is waiting for the EMA. Barcelona is ready". With this conviction, and with the conviction that everything is ready, the Spanish Minister for Health addressed the European Commissioner for Health & Food Safety, Mr...more

DOE Extends Abstract Submission Deadline For Annual Bioeconomy Conference

by Bergeson & Campbell, P.C. on

On May 18, 2017, the Department of Energy (DOE) announced that the abstract submission deadline for its tenth annual Bioeconomy 2017: Domestic Resources for a Vibrant Future conference has been extended. Abstracts for the...more

Why Design Patents Are Surviving Post-Grant Challenges

As of January 2017, the institution rate for Patent Trial and Appeal Board trials involving design patents was 37 percent. That is significantly lower than every other technology area and makes design patents the only...more

Maine Senate Approves Bill To Support Bioplastics

by Bergeson & Campbell, P.C. on

On May 2, 2017, the Maine Senate approved a bill to support Maine’s emerging biobased products industry. An Act to Improve the Ability of Maine Companies to Manufacture and Market Bioplastics (LD 656) would provide the Maine...more

USPTO Files Response Brief in In re Janssen Biotech, Inc. & New York University

The U.S. Patent and Trademark Office has now filed its response brief in In re: Janssen Biotech, Inc., New York University, No. 2017-1257 (Fed. Cir.), the Federal Circuit appeal involving U.S. Patent No....more

April 1, 2017 Revision of Chinese Patent Examination Guidelines may be Good News for Patentees

With continued extraordinary growth, including a record number of patent applications filed in a single year[1], the importance of intellectual property rights in China is undeniable. And so, all eyes are on the recent...more

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

by Bergeson & Campbell, P.C. on

TSCA/FIFRA - Lynn L. Bergeson, Environmental Quality Management, Winter 2016: On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The law substantially...more

21st Century Cures: What's In the Box?

by Mark Mansour on

One of FDA’s most important tasks in the coming months will be the implementation of the 1,000 page long 21st Century Cures bill, enacted last year. We have assembled a quick, bullet-pointed summary of some of the major...more

UK Government Given Additional Powers to Control NHS Medicine Prices

by Hogan Lovells on

The new Health Service Medical Supplies (Costs) Act 2017 came into force on 27 April 2017, giving the Department of Health greater powers to control the cost of medicines supplied to the National Health Service (NHS)....more

How Washington Can Help Biotechs

by Mark Mansour on

Biotechnology companies are making daily breakthroughs in understanding genetic and biomolecular causes of disease, and are committed to developing the next generation of medicines to transform patient care. It has been...more

Relocation of the EU Medicines Agency – Germany

by Hogan Lovells on

"EMA" and "gErMAny" – far more in common than mere letters - The European Medicines Agency (the "EMA"/"Agency") has reached celebrity-style status in the aftermath of the Brexit vote, and is being wooed by most European...more

In Helsinn Healthcare, the Federal Circuit Offers Guidance on the On-Sale Bar under the AIA

by Knobbe Martens on

The sale of a product prior to filing a patent application, or “on-sale bar,” has long been a potential barrier to obtaining a patent in the United States. Especially in the biotechnology space, which can involve a long...more

AkzoNobel Announces Finalists For Imagine Chemistry Start-Up Challenge

On April 21, 2017, AkzoNobel announced the 20 finalists for its Imagine Chemistry initiative. The initiative, which was launched earlier this year as reported in the Biobased and Renewable Products Advocacy Group’s (BRAG®)...more

Breaking Down Barriers Between Pre-clinical and Clinical Adoption of Personalized Medicine

by Foley & Lardner LLP on

Personalized medicine will change how health care is delivered and disease is prevented and treated. But first, how disease and health is defined, as well as the clinical development and adoption of new therapies must align...more

How Pharma, Biotech and Medical Device Companies Can Protect Against Product Liability Lawsuits

by Mark Mansour on

Among the many concerns manufacturers of therapeutics face is that of product liability lawsuits. While it is difficult to entirely eliminate the risk, there are steps companies can take to minimize it. Here are a few...more

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