News & Analysis as of

Biotechnology

Biotech Institute's Growing Patent Portfolio -- U.S. Patent No. 9,095,554 and the Path Forward

As with any billion dollar market, patents are an important consideration for the cannabis industry. Despite its current classification as a Schedule I drug under the Controlled Substances Act, however, the U.S. Patent and...more

Biotechnology Risk Assessment Research Grants Program Accepting Applications

by Bergeson & Campbell, P.C. on

On November 8, 2017, the U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA) issued a statement soliciting applications for its Biotechnology Risk Assessment Research Grants Program. The...more

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

by Bergeson & Campbell, P.C. on

TSCA/FIFRA - EPA Extends Comment Period For Draft Guidance For Pesticide Registrants On Notifications, Non-notifications, And Minor Formulation Amendments: On October 5, 2017, the U.S. Environmental Protection Agency (EPA)...more

Pharma and Biotech: Key Trends and Legal Risks

by Latham & Watkins LLP on

How to thrive amid uncertainty? This was the question we explored at the 35th FT Global Pharmaceutical and Biotechnology Conference. Here are five key industry trends and corresponding practical legal tips to help companies...more

Brexit Bill - Impact on patents

by Hogan Lovells on

The UK government’s draft EU Withdrawal Bill (the “Brexit Bill“) aims to incorporate EU directives and regulations into UK domestic law in their current form immediately following Brexit (“Retained EU Law“).  This article...more

New rules for expanded access in Italy

by Hogan Lovells on

Fast track for orphan diseases and rare forms of cancers - By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more

Global Patent Prosecution Newsletter - November 2017

An Update on Brazilian Patent Law – Emergency Backlog/Fast-Track Options and Enforcement Issues - We are delighted to have as contributors to the November Global Patent Prosecution newsletter, Ricardo Nunes and Andre...more

USDA Withdraws Proposed Rule on the Importation, Interstate Movement, and Environmental Release of Certain GE Organisms

by Bergeson & Campbell, P.C. on

On November 7, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a notice in the Federal Register (82 Fed. Reg. 51582) stating that it was withdrawing its January 19,...more

Senators Introduce Bipartisan Bill To Establish Renewable Chemicals Tax Credit

by Bergeson & Campbell, P.C. on

On October 18, 2017, Senator Debbie Stabenow (D-MI) introduced to the Senate the Renewable Chemicals Act of 2017 (S. 1980), which aims to establish a short-term tax credit for the production of renewable chemicals and for...more

Biotech Patent Applications May be Eligible to Receive Benefits From Ongoing USPTO Initiatives

by Knobbe Martens on

A pair of ongoing USPTO initiatives, Patents for Humanity and Patents 4 Patients, offer incentives that certain biotechnology patent applications may be eligible for. Patents for Humanity is open to patents and applications...more

Bioquark Seeks to Reverse Brain Death

Last year, two biotech companies announced that they had received institutional review board (IRB) approval for a study focused on the clinical intervention of brain death in humans. The study, entitled "Non-randomized,...more

BIO Requests Reauthorization Of Biobased Assistance Program

by Bergeson & Campbell, P.C. on

On October 19, 2017, the Biotechnology Innovation Organization (BIO), an Associate member of the Biobased and Renewable Products Advocacy Group (BRAG®), announced that it and its member companies sent a letter to the House...more

Congressmen Send Bipartisan Letter On Regulating Agricultural Biotechnology To USDA, FDA, EPA

by Bergeson & Campbell, P.C. on

On October 17, 2017, Congressman Jimmy Panetta (D-CA), Congressman Neal Dunn, M.D. (R-FL), and 77 additional House members sent a bipartisan letter to the U.S. Department of Agriculture (USDA), U.S. Food and Drug...more

FDA, USDA, and EPA to Hold Public Sessions on Agricultural Biotechnology

by Bergeson & Campbell, P.C. on

On October 25, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that the U.S. Food and Drug Administration (FDA), in coordination with the U.S. Department of Agriculture’s...more

American Process and Byogy Renewables Launch Phase 1 Of DOE-Funded Biofuels And Bioproducts Project

by Bergeson & Campbell, P.C. on

On October 9, 2017, American Process Inc. and Byogy Renewables, Inc. announced the launch of Phase 1 of its “Advanced Biofuels and Bioproducts with AVAP (ABBA)” project following the completion of negotiations with the U.S....more

FDA Announces Public Meetings and Requests Comments on Agricultural Biotechnology Education and Outreach Initiative

by K&L Gates LLP on

On October 13, 2017, the U.S. Food and Drug Administration (the “FDA”) announced in the Federal Register a notice of two upcoming public meetings and request for comments related to the initial phase of the Agency’s...more

Swissmedic updates requirements concerning the Fast-Track Authorisation Procedure

by Hogan Lovells on

On 1 October 2017, the Swiss Agency for therapeutic products (“Swissmedic”) updated its guidance document concerning the Fast-Track authorisation procedure (“FTP”). The modified guidance document replaced the formerly...more

USDA Announces $21 Million In Funding For Biobased Products

by Bergeson & Campbell, P.C. on

On September 22, 2017, the U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA) awarded six grants totaling nearly $21.1 million to support the development of new jet fuel, biobased...more

FDA Announces Meeting, Calls For Comments On FDA/USDA Agricultural Biotechnology Education And Outre

by Bergeson & Campbell, P.C. on

On October 12, 2017, the U.S. Food and Drug Administration (FDA) announced two public meetings regarding its Agricultural Biotechnology Education and Outreach Initiative. The meetings will be held in Charlotte, North...more

The Joshua Frase Foundation For Congenital Myopathy Research, Inc.

by Fox Rothschild LLP on

I recently attended the 2017 National Animal Interest Alliance (NAIA) Conference, titled “Animal Nation.” There, I heard the remarkable, heart-wrenching but uplifting story about the life of Joshua Frase and the challenges...more

A road map to life sciences M&A in the Netherlands

by Hogan Lovells on

U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions...more

The commission assessment – a decision-making aid for EMA's relocation?

by Hogan Lovells on

Last week, a staff retention survey was published, according to which certain contestants in the race for hosting the EMA were less liked by the EMA staff. And now the decision-making progress is going forward....more

European Commission adopted legal acts to improve Good Manufacturing Practices for medicinal products

by Hogan Lovells on

On 15 September 2017, the European Commission adopted two legal acts intended to update good manufacturing practice (“GMP”) requirements for investigational and authorised medicinal products in the EU. The purpose of these...more

PTAB Finds Personalized Treatment Claims Unpatentable under Mayo

On August 14, 2017, the USPTO Patent Trial and Appeal Board (PTAB) issued a decision in Ex parte Ramsey, an unfavorable decision to applicants seeking to obtain claims directed to personalized medicine inventions. ...more

Blog: Pharmaceutical and Biotechnology Industry Representatives File Lawsuit Over Nevada’s Prescription Drug Transparency Bill

by Cooley LLP on

On September 1, 2017, Pharmaceutical Research and Manufacturers of America and Biotechnology Innovation Organization (collectively “Plaintiffs”) filed a complaint (the “Lawsuit”) in the United States District Court for the...more

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