News & Analysis as of

European Commission Biotechnology

Bergeson & Campbell, P.C.

EC Publishes Communication on Biotechnology and Biomanufacturing, Announces Targeted Actions

The European Commission (EC) announced on March 20, 2024, that it has proposed a series of targeted actions to boost biotechnology and biomanufacturing in the European Union (EU). The EC states that its March 20, 2024,...more

Jones Day

Ban on European Patents for Plants Engineered by "New Genomic Techniques" Nearing Reality

Jones Day on

The European Parliament has adopted an amended European Commission proposal to regulate plants engineered using techniques such as CRISPR/Cas and ban any patenting of plants, plant parts, material, genetic information, or...more

Goodwin

European Biologics Regulatory Updates

Goodwin on

Bayer’s aflibercept 8 mg recommended for approval in Europe: On November 10, 2023, Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive...more

Jones Day

European Commission Signals Increased Scrutiny in Semiconductors, AI, Quantum Technologies, and Biotechnologies

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On October 3, 2023, the European Commission ("Commission") unveiled a list of 10 technology areas qualified as "critical" to the European Union's ("EU") economic security, out of which four (Semiconductors, AI, Quantum...more

Bergeson & Campbell, P.C.

Council of the EU Approves Conclusions on the Opportunities of the Bioeconomy

On April 25, 2023, the Council of the European Union (EU) announced that it approved the conclusions on the opportunities of the bioeconomy in light of current challenges, with special emphasis on rural areas. Using biomass...more

McDermott Will & Emery

General Court Upholds European Commission’s Power to Review Illumina-Grail Despite Untriggered Turnover Thresholds

McDermott Will & Emery on

In Illumina v Commission, the General Court has confirmed the authority of the European Commission (EC) under Article 22 EU Merger Regulation (EUMR) to examine a transaction that does not have a European dimension, but which...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Growing Competition for the World’s Most Profitable Drug as Multiple New Adalimumab Biosimilars Launch

During the first quarter of 2021, multiple companies launched adalimumab biosimilars as a growing number of biosimilar players marketed their versions of the world’s most profitable drug, Humira®, which had sales of about $20...more

Goodwin

Global Biosimilar Update

Goodwin on

The European Commission has approved mAbxience’s bevacizumab biosimilar, MB02, for marketing in Europe. As we previously reported, MB02, which will be known as Alymsys and Oyavas, is intended for the treatment of colon or...more

Bergeson & Campbell, P.C.

EC To Hold Webinar On Biotechnology IP

On May 12, 2021, from 3:30 p.m. to 5:00 p.m. (EDT), the European Commission (EC) Helpdesk will host a webinar on appropriate Intellectual Property (IP) rights for biotechnology inventions....more

Rothwell, Figg, Ernst & Manbeck, P.C.

Breaking Down Moderna’s COVID-19 Patent Pledge: Why Did They Do It?

Last month, Moderna Therapeutics, one of the global leaders in the race to produce a COVID-19 vaccine, made the following statement regarding enforcement of its patents: We feel a special obligation under the current...more

Dechert LLP

Increased regulatory scrutiny of foreign direct investments in the healthcare sector

Dechert LLP on

Key Takeaways - - Foreign Direct Investment (FDI) controls are proliferating around the globe. Since the pandemic, “health” has become a particular focus.  - Several countries have adapted their existing FDI rules, or...more

Jones Day

A Dynamic Reversal by the EPO's Enlarged Board of Appeal

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The Enlarged Board of Appeal of the European Patent Office has decided that the exclusion from patentability of essentially biological processes for the production of plants or animals now also extends to plant or animal...more

Bergeson & Campbell, P.C.

EC Launches Initiative Aimed At Connecting Stakeholders With Biobased Compounds

On April 10, 2020, the European Commission (EC) announced the launch of its new online service that connects crop and food producers with biorefineries. This European Union (EU) project aims to address food waste by enabling...more

Bergeson & Campbell, P.C.

EC To Host Webinar On Fast Pyrolysis Oil Biobased Products

The European Commission (EC) will host a webinar on biobased products developed from fast pyrolysis oil, where four companies will present their work. A technology that can convert a wide range of biomass into clean and...more

American Conference Institute (ACI)

[Event] Pharmaceutical Patent Term Extensions – The Only Specialized Forum on SPCs and Patent Protection in Europe and Around the...

This year’s C5’s Pharma Patent Term Extensions Forum arrives at a critical time for the pharmaceutical industry. Overarching developments from the Teva U.K. decision (C-121/17) to the SPC Manufacturing Waiver and the most...more

Hogan Lovells

New Brexit Q&A provides several examples in relation to the “placing on the EU market” of products including medical devices

Hogan Lovells on

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, November 2018

TSCA/FIFRA/TRI - EPA Issues Final TSCA Fees Rule: On October 17, 2018, EPA issued a final fees rule under TSCA. 83 Fed. Reg. 52694. The final rule largely tracks the proposed rule....more

Bergeson & Campbell, P.C.

EC Announces BioWatch

The European Commission (EC) announced on October 16, 2018, the launch of a new web-based tool called BioWatch. Developed by BIOWAYS, a project funded by the European Union (EU), this new tool expands BIOWAYS’ efforts in...more

Bergeson & Campbell, P.C.

European Commission Announces New Bioeconomy Strategy

On October 11, 2018, the European Commission (EC) released a statement announcing its new action plan for a sustainable bioeconomy in Europe. The new action plan, originally announced by President Juncker and First...more

Bergeson & Campbell, P.C.

AgriChemWhey To Receive €22 Million In Funding Through BBI JU

On April 26, 2018, the European Commission (EC) announced €22 million in funding though the Bio-Based Industries Joint Undertaking (BBI JU) for AgriChemWhey, a bio-economy research project aiming to convert dairy byproducts...more

Bergeson & Campbell, P.C.

JRC Extends Call to Access Its Nanobiotechnology Laboratory

As reported in our February 16, 2018, blog item, the European Commission (EC) Joint Research Center (JRC) has opened a call to access its Nanobiotechnology Laboratory. The Nanobiotechnology Laboratory features...more

Hogan Lovells

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

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

Bergeson & Campbell, P.C.

European Commission Launches Bioeconomy Knowledge Centre

On July 26, 2017, the European Commission announced the launch of the Bioeconomy Knowledge Centre, which was created by the Joint Research Centre (JRC) and the Directorate General for Research and Innovation (DG RTD) to...more

Jones Day

Clarifying or Conforming? The EPO Bows to the European Commission

Jones Day on

In December, we reported that the European Commission ("Commission") had issued an Interpretive Notice (2016/C 411/03) stating products produced by essentially biological processes should not be patentable. The notice came as...more

Bergeson & Campbell, P.C.

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

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