Germany: Life Sciences, Biotechnology & Nanotechnology

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.

European Biosimilar Updates – Formycon's Ustekinumab And Alvotech's Cetrolizumab Pegol

On June 26, 2025, Formycon AG ("Formycon") announced a distribution agreement with Teva Group subsidiary Ratiopharm GmbH ("Ratiopharm") for the semi-exclusive commercialization...

Germany Healthcare

GP

Goodwin Procter LLP

Nordic-Baltic Regional Division, July 21, 2025, Decision In First Instance, UPC_CFI_380/2023

The importance of the patent claims means, inter alia, that a narrowing interpretation of the claims which deviates from the broader general understanding of the terms used therein by the person...

BP

Bardehle Pagenberg

Konsultation der EU-Kommission zu Hochrisiko-KI-Systemen: Kernpunkte für den Life Sciences- und Health Care-Sektor

Am 6. Juni 2025 hat die Europäische Kommission eine Konsultation zur Einstufung und Regulierung von Hochrisiko-KI-Systemen im Rahmen der...

Germany Technology

GT

Greenberg Traurig, LLP

EU Commission Consultation On High-Risk AI Systems: Key Points For Life Sciences And Health Care

On 6 June 2025, the European Commission launched a targeted stakeholder consultation on the classification and regulation of high-risk artificial intelligence (AI) systems under the EU Artificial Intelligence Act (AI Act).

European Union Healthcare

GT

Greenberg Traurig, LLP

Second Medical Use Claims In The UPC System: Prerequisites And Mechanism Of Examination For Infringement

Germany Healthcare

BP

Bardehle Pagenberg

New German Government: Key Plans For The Life Sciences And Healthcare Sector

Germany Healthcare

AO

A&O Shearman

New CJEU Ruling On The Borderline Between Medicinal Products And Medical Devices: Key Takeaways

Germany Healthcare

AO

A&O Shearman

The CJEU Issues New Ruling On Advertising Of Medicinal Products

Germany Media & IT

P

Plesner

RD Nordic-Baltic, January 21, 2025, Procedural Order On Costs For Access To Pleadings And Evidence, UPC_CFI_380/2023

BP

Bardehle Pagenberg

Key Regulatory Changes Impacting The Healthcare Industry In The EU And Germany In 2025

European Union Healthcare

AO

A&O Shearman

CD Paris, 23 September 2024, Public Access To File, UPC_CFI_189/2024

European Union IP

BP

Bardehle Pagenberg

EU Parliament Adopts SPC Reform Proposals: Clarifying The Protection Scope For Biologics

European Union IP

JD

Jones Day

Dynamic German Cannabis Market: Rising Medical Use Today | Recreational Use Tomorrow

Germany Cannabis

GL

Gleiss Lutz

The Digital Act: A Boost For Digitalisation In German Healthcare

Germany Healthcare

GL

Gleiss Lutz

Second Medical Use Claims At The UPC: What Are The Infringement Prerequisites And Legal Standards? (Video)

BP

Bardehle Pagenberg

Focus IT&C – 2nd Quarter 2025

European Union Privacy

OP

Oppenhoff

The Silent Epidemic: Infostealers And The Evolution Of Cybercrime In 2025

Germany Technology

AC

Ankura Consulting Group LLC

Ensuring „Accessibility" – New Legal Requirements For Many Products And Services From June 29, 2025

Germany Commercial

SZ

SZA Schilling, Zutt & Anschütz

Together Or Alone? The Unexplored Potential Of Caucus In The German Mediation Landscape

Germany Litigation

PL

PwC Legal Germany

Bundestag Debates Government Bill On Medicines Shortage

In a move to tackle the severe shortage of medicines, the German Federal Government has adopted the draft Act to Improve the Supply of Medicines and Avoid Shortages...

Germany Healthcare

GL

Gleiss Lutz

Cannabis Legalisation In Germany: What Will Change In The Medical Sector?

Not only does the Act partially legalise recreational cannabis, it also signifies important changes in the area of medical cannabis.

Germany Cannabis

GL

Gleiss Lutz

Germany As A Location For Pharmaceutical Businesses - Quo Vadis, 2024?

Unbureaucratic approvals for clinical trials with medicinal products.

Germany Healthcare

TW

Taylor Wessing PartG mbB

Trademark Protection In The Life Sciences Business - Why Start-Ups And Founders Should Take Care

For the founders of a company, their first thought is not necessarily about brand protection, most likely other issues seem to be more pressing and the approach may be...

Germany Healthcare

TW

Taylor Wessing PartG mbB

OLG Hamburg On The Inadmissibility Of Issuing Pharmaceutical Prescriptions Over The Internet

Germany Healthcare

TW

Taylor Wessing PartG mbB

Important For Start-Ups: Confidentiality Agreements And Material Transfer Agreements (MTAs)

Germany Healthcare

TW

Taylor Wessing PartG mbB

CD Munich, 27 February 2024, Order To Combine Cases In Revocation Actions, UPC_CFI_1/2023, UPC_CFI_14/202

BP

Bardehle Pagenberg

EU MDR And IVDR Implementation: New Transitional Regime Enters Into Force

European Union Healthcare

MF

Morrison & Foerster LLP

Digital Health Laws & Regulations 2023

Germany Healthcare

MW

McDermott Will & Emery

Patent Prosecution

HL

HGF Ltd

EU MDR And IVDR Implementation: European Commission Publishes Full Proposal For Amending Transitional Regime

European Union Healthcare

MF

Morrison & Foerster LLP

Expected Amendments Of The Medical Device Regulation Will Most Likely Increase The Attractiveness Of Investments In The Sector

Germany Healthcare

OP

Oppenhoff

In Vitro Diagnostic Regulation Entered Into Force (Part 2 Of 3)

European Union Healthcare

MF

Morrison & Foerster LLP

In Vitro Diagnostic Regulation Entered Into Force (Part 1 Of 3)

European Union Healthcare

MF

Morrison & Foerster LLP

EU MDR And IVDR Implementation: European Commission Publishes Full Proposal For Amending Transitional Regime

Following up on its announcement in the EU Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) Meeting, the European Commission (Commission) released on January 6, 2023...

European Union Healthcare

MF

Morrison & Foerster LLP

Expected Amendments Of The Medical Device Regulation Will Most Likely Increase The Attractiveness Of Investments In The Sector

Investments in the health care sector are very popular since the start of the COVID-19 pandemic. In Germany, there has been a particular interest in the strong German medical technology sector...

Germany Healthcare

OP

Oppenhoff

In Vitro Diagnostic Regulation Entered Into Force (Part 2 Of 3)

After having discussed the general purpose and background of the IVDR, the new definition of IVDs, and the conformity assessment in light of the new risk classification as well as the role of notified bodies...

European Union Healthcare

MF

Morrison & Foerster LLP

In Vitro Diagnostic Regulation Entered Into Force (Part 1 Of 3)

In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body,...

European Union Healthcare

MF

Morrison & Foerster LLP

Just-In-Time: Trends & Future Developments In Supply Chains - Issue 2

Germany Healthcare

MB

Mayer Brown

No Supplementary Protection Certificate For Medical Devices … At Least For Now

On 25 October 2018, the European Court of Justice ("ECJ") ruled on the Boston Scientific case (Case C-527/17)

European Union Healthcare

MB

Mayer Brown

CJEU Raises Bar For Use Of CRISPR In Europe's Agribusiness: What You Need To Know

Today, the CJEU has issued its much awaited decision on the classification of genome-editing tools such as CRISPR/Cas9, Talen or zinc finger within the framework of the EU's Directive 2001/18/EC...

European Union Healthcare

MF

Morrison & Foerster LLP

Boost For Digital Health In Germany – Restrictions On Remote Treatment Could Be Overturned In May 2018

At the next Annual General Meeting of the German Medical Association (Deutscher Ärztetag), the current restrictions on remote treatment by German physicians will most likely be overturned.

Germany Healthcare

HL

Hogan Lovells

The Medical Devices Regulation – Key Dates And Roadmap For The Implementation Of The New Rules

The Regulation (EU) 2017/745 on Medical Devices (MDR) entered into force in 2017. Although most of the provisions will only apply as of 26 May 2020, the time for impact assessments ...

European Union Healthcare

MB

Mayer Brown

Germany – A Major Hub For Patent Litigation

Germany Healthcare

RS

Reed Smith (Worldwide)

The Implementation Of The Nagoya Protocol In The EU

European Union IP

TW

Taylor Wessing

The Implementation Of The Nagoya Protocol In Germany

TW

Taylor Wessing

New Rules For Licence And Other Technology Transfer Agreements In The EU

European Union IP

MB

Mayer Brown

A Revolution of Reimbursement in Germany

Germany Healthcare

JD

Jones Day

Methods of Treatment in Europe: Patent Claims Covering Second or Further Medical Uses and Dosage Regimens

JD

Jones Day

G1/07: EPO Enlarged Board Rules on Methods of Surgery

JD

Jones Day

European Court Of Justice (Court Of First Instance): First Decision On Application Proceedings Of A Community Plant Variety Right (Decision Of November 19, 2008 – Case T–187/06 – Schräder v Community Plant Variety Office)

Germany Healthcare

BP

Bardehle Pagenberg

UPDATE: The German Plavix Case: Loopholes In European Data Protection?

Germany Healthcare

JD

Jones Day

The German Plavix Case: Loopholes In European Data Protection?

Germany Healthcare

JD

Jones Day

Overview of the 14th Amendment of the German Drug Act

Germany Healthcare

L

Lovells

Reform of European Pharmaceutical Legislation

Germany Healthcare

MB

Mayer Brown

Reach-Through and Experimental Use: Some Remarks on the Situation in Germany

BP

Bardehle Pagenberg

Licensing Of Pharmaceuticals

Germany Healthcare

BB

Boehmert & Boehmert

Will The Human Genome Soon Be Patented?

DV

Dr Volker Vossius Patent & Law Firm

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Latest Videos

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What Regulatory Challenges Are Facing The Life Sciences Sector? (Video)

WF

William Fry

Webinar Video | Lunch & Learn: Life Sciences : Morceaux Choisis

A

Altius

Webinar Video | Life Sciences Session #2: Vaccine Liability: What If Vaccination Goes Wrong?

A

Altius

Launch Of Our Medical Device Publication (Video)

WF

William Fry

Understanding Sunshine Rules: How New Transparency Regulations In Europe Are Changing Relationships Between Industry And Health Care Professionals (Video)

HL

Hogan Lovells

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