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European Union › Generic Drugs › Pharmaceutical Industry

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Goodwin

Biocon Regulatory Approval Updates in the U.S. and Europe: Insulin Aspart and Denosumab

Goodwin on

On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and...more

A&O Shearman

Council position on EU pharma package adopted

A&O Shearman on

On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package’. The pharma package now moves to the next...more

Hogan Lovells

EU Pharma Law Package: Council Position on Reduction of Regulatory Exclusivity Rights

Hogan Lovells on

On 4 June 2025, the Council of the EU adopted its position on the EU Pharma Law Package legislative proposal to revise the EU’s general pharmaceutical legislation. The Council, consisting of all the 27 EU Member States and...more

McDermott Will & Schulte

European Commission Fines Teva €462.6 Million for Misusing Divisional patents and Disparaging Generic Competitors in the Copaxone...

McDermott Will & Schulte on

On October 31, 2024, the European Commission (the Commission) delivered its long-awaited decision in the Teva Copaxone case (which was published on April 8, 2025). Teva, a global pharmaceutical company, was fined EUR 462.6...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

Sheppard Mullin Richter & Hampton LLP on

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

A&O Shearman

European Commission sanctions first ever pharmaceuticals cartel and scores victory in pay-for-delay appeal

A&O Shearman on

The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...more

A&O Shearman

[Webinar] Life Sciences Series | Generics Market Entry in the EU: Key Considerations for Innovators - January 25th, 11:30 am EST

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In this episode of our Exclusively Life Sciences webinar series, our experts from our EU team will share best practices for innovators to protect their competitive advantage when generics enter the market....more

Goodwin

EMA Reports on Pilot Program on Tailored Scientific Advice for Biosimilar Development

Goodwin on

On September 30, 2021, the European Medicines Agency (EMA) released a report entitled “Tailored Scientific Advice for Biosimilar Development,” describing results from its pilot program in which biosimilar applicants were...more

A&O Shearman

Beyond “pay-for-delay” – the EU-Commission’s investigation into patent filing practices and communication measures

A&O Shearman on

On 4 March 2021, the European Commission (Commission) opened a formal investigation into alleged anti-competitive conduct by the pharmaceutical company Teva. The Commission suspects Teva of having deployed a strategy with the...more

MoFo Life Sciences

Pay-For-Delay Has A Tough (Antitrust) Time At EU Top Court

MoFo Life Sciences on

In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission (EC) and the European Courts. In two recent rulings – “Lundbeck and...more

A&O Shearman

Patent settlements and competition law – guidance from Europe’s top court

A&O Shearman on

On 25 March 2021, the European Court of Justice (ECJ) ruled for the second time on a “pay-for-delay” settlement. These are settlements of a patent dispute that involve payments or other value transfers from the originator...more

Latham & Watkins LLP

Pay-for-delay: Review of the ECJ judgment in Lundbeck (Citalopram)

Latham & Watkins LLP on

The Court of Justice of the European Union (ECJ) has confirmed that pay-for-delay agreements with generic manufacturers ready to enter the market violate EU antitrust rules. ...more

Hogan Lovells

[Webinar] Antitrust today: Emerging issues affecting the life sciences industry - March 12th, 9:00 am - 10:00 am PST

Hogan Lovells on

Join the Hogan Lovells Antitrust and Competition team on Friday, March 12, 2021 to discuss hot antitrust topics in the life sciences industry, including: - What life sciences companies should expect with respect to...more

Hogan Lovells

Nouvelle doctrine de la Commission de la Transparence de la Haute Autorité de santé

Hogan Lovells on

Dans la continuité de son Plan d’action pour les médicaments innovants exposé début 2020, la Haute Autorité de santé a mis à jour sa doctrine d’évaluation des médicaments. ...more

A&O Shearman

European Commission completes current cycle of pay-for-delay probes with fines imposed on Teva and Cephalon

A&O Shearman on

On 26 November 2020, the European Commission (Commission) issued a decision fining pharmaceutical companies Teva and Cephalon EUR60.5 million for infringing Article 101 TFEU by agreeing to delay the entry of a cheaper generic...more

Skadden, Arps, Slate, Meagher & Flom LLP

Investment in Possible Future Generic Marketing Excludes Legitimate Basis for Pharma Settlement, Suggests EU Advocate General

Skadden, Arps, Slate, Meagher & Flom LLP on

In her opinion issued on June 4, 2020, Advocate General (AG) Juliane Kokott recommended that the European Court of Justice (ECJ) dismiss in its entirety the appeal by Lundbeck A/S and Lundbeck Ltd against the General Court’s...more

Robins Kaplan LLP

Financial Daily Dose 3.3.2020 | Top Story: Promised Central Bank Action Halts Market Slide (for now)

Robins Kaplan LLP on

Despite news of additional COVID-19-related deaths and infections in America, central bankers appear to have bought at least one day of peace for US markets, which posted strong gains on a late surge on Monday, breaking a...more

Hogan Lovells

The Court of Justice of the European Union provides clarifications on the assessment under competition law of pay-for-delay deals...

Hogan Lovells on

On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more

King & Spalding

European Commission Proposal Would Make It Harder for Innovator Companies to Launch Friendly Duplicates (Biosimilars)

King & Spalding on

The European Commission ("Commission") presented the results of the stakeholders’ consultation on its "Note on Handling of Duplicate Marketing Authorisation Applications" ("Note on Duplicates") during the Pharmaceutical...more

Hogan Lovells

EU SPC Manufacturing Waiver Now in Force

Hogan Lovells on

The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469).  The Waiver has been introduced with the stated aim of putting EU generic and...more

Hogan Lovells

The Court of Justice clarifies the EU customs rules applicable to customs valuation

Hogan Lovells on

The Court of Justice of the European Union (“Court”) just released its judgement in Case C-1/18 Oribalt Riga concerning the customs valuation methodologies applicable to generic medicines in the framework of consignment...more

Hogan Lovells

EU: New developments in the SPC manufacturing waiver legislative process

Hogan Lovells on

Following the European Commission’s draft proposal for implementing the so-called SPC manufacturing waiver the Committee on Legal Affairs of the European Parliament published a draft report on presenting its suggested...more

Hogan Lovells

Updated UK “no deal” Brexit guidance on medicines, medical devices and clinical trials

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019...more

American Conference Institute (ACI)

[Event] 11th Pharma & Biotech Patent Litigation - February 26 - 27, 2019 - Radisson Blu Hotel, Amsterdam

American Conference Institute (ACI) on

The annual gathering exploring the inherently complex and continually contentious pharma and biotech patent litigation - Life Science patent litigation filings are predicted to rise at new levels. Be part of the only event...more

Jones Day

The Proposed SPC Export Manufacturing Waiver: Really a Balanced Approach?

Jones Day on

The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more

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