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Intellectual Property Protection Regulatory Requirements Regulatory Oversight

Ropes & Gray LLP

Federal Circuit Expands the Scope of Investments That Can Satisfy the ITC’s Domestic Industry Requirement—Will More Section 337...

Ropes & Gray LLP on

On March 5, 2025, the United States Court of Appeals for the Federal Circuit issued a precedential opinion that will change the way the U.S. International Trade Commission addresses the threshold “domestic industry...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2023 ITC Section 337 Year in Review: Analysis & Trends: Data and Trends: ITC Cases Instituted in 2023, Case Flow and Outcomes, and...

In comparison to prior years, the ITC had a lower case load in 2023. This does not appear to have any relationship with the average time to resolution, but it could be contributing to the ITCs increased tendency to resolve...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l February 2020 #3

LEGISLATION, REGULATIONS & STANDARDS - FDA Releases Guidance on Intentional Adulteration - The U.S. Food and Drug Administration (FDA) has released the third and final installment of its draft guidance on intentional...more

Latham & Watkins LLP

What Does Brexit Mean for the Copyright Directive in the UK?

Latham & Watkins LLP on

Companies may face a challenging regulatory environment following the EU-wide implementation of the Copyright Directive by 7 June 2021. On 21 January 2020, the UK government confirmed that the UK will not be required to...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

DSM Watch: Implementing the new Copyright Directive in France

Hogan Lovells on

The Copyright Directive (“the Directive”) came into force on 7 June 2019. Member States now have two years to implement it. Amongst the key provisions, Article 15 (former Article 11) creates neighbouring rights for press...more

Hogan Lovells

DSM Watch: EU Copyright Directive clears the finish line

Hogan Lovells on

Today the Council of the European Union adopted the EU Copyright Directive (the “Directive”), ending a negotiation process which first started with the Commission’s proposal for a new Directive in early 2016. ...more

Hogan Lovells

DSM Watch: Navigating Article 13 (now 17) of the Copyright Directive

Hogan Lovells on

On 26 March 2019 the EU Parliament voted to pass the draft Copyright Directive (“Directive”) into EU law.  After adoption by the EU Council (representatives of Member State governments) and official publication, the EP’s...more

Foley Hoag LLP - Making Your Mark

EU Parliament Approves New Copyright Rules for the Internet

We had been following on this blog the heated debates around the proposed EU Copyright Directive. These debates now belong to history since on March 27, 2019, the European parliament adopted the Directive with 348 votes...more

Hogan Lovells

Polish Patent Office publishes guidelines on new types of trademarks

Hogan Lovells on

Following the enactment of the Act amending the Industrial Property Law of 20 February 2019 which implements the Directive of the European Parliament and of the Council (EU) 2015/2436 of 16 December 2015, the Polish Patent...more

Orrick, Herrington & Sutcliffe LLP

Comment Period on Regulations Relating to Mechanical Licensing Collective Created by the Music Modernization Act

On March 13, 2019, the Copyright Royalty Judges issued regulations regarding the procedures for determination and allocation of assessments to fund the mechanical licensing collective and other amendments required by the MMA....more

Hogan Lovells

DSM Watch: EU Copyright Directive passed by European Parliament

Hogan Lovells on

Today a short time ago the EU Parliament voted to pass the draft Copyright Directive into EU law.  After adoption by the EU Council (representatives of Member State governments) and official publication, it will become EU...more

Hogan Lovells

DSM Watch: Navigating Article 13 of the Copyright Directive

Hogan Lovells on

On 13 February 2019 the Commission, the European Parliament and the Council finally agreed the text of the long-awaited draft Copyright Directive (COM(2016)593) (“Directive“). ...more

Hogan Lovells

DSM Watch: EU Copyright Directive, the big picture

Hogan Lovells on

Agreement on a compromise text for the new Copyright Directive was reached between Member State government representatives, EU Parliament representatives and the EU Commission last week. ...more

Hogan Lovells

EU Copyright Directive: Breakthrough

Hogan Lovells on

Last night the Commission, the European Parliament and the Council finally agreed the text of the long-awaited draft Copyright Directive....more

Hogan Lovells

UK implements the Trade Mark Directive

Hogan Lovells on

The Trade Mark Directive (EU 2015/2436) came into force in the UK on 14 January 2019, in the form of the Trade Mark Regulations 2018, bringing about a number of key changes to UK trade mark law. ...more

Hogan Lovells

Patents - Patent litigation - Japan

Hogan Lovells on

In Japan, the Intellectual Property High Court (IPHC) established in 2005 has jurisdiction to handle intellectual property cases as second instance, and registered IP cases appealed against trial decisions of the Japan Patent...more

Hogan Lovells

DSM Copyright Directive: a new leak reveals there is still a long way to go

Hogan Lovells on

The provisions of the Copyright Directive (COM(2016)593) are currently being discussed between the Council, the Parliament and the Commission in order to reach a compromise wording....more

Hogan Lovells

Europe: Everything you always wanted to know about certification marks

Hogan Lovells on

Certification marks are part of national trade mark law in a number of Member States and since the reform of European trade mark law, the EUTMR now covers them under articles 83 to 93. ...more

Polsinelli

FDA Publishes Industry Guidance Document for Amendments to Abbreviated New Drug Applications

Polsinelli on

In early July 2018, the United States Food and Drug Administration (FDA) issued a final guidance document titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA – Guidance for Industry." A...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | August 2018

LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Modernization for Dairy Product Identities - Following his related statements at a conference, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has...more

Hogan Lovells

UKIPO responds to consultation on implementing Trade Marks Directive

Hogan Lovells on

The UK Intellectual Property Office (IPO) has published its response to its consultation on the implementation of the Trade Marks Directive 2015 (the “Directive”), which ran from the 19th of February to the 16th of April of...more

Hogan Lovells

DSM Watch: One step closer to a European copyright reform

Hogan Lovells on

After a long and intense debate – including several postponements – the Committee of Legal Affairs of the European Parliament (JURI) finally agreed on its position on the draft DSM Copyright Directive. Of course, the plenary...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

Hogan Lovells

European Commission proposes SPC waiver for EU biosimilars or generics manufactured solely for export from the EU

Hogan Lovells on

On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more

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