General Court

European Commission revokes all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm

Retrieved on:

Wednesday, December 20, 2023

General Court, European Commission, Dimethyl fumarate, Justice, European, Civil service commission, DMF, European Medicines Agency, Public, CNS, Face, Central nervous system, Patient, Commission, Pressure, Judgement

BARCELONA, Spain and DÜSSELDORF, Germany, Dec. 20, 2023 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, today announces that it has been notified by the European Commission of its decision to revoke all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm.

Key Points:

BARCELONA, Spain and DÜSSELDORF, Germany, Dec. 20, 2023 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, today announces that it has been notified by the European Commission of its decision to revoke all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm.
This decision contradicts the European Medicines Agency's own prior scientific review, when the Commission granted an unconditional marketing permission to Neuraxpharm in 2022.
Neuraxpharm will swiftly contest this decision at the General Court of the European Union, with the aim of reintroducing Dimethyl Fumarate Neuraxpharm to the European market as soon as possible.
Neuraxpharm remains committed to our mission of providing affordable, high-quality medication to patients across the European Union, including patients who depend on the more affordable generic versions of Tecfidera such as Dimethyl Fumarate Neuraxpharm."

European Commission revokes all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm

Retrieved on:

Wednesday, December 20, 2023

BARCELONA, Spain and DÜSSELDORF, Germany, Dec. 20, 2023 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, today announces that it has been notified by the European Commission of its decision to revoke all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm.

Key Points:

BARCELONA, Spain and DÜSSELDORF, Germany, Dec. 20, 2023 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, today announces that it has been notified by the European Commission of its decision to revoke all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm.
This decision contradicts the European Medicines Agency's own prior scientific review, when the Commission granted an unconditional marketing permission to Neuraxpharm in 2022.
Neuraxpharm will swiftly contest this decision at the General Court of the European Union, with the aim of reintroducing Dimethyl Fumarate Neuraxpharm to the European market as soon as possible.
Neuraxpharm remains committed to our mission of providing affordable, high-quality medication to patients across the European Union, including patients who depend on the more affordable generic versions of Tecfidera such as Dimethyl Fumarate Neuraxpharm."

Hausfeld: Google faces new multibillion-pound lawsuit from UK consumers for stifling competition in the search engine market, causing price rises across the UK economy

Retrieved on:

Thursday, September 7, 2023

The claim seeks approximately £7bn in redress on behalf of UK consumers from Google for breaches of competition law in shutting out competition in mobile search.

Key Points:

The claim seeks approximately £7bn in redress on behalf of UK consumers from Google for breaches of competition law in shutting out competition in mobile search.
Google uses its market dominance to raise the prices paid by advertisers for prominence on the Google search page, according to the claim.
Those increased prices are systematically passed on to consumers, who are charged higher prices for the goods and services they buy.
Google’s role in driving prices higher has happened by stealth, but is finally laid bare in the legal claim.

TA Advisory FZ LLC: Saif Alketbi Expresses Strong Interest in Acquiring Fortenova Group

Retrieved on:

Wednesday, June 21, 2023

Professional Services, Finance, ART, Sberbank, Sale, Lazard, Massachusetts General Court, General Court, Letter, SBK, United Arab Emirates, Cryptocurrency, Auction, Security (finance), EU, Fortenova Group

Saif Jaffair Markhan Alketbi expressed his strong interest in acquiring Fortenova Group MidCo.

Key Points:

Saif Jaffair Markhan Alketbi expressed his strong interest in acquiring Fortenova Group MidCo.
Lazard has been previously engaged by Fortenova Grupa d.d., the Croatian operational company of the Group, to support the process for examining interest by potential investors for purchase of Fortenova Group MidCo B.V., one of the Dutch companies through which Fortenova Grupa is held.
As I expressed in my letter to Lazard on June 16, I am strongly interested in acquiring Fortenova Group MidCo.
Given the circumstances, I am keen to help the company come to the ‘alternative solution’ that it has itself requested.”
Mr Alketbi indirectly owns 43.41 percent in Fortenova Group.

REPORT on the request for waiver of the immunity of Anna Júlia Donáth - A9-0071/2023

Retrieved on:

Friday, March 24, 2023

= REPORT on the request for waiver of the immunity of Anna Júlia Donáth =

Key Points:

= REPORT on the request for waiver of the immunity of Anna Júlia Donáth =
23.3.2023 - (2022/2208(IMM))
Committee on Legal Affairs
Rapporteur: Sergey Lagodinsky on the request for waiver of the immunity of Anna Júlia Donáth
The European Parliament,
– having regard to the request dated 21 October 2022 of the District Court of Kecskemét in Hungary for the waiver of the immunity of Anna Júlia Donáth in connection with criminal proceedings brought against her by way of a private indictment pending before the District Court of Kecskemét, and announced in plenary on 24 November 2022,
– having regard to the fact that Anna Júlia Donáth has renounced her right to be heard under Rule 9(6) of its Rules of Procedure,
– having regard to Articles 8 and 9 of Protocol No 7 on the Privileges and Immunities of the European Union, and Article 6(2) of the Act of 20 September 1976 concerning the election of the members of the European Parliament by direct universal suffrage,
– having regard to Article 4(2) of the Basic Law of Hungary, to Articles 10(2) and 12(1) of Act LVII of 2004 on the Legal Status of the Hungarian Members of the European Parliament and to Article 74 of Act XXXVI of 2012 on the Hungarian National Assembly,
– having regard to the judgments of the Court of Justice of the European Union of 21 October 2008, 19 March 2010, 6 September 2011, 17 January 2013 and 19 December 2019[1],
– having regard to Rule 5(2), Rule 6(1) and Rule 9 of its Rules of Procedure,
– having regard to the report of the Committee on Legal Affairs (A9-0071/2023),
A. whereas on 21 October 2022, the District Court of Kecskemét, Hungary, submitted a request for waiver of the parliamentary immunity of Anna Júlia Donáth, Member of the European Parliament elected for Hungary, in the context of the criminal proceedings for defamation brought against her by way of private indictment; whereas the request includes a previous request for waiver of the immunity of Anna Júlia Donáth by the same District Court, dated 28 June 2022, which, however, appears never to have been received by the European Parliament;
B. whereas on 20 January 2022, a statement by the Executive Committee of the Momentum Mozgalom Párt (Momentum Movement party) referring to the suspension of the claimant’s party membership, alleging that this suspension came after a series of ethical violations by the claimant, was published in the party’s online newspaper and on its Facebook page; whereas it appears that, between 21 November 2021 and 29 May 2022, Anna Júlia Donáth was serving as president of the Momentum Mozgalom Párt’s Executive Committee;
C. whereas on 31 January 2022, the claimant brought a private action before the District Court of Kecskemét against Anna Júlia Donáth, in her capacity as president of the Momentum Mozgalom Párt’s Executive Committee, claiming the statutory offence of defamation in public pursuant to Article 226(2)(b) of Act C of 2012 on the Hungarian Criminal Code; whereas pursuant to Article 231(2) of the Hungarian Criminal Code, that offence may be punished only in the context of a private action;
D. whereas the purpose of parliamentary immunity is to protect Parliament and its Members from legal proceedings in relation to activities carried out in the performance of parliamentary duties and which cannot be separated from those duties;
E. whereas the alleged offence does not constitute an opinion expressed or a vote cast in the performance of Anna Júlia Donáth’s duties as a Member of the European Parliament within the meaning of Article 8 of Protocol No 7 on the Privileges and Immunities of the European Union; whereas the alleged offence instead concerns activities of a national nature, carried out in her capacity as president of her national party;
F. whereas, according to Article 9 of Protocol No 7 on the Privileges and Immunities of the European Union, Members of the European Parliament enjoy, in the territory of their own State, the immunities accorded to members of their parliament and, in the territory of any other Member State, immunity from any measure of detention and from legal proceedings; whereas immunity cannot be claimed when a Member is found in the act of committing an offence and does not prevent the European Parliament from exercising its right to waive the immunity of one of its Members;
G. whereas according to Article 4(2) of the Basic Law of Hungary, members of the Hungarian Parliament shall be entitled to immunity; whereas according to Article 10(2) of Act LVII of 2004 on the Legal Status of the Hungarian Members of the European Parliament, Members of the European Parliament are entitled to immunity equal to the immunity of members of the Hungarian Parliament, and whereas according to Article 12(1) of the same act, the decision to suspend the immunity of a Member of the European Parliament shall fall within the competence of the European Parliament; whereas pursuant to Article 74(1) of Act XXXVI of 2012 on the Hungarian National Assembly, criminal proceedings can only be initiated against a member with the prior consent of the National Assembly;
H. whereas, in this case, Parliament has found no evidence of fumus persecutionis, namely factual elements indicating that the intention underlying the legal proceeding may be to damage the Member’s political activity in her capacity as a Member of the European Parliament;
I. whereas it is for Parliament alone to decide, in a given case, whether or not to waive immunity; whereas Parliament may reasonably take account of the position of the Member in order to decide whether or not to waive his or her immunity[2]; whereas Anna Júlia Donáth has stated that she does not object to her parliamentary immunity being waived;
J. whereas Parliament cannot assume the role of a court, and whereas, in a waiver of immunity procedure, a Member cannot be regarded as a defendant[3];
1.
Decides to waive the immunity of Anna Júlia Donáth;
2.
Instructs its President to forward this decision and the report of its committee responsible immediately to the competent authority of Hungary and to Anna Júlia Donáth.

Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA® (dimethyl fumarate) Regulatory Data and Marketing Protection

Retrieved on:

Thursday, March 16, 2023

EMA, European Medicines Agency, European, General Court, Court of Justice of the European Union, EP, BIIB, European Commission, Marketing, Dimethyl fumarate, Patent, Justice, Civil service commission, Risk management, Biogen

CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines Agency (EMA), and the European Commission in their appeal of a General Court decision annulling the EMA’s refusal to evaluate a generic version of TECFIDERA® (dimethyl fumarate) because of TECFIDERA’s regulatory data and marketing protection.

Key Points:

CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines Agency (EMA), and the European Commission in their appeal of a General Court decision annulling the EMA’s refusal to evaluate a generic version of TECFIDERA® (dimethyl fumarate) because of TECFIDERA’s regulatory data and marketing protection.
With this favorable decision, Biogen believes that TECFIDERA is entitled to regulatory marketing protection in the European Union until at least February 4, 2024.
Biogen will seek to enforce this protection and continue to enforce its EP 2 653 873 patent related to TECFIDERA, which expires in 2028.
Biogen’s Full Year 2023 Financial Guidance issued on February 15, 2023, assumed a favorable decision such as this in this case.

General Court: WhatsApp annulment action inadmissible

Retrieved on:

Friday, December 16, 2022

DPA, Person, Addressee, Court, CJEU, Review, Justice, WhatsApp, General Court, IE, Court of Justice of the European Union, General Court (European Union), Risk management

The EDPB welcomes todays CJEU's General Court ruling stating that the action for annulment brought by WhatsApp Ireland Ltd (WhatsApp IE) against binding decision 01/2021 of the EDPB is inadmissible.

Key Points:

The EDPB welcomes todays CJEU's General Court ruling stating that the action for annulment brought by WhatsApp Ireland Ltd (WhatsApp IE) against binding decision 01/2021 of the EDPB is inadmissible.
It is now up to the Irish court to review the legality of the final decision of the Irish DPA, which is enforceable against WhatsApp IE.
The Court's decision confirms the EDPBs position, namely that WhatsApp IE was not directly concerned by the EDPB decision.
WhatsApp IE also challenged the IE SA decision before Irish courts and, according to the General Court, it may, in that action, contest the validity of the EDPB decision.

Illumina Intends to Appeal European Commission's Decision in GRAIL Deal

Retrieved on:

Tuesday, September 6, 2022

The EC decision follows last week's ruling by US Federal Trade Commission judge in favor of Illumina's acquisition of GRAIL.

Key Points:

The EC decision follows last week's ruling by US Federal Trade Commission judge in favor of Illumina's acquisition of GRAIL.
"We are disappointed with the European Commission's decision prohibiting us from acquiring GRAIL back to Illumina," said Charles Dadswell, General Counsel of Illumina.
Last week the Chief Judge of the US Federal Trade Commission issued a decision supporting Illumina acquiring GRAIL."
Illumina is separately appealing a July 2022 decision by the General Court of the European Union regarding the European Commission's jurisdiction to challenge the GRAIL deal.

Scania appeals against judgment by the EU General Court in the case of alleged violations of EU antitrust rules

Retrieved on:

Monday, April 11, 2022

General Court (European Union), Minister charged with the administration of The Crown Corporations Public Review and Accountability Act (Manitoba), Legislation, European Court of Justice, European Commission, Judgement, Royal commission, Justice, General Court, European Court, Online gambling, EU

SDERTLJE, Sweden, April 11, 2022 /PRNewswire/ -- In a judgment rendered earlier this year, the General Court of the EU found in favour of the EU Commission that Scania had violated EU antitrust rules.

Key Points:

SDERTLJE, Sweden, April 11, 2022 /PRNewswire/ -- In a judgment rendered earlier this year, the General Court of the EU found in favour of the EU Commission that Scania had violated EU antitrust rules.
Scania has now appealed against this judgment, to the European Court of Justice.
On 2 February 2022, the General Court rendered a judgment that confirmed the EU Commission's findings against Scania, dismissed Scania's appeal entirely and upheld the amount of fines as set by the EU Commission.
Scania therefore filed an appeal on 8 April 2022 against the General Court's judgment, to the European Court of Justice as the last court of instance in the EU.