Legal & IP
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Legal Issues
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US FDA’s Anti-Misinformation Campaigns Look Safer After Supreme Court Oral Arguments
FDA’s efforts to tackle misinformation may face fewer legal obstacles moving forward, following oral arguments at the Supreme Court on a case that could have broad ramifications for how the government communicates public health information.
Payors Take Lead From FTC In Suing BI Over Its Orange Book Patent Listings For Inhalers
Class action complaint alleges Boehringer Ingelheim engaged in a ‘Respimat Orange Book scheme’ to thwart generic competition for Combivent Respimat and Spiriva Respimat that cost payors millions, if not billions, in overcharges.
UK Competition Watchdog Attacks Tribunal As Hydrocortisone Fines Overturned
UK competition watchdog the CMA says it will be appealing against a tribunal decision that has overturned nearly £100m of fines imposed over anti-competitive deals around hydrocortisone, based on what the CMA criticized as a “fundamentally misconceived procedural point” linked to the cross-examination of witnesses.
Pink Sheet Podcast: Vanda Takes Jet Lag Denial To Court, Mark Cuban vs. PBMs, Austere FDA Budget
Pink Sheet reporters and editor discuss Vanda’s decision to sue the FDA over the rejection of the Hetlioz jet lag indication, Mark Cuban’s comments at a White House event that the federal government and others should stop doing business with the big three PBMs, and the cut in non-user fee dollars in the FY 2024 FDA appropriations bill.
IRA Litigation: NJ Judge Looks For Own Path In Evaluating Medicare Price Negotiation Program
During oral argument in four cases challenging the IRA, Judge Zahid Quraishi suggested he may find that Medicare participation is voluntary but takings claim would still need to be considered. On question of whether the program is hurting innovation, Quraishi seemed skeptical.
Who's Who In The IRA Court Drama
Pink Sheet offers a graphical guide to the lawyers behind the briefs and at the podiums for the big showdown in Trenton.
Vanda Appeals FDA’s Denial Of Hetlioz Jet Lag Application As It Is Hit With CRL For Insomnia
Vanda CEO tells the Pink Sheet that the firm is going straight to appellate court to refute agency’s rejection of jet lag indication for Hetlioz. Similar battles may lie ahead over Vanda’s applications on Hetlioz for insomnia and tradipitant for gastroparesis.
Second Judge Rejects Constitutional Challenges To Medicare Price Negotiation Program
Delaware district judge rules against AstraZeneca’s claim the IRA violates its due process rights, echoing findings made by Ohio district judge in Chamber of Commerce’s suit. Only other IRA ruling to date dismissed PhRMA’s complaint on procedural grounds without addressing the merits.
European Parliament Supports Explicit Patent Linkage Ban
An explicit ban on patent linkage would ensure that competition to originator drugs is not delayed, according to off-patent industry group Medicines for Europe.
EU Parliament Backs Plan To Allow Pre-Grant Opposition To Patent Extension Requests
Members of the European Parliament have ignored pleas from the EPP political group and the German Federal Council to drop a proposal allowing third parties to oppose the granting of a supplementary protection certificate.
UTC’s Suit Against US FDA To Block Application For Tyvaso Rival Invokes Arcane ‘Bundling Rule’
United Therapeutics Corp. claims the agency wrongly allowed Liquidia to submit an amendment to add a new indication to its tentatively approved NDA for a rival version of its pulmonary arterial hypertension blockbuster treprostinil.
Copay Accumulator Lawsuit Comes To An End; Will Ruling Be Enforced?
The ball is now in the federal government’s and state insurance commissioners’ courts to enforce a district court ruling after HHS stops its appeal. As groups that brought the suit press CMS for guidance, they also eye complaints with DOL and class-action suits.
Intellectual Property
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EC Defends Data Protection Cut As EU ‘Pharma Package’ Nears Crucial Milestone
Proposals to overhaul the general pharmaceutical legislation will ensure that the EU “continues to have one of the most generous systems of incentives in the world,” the European Commission says.
European Parliament Clears EU-Wide Compulsory Licensing Proposal
The draft regulation, which includes a ban on exports of drugs manufactured under an EU compulsory license, will be discussed with the EU member states after the June parliamentary elections.
Payors Take Lead From FTC In Suing BI Over Its Orange Book Patent Listings For Inhalers
Class action complaint alleges Boehringer Ingelheim engaged in a ‘Respimat Orange Book scheme’ to thwart generic competition for Combivent Respimat and Spiriva Respimat that cost payors millions, if not billions, in overcharges.
As Vote Nears, EFPIA Chief Sounds The Alarm Over Data Protection Cuts
Nathalie Moll says that the European Commission’s estimates of the costs to EU member states of regulatory data protection are “incorrect and over-estimated.”
Cut In Data Protection Looms Large As EU Vote On Pharma Revision Nears
All eyes will be on the European Parliament’s ENVI committee later this month when it votes on the planned overhaul of the EU pharmaceutical legislative framework, including a highly controversial proposal to cut regulatory data protection for originator drugs.
European R&D Industry Warns SPC Proposals Could Cause Delays & Invite Abuse
A pre-grant opposition mechanism would introduce uncertainty into the existing supplementary protection certificate framework and would be open to abuse by third parties seeking to exploit gaps in the protection of originator drugs, according to EFPIA and the Chartered Institute of Patent Attorneys.
Lilly CEO: Affordable Generics And IP Support 'Not Incompatible Ideas'
Lilly’s CEO indicates that the long-standing IPR debate that has generally divided the developed and developing world is largely a “false narrative.” The executive also called for lowering regulatory barriers in India amid expectations of the potential debut of Zepbound/Mounjaro in the country next year.
European Parliament Supports Explicit Patent Linkage Ban
An explicit ban on patent linkage would ensure that competition to originator drugs is not delayed, according to off-patent industry group Medicines for Europe.
EU Parliament Backs Plan To Allow Pre-Grant Opposition To Patent Extension Requests
Members of the European Parliament have ignored pleas from the EPP political group and the German Federal Council to drop a proposal allowing third parties to oppose the granting of a supplementary protection certificate.
EU Parliament OKs Legislation To ‘Reduce Cost & Burden’ Of Patent Extensions
Legislation intended to remove the fragmentation in the supplementary protection certificate system has been OKd by the European Parliament, which will try to reach agreement with the EU member states following the June parliamentary elections.
UTC’s Suit Against US FDA To Block Application For Tyvaso Rival Invokes Arcane ‘Bundling Rule’
United Therapeutics Corp. claims the agency wrongly allowed Liquidia to submit an amendment to add a new indication to its tentatively approved NDA for a rival version of its pulmonary arterial hypertension blockbuster treprostinil.
Disputes Over Access & Benefit Sharing Dog Pandemic Treaty Talks
As talks restart this week on a future pandemic accord, the international drug industry body, the IFPMA, has reiterated its concerns over the negotiating text, saying some measures could “severely hinder responses to future pandemics.”
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