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Legal & IP

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Legal Issues

Set Alert for Legal Issues

FTC Commissioner Recusal Decisions Should Be Public, US Chamber Of Commerce Says

Chamber files petition to have FTC amend its disqualification rules to have commissioners explain their rejection of recusal requests. FTC is seeking public comments on the petition.

Enforcement M & A

FTC Merger Guidelines Cast ‘Perilous Shadow’ Over Biopharma

BIO objects to guidelines seeking to block mergers that would eliminate a potential entrant in a concentrated market and give greater scrutiny to transactions that are part of a series of company deals. APhA and NCPA call for FTC to consider more factors in PBM mergers.

M & A Enforcement

Takeda Pens Mid-Trial Settlement To Dismiss US Colcrys Antitrust Suit

Japanese originator Takeda has agreed to settle two-year-old anticompetitive claims lodged by wholesalers in the US that it conspired with several generics manufacturers to maintain supracompetitive pricing for its Colcrys branded treatment for gout.

Legal Issues Deals

Medicare Drug Pricing In Court: Judge Praises ‘Zealous Advocacy’ Of Attorneys In First Hearing On IRA

DOJ and Chamber of Commerce attorneys argue over whether Chamber has standing to sue and whether AbbVie has suffered harm meriting a preliminary injunction to halt the program. With Medicare’s Oct. 2 deadline looming, Judge Newman said he would issue a decision ‘as quickly as we can.’

Legal Issues Medicare

IRA Litigation Landscape: Where The Cases Are And Where They Are Headed

Pink Sheet infographic details the district court judges and circuit courts that will be deciding the cases brought by industry against the IRA, breaking down the Democrat and Republican appointees as well as the arguments in each suit.

Medicare Legal Issues

Stealth Defense: Medicare, IRS Implementation May Weaken Pharma’s Arguments Against IRA

Flexibility included in guidance issued after many IRA lawsuits were filed put some of the arguments industry has made on shakier footing, legal experts explain.

Legal Issues Medicare

Court Could Pause Medicare Drug Price Negotiation Process Following First Hearing In IRA Litigation

Ahead of Friday’s hearing on US Chamber of Commerce's suit against HHS, attorneys discuss potential remedies and carveouts to Inflation Reduction Act's drug price negotiation provisions, harms to industry that may support a preliminary injunction, and what would prompt Supreme Court review.

Legal Issues Medicare

FTC Set To Take Enforcement Action Against Drugmakers Over Orange Book Patent Listings

Merger reviews could take into account sponsor's Orange Book behavior. FTC's statement does not detail what would make a patent listing 'improper' but the precedents from court cases against various sponsors should offer industry some guideposts.

Generic Drugs Enforcement

Pink Sheet Podcast: FTC Ends Amgen-Horizon Case, New Ultra-Rare Cancer Partnership, Generic Applications Lag

Pink Sheet reporter and editors discuss the US Federal Trade Commission ending its attempt to block the Amgen acquisition of Horizon Therapeutics, a proposed public-private partnership to develop ultra-rare cancer drugs, and a slow-down in ANDA submissions to the US Food and Drug Administration.

M & A Rare Diseases

FTC’s Test Case Opposing Amgen-Horizon Deal Ends With No-Bundling Agreement

Commission pursued merger challenge to halt pharma practices it believes can stifle competition and keep drug prices high. Other large biopharma transactions may face similar challenges as FTC pursues its new merger program.

M & A Legal Issues

Pharma Firms Can Sue Competitors For Violating Orphan Exclusivity, German Court Rules

A German civil court has ruled that pharma firms can enforce market exclusivity rights for orphan drugs by taking legal action against competitors. Lawyers say this decision, which relates to Alexion’s Soliris, is the first of its kind and will likely have a wider impact across the EU.

BioPharmaceutical Companies

Quotable: Top Experts On Policy Hot Topics

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

International Europe
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Intellectual Property

Set Alert for Intellectual Property

Dissent In Parliament As Commission Claims EU Pharma Revision Will Improve Competitiveness and Access

Proposals on regulatory data protection and transferable exclusivity vouchers to encourage antimicrobial R&D have received mixed reactions from the parliament’s rapporteurs for the draft legislation.

Europe EU Legislative Reform

Ultra-Rare Tumors: Public-Private Partnership Eyed To Boost Drug Development

US FDA, Foundation for the NIH, and NCI are considering a new PPP aimed at creating a repeatable process for development of drugs to treat ultra-rare cancers where commercial viability is lacking. Stakeholders say industry incentives, IP issues and reimbursement need attention.

Rare Diseases Research & Development

Pharma Firms Can Sue Competitors For Violating Orphan Exclusivity, German Court Rules

A German civil court has ruled that pharma firms can enforce market exclusivity rights for orphan drugs by taking legal action against competitors. Lawyers say this decision, which relates to Alexion’s Soliris, is the first of its kind and will likely have a wider impact across the EU.

BioPharmaceutical Companies

Patent Cliff Likely Accelerated By Two Years For Most Drugs On Medicare Price Negotiation List

The Class of ’26 of Medicare Price Negotiation University is now on stage. Our infographic profiles who they are and where they come from, breaking down the $50.5B in gross annual Part D spending, about 20% of the total.

Medicare Reimbursement

Ultragenyx Faces Henrietta Lacks Suit Modeled On Action Against Thermo Fisher

While the unjust enrichment claim against Ultragenyx uses the same argument the estate of Henrietta Lacks employed against Thermo Fisher, resulting in a settlement earlier this month, one big difference between the cases is that Ultragenyx does not yet have a commercial product that relies on the HeLa cells.

Legal Issues Intellectual Property

How NHS England Plans To Charge Companies A ‘Fair Price’ For Access To Its Health Data

Setting a specific monetary value for data is complex, says the National Health Service, which has published a new framework to ensure that fair terms are agreed for the use of public resources in data partnerships, including a fair share of any profits generated from partnerships that are commercialized.

Research & Development United Kingdom

‘Deeply Troubling’ – Pharma Industry's Verdict On EU Compulsory Licensing Plan

The European Commission’s plans for an EU-wide compulsory licensing mechanism have drawn a wide range of responses, with some stakeholders wanting the whole idea dropped and others applauding it and calling for the mechanism to be used outside health emergency situations too.

Europe Intellectual Property

Companies Advised To ‘Re-Think’ SPC & Regulatory Strategies For ‘Loose’ Combination Products

A key problem with obtaining supplementary protection certificates for combination drug therapies, particularly for “add-on” therapies where patients have access to the remaining active components, was highlighted in a UK court case judgement, the principle of which is expected to be followed in Europe.

Intellectual Property Approvals

Firms Await Brazilian Regulator’s Decision On Allowing ‘Skinny Labels’ For Generics

The Brazilian medicines regulator, ANVISA, is considering whether to allow generic drug labeling to omit indications of the originator product that are still under patent. "Skinny labels" also figure in an ongoing court case involving Boehringer Ingelheim's Ofev (nintedanib).

South America Brazil

WHO Meeting Reveals Differences Over Sharing Of Genomic Data In Public Health Crises

Members of the WHO’s working group on the International Health Regulations met for the fourth time last month to discuss proposed amendments to “important and substantive areas” of the IHR.

International Policy

EU’s New Unitary Patent Proves Popular, Albeit With A High Opt-Out Rate

The European Patent Office has reported a steady flow of requests for unitary patents since the new system was introduced in June, with more than 1,100 applications in the “health” sector. But many patentees are choosing not to take part, with some estimates putting the number of patents opted out of the system at half a million so far.

Europe Intellectual Property

EU Pharmaceutical Reform: A Delicate Negotiation

The European Commission may well be flexible over its proposals on data protection periods, but it is unlikely to give ground on plans to restructure the European Medicines Agency and to introduce a new temporary emergency marketing authorization, says lawyer Vincenzo Salvatore.

Europe EU Legislative Reform
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