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Legal & IP

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Legal Issues

Set Alert for Legal Issues

Weight Loss, Diabetes Treatments Focus Of FTC's Second Round Of Patent Listing Challenges

The Pink Sheet takes a deep dive into the Federal Trade Commission's second wave of challenges to patents it asserts are improperly listed in the FDA's Orange Book, including patents covering Novo Nordisk's self-injection pens for Saxenda (liraglutide) and Ozempic (semaglutide).

Intellectual Property Pricing Debate

Former Sandoz Exec Kellum Avoids Jail Time Over US Price Fixing

Four years after pleading guilty plea generic price-fixing allegations, the former Sandoz US vice-president of business contracting and analytics, Hector Armando Kellum, will serve his sentence outside a jail cell and pay a fine.

Legal Issues Generic Drugs

US Appeals Court Backs Dismissal Of Bystolic ‘Pay-For-Delay’ Case

The US Court of Appeals for the Second Circuit afirmed a US district court decision to dismiss purchaser and payer claims linked to so-called “pay-for-delay” agreements with generics firms over nebivolol rivals to Bystolic.

Generic Drugs Legal Issues

FDA Medical Product Communications Need More Nuance To Deter Misinformation, Experts Say

Government agencies and others need to improve their communication to a broad audience about the relative safety of vaccines, as well as current scientific uncertainty, experts said at the FDLI annual meeting.

FDLI Legal Issues

Pandemic Treaty Negotiators Plan Five More Days Of Talks On ‘Critical’ Issues

A co-chair of the Intergovernmental Negotiating Body says that whatever happens over the coming fortnight, a report on the outcome of the talks will be delivered to the World Health Assembly at the end of this month.

International Coronavirus COVID-19

Pharma’s IRA Complaints Find Sympathetic Ear In US Appeals Court But Near-Term Relief Unlikely

At issue is a narrow jurisdictional ruling, not the constitutionality of the Medicare price negotiation program, US attorney reminds the judges.

Reimbursement Legal Issues

Bolar Exemption India Files: Roche Blocks Alleged Infringer Of Evrysdi Patent

More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance warding off a local drug maker in the Evrysdi patent infringement case.

Legal Issues India

JNJ, BMS’s IRA Loss Is First Time Court Rejects Industry’s First Amendment, Takings Claims

The fourth court loss for pharma in industry's attempts to kill Medicare’s drug price negotiation program adds to the list of reasons courts have rejected legal challenges to the Inflation Reduction Act.

Litigation Pricing Debate

It’s Official: FDA Drops Final Rule On LDTs

The US FDA's controversial final rule places laboratory developed tests under same regulatory purview as other in vitro diagnostics. While the agency opted to include an exemption for LDTs already on the market, it did not provide an exemption for tests developed in academic medical centers.

In Vitro Diagnostics Legal Issues

Generic Or Innovator? Sandoz Sues CMS Over Potential Change In Rebate Classification

Sandoz argued against paying higher rebates for two of its drugs via the Centers for Medicare and Medicaid Services’ Medicaid drug rebate program in a US court six years after the suggestion was first made.

Generic Drugs Legal Issues

Ivermectin Settlement Brings Relief And Worry For US FDA Communications

The FDA’s decision to end litigation challenging an agency communication that tried to tackle COVID-19 misinformation leaves an appeals court opinion in place that could haunt it later. But continuing to fight the case could have left the agency in a far worse position.

Legal Issues Drug Safety

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

NIH Drug Patent Licensees Would Develop ‘Access Plan’ Under Proposal; Pricing Commitments Optional

Proposed rule would not require price concessions in the interest of balancing enhanced access with protecting the ‘viability and sustainability of a product’ in the market.

Policy Research & Development

Weight Loss, Diabetes Treatments Focus Of FTC's Second Round Of Patent Listing Challenges

The Pink Sheet takes a deep dive into the Federal Trade Commission's second wave of challenges to patents it asserts are improperly listed in the FDA's Orange Book, including patents covering Novo Nordisk's self-injection pens for Saxenda (liraglutide) and Ozempic (semaglutide).

Intellectual Property Pricing Debate

Industry Calls For More Clarity On EU Compulsory Licensing Proposal

Industry groups say the initiative will undermine innovation and the competitiveness of European companies, impeding Europe's ability to tackle future crises effectively.

Europe Innovation

Patent Office Issues Proposed Rule For Rarely Successful Director Review Requests

The rulemaking is supposed to formalize the Patent Trial and Appeal Board process, which has been in an interim status since a Supreme Court decision, giving manufacturers more ability to request oversight of the decisions. 

Patents Intellectual Property

Califf Suggests Congress ‘Tighten Up Laws’ To Address Orange Book Abuses

US FDA Commissioner repeats longstanding FDA policy that the agency doesn’t have much power to address frivolous patent listings in the Orange Book, but seems to support Congress providing more authority.

Intellectual Property Generic Drugs

Industry Calls On G20 To Boost Regulatory Harmonization & Tackle AMR

Robust regulatory systems with effective approval pathways and surveillance mechanisms to ensure continuity in clinical research, manufacturing and supply are needed to prepare for current and future health threats, says industry.

International Market Access

WHO Allots Extra Time To Get Pandemic Treaty Talks Over The Line

The body that is steering the talks on a future pandemic treaty says it wants to focus on areas where consensus has been reached in order to maximize the chances of agreement by the end of May.

BioPharmaceutical International

'Don't Compromise The Pharma Innovation System,' Says Outgoing IFPMA Head Thomas Cueni

Thomas Cueni is stepping down after seven years at the helm of the International Federation of Pharmaceutical Manufacturers and Associations. In an interview with the Pink Sheet ahead of his retirement, he reflects on the proposed pandemic treaty, what still needs to be done to ensure equitable access to medicines, the importance of tackling AMR, moves towards regulatory reliance – and what his post-IFPMA life might look like. 

Intellectual Property Innovation

India IPR Wheels Are Turning: Novartis, Bayer, Sun, Legal Heads Discuss Realities

Leaders from Novartis, Bayer, Sun Pharma, the Indian Pharmaceutical Alliance, Médecins Sans Frontières and Anand and Anand discuss India’s evolving intellectual property rights landscape, including pre-grant oppositions, enforcement action and other realities. Concerns around evergreening, restrictions on patent-eligible subject matter and compulsory licensing were also key talking points at a recent conference in Hyderabad.

Regulation Intellectual Property

Latest Changes To EU Regulatory Data Protection Mean New ‘Uncertainties & Risks’

Law firm Sidley Austin says the net overall effect of the pharmaceutical package on innovation and investment is “uncertain at best.”

Europe Intellectual Property

Singapore To Demystify Rules On Declaring Patents In Drug Marketing Applications

Regulatory amendments aimed at addressing the confusion over whether companies need to declare patents when they apply for drug registrations are under consultation.

Singapore Approvals

EU Pharma Reform Passes Major Hurdle, With Big Changes To Data Protection Proposals

Members of the European Parliament have significantly watered down plans for a cut to regulatory data protection, but industry says the net effect of the proposals will still be to make Europe “less competitive and less attractive” to investment in innovation.

Intellectual Property Legislation
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