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Latest From Legal Issues

Pfizer Ex-Marketing Director Agrees To Injunction, Ending Trade Secret Suit

Former Pfizer employee has joined Sun Pharma as it launches ophthalmic drug and expands its specialty portfolio, which includes Phase III monoclonal antibody for treatment of psoriasis.

BioPharmaceutical Policy

EC To Consult On Ways To Boost Generics & Biosimilars Industry, Introduce EU-wide SPC

A new package of measures from the European Commission will introduce an SPC export manufacturing waiver to help improve the competitiveness of Europe’s generics and biosimilars industry, while originator companies should benefit from steps to smooth out the rules on the “Bolar” research exemption and implement an EU-wide SPC.

Manufacturing Legal Issues

Biopharma Asks US Supreme Court Not To Limit Patent Litigation Venue

Innovators say case before court could upend ANDA litigation by preventing consolidation of cases; Genentech sees potential impact on biosimilar suits.

Legal Issues Intellectual Property

REMS Abuses: Congressional Panel’s Focus Turns To Federal Trade Commission

During bipartisan, but one-sided, hearing about US FDA’s limited authority to ensure generic drug makers can access restricted distribution reference products for bioequivalence testing, one lawmaker wants to know what FTC is doing about the issue.

Regulation Pricing Debate

Pharma Patents Are Vulnerable In Canada As Lilly Loses NAFTA Challenge

Tribunal finds Lilly did not prove that Canada's promise utility doctrine discriminates against pharmaceutical patents; 25 pharma patents have been invalidated in past decade.

Intellectual Property Legal Issues

Insulin Pricing, PBM Relationships Under Government Microscope

Minnesota Attorney General demands Novo Nordisk and Sanofi provide information on their insulin pricing; they are also among several companies facing probes over their contracts with pharmacy benefit managers.

Pharmacy Benefit Management Pricing Debate
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