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Latest From Teva Pharmaceuticals USA Inc.

In Swift Challenge To Orange Book Patent Listings, Federal Trade Commission Fills FDA Ministerial Gap

Agency sends letters to 10 companies saying they improperly listed patents in US FDA’s Orange Book covering drug-device combination products. FTC does not specify why it believes the patents were improperly listed.

Intellectual Property Legal Issues

Amgen Biosimilar For Stelara May Face Price Drop In Medicare Shortly After Launch; What’s A Follow-On To Do?

With J&J's Stelara set for Medicare negotiation, the fate of Amgen’s new ustekinumab interchangeable be a test case for concerns that the pricing program will significantly undercut incentives for developing biosimilars for blockbusters in the Medicare market.

Reimbursement Policy

Vanda Launches Barrage Of Suits Against FDA Seeking To Retain Hetlioz Market

In 17 suits against FDA in the last two years, firm seeks to block generics of its sleep-wake disorder drug and gain a jet lag indication. CEO Mihael Polymeropoulos tells the Pink Sheet that FDA has retaliated against Vanda for its first suit challenging a partial clinical hold on another drug.

FDA Drug Approval Standards

FDA-USPTO Collaboration: Stakeholders Want More Clarity On Orange Book Patent Listings

Officials from the two agencies note the real-world benefit of cross-training in helping patent examiners find prior art based on product labeling. A USPTO administrative patent judge also nixes a suggestion that the agency hold proceedings to determine if patents were properly listed in the Orange Book.  

FDA Intellectual Property
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