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Patenting and the New FDA Guidance on 3-D Printing of Medical Devices

USA - January 25 2018 The U.S. Food and Drug Administration (FDA) recently finalized its publication on additive manufacturing (commonly referred to as 3-D printing) for...


FDA Includes Patent Submission Date Updates in Orange Book

USA - December 10 2017 The U.S. Food and Drug Administration (FDA) recently updated the Orange Book to include patent submission dates. A patent submission date is the date...


New FDA Guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application

USA - December 4 2017 The U.S. Food and Drug Administration (FDA) recently published a draft guidance summarizing the differences between abbreviated new drug applications...


2017 European Patent Office Updates

European Union - December 4 2017 The European Patent Office recently revised its Examination Guidelines. These Guidelines are primarily directed to the patent examiners and...


License Agreement Restrictions Can Provide a Real Advantage to Patent Holders

USA - November 20 2017 Generally, a patent owner's rights are exhausted after an authorized sale; the patent owner cannot sue a downstream customer who purchased an...

Alan Tenenbaum.