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Searching Content by M. David Weingarten ordered by Published Date Descending.
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Podcast: Navigating Orange Book Listings
The Drug Price Competition and Patent Term Restoration Act of 1984–also known as the Hatch-Waxman Act–amended patent law ...
United States
6 Nov 2018
2
FDA Draft Guidance On Indications And Usage Labeling
On July 6, 2018, the U.S. Food and Drug Administration (FDA) issued draft guidance to assist applicants in writing the Indications and Usage section of labeling for human prescription drug
United States
20 Aug 2018
3
Requirements, Benefits, And Possible Consequences Of Listing Patents In FDA's Orange Book
NDAs must be accompanied by certain patent information, which the FDA then lists in its Approved Drug Products with Therapeutic Equivalence Evaluations publication.
United States
20 Jul 2018
4
A Foreign Corporation That Installed Infringing Products On U.S.-Flagged Ships May Be Sued For Patent Infringement In Any Federal Court, Regardless Of Connection To That Forum
The U.S. Court of Appeals for the Federal Circuit determined that a Brazilian corporation that installed infringing conveyor systems on a U.S.-flagged ship could be sued for patent infringement...
United States
17 Jul 2018
5
FDA Final Guidance On: Bioanalytical Method Validation
On May 21, 2018, FDA issued final guidance on Bioanalytical Method Validation. The guidance incorporates public comments to the revised draft published in 2013 ...
United States
30 May 2018
6
Some Decisions For The Patent Office To The Institute IPR Validity Challenges May Be Appealed To The Federal Circuit
A split decision of the U.S. Court of Appeals for the Federal Circuit determined that decisions by the Patent Office to institute IPR validity challenges may be appealed to the Federal Circuit when such decisions relate to the timing of the petitions.
United States
21 Feb 2018
7
Factual Evidence Of Conventionality May Be Required For Section 101 Findings
The Federal Circuit affirmed the district court's finding that certain claims of U.S. Patent No. 7,447,713—directed to digital processing and archiving in a digital asset management system—were indefinite...
United States
20 Feb 2018
8
Patent Owner's Statements In Related Prosecution Can Support Obviousness Findings
The Federal Circuit affirmed-in-part and vacated-in-part the Board's IPR decisions finding certain claims of U.S. Patent Nos. 7,237,634 and 8,214,097, related to hybrid vehicle engine technology, obvious...
United States
13 Feb 2018
9
En Banc Federal Circuit Finds PTAB Time Bar Determinations Appealable
On January 10, the en banc Federal Circuit held in Wi-Fi One, LLC v. Broadcom Corp. that inter partes review time bar determinations under 35 U.S.C. § 315(b) are appealable ...
United States
17 Jan 2018
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