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Searching Content indexed under Intellectual Property by Shana Cyr ordered by Published Date Descending.
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1
U.S. Patent Rights: Think Twice Before Disclosing Your Invention
Cautionary tales of inventors who have risked their own U.S. patent rights provide valuable insight for scientists in developing their own best practices.
United States
15 Apr 2019
2
FDA Commissioner's Statement On Plans For The Orange Book
After dropping hints in recent months that he intended to use creative policy efforts to promote competition in the American pharmaceutical industry, U.S. Food and Drug Administration Commissioner Scott Gottlieb...
United States
28 Mar 2019
3
FDA Commissioner Statement About The Orange Book
On January 30, 2019, FDA Commissioner Scott Gottlieb issued a statement on FDA's efforts to enhance the utility of the Orange Book to foster drug competition.
United States
14 Feb 2019
4
Five Most Popular IP FDA Blog Posts From 2018
Happy New Year! In case you missed them, here are our five most popular posts from 2018. This has been an exciting year for the Finnegan IP FDA Blog ...
United States
17 Jan 2019
5
FDA Draft Guidance On The BPCIA "Deemed To Be A License" Provision - Questions And Answers
On December 11, 2018, FDA issued draft guidance on questions and answers about the "deemed to be a license" provision of BPCIA.
United States
2 Jan 2019
6
FDA Final Guidance On The BPCIA "Deemed To Be A License" Provision
On December 11, 2018, FDA issued final guidance on interpreting the "Deemed to be a License" provision of BPCIA. The guidance provides FDA's interpretation ...
United States
2 Jan 2019
7
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
8
Four Ways To Show Nonobviousness Of ADC Inventions
When the first antibody-drug conjugate (ADC) was approved by the U.S. Food and Drug Administration (FDA) in 2000, only a handful of patent applications claiming ADCs had been published.
United States
18 Oct 2018
9
FDA Final Guidance On Physiologically Based Pharmacokinetic Analyses
On September 4, 2018, the FDA issued final guidance on Physiologically Based Pharmacokinetic Analyses — Format and Content.
United States
17 Sep 2018
10
When Do Collaborators Become Coinventors?
Every invention begins with an inventor, someone who birthed an idea, solved a problem, or refined an existing idea to create something new.
United States
23 Aug 2018
11
SaMD Series: The Interplay Between IP And FDA Submissions
Software as a Medical Device – also referred to as SaMD – is one of the fastest growing innovations in the medical device industry
United States
6 Aug 2018
12
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
13
Dead Zone: Are Your Biological Products Ready For FDA's Regulatory Transition?
On March 23, 2020, hundreds of approved and pending applications for biological products will face a regulatory transition as the U.S. Food and Drug Administration (FDA) implements...
United States
6 Jun 2017
14
Dead Zone: Are Your Biological Products Ready For FDA's Regulatory Transition?
On that date, FDA will replace all approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for biologics with biologic license applications (BLAs) or abbreviated...
United States
1 Jun 2017
15
Recent Federal Circuit Cases Affecting Practice Before The USPTO Patent Trial And Appeal Board
IP lawyers need to keep current with the growing body of case law from the Federal Circuit. Those decisions affect a company’s IP portfolio strategy on many levels in significant, and sometimes subtle, ways.
United States
26 Nov 2013
16
Using PTO’s Standard Form For Unintentional Delayed Payment, Without Disclosing Why Unintentional Delay Occurred, Does Not Constitute Inequitable Conduct
In Network Signatures, Inc. v. State Farm Mutual Automobile Insurance Co., No. 12-1492 (Fed. Cir. Sept. 24, 2013), the Federal Circuit held that using the PTO’s standard form for delayed payment, without further disclosing why the unintentional delay occurred, does not constitute material misrepresentation with intent to deceive.
United States
5 Nov 2013
17
The Ordinary Meaning Of "Connected To" Encompasses Indirect Linkages
In a recent case, the Federal Circuit reversed the SJ of noninfringement of U.S. Patent No. Re. 35,700, reversed the denial of a permanent injunction against continued infringement of U.S. Patent No. 6,944,978, and instructed the district court to enter a permanent injunction.
United States
17 Jul 2013
18
Best Mode Violation Requires Intentional Concealment
In a recent case, the Federal Circuit reversed the district court's entry of SJ of invalidity on best mode grounds, affirmed that U.S. Patent No. 5,011,339 was not abandoned, and remanded for further infringement proceedings.
United States
17 Jul 2013
19
Clinical Trials Conducted With A Reasonable Expectation Of Confidentiality Do Not Constitute Public Use Under 35 U.S.C. § 102(B)
In Dey, L.P. v. Sunovion Pharmaceuticals, Inc., No. 12-1428, the Federal Circuit reversed the district court's grant of SJ of invalidity based on prior public use and remanded the case for further proceedings.
United States
17 Jul 2013
20
A Given Claim Term Can Have Different Meanings In Different Contexts In The Patent
In a recent case, the Federal Circuit reversed and remanded the district court's entry of a stipulated judgment of noninfringement, concluding that the district court's Markman opinion misinterpreted claim terms of U.S. Patent No. 5,750,703.
United States
16 Jul 2013
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