Searching Content indexed under Food and Drugs Law by Finnegan, Henderson, Farabow, Garrett & Dunner, LLP ordered by Published Date Descending.
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A Piece Of Federal Circuit History: It's A Little Cheesy
One of the most cited decisions issued by the Federal Circuit is University of Notre Dame Du Lac v. J.C. Gourmet Food Co., Inc., 703 F.2d 1372 (Fed. Cir. 1983).
United States
11 Jun 2019
Courts Are Trending Toward Broader Patent Eligibility
Lab-engineered meats, milks, gelatin and other replacements for animal-based foods is a growing industry.
United States
3 Dec 2018
FDA Draft Guidance On Early Drug Development And The Role Of Pre-IND Meetings For Rare Diseases
On October 15, 2018, FDA issued draft guidance on Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings.
United States
8 Nov 2018
CAFC Affirms PTAB's Priority Determination In Natural Alternatives v. Iancu
In Natural Alternatives International, Inc. v. Iancu., No. 2017-1962 (Fed. Cir. Oct. 1, 2018), the CAFC affirmed the PTAB's priority determination invalidating Natural Alternative's patent directed to a human dietary supplement that increases the anaerobic working capacity of muscle and other tissues.
United States
15 Oct 2018
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
Preparing A Promising Drug Candidate For ANDA Litigation - Part 1
Having a promising drug candidate in clinical trials can be an exciting time for a pharmaceutical company.
United States
12 Sep 2018
IP Considerations For The Food And Beverage Industry Series: Engineered Foods And Patent Eligibility Issues
Engineered natural products, like lab-grown meat and synthetic milks, are on the cutting edge of food science.
United States
11 Sep 2018
Podcast: Engineered Foods And Patent Eligibility Issues
Engineered natural products like lab-grown meat and synthetic milks represent the next step in food science.
United States
2 Sep 2018
ODP: Cracks In The Armor? An Alert Regarding The Pending Breckenridge And Ezra Federal Circuit Appeals
In June 2018, the United States Court of Appeals for the Federal Circuit heard two cases, Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical (Docket No. 2017-2173) ...
United States
3 Aug 2018
FDA Guidance On ANDA Submissions — Amendments To Abbreviated New Drug Applications Under GDUFA
On July 5, 2018, FDA issued nonbinding guidance on ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA.
United States
1 Aug 2018
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
FDA Proposed Rule On Product Jurisdiction
Product classification is already part of determining which Agency Center will have primary jurisdiction.
United States
6 Jun 2018
Time To GAIN: Are Your FDA Marketing Exclusivities Eligible For Extension?
Some innovative drugs are receiving an additional five years of marketing exclusivity on top of their other exclusivities because they qualify under the Generating Antibiotic Incentives...
United States
29 May 2018
FDA Draft Guidance On Uncomplicated Urinary Tract Infections: Developing Drugs For Treatment
On May 9, 2018, FDA issued draft guidance on Uncomplicated Urinary Tract Infections (uUTIs): Developing Drugs for Treatment. The guidance addresses the clinical development of drugs...
United States
24 May 2018
FDA Draft Guidance On Pediatric HIV Infection: Drug Development For Treatment
On March 14, 2018, FDA issued draft guidance on Pediatric HIV Infection: Drug Development for Treatment. The draft guidance provides general guidance on the development of drug products ...
United States
24 May 2018
State Law Cannot Circumvent Congress's Scheme For Biologics
In Amgen v. Sandoz, No. 2015-1499, the Federal Circuit affirmed the Northern District of California's decision that Sandoz had not waived its preemption defense and that the BPCIA of 2009 preempted Amgen's state law...
United States
11 Jan 2018
Sandoz v. Amgen Supreme Court Oral Argument
On April 26, 2017, the U.S. Supreme Court heard oral arguments in Sandoz Inc. v. Amgen Inc., Nos. 15-1039, 15-1195, concerning Sandoz's petition and Amgen's cross-petition from the Federal Circuit's...
United States
4 May 2017
Infringement Of Second Medical Use Claims In Europe
It is possible to obtain a patent from the European Patent Office (EPO) based on a new medical use of a known drug.
European Union
2 Dec 2016
Rise In Generic Competition For Animal Drugs Could Result In PTAB Seeing Green
Most approved animal drugs do not have a generic version, so it's not surprising that we haven't seen many district court litigations concerning generic animal drugs.
United States
13 Aug 2015
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