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Searching Content indexed under Food and Drugs Law by Foley & Lardner ordered by Published Date Descending.
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1
Is An Employer's Health Plan Required To Count The Value Of Drug Manufacturer Coupons Towards An Employee's Out-Of-Pocket Maximum?
These days, almost all employer-sponsored group health plans require an employee (and any dependents) covered under the plan
United States
11 Sep 2019
2
Statements Of Efficacy And Safety Material Claim Limitations
In Allergan Sales, LLC v. Sandoz, Inc., (Fed. Cir. 2018-2207, Aug. 29, 2019), the Federal Circuit held that "wherein" clauses in a patent claim were limitations
United States
4 Sep 2019
3
Federal Circuit Finds Method Withholding Treatment Ineligible For Patenting
In its non-precedential decision in INO Therapeutics LLC v. Praxair Distribution Inc., the Federal Circuit agreed with the district court that method of treatment claims reciting "excluding"
United States
4 Sep 2019
4
Federal Circuit Contrives Substantially Similar Written Description Test
In contrast to its decision in Nuvo Pharmaceuticals, Inc. v. Dr. Reddy's Laboratories Inc., which seemed to impose a higher standard for satisfying the written description requirement
United States
28 Aug 2019
5
The Era Of Personalized Medicine Has Arrived - PMC's Annual Progress And Outlook Report
The Personalized Medicine Coalition (PMC) released its annual "Personalized Medicine At FDA: A Progress & Outlook Report" (Report) that monitors current successes and challenges in bringing
United States
28 Aug 2019
6
Drug Pricing: White House Announces Withdrawal Of Proposed Changes To Anti-Kickback Safe Harbors
On July 11, 2019, the Trump administration announced it would withdraw a proposed rule that would eliminate the Anti-Kickback Statute (AKS) safe harbor that protected rebates made from pharmaceutical manufacturers.
United States
26 Jul 2019
7
Blockchain: A Tool With A Future In Healthcare
Blockchain technology originated in 1991, and was conceived as a secure way to timestamp digital documents akin to how a notary timestamps physical documents.
United States
25 Jul 2019
8
Manufacturing MarketTrends | July 2019, Issue 2
Welcome to issue two of Foley's Manufacturing MarketTrends newsletter, which highlights key trends with the potential to make 2019 a year of change for manufacturers. In this issue
United States
25 Jul 2019
9
Marijuana Is Now Legal In My State, But Is It A ‘Lawful Product?'
The trend of states legalizing both medical and recreational marijuana use continues to gain momentum.
United States
11 Jul 2019
10
Federal Circuit Agrees "Pharmaceutical Composition" May Be Toxic
The claim construction determinations in Mayne Pharma International Pty. Ltd. V. Merck Sharp & Dohme Corp. may leave stakeholders in the pharmaceutical space scratching their heads
United States
8 Jul 2019
11
Your Next Hamburger Could Be "Slaughter-Free"
In the face of an ever increasing global population set to surpass 9 billion by 2050, agriculture and science have converged to create sustainable
United States
3 Jul 2019
12
Why The TERM Act Is A Misguided Solution To A Different Problem
The "Terminating the Extension of Rights Misappropriated (TERM) Act of 2019" would create a presumption that every other patent listed in the Orange Book
United States
1 Jul 2019
13
340B Rate Cuts: DC Court Enjoins And Remands CMS' 2018 And 2019 Reductions For Hospital Outpatients
Instead, the court remanded both rules to HHS to determine proper remedies.
United States
3 Jun 2019
14
Federal Circuit Invalidates Patented Cancer Therapy
In BTG International Limited v. Amneal Pharmaceuticals LLC, (Fed. Cir. Slip Op. 2019-1147, May 14, 2019), the Federal Circuit held that U.S. Patent No. 8,822,438 ("the ‘438 Patent") was invalid as obvious over the prior art.
United States
30 May 2019
15
Starbucks' Blockchain Allows Traceability To 380,000 Coffee Farms!
Computerworld reported that "Starbucks is working with Microsoft to develop a blockchain-based supply chain tracking system and mobile app that will allow customers to track the supply chain journey of the beans they buy and the coffee they drink."
United States
30 May 2019
16
Will The Biologic Patent Transparency Act Shrink The Biosimilar Patent Dance Floor?
The Biologics Price Competition and Innovation Act (BPCIA) has been criticized for creating a complicated framework for resolving patent disputes, often referred to as the biosimilar "patent dance."
United States
22 May 2019
17
A Sticky Situation For Employers: New York City Council Passes Bill Restricting Marijuana Drug Testing
New York City employers will need to reconsider their drug testing policies. On April 9, 2019, the City Council passed a bill that would prevent most employers
United States
7 May 2019
18
Is 101 Relief In Sight?
Senators Thom Tillis (R-N.C.) and Chris Coons (D-Del.) released a plan to revise Section 101 of Title 35 of the U.S. Code relating to U.S. patent law,
United States
3 May 2019
19
Federal Circuit Upholds Method Of Treatment Claims Under Vanda And Distinguishes Mayo
In Natural Alternatives Internat'l v. Creative Compounds, LLC, the Federal Circuit vacated the district court decision that held the asserted claims invalid under 35 USC § 101 at the pleadings stage.
United States
5 Apr 2019
20
New Guidance From Federal Circuit For Computer-Implemented Medical Methods
A patent claiming methods to integrate physiological treatment data remotely using a computer was held invalid under 35 U.S.C. § 101
United States
19 Mar 2019
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