Searching Content indexed under Food and Drugs Law by Jones Day ordered by Published Date Descending.
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Lead Compound Analysis Not Applicable To Certain Method-Of-Treatment Claims
The Federal Circuit distinguished method-of-treatment claims from compound claims to which the lead compound analysis applies.
United States
10 Jun 2019
Confidential FDA Communications As Prior Art In Hatch-Waxman Litigation
In a Hatch-Waxman litigation, the claims recite oxymorphone with less than 0.001% of an impurity called 14-hydroxymorphinone.
United States
31 May 2019
Supreme Court Sides With Merck In Unanimous Fosamax® Product-Liability Decision
Pharmaceutical company Merck recently obtained a unanimous win before the Supreme Court in a product-liability matter involving Merck's prescription medicine Fosamax®.
United States
29 May 2019
Federal Circuit Asserts Jurisdiction To Review ITC's Non-Institution Decision
In a long-awaited decision, a split panel of the Federal Circuit confirmed on May 1, 2019, that the Court has jurisdiction to review the ITC's decision not to institute an investigation.
United States
8 May 2019
Certain Pharmaceutical Discounts No Longer Safe Under The "Safe Harbors"?
Importantly, HHS does not intend for the proposed rule to have any effect upon existing protections for value-based arrangements.
United States
5 Mar 2019
French Food Safety Agency Launches Call For Information About Nanomaterials Used In Food
A similar call also could be carried out for nanomaterials potentially present as residues.
1 Mar 2019
United States
6 Feb 2019
New Law Requires Disclosure Of Biologic Patent Settlement Agreements To Antitrust Authorities
Last week, the Patient Right to Know Drug Prices Act ("Act") became law.
United States
18 Oct 2018
Pharmaceutical Company Agrees To $625 Million False Claims Act Settlement
The Department of Justice ("DOJ") recently announced that it agreed with AmerisourceBergen Corporation ("ABC") and several of its subsidiaries to resolve a False Claims Act ("FCA") case for $625 million.
United States
18 Oct 2018
PTAB Grants Rare Motion For Additional Discovery
This is consistent with the limited discovery in proceedings held before the PTAB.
United States
30 Aug 2018
PTAB Upholds GILENYA™ Method Of Treatment Patent, Prompting New ANDA Litigation
In Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 (Jul. 11, 2018), the PTAB held that the claims of U.S. Patent No. 9,187,405 were not unpatentable on three separate grounds.
United States
13 Aug 2018
Sen. Hatch On Amendment To Incentivize Generic Drug Development
I would note as well that for purposes of symmetry, the amendment also applies to post-grant review and to biologics. It will not have any impact on the use of IPR by the tech community.
United States
6 Aug 2018
Enforcement Of The Next Generation Medical Infrastructure Act
The Act Regarding Anonymized Medical Data to Contribute to R&D in the Medical Field ("Next Generation Medical Infrastructure Act") ...
16 Jul 2018
Hatch Bill: Restore Hatch-Waxman Balance; Limit Generics' Access To PTAB
Senator Orrin Hatch (R-Utah), the namesake and coauthor of the Hatch-Waxman Act, proposed an amendment titled the "Hatch-Waxman Integrity Act of 2018" during the Senate Judiciary Committee held on June 13, 2018.
United States
10 Jul 2018
FDA Draft Guidance Regarding Inclusion Of Pregnant Women In Clinical Trials
On April 3, 2018, FDA published long awaited draft guidance entitled " Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials."
United States
6 Jul 2018
The Proposed SPC Export Manufacturing Waiver: Really A Balanced Approach?
The proposed amendment to the European regulation 469/2009 concerning the supplementary protection certificate for medicinal products would introduce an exception to the scope of protection...
European Union
25 Jun 2018
FDA Releases Software Precertification Working Model
As has been true generally across FDA's digital health endeavors, the working model notes that FDA is actively seeking public engagement on this topic.
United States
30 May 2018
ITC Institutes Investigation Based On Allegation Of Drug Sales Without FDA Approval
Normally, it is the FDA that monitors the improper distribution of drugs. But, as it turns out, the International Trade Commission ("ITC") might be able to enter the fray too
United States
25 May 2018
Meetings, Workshops, And Conferences
Public Meeting of FDA, USDA, and DHHS to provide information and receive public comments on agenda items and draft U.S. positions to be discussed at the 50th Session of the Codex Committee ...
United States
17 Jan 2018
European Food Safety Authority Publishes The Hazard Assessment Protocol To Start Re-Evaluation Of The Toxicity Of Bisphenol A In 2018
On December 21, 2017, the EFSA published the Bisphenol A ("BPA") hazard assessment protocol, setting out the EFSA strategy for the re-evaluation of the toxicity of BPA in 2018.
European Union
17 Jan 2018
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