Searching Content indexed under Food and Drugs Law by Antoinette Konski ordered by Published Date Descending.
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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
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
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
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
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
USPTO Patent Eligibility Training On 2019 Revised Subject Matter Guidance
On February 28, 2019, the USPTO summarized and explained the recently issued 2019 Revised Patent Subject Matter Eligibility Guidance
United States
12 Mar 2019
USPTO Releases 2019 Eligibility Update
The Guidance takes effect Monday, January 7, 2019.
United States
10 Jan 2019
Diagnostic Method Claims And Primer Tools Lack Patent-Eligibility
The decision summarizes this panel's current thinking on the patent-eligibility of unmodified polynucleotides and methods to detect "natural phenomena" using "conventional" tools.
United States
23 Oct 2018
Medical Treatment Patent Claims Held Patentable Subject Matter Under The Alice/Mayo Section 101 Test
In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int'l Ltd, Slip Op. (Nos. 2016-2707, 2016-2708, April 13, 2018) the U.S. Court of Appeals ...
United States
29 May 2018
All Of Us Research Program Opens May 6th
The National Institutes of Health (NIH) opened national enrollment today, May 6th, for the All of Us research program. Initially branded as the "Precision Medicine Initiative Cohort Program,"...
United States
8 May 2018
Advancing Access To Precision Medicine Act - A Bipartisan Bill
On February 15, 2018, representatives Eric Swalwell (CA-15), John Shimkus (IL-15), Scott Peters (CA-52), Erik Paulson (MN-03), and Juan Vargas (CA-51) ...
United States
6 Mar 2018
Over 30% Of New Drug Approvals In 2017 Were Personalized Medicines
The Personalized Medicine Coalition (PMC) recently published its "Personalized Medicine at FDA: 2017 Progress Report" (Report) that highlights drug approval developments and milestones achieved in 2017.
United States
21 Feb 2018
FDA Releases Stem Cell Guidance Documents
Therapies that use autologous or allogeneic stem cells are examples of early personalized therapies. Removing cells from a patient and reintroducing them to the same or a matched patient ...
United States
28 Nov 2017
FDA Approves Companion Dx For PD-1 Inhibitor
According to the American Cancer Society ("ACS"), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer).
United States
19 Oct 2017
Breaking Down Barriers Between Pre-clinical and Clinical Adoption Of Personalized Medicine
Personalized medicine will change how health care is delivered and disease is prevented and treated.
United States
4 May 2017
FDA Hits "Pause" On Regulation Of LDTs
On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a Discussion Paper on Laboratory Developed Tests (LDTs) (LDTs) (Discussion Paper).
United States
17 Feb 2017
More Than 25% Of New Molecular Entities Approved In 2016 Are Personalized Medicines
The Personalized Medicine Coalition (PMC) recently reported that for the third year in a row...
United States
15 Feb 2017
FDA Issues Guidance On Use Of Public Human Genetic Variant Databases And Their Use In Personalized Medicine
Next Generation Sequencing (NGS) permits the analysis of millions of genetic variants at a time and has proven to be invaluable for the development of personalized or precision medicine.
United States
9 Aug 2016
EMA's New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine
The Guidance notes that these recommendations apply to Marketing Authorization Applications for medicines for human use and they should be read in conjunction with other relevant EU and ICH guidelines and reflection papers.
European Union
21 Jun 2016
The President's Precision Medicine Initiative – The First Annual Check-Up
Soon after the President's address, details emerged regarding the Precision Medicine Initiative ("PMI").
United States
27 Jan 2016
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