Antoinette F. Konski

Antoinette F. Konski

Foley & Lardner LLP

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Latest Posts › Personalized Medicine


Inherent Disclosure Satisfied Written Description

In Yeda Research and Development Co., Ltd. v. Abbott GMBH & Co. KG, Slip Op. 2015-1662 (Fed. Cir. 2016), the Federal Circuit held that a claim to an isolated protein described by its partial amino acid sequence satisfies 35...more

9/28/2016 - Appeals Board of Patent Appeals Inherent Disclosure Doctrine Patent Litigation Patents Personalized Medicine Prior Art Written Descriptions

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. Analysis of whole genomes is providing...more

8/5/2016 - Barack Obama Databases DNA Draft Guidance FDA Genetic Materials Personalized Medicine Public Comment

FDA Issues Draft Guidance To Streamline Regulatory Oversight Of NGS-Based Tests For Diagnosing Germline Diseases

Personalized or Precision Medicine needs reliable and accurate diagnostic tests to guide clinical intervention and treatment decisions. Traditional testing of germline variants is site-specific and therefore only provides...more

8/2/2016 - DNA Draft Guidance FDA Federal Register Personalized Medicine

Federal Circuit’s Recent Primer on Patent-Eligibility

A method of producing a desired population of multi-cryopreserved hepatocytes was held to be patent-eligible because the challenged claims did not recite a judicial exception. Rapid Litig. v. CellzDirect, Inc.., 2015-1570...more

7/8/2016 - Appeals CLS Bank v Alice Corp Diagnostic Method Life Sciences Mayo v. Prometheus Patent Litigation Patent-Eligible Subject Matter Personalized Medicine Summary Judgment

Will the Supreme Court Clarify Patent-Eligibility?

The United States Supreme Court is set to render its decision on the grant or denial of Sequenom, Inc.’s (“Sequenom’s”) petition for writ of certiorari that posed the issue: ..Whether a novel method is patent-eligible...more

6/27/2016 - Ariosa CLS Bank v Alice Corp Diagnostic Method Patent Litigation Patent-Eligible Subject Matter Personalized Medicine Petition for Writ of Certiorari Pharmaceutical Patents Section 101 Sequenom USPTO

EMA’s New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine

Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated...more

6/20/2016 - Clinical Trials Comment Period DNA Draft Guidance EU Genetic Markers Personalized Medicine Pharmaceutical Industry Prescription Drugs

Despite Barriers, Community Speciality Clinics are Eager to Adopt Precision Medicine Tools

Fueled by technological advances, scientific breakthroughs and significant financial investments, precision medicine (PM) has emerged as a promising approach to disease prevention and treatment. A multi-faceted solution to...more

5/23/2016 - Clinical Trials Diagnostic Tests Genetic Testing Health Care Providers Personalized Medicine Physicians Precision Medicine Initiative (PMI) Reimbursements

USPTO Releases Patent Eligibility Update

On May 4, 2016, the USPTO released a “May 2016 Subject Matter Eligibility Update” (“Update”) providing guidance to patent examiners on formulating a subject matter eligibility rejection and evaluating an applicant’s response...more

5/10/2016 - Diagnostic Method Life Sciences Patent-Eligible Subject Matter Patents Personalized Medicine Pharmaceutical Industry Pharmaceutical Patents USPTO

Data Transmission, Personalized Medicine, and Privacy

Health care analytics make use of patient data to inform treatment decisions and is increasingly moving front and center in personalized medicine. For example, the President’s Precision Medicine Initiative (see post of...more

2/10/2016 - Analytics EU-US Privacy Shield Health Information Technologies International Data Transfers Personal Data Personalized Medicine US-EU Safe Harbor Framework

Navigating the Diagnostic Commercialization Process

Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

10/13/2015 - American Medical Association CLIA Clinical Laboratories Clinical Trials CMS Coding Data Collection Diagnostic Tests FDA Health Care Providers Health Insurance Healthcare Manufacturers Personalized Medicine Physicians Reimbursements

FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more

9/24/2015 - 510(k) RTA Diagnostic Tests FDA FDA Approval Medical Devices Patent Infringement Patent Invalidity Patent Litigation Patents Personalized Medicine Premarket Approval Applications Proposed Regulation Regulatory Oversight USPTO

Patent Subject Matter Eligibility – Impact on Litigation and Prosecution

Personalized medicine relies on diagnostic technologies to accurately evaluate a patient’s clinical or genetic signature to guide treatment decisions. Protecting innovation by patenting the diagnostic methods and tools that...more

9/21/2015 - Algorithms AMP v Myriad CLS Bank v Alice Corp Diagnostic Method Innovation Patent Intellectual Property Protection Mayo v. Prometheus Patent Infringement Patent Litigation Patent-Eligible Subject Matter Patents Personalized Medicine SCOTUS Software USPTO

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more

8/28/2015 - Diagnostic Tests FDA Health Care Providers Health Insurance Healthcare Medical Devices Patients Personalized Medicine Pharmaceutical Industry Prescription Drugs Reimbursements

Will Personalized Medicine Survive Alternative Payment Models?

There is no doubt that health care costs in the United States are rising. According to a recent study published by the U.S. Department of Health and Human Services, personal health care expenditures in the United States...more

6/22/2015 - ACOs Affordable Care Act Alternative Payment Models (APM) Bundled Payments Cost-Containment Department of Health and Human Services Health Care Providers Healthcare Healthcare Costs Patient Centered Medical Homes Personalized Medicine

California's Bet on Precision Medicine

California sees opportunities in personalized medicine. Earlier this month, Governor Brown announced the creation of a two year initiative – California Initiative to Advance Precision Medicine to “begin building...more

4/28/2015 - Health Care Providers Healthcare Jerry Brown Personalized Medicine Public Private Partnerships (P3s)

Perspectives on the President’s Precision Medicine Initiative

President Obama’s “precision medicine initiative” earmarked over $200 million from his proposed 2016 budget to “bring us closer to curing diseases like cancer and diabetes – and to give all of us access to the personalized...more

3/31/2015 - Barack Obama Federal Budget Healthcare Medical Research Personalized Medicine Regulatory Standards Research Funding

Details Emerge for President’s Precision Medicine Initiative

Personalized medicine has a friend in high places. President Obama recently announced an initiative to support “precision” or personalized medicine. In very general terms, the President stated during his 2015 State of the...more

2/4/2015 - Barack Obama Complete Genomics FDA Federal Funding Healthcare NIH ONC Personalized Medicine State of the Union Technology

President Obama Revisits Interest in Personalized Medicine

President Obama announced during his 2015 State of the Union Address that he is launching a new “precision” or personalized medicine initiative to advance personalized, effective therapies for the American public. As reported...more

1/27/2015 - Barack Obama Genetic Markers Healthcare Personalized Medicine Proposed Legislation

Another Patent Challenge for Personalized Medicine

The U.S. Supreme Court’s recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles...more

12/9/2014 - Diagnostic Tests Genetic Materials Healthcare Patent Litigation Patent-Eligible Subject Matter Patents Personalized Medicine

Unlocking the Promise of Personalized Medicine: Reimbursement, Coverage, and Clinical Utility

AmerisourceBergen, in connection with the Business of Personalized Medicine Summit, released “Unlocking the Promise of Personalized Medicine: Perspectives on Reimbursement, Coverage, and Clinical Utility” (“Report“). The...more

9/16/2014 - Healthcare Personalized Medicine

Considering Sex-Specific Variation for Personalized Medicine

Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more

9/3/2014 - 510(k) RTA FDA Healthcare Medical Devices Personalized Medicine Premarket Approval Applications

Managing IP Risk in the Age of Personalized Medicine

As discussed on Foley’s Health Care Law Today blog, personalized medicine treatment trends and innovations are leading diagnostic and therapeutic companies to form complex arrangements and partnerships with the ultimate goal...more

8/8/2014 - Confidential Information Healthcare Patents Personalized Medicine Trade Secrets

Personalized Medicine Today: PMC Issues Fourth State of the Industry Report

Personalized medicine is changing the paradigm of the research, development and delivery of health care. The Personalized Medicine Coalition (PMC), a consortium of interested stakeholders that seeks to promote the...more

7/8/2014 - CMS FDA Healthcare Personalized Medicine

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