Antoinette F. Konski

Antoinette F. Konski

Foley & Lardner LLP

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HHS and Medicare Asked to Expand Coverage for Genetic Tests

Fifteen members of Congress have asked the Department of Health and Human Services (HHS) and the Medicare Payment Advisory Commission (Medicare) to examine how the federal government can help improve patient access to genetic...more

3/27/2017 - 21st Century Cures Act Genetic Testing HHS Legislative Agendas Medicaid Medicare National Cancer Moonshot Personalized Medicine

One is Not Enough – Infringement Liability under § 271(f)(1)

In Life Technologies Corp. v. Promega Corp., Slip Op. 14-1538 (Feb. 22, 2017), the U.S. Supreme Court held that the supply of a single component of a multicomponent invention for manufacture abroad does not give rise to...more

3/9/2017 - Appeals Component Parts Doctrine Cross-Border Transactions Exports Extraterritoriality Rules IP License Life Technologies v Promega Manufacturer Liability Patent Infringement Patents Reversal SCOTUS The Patent Act

Federal Circuit Knocks Out Patents After CBM Challenge

Apple successfully invalidated three patents for failure to recite patent eligible subject matter. Apple, Inc. v. Ameranth, Inc., 2015-1792, 2015-1793 (Fed. Cir. 2016). The patents relate to synchronous communication systems...more

2/23/2017 - Abstract Ideas Appeals Apple Claim Construction Computer-Related Inventions Covered Business Method Patents Patent Trial and Appeal Board Patent-Eligible Subject Matter Patents Personalized Medicine Section 101 Standard of Review

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). The Discussion Paper follows FDA’s late 2016 announcement that,...more

2/17/2017 - Diagnostic Tests Discussion Draft FDA Laboratory Developed Tests

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, personalized medicines accounted for more than 25% of all new molecular entities (NMEs) approved by the US Food & Drug...more

2/8/2017 - Biologics FDA Personalized Medicine

Precision Medicine - Obama’s Health Care Legacy

As we come to the end of President Obama’s administration, it is time to look back on the past eight years and the administration’s impact on the delivery of the nation’s health care. While the Affordable Care Act (signed...more

12/27/2016 - 21st Century Cures Initiative Barack Obama Healthcare National Cancer Moonshot Personalized Medicine Precision Medicine Initiative (PMI)

New Report Outlines 5 Year Plan to Achieve Cancer Moonshot

The Cancer Moonshot Task Force has just released its 5 year plan for implementing President Obama’s “Cancer Moonshot” program (“Report”). The initiative, announced during President Obama’s 2016 State of the Union Address, is...more

10/24/2016 - Barack Obama Data Collection Data-Sharing Health Care Providers National Cancer Moonshot Patient Access and Medicare Protection Act Personalized Medicine Pharmaceutical Industry Research and Development

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

Ariosa Loses Verinata Patent Challenge

Fetal diagnostic pioneer Ariosa Diagnostics lost its latest attempt to invalidate competitor Verinata Health’s U.S. Patent No. 8,318,430, “Methods of Fetal Abnormality Detection.” The USPTO’s Patent Trial and Appeal Board...more

8/25/2016 - Appeals Inter Partes Review (IPR) Proceeding Obviousness Patent Validity Patent-Eligible Subject Matter Patents Prior Art Remand

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

Supreme Court Declines Sequenom Review

Last week the United States Supreme Court denied Sequenom’s petition to review the Federal Circuit’s holding in Sequenom Inc. v. Ariosa Diagnostic Inc., 788 F.3d 1371 (2015) that claims directed to detecting fetal DNA in...more

7/6/2016 - Ariosa CLS Bank v Alice Corp Diagnostic Method Mayo v. Prometheus Patent Litigation Patent-Eligible Subject Matter Petition for Writ of Certiorari Section 101 Sequenom

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

Another Diagnostic Patent Falls Under 101

In Genetic Techs Ltd v Merial LLC (Fed. Cir., April 8, 2016), the Federal Circuit invalidated yet another diagnostic patent for failing to satisfy 35 U.S.C. § 101 on the ground that the claims recite nothing more than a law...more

4/12/2016 - Biotechnology CLS Bank v Alice Corp Corporate Counsel Diagnostic Method DNA Genetic Technologies Ltd. Mayo v. Prometheus Patent Litigation Patent-Eligible Subject Matter SCOTUS

Capitalizing on Collaboration – The President’s Precision Medicine Initiative

Last week President Obama marked the one year anniversary of his Precision Medicine Initiative (“PMI”) by holding a web-accessible panel discussion where he and interested stakeholders discussed his PMI initiative, its...more

3/3/2016 - Cybersecurity Framework FDA Health Information Technologies Human Genes NIH NIST Obama Administration Precision Medicine Initiative (PMI) Public Private Partnerships (P3s)

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

The President’s Precision Medicine Initiative – The First Annual Check-Up

Watching President Obama’s recent 2016 State of the Union Address reminded me that one year has passed since the President announced a new “precision” or personalized medicine initiative to advance personalized, effective...more

1/27/2016 - Barack Obama Cancer Data Security FDA Health Information Technologies NIH ONC Precision Medicine Initiative (PMI) State of the Union

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

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