Antoinette F. Konski

Antoinette F. Konski

Foley & Lardner LLP

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8/5/2016 - Barack Obama Databases DNA Draft Guidance FDA Genetic Materials Personalized Medicine Public Comment

FDA Issues Draft Guidance To Streamline Regulatory Oversight Of NGS-Based Tests For Diagnosing Germline Diseases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8/2/2016 - DNA Draft Guidance FDA Federal Register Personalized Medicine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

Nautilus Standard Sinks Dow Patents

Dow Chemical Company (“Dow”) lost a ruling that competitor NOVA Chemical Corporation and NOVA Chemicals Inc. (collectively “NOVA”) infringed claims of two Dow patents when the Federal Circuit applied the U.S. Supreme Court’s...more

9/1/2015 - Best Practices Definiteness Dow Chemical Indefiniteness Issue Preclusion Nautilus Inc. v. Biosig Instruments Patent Applications Patent Infringement Patent Invalidity Patent Litigation Patents Popular SCOTUS Stare Decisis Teva v Sandoz

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

Inventorship, Ownership Issues Cause Dismissal of Suit

On July 22, 2015, the U.S. District Court for the District of Maryland dismissed a long standing patent infringement suit brought by StemCells, Inc. against Neuralstem, Inc., on the ground that all those with an ownership...more

8/3/2015 - Joint Inventors Memorandum of Agreement Oral Contracts Patent Applications Patent Infringement Patent Litigation Patent Ownership Patent-in-Suit Patents Real Party in Interest Standing Stem cells USPTO

Biosimilars Can Sit Out Patent Dance, But May Have To Wait Out Second Exclusivity Period

In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that...more

7/23/2015 - Amgen Biosimilars BPCIA Generic Drugs Patent Infringement Patent Litigation Patents Pharmaceutical Industry Prescription Drugs Sandoz Sandoz v Amgen

Federal Circuit Invalidates Another Diagnostic Patent

In Ariosa Diagnostics, Inc. v. Sequenom, Inc., Slip Op. 2014-1139, 2014-114 (Fed. Cir. June 12, 2015), the U.S. Court of Appeals for the Federal Circuit held that Sequenom’s U.S. Patent No. 6,258,540 (the ‘540 Patent) was...more

7/2/2015 - Appeals Diagnostic Method Patent Infringement Patent Invalidity Patent Litigation Patent-Eligible Subject Matter Patents Sequenom

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

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