Antoinette F. Konski

Antoinette F. Konski

Foley & Lardner LLP

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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

Federal Circuit Frames Test for Patent-Eligibility

Personalized medicine relies on diagnostics to analyze a patient for individualized therapy and for monitoring a patient’s health status. Some diagnostic tests use natural products, for example gene sequences, either as the...more

9/9/2014 - Patent Applications Patent Prosecution Patent-Eligible Subject Matter Patents Popular

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

Will the USPTO Respond to Public Feedback of Its Eligibility Guidance?

Periodically, the USPTO holds open meetings with the public to discuss its thinking on current topics relating to the patent procurement process. Late last week, the Biotechnology, Chemical and Pharmaceutical Customer...more

8/26/2014 - Mayo v. Prometheus Myriad Myriad-Mayo Patent-Eligible Subject Matter Patents Public Comment Public Procurement Policies USPTO

Yamanaka iPSC Patent Challenged

Dr. Shinya Yamanaka of Kyoto University shared the 2012 Nobel Prize in Physiology or Medicine with Dr. John B. Gurdon for their respective discoveries that mature, specialized cells can be reprogrammed to become immature...more

8/22/2014 - DNA Inter Partes Review Proceedings Patents Shinya Yamanaka USPTO

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

FDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies

Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...more

8/4/2014 - CLIA Clinical Laboratories CMS Diagnostic Tests Draft Guidance Enforcement FDA Healthcare Laboratory Developed Tests NIH Physicians

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

USPTO Extends Deadline to Comment on Subject Matter Eligibility Analysis

Yesterday at BIO’s session entitled “Patent-Eligibility from the Trenches: Practical Implications of the Supreme Court’s Prometheus (Mayo) and Myriad Decisions” a panel of experts and an engaged audience discussed the...more

6/27/2014 - Patent Litigation Patent-Eligible Subject Matter Patents USTPO

Federal Circuit Dismisses WARF Stem Cell Case – A Missed Opportunity

Recently in Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 2013-1377 (Fed. Cir. 2014), the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) dismissed Appellant Consumer Watchdog’s appeal on the...more

6/16/2014 - Appeals Article III Consumer Watchdog DNA Inter Partes Review Proceedings Litigation Strategies Myriad Patent Litigation Patent-Eligible Subject Matter Patents SCOTUS Section 101 Stem cells USPTO WARF

Regulating Point of Care Diagnostics

Personalized medicine relies on diagnostic medicine to identify the best therapy for the patient at the right time. Tests that match a therapy to the patient fall into one of two categories. In vitro diagnostic devices or...more

6/2/2014 - CLIA CMS Diagnostic Tests FDA Healthcare Medical Devices

Is Next Generation Sequencing Ready for Personalized Medicine?

Next generation sequencing (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application...more

5/20/2014 - Clinical Laboratories Diagnostic Tests FDA Genetic Materials Healthcare Laboratories Personalized Medicine

Federal Circuit Adds to Section 101 Jurisprudence

The U.S. Court of Appeals for the Federal Circuit, relying on U.S. Supreme Court patent-eligibility precedent, held that a claim to a live-born clone of a pre-existing, non-embryonic, donor mammal is not patent-eligible. The...more

5/9/2014 - Appeals Genetic Materials Patent-Eligible Subject Matter Section 101

Patent-Eligibility of Stem Cells Under New USPTO "Myriad-Mayo" Guidance

In March, the U.S. Patent and Trademark Office (USPTO) implemented new procedures to address whether inventions that relate in whole or in part to laws of nature and naturally occurring products are patent-eligibility in...more

4/29/2014 - AMP v Myriad Mayo v. Prometheus Myriad Patent-Eligible Subject Matter Patents SCOTUS Stem cells USPTO

Recommendations for NextGen Health IT Infrastructure

Health care information technology (health IT) facilitates the delivery of personalized medicine by providing and supporting the infrastructure for patients, consumers and health care providers to communicate and distribute...more

4/21/2014 - FCC Healthcare Medical Devices ONC Technology

USPTO Issues Guidance for Examining Process Patents

On March 4th, 2014, the U.S. Patent and Trademark Office (USPTO) issued “2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or...more

3/7/2014 - AMP v Myriad Mayo v. Prometheus Myriad Patent Litigation Patents SCOTUS USPTO

USPTO Issues New Guidelines on Subject Matter Eligibility Under 35 USC 101 in View of Myriad and Prometheus

The USPTO issued new guidelines for determining if claims are eligible for patenting in light of the Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S., 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013), and...more

3/6/2014 - Patent-Eligible Subject Matter USPTO

USPTO to Apply Myriad Beyond Isolated DNA

Today, the United States Patent and Trademark Office (“USPTO”) issued a Guidance, advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court’s interpretation of 35...more

3/5/2014 - AMP v Myriad DNA Genetic Materials Myriad SCOTUS USPTO

Genentech’s Distribution of Prescribing Information to Physicians is Alleged to Infringe Method Patent

On January 31, 2014, Phigenix, Inc. (“Phigenix”) filed a lawsuit in federal district court in Georgia alleging that the sale and use of the drug Kadcyla by Genentech, Inc. (“Genentech”) infringed U.S. Patent No. 8,080,534B2,...more

2/25/2014 - Genentech Healthcare Patent Infringement Patent Litigation Patents

Computer-Aided Selection Method Fails Patent-Eligibility

In SmartGene, Inc. v. Advanced Biological Labs., S.A., No. 2013-1186 (Fed. Cir., Jan. 24, 2014), the Federal Circuit held that a patent claiming the use of a computer to implement routine mental information-comparison and...more

2/11/2014 - Patent Applications Patent-Eligible Subject Matter Patents

Six Hot Opportunities in Genomic Medicine

Advances in DNA sequencing technology and the interpretation of the acquired data have fueled advances in genomics and its application in the delivery of personalized healthcare. Illumina recently announced a new milestone...more

1/28/2014 - Birth Defects Cancer DNA Genetic Markers Genetic Services Genetic Testing Healthcare Personalized Medicine

Task Force Recommendation for BRCA-Related Genetic Testing

The U.S. Preventive Services Task Force (“USPSTF”) recently issued a report regarding the effectiveness of BRCA1/BRCA2 genetic tests for women and within the report, issued recommendations for preventive screening for women...more

1/13/2014 - BRCA DNA Genetic Materials Genetic Testing Preventive Health Care

WARF Could Avoid Federal Circuit Review

On November 25, 2013, Consumer Watchdog (“CW”) and Wisconsin Alumni Research Foundation (“WARF”) responded to the Federal Circuit’s Order directing each party to brief whether CW, as a third party requester, has standing to...more

12/2/2013 - America Invents Act Inter Partes Review Proceedings Patent Litigation Patent Reform Patents

FDA Issues Draft Guidance to Expedite Device Development

On November 14, 2013, the Food and Drug Administration (“FDA”) issued a draft guidance document - “Draft Guidance for Industry, Tool Developers, and Food and Drug Administrative Staff” (“Draft Guidance”) reporting a voluntary...more

11/19/2013 - FDA Medical Devices

FDA Issues Draft Guidance to Expedite Device Development

On November 14, 2013, the Food and Drug Administration (“FDA”) issued a draft guidance document - “Draft Guidance for Industry, Tool Developers, and Food and Drug Administrative Staff” (“Draft Guidance”) reporting a voluntary...more

11/19/2013 - FDA Medical Devices

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