Antoinette F. Konski

Antoinette F. Konski

Foley & Lardner LLP

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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

11 New Biomarkers Identified for Alzheimer’s Disease

A two-stage meta-analysis of genome-wide association studies (GWAS) in individuals of European ancestry identified 11 new loci associated with Alzheimer’s disease. The multidisciplinary study, recently reported in Nature...more

11/12/2013 - Alzheimer's DNA Human Genes

California Court Holds Diagnostic Claims Not Patent-Eligible

In one of the first district court decisions applying the U.S. Supreme Court’s new Myriad patent-eligibility standard, the Northern District of California held that diagnostic claims containing only conventional and existing...more

11/4/2013 - Biotechnology Diagnostic Tests DNA Genetic Materials Genetic Testing Patent-Eligible Subject Matter Patents Pharmaceutical

FDA Reaffirms Commitment to Personalized Medicine

In a report released on October 29, 2013, the U.S. Food and Drug Administration (FDA) announced its continued commitment to advancing personalized medicine. “Paving the Way for Personalized Medicine: FDA’s Role in a New Era...more

10/30/2013 - FDA Healthcare Personalized Medicine

Risk-Sharing and Reimbursement of Diagnostic Tests

Five industry executives argue for an overhaul of the current approval and reimbursement framework for diagnostic tests. In A Pay-For-Value, Data-Driven Approach for the Coverage of Innovative Genetic Tests a case is made for...more

9/30/2013 - Diagnostic Method Diagnostic Tests Fee-for-Service Innovation Reimbursements Risk Management

Update on WARF Stem Cell Patent Challenge

As reported in my July 8, 2013 post, Consumer Watchdog (formerly known as The Foundation for Taxpayer and Consumer Rights) and the Public Patent Foundation (collectively “CW”) asked the Federal Circuit to determine if in...more

9/18/2013 - Biotechnology Genetic Materials Medical Research Patent Applications Patent-Eligible Subject Matter Patents Stem cells

Study Advances Personalized Medicine for Newborns

Earlier this year, the American Academy of Pediatrics (AAP) and the American College of Medical Genetics and Genomics (ACMG) issued recommendations and proposed best practices for genetic testing and screening of infants and...more

9/13/2013 - American Academy of Pediatrics Genetic Testing Healthcare Medical Research Personalized Medicine

From Personal Computers to Personalized Medicine

Personalized medicine offers something for everyone. Dell Corporation, most notably known for producing computers has recently become deeply involved in the health industry....more

8/22/2013 - Biotechnology Healthcare Personalized Medicine Technology

Clinical Progress in Regenerative Medicine

Two separate clinical initiatives were recently announced that support the therapeutic use of regenerative medicine. The first utilzing induced pluripotent stem cells and the second, a state-wide network in support of...more

8/7/2013 - Healthcare Medical Research Personalized Medicine Stem cells

Expanding Access to, and Development of, Personalized Medicine

In a July 8th, 2013 letter to the Centers for Medicare & Medicaid Services (CMS), the Personalized Medicine Coalition (PMC) advised that proposed reimbursement schedules for diagnostic medicine will threaten the development...more

7/24/2013 - CMS Diagnostic Method Healthcare Medical Reimbursement Patients Personalized Medicine

Patents, Genetic Testing, and Federal Funding

In a July 12, 2013 letter to Dr. Francis S. Collins of the National Institutes of Health (“NIH”), Senator Patrick J. Leahy urged the NIH to exercise its march-in rights under the Bayh-Dole Act to directly license the genetic...more

7/18/2013 - Bayh-Dole Act DNA Federal Funding Genetic Materials Genetic Testing Myriad NIH Patents

Patent-Eligibility of hESC Challenged

Now that the U.S. Supreme Court has determined that isolated, naturally-occurring genes are not patent-eligible (see, Ass’n. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __ (2013))(“Myriad”), Consumer Watchdog...more

7/8/2013 - AMP v Myriad Myriad Patent-Eligible Subject Matter Patents SCOTUS Stem cells

Monsanto Averts Declaratory Judgment Suit

On June 10, 2013, the U.S. Court of Appeals for the Federal Circuit held that Monsanto’s representation that it would not pursue farmers and seed sellers for patent infringement if they inadvertently use Monsanto’s patented...more

6/17/2013 - Declaratory Judgments Farms Genetically Engineered Seed Infringement Monsanto Organic Seed Growers & Trade Assn Patents

Isolated DNA Is Not Patent-Eligible

On June 13, 2013, the U.S. Supreme Court in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., __ U.S. __ (2013), held that genes and DNA fragments merely isolated from nature without alteration are not patent-eligible....more

6/17/2013 - AMP v Myriad DNA Human Genes Myriad Patent-Eligible Subject Matter Patents SCOTUS

FDA's Plan to Regulate LDTs

In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement...more

6/17/2013 - DNA Enforcement FDA Laboratory Developed Tests Regulation

Supreme Court Holds Isolated Naturally Occurring DNA Cannot Be Patented, Sustains Patent-Eligibility of cDNA

On June 13, 2013, the U.S. Supreme Court issued its long-awaited decision in the “ACLU/Myriad” gene patenting case (formally, Association For Molecular Pathology. et al. v. Myriad Genetics, Inc., et al., Supreme Court No....more

6/14/2013 - AMP v Myriad Biotechnology DNA Human Genes Myriad Patent-Eligible Subject Matter Patents SCOTUS

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