Antoinette F. Konski

Antoinette F. Konski

Foley & Lardner LLP

Contact  |  View Bio  |  RSS

Latest Publications

Share:

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 Law-of-the-Case Nautilus Inc. v. Biosig Instruments Patent Applications Patent Infringement Patent Invalidity Patent Litigation Patents Popular SCOTUS 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 - Device Manufacturers Diagnostic Tests FDA Health Insurance Healthcare Healthcare Providers Medical Devices Patients Personalized Medicine Pharmaceutical Manufacturers 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 Drug Manufacturers Generic Drugs Patent Infringement Patent Litigation Patents Pharmaceutical Manufacturers 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 Healthcare Healthcare Costs Healthcare Providers 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 P3s Personalized Medicine Public-Private Partnerships

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

Direct-to-Consumer Genetic Test Authorized by FDA

23andMe is not a traditional diagnostics company. Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order...more

2/24/2015 - 23andMe Clinical Laboratories FDA Genetic Testing Laboratory Developed Tests Medical Devices

Patenting Stem Cells in View of the USPTO’s New Interim Guidance

Late last year, the USPTO issued its modified and revised 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Guidance) to assist patent examiners and the public in determining if a claim presented for...more

2/18/2015 - CLS Bank v Alice Corp Genetic Materials Interim Guidance Myriad-Mayo Patent-Eligible Subject Matter Patents Stem cells USPTO

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

FDA Considering New Regulatory Approaches for NGS – Part II

The Food and Drug Administration (“FDA”) announced a workshop to be held February 20th, 2015, entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” to obtain public input regarding...more

1/5/2015 - Diagnostic Tests FDA Regulatory Agenda Rulemaking Process

FDA Considering New Regulatory Approaches for NGS – Part I

The Food and Drug Administration (“FDA”) announced a workshop to be held February 20th, 2015, entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” to obtain public input regarding...more

12/29/2014 - Diagnostic Tests FDA Healthcare Regulatory Agenda

An Early Test for the USPTO’S Eligibility Analysis

Just last week, the USPTO released its revised subject matter eligibility guidance (2014 Interim Guidance on Patent Subject Matter Eligibility “Interim Guidance” reviewed in my prior post of December 16th, 2014). The Interim...more

12/23/2014 - DNA Genetic Materials Guidance Update Myriad Myriad v Ambry Patent-Eligible Subject Matter Patents USPTO

Fetal Diagnostics Patent Claims Fall in Inter Partes Review

Post grant inter partes review proceedings have lowered the hurdle to invalidate U.S. patents. The “broadest reasonable construction” of the claims and the lower burden to prove invalidity (by a preponderance of the evidence)...more

12/19/2014 - Claim Construction Inter Partes Review Proceedings Patent Trial and Appeal Board Patents

USPTO Releases Revised Subject Matter Eligibility Guidance

On December 15th, 2014, the USPTO released its much anticipated revised subject matter eligibility examination guidance to assist patent examiners evaluate inventions that may be related to any one of the three judicial...more

12/17/2014 - CLS Bank v Alice Corp Guidance Update Patent-Eligible Subject Matter Patents USPTO

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

Canada Joins the Gene Patenting Debate

Canada has joined the gene patenting debate. Children’s Hospital of Eastern Ontario (“Children’s”) sued the University of Utah Research Foundation, Genzyme Genetics, and Yale University (“Defendants”) in Canada’s Federal...more

11/24/2014 - Canada Genetic Markers Genetic Materials Patents

Federal Circuit’s Post-Alice Eligibility Analysis of Business Methods

The Federal Circuit in Ultramercial, Inc. v. WildTangent, Inc., held that an “entrepreneurial” multi-step process for distributing copyrighted media products over the Internet to consumers is not patent-eligible under 35...more

11/18/2014 - CLS Bank v Alice Corp Copyright Patent Infringement Patent-Eligible Subject Matter Patent-in-Suit Patents Section 101 WildTangent v Ultramercial

Supreme Court Asked to Review Standing in Stem Cell Challenge

The Public Patent Foundation and Consumer Watchdog (collectively “CW”) petitioned the U.S. Supreme Court on October 31, 2014, seeking reversal of the Federal Circuit’s dismissal of its appeal from a decision of the USPTO that...more

11/3/2014 - Appeals Federal Jurisdiction Inter Partes Review Proceedings Patent Litigation Patents Standing Stem cells

Myriad’s Continuing Patent Debate

On October 6, 2014, the U.S. Court of Appeals for the Federal Circuit entertained oral argument in the interlocutory appeal of the district court’s denial of Myriad’s motion for preliminary injunction against Ambry Genetics....more

10/20/2014 - Appeals CLS Bank v Alice Corp DNA Interlocutory Appeals Myriad v Ambry Patent Litigation Patent-Eligible Subject Matter Patents Pharmaceutical Patents

FDA Issues Draft Guidance for Regulation of LDTs

On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance”). The publication of the draft Guidance...more

10/6/2014 - Draft Guidance Enforcement Guidance FDA Laboratory Developed Tests Medical Devices Public Comment

Myriad Set for Another Round

On Monday October 6th, the U.S. Court of Appeals for the Federal Circuit will entertain oral argument in another case involving Myriad’s BRCA1/BRCA2 diagnostic tests. In re BRCA1- and BRCA2- Based Hereditary Cancer Test...more

9/30/2014 - BRCA DNA Genetic Materials Myriad Patent Infringement Patent Litigation Patent-Eligible Subject Matter Patents

82 Results
|
View per page
Page: of 4

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×