In Illumina, Inc. v. Ariosa Diagnositcs, Inc., (Fed. Cir. Slip Op. 2019-1419, March 17, 2020) the Federal Circuit held that process claims that exploit the discovered size differences between fetal and maternal DNA in serum...more
4/1/2020
/ Dismissals ,
Doctrine of Equivalents ,
Failure To State A Claim ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Reversal ,
USPTO
In OSI Pharmaceuticals, LLC v. Aoptex Inc. (Fed. Cir. 2018-1925, Oct. 4, 2019), the Federal Circuit reversed the Patent Trial and Appeal Board’s (Board) decision that certain claims of US Patent No. 6,900,221 were...more
10/16/2019
/ America Invents Act ,
Form 10-K ,
Obviousness ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Personalized Medicine ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
Retroactive Application ,
Reversal
In a non-precedential opinion, the Federal Circuit held as patent-ineligible patent claims to personalized therapy to treat patients who would benefit from inhaled nitric oxide treatment and withhold treatment from patients...more
In Allergan Sales, LLC v. Sandoz, Inc., (Fed. Cir. 2018-2207, Aug. 29, 2019), the Federal Circuit held that “wherein” clauses in a patent claim were limitations because the “wherein” elements were material to patentability....more
A patent claiming methods to integrate physiological treatment data remotely using a computer was held invalid under 35 U.S.C. § 101. University of Florida Research Foundation, Inc. v. General Electric Company, et al. (Fed....more
In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd, Slip Op. (Nos. 2016-2707, 2016-2708, April 13, 2018) the U.S. Court of Appeals for the Federal Circuit provided useful guidance for patentees seeking to...more
5/29/2018
/ Abbreviated New Drug Application (ANDA) ,
CLS Bank v Alice Corp ,
Mayo v. Prometheus ,
Method Claims ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Prior Art ,
Product of Nature Doctrine ,
Section 101
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
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
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
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
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
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 Approval ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Personalized Medicine ,
Premarket Approval Applications ,
Proposed Regulation ,
Regulatory Oversight ,
USPTO
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
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
In Akamai Techs. Inc. v. Limelight Networks, Inc., (August 13, 2015 Fed. Cir.) an en banc Federal Circuit unanimously held that direct infringement under Section 271(a) can occur...more
8/25/2015
/ Akamai Technologies ,
CLS Bank v Alice Corp ,
Diagnostic Tests ,
Direct Infringement ,
En Banc Review ,
Induced Infringement ,
Limelight v Akamai ,
Mayo v. Prometheus ,
Myriad ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
SCOTUS ,
USPTO
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
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 ,
Marketing Exclusivity Periods ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Sandoz ,
Sandoz v Amgen
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
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
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
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
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
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
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 (IPR) Proceeding ,
Litigation Strategies ,
Myriad ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
SCOTUS ,
Section 101 ,
Stem cells ,
USPTO ,
WARF
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