Precision or personalized medicine seeks to find the right treatment for each patient at the right time based on the patient’s genes, proteins and other personal characteristics. The approach has been successfully used to...more
The USPTO recently released a Report to Congress (“Report”) detailing the results of its call for public comments regarding the impact of U.S. jurisprudence on patent subject matter eligibility. The Report is responsive to...more
On December 12, 2019, an outbreak of a severe pneumonia broke out of Wuhan, China. The causative agent of the outbreak was determined to be a coronavirus, an enveloped positive- and single-stranded RNA virus that infects...more
In 2014, the U.S. Supreme Court’s Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014) (“Alice”) held that technologies that merely implemented an abstract idea with a generic computer were not eligible for patent...more
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
On January 4, 2019, the US Patent and Trademark Office (USPTO) announced revised guidance for determining subject matter eligibility under 35 U.S.C. § 101 for computer-implemented inventions (Guidance). The Guidance takes...more
On August 2nd 2017, the USPTO hosted a Bicoastal Biotechnology/Chemical/Pharmaceutical Customer Partnership that focused on the USPTO’s current thinking on patent-eligibility. The meeting followed the USPTO’s June 25th, 2017...more
10/7/2017
/ Abstract Ideas ,
CLS Bank v Alice Corp ,
Inventions ,
Judicial Exception ,
Life Sciences ,
Mayo v. Prometheus ,
Patent-Eligible Subject Matter ,
Patented Medicines ,
Patents ,
Product of Nature Doctrine ,
Section 101 ,
USPTO
On June 29th, 2016, the USPTO announced the Cancer Immunotherapy Pilot Program to allow expedited examination of patent applications that pertain to cancer immunotherapy. Under the Program and after proper petition, the USPTO...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
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
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
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
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
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
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
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
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
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
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
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
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
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
Patenting diagnostic methods is more challenging in the wake of the U.S. Supreme Courts Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (Prometheus) and the USPTO’s application of the...more