As retailers or distributors that are not manufacturers of a product, companies may believe they cannot infringe a patent claiming how the product is made. After all, the retailers or distributors are not performing any steps...more
On April 1, 2019, the Federal Circuit issued a non-precedential decision in Cleveland Clinic Foundation, Cleveland HeartLab, Inc. v. True Health Diagnostics LLC (“Cleveland Clinic II”), affirming the district court’s holding...more
On February 6, 2019, the Federal Circuit decided Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, affirming a District Court for the District of Massachusetts decision that the claims at issue were patent...more
Federal Circuit Summary -
On September 10, 2018, the Federal Circuit decided Regents of the University of California v. Broad Institute, Inc., affirming the Patent Trial and Appeal Board (PTAB)’s determination of no...more
9/17/2018
/ Appeals ,
CRISPR ,
Interference Proceeding ,
Life Sciences ,
Obviousness ,
Patent Applications ,
Patent Infringement ,
Patent Trial and Appeal Board ,
Patents ,
Prior Art ,
Reaffirmation ,
Substantial Evidence Standard ,
University of California
On June 25th, 2018, the U.S. Food and Drug Administration (FDA) approved the drug, Epidiolex, for the treatment of seizures associated with two rare forms of epilepsy, Dravet syndrome, and Lennox-Gastaut syndrome. The active...more
The United States Patent and Trademark Office (USPTO) recently published a new revision to the Ninth Edition of the Manual of Patent Examining Procedure (MPEP) (Revision 08.2017). This revision added a number of chapters...more
3/22/2018
/ Administrative Procedure ,
Amended Rules ,
Appeals ,
CLS Bank v Alice Corp ,
Duty to Disclose ,
Examination Manual ,
Mayo v. Prometheus ,
Method Claims ,
MPEP ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Product of Nature Doctrine ,
Rules of Practice ,
USPTO
The U.S. District Court for the District of Delaware recently handed down two important decisions on motions to transfer for improper venue. Judge Stark presided over both cases, transferring one case and ordering further...more
10/6/2017
/ Abbreviated New Drug Application (ANDA) ,
Bristol-Myers Squibb ,
Hatch-Waxman ,
Judge Stark ,
Patent Infringement ,
Patents ,
Personal Jurisdiction ,
Physical Presence Test ,
Principal Place of Business ,
TC Heartland LLC v Kraft Foods ,
Venue
On August 1, 2017, the U.S. Food and Drug Administration released its draft guidance titled Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases, detailing proposals...more
New York City took a step toward its goal of becoming a life sciences hub with a $5 million grant from the mayor’s office to BioLabs@NYULangone, a biotech incubator in Manhattan formed from a collaboration between BioLabs and...more
On March 28, 2017, the U.S. Food and Drug Administration (FDA) approved the use of Ocrevus (ocrelizumab) in treating multiple sclerosis (MS). Ocrevus is a new biologic and is the first drug approved by the FDA to treat...more
The Supreme Court in Life Technologies Corp. v. Promega Corp held that providing a single component of a multicomponent invention for manufacture abroad does not give rise to patent infringement liability under 35 U.S.C. §...more
3/15/2017
/ Appeals ,
Component Parts Doctrine ,
Cross-Border Transactions ,
Exports ,
IP License ,
Life Technologies Corp v Promega Corp ,
Patent Infringement ,
Patents ,
Reversal ,
SCOTUS ,
Supply Contracts
Anticipation by inherent disclosure requires that a single prior art reference necessarily includes the unstated limitation. The unpredictable nature of biological processes means that winning summary judgment of invalidity...more
1/19/2017
/ Anticipation ,
Appeals ,
Biologics ,
Biotechnology ,
Expert Testimony ,
Inherent Disclosure Doctrine ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Prior Art ,
Summary Judgment ,
Vacated
On October 20, 2016, the Federal Circuit issued yet another opinion finding that the Patent Trial and Appeal Board’s decisions related to the institution of an inter partes review (IPR) are not subject to judicial review. ...more
11/3/2016
/ Appeals ,
Assignor Estoppel ,
Covered Business Method Patents ,
Cuozzo Speed Technologies v Lee ,
Inter Partes Review (IPR) Proceeding ,
Judicial Review ,
Jurisdiction ,
Medtronic ,
Non-Appealable Decisions ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patent Validity ,
Patents ,
Pleading Standards ,
Popular ,
Real Party in Interest ,
Time-Barred Claims
During its August Patent Quality Chat, the USPTO discussed the recently launched Patent Prosecution Pilot Program (P3). The P3 program is a hybrid of the After-final Consideration Pilot (AFCP 2.0), which has been available...more