Late last week in Natera, Inc. v. NeoGenomics Laboratories, Inc. (24-1324), the Federal Circuit affirmed a preliminary injunction ruling from the lower court that mostly prohibits NeoGenomics from selling its oncology test...more
There have been only a few precedential decisions from the Federal Circuit related to obviousness since spring sprung. While these decisions have produced mixed results for the lower courts, clinical study protocols have held...more
5/2/2024
/ Apotex ,
Clinical Trials ,
Inventions ,
Janssen Pharmaceuticals ,
Motivation to Combine ,
Obviousness ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Remand ,
Reversal ,
SCOTUS ,
Teva Pharmaceuticals
With only two precedential IP decisions coming down from the Federal Circuit in the second half of September, pickings were a little slim for blogging. That said, the opinion in Baxalta v. Genentech (2022-1461) — drafted by...more
The questions from the high court during oral argument at the end of March 2023 were fairly telling of the 9-0 ruling that came down yesterday in Amgen, Inc. v. Sanofi (No. 21-757). In fact, it did not come as much of a...more
5/19/2023
/ Amgen ,
Biotechnology ,
Enablement Inquiries ,
Healthcare ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Inventions ,
Judicial Proceedings ,
Life Sciences ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sanofi ,
SCOTUS ,
Section 112
The Supreme Court is set to hear oral arguments in Amgen, Inc. v. Sanofi (No. 21-757) on Monday, March 27, 2023. The highly contentious question before the high court focuses what an applicant must show to meet the enablement...more
3/24/2023
/ Appeals ,
Claim Construction ,
Enablement Inquiries ,
Innovation Patent ,
Oral Argument ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
SCOTUS ,
Section 112 ,
Written Descriptions
The Federal Circuit has affirmed infringement under the doctrine of equivalents in a number of cases over the last few years. Briefly, the judicially created doctrine of equivalents is intended to expose those who adopt the...more
Last week, the Federal Circuit confirmed that Idenix Pharmaceuticals will not be the proud recipient of what was previously regarded as the largest damages award ever recorded in a U.S. patent case. In fact, the majority’s...more
As discussed in a previous blog post, since Mayo v. Prometheus, critics of medical treatment patents have advocated that such patents should be banned from patenting. While such arguments seemed futile based on the consistent...more
9/3/2019
/ CAFC ,
Diagnostic Method ,
Intellectual Property Protection ,
Inventions ,
Myriad-Mayo ,
Patent Invalidity ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
Pharmaceutical Patents ,
Section 101 ,
Treatment Method Patents
The Federal Circuit recently reversed a lower court’s ruling of validity under the § 112 written description requirement effectively opening the door for a number of generic drug manufacturers to enter the market with a...more
5/24/2019
/ Abbreviated New Drug Application (ANDA) ,
Claim Construction ,
Patent Infringement ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Precedential Opinion ,
Prior Art ,
Section 103 ,
Section 112 ,
Written Descriptions
In a precedential decision delivered this week, the Federal Circuit shot down arguments from Appellants BTG International Limited; Janssen Biotech, Inc.; Janssen Oncology, Inc.; and Janssen Research & Development, LLC (BTG),...more
5/17/2019
/ Appeals ,
Collateral Estoppel ,
Generic Drugs ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prior Art ,
USPTO
In a precedential decision delivered recently, the Federal Circuit shot down arguments from Neptune Generics, LLC, Mylan Laboratories Ltd., and Fresenius Kabi USA, LLC that the Patent Trial and Appeals Board (PTAB) erred in...more
5/6/2019
/ Clinical Trials ,
Food and Drug Administration (FDA) ,
Inter Partes Review (IPR) Proceeding ,
Nonobvious ,
Obviousness ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Pharmaceutical Patents ,
Precedential Opinion ,
Prior Art ,
Section 101
In a decision issued by the Federal Circuit on October 24, 2018, the court affirmed a finding by the Patent Trial and Appeal Board (PTAB) that a multiple sclerosis (MS) treatment claimed in an application owned by FWP IP APS...more