News and Analysis
Innovation, Technology, and IP News
Prosecution History May Support a Motivation to Combine
Written by: Rhett D. Ramsey & Jacob R. Rosenbaum Elekta Limited v. Zap Surgical Systems, Inc. Before: Reyna, Stoll, and Stark. Appeal from the Patent Trial and Appeal Board. ...
Landmark CAFC Cases in Patent Law: Shaping the Future of Innovation
In the ever-evolving landscape of patent law, the Court of Appeals for the Federal Circuit (CAFC) has played a pivotal role in shaping the rules and precedents governing intellectual...
FDA Releases Draft Guidances on 510(k) Submissions
Written by: Paige L. Cappelli On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated...
IPR Decision Based on a Barely Mentioned Typo Violated the APA Notice Requirement
Written by:Brianne M. Kingery & Daniel Kiang APPLE INC. v. COREPHOTONICS, LTD. Before Stoll, Linn, and Stark. Appeal from the Patent Trial and Appeal Board. Summary: An IPR...
Feed tagged as "fda":
The FDA has published new web pages about Monkeypox and medical devices. The new web page, titled Monkeypox and Medical Devices, includes ... Read More »
Written by Scott Siera, Ph.D. and Eric Furman, Ph.D.
Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S... Read More »
In Intendis v Glenmark, the Federal Circuit affirmed a finding of infringement under the doctrine of equivalents based on statements made by Glenmark to the... Read More »
Comments
Curtis LeeSo in essence, the doctrine of estoppel is being applied to statements or positions taken outside the courtroom?
Oct 12, 2016
Jeff McIntyreNot necessarily estoppel. More like reliable evidence which can help prove the fact and which is difficult to rebut
Oct 12, 2016
Ever forget to take your morning pills? Or can’t remember if you have to take the blue pill today or the yellow one? Suddenly, life just got a lot... Read More »
Medtronic, Inc. is developing a new stent graft system designed to repair thoracic aortic aneurysm. It has been selected by the FDA for an early feasibility pilot... Read More »
We’re all familiar with the so-called weight loss drugs advertised on TV that claim unbelievable results, show before and after shots of what are clearly... Read More »
There has been an explosion of news suggesting a bioethical scandal in recent days. A quick Google search for “CellTex scandal” will produce over 7,000... Read More »
Comments
Rich VNatural Embryonic or adult stem cells are not a drug and cannot be patented, but once they are manipulated they can be patented and sold. Big bucks for the companies and more power to a very corrupt FDA.
There are people on their deathbed that would be willing to take a chance with embryonic cells but the government can’t let that happen because if it works those patented stem cells would be worth nothing. It’s all about the money, and that’s it.
I know of a patient that was killed the night before he was to be transferred to a university hospital back in 2005 to have the procedure done – Of course the report said natural circumstances.
It’s bad enough that the lawyers are crooks but now the FDA and some doctors have become murderers.
There are people on their deathbed that would be willing to take a chance with embryonic cells but the government can’t let that happen because if it works those patented stem cells would be worth nothing. It’s all about the money, and that’s it.
I know of a patient that was killed the night before he was to be transferred to a university hospital back in 2005 to have the procedure done – Of course the report said natural circumstances.
It’s bad enough that the lawyers are crooks but now the FDA and some doctors have become murderers.
Aug 7, 2012
Here's your weekly summary of the top medical news of the week!
CellTex scandal breakdown: Stem cells, Rick Perry and the FDA
There has been an explosion... Read More »
Competing medical device manufacturers are racing to get an artificial pancreas to the market. The FDA has yet to approve specific artificial pancreas... Read More »
For medical uses, the only FDA-approved radio frequency identification (RFID) chip is the one made by VeriChip Corp, a division of Applied Digital Solutions... Read More »
Recent news reports attacking the US drug approval process are not considering all the facts. The Food and Drug Administration (FDA) has been under fire for several... Read More »
Biological pharmaceuticals are therapeutic drugs made from human or animal materials rather than chemicals, often indicated for immune system-related deficiencies... Read More »
The US Food and Drug Administration (FDA) today issued three draft guidance documents on biosimilar product development to assist industry in developing these... Read More »
Two new blood thinners, Xarelto (rivaroxaban) and Pradaxa (dabigatran etexilate) have been approved by the FDA for patients with atrial fibrillation that is not... Read More »
Transparency Life Sciences, LLC (TLS), a new drug development company, has launched a thoroughly innovative platform for clinical studies, with an objective of... Read More »
Pfizer announced that the U.S. Food and Drug Administration has approved their kidney cancer drug INLYTA (axinib). The treatment will be available for patients... Read More »
The horrors of Alzheimer’s disease are well known, and the specter of this disease will fall over most of us in one way or another. Enormous quantities of ... Read More »
Amgen announced today that the FDA has agreed to modify the requirements of the Nplate® Risk Evaluation and Mitigation Strategy Program (REMS). When reviewing the ... Read More »
Boston Scientific announced its next-generation drug-eluting stent was approved by the Federal Food and Drug Administration. With it’s innovative platinum... Read More »
CHICAGO (Reuters) - An experimental drug that chokes off the blood supply to fat cells helped obese monkeys slim down, a sign that it may work in people... Read More »
