Posts Tagged: FDA
FDA Resists FOIA Request for Vaccine Approval Info as Biden Administration Offers to Share it with the World
From the “one hand doesn’t know what the other hand is doing” category, believe it or not, the Food and Drug Administration (FDA) is effectively refusing …
New Dance Moves? Purple Book Amendments Require Public Disclosure of ‘Patent Dance’ Patent Lists
Innovator (or “reference”) biologic drug makers and small-molecule drug makers face differing legal obligations with respect to public patent disclosures. Under the Hatch-Waxman Act, reference small-molecule drug …
Federal Circuit Weighs in on Proper Venue in Hatch-Waxman Cases Under TC Heartland
Last week, the U.S. Court of Appeals for the Federal Circuit addressed a question of first impression regarding whether an act of patent infringement occurs in …
No, You Can’t March in On Remdesivir
One thing you should never say in 2020 is: "Well, at least things can't get any worse." They can and often do. The latest exhibit—in the intellectual …
Trusting Your Secrets to the Government
According to Merriam-Webster, the “Word of the Year for 2019 is “they” when used in the singular, typically to avoid ascribing a gender to the person being referred …
Rare Diseases as A Strategic Springboard: Leveraging Orphan Drug Designations and Patent Protection for Increased Investment
Drug innovators are providing much needed focus on rare diseases and, at the same time, leveraging early-stage rare disease results to facilitate down-stream market entry in broad-spectrum …
The Dark Side of Secrecy: What Theranos Can Teach Us About Trade Secrets, Regulation and Innovation
The spectacular failure of blood-testing firm Theranos is the subject of a riveting book, Bad Blood by investigative reporter John Carreyrou, and an engaging documentary, “The Inventor” …
Other Barks & Bites, Friday, September 6: CAFC Says State Sovereignty Doesn’t Authorize Suit in Improper Venue; USPTO Revises Guidance on U.S.-Licensed Attorney Requirement for Trademark Applicants
This week in Other Barks & Bites: the Chinese government announces stricter punitive measures in its IP system; the Federal Circuit says state sovereignty principles do not allow …
India’s Patent Law is No Model for the United States: Say No to No Combination Drug Patents Act
The United States is on the brink of making changes to the U.S. patent law that would be modeled on India’s Patent Law. At a …
Other Barks & Bites for Friday, March 8
This week in Other Barks & Bites: The United Nations highlights the importance of women in innovation on International Women's Day; Comments due today on USPTO Section 101 Guidance; …
Federal Circuit Rules Momenta Has No Standing after Ceasing Development of a Biosimilar
Earlier this month, the Federal Circuit dismissed an appeal from the Patent Trial and Appeal Board (Board) where the Board upheld the patentability of a biologics patent. …
Blockbuster Restasis Patent Goes Down at Federal Circuit a Victim of Rule 36
Without any explanation, analysis or justification, Chief Judge Prost, and Judges Reyna and Hughes affirmed the decision of colleague Judge Bryson. A patent to a blockbuster drug …
IPR Outcomes of Orange Book Patents and its Effect on Hatch-Waxman Litigation
Out of the 230 Orange Book patents challenged in IPR proceedings, 90.4% (208) of these patents were also challenged in Hatch-Waxman litigation perhaps due to the lucrative 180-day exclusivity incentive …
The Updated PTAB Trial Practice Guide – Not Quite There Yet
While the changes to the Trial Practice Guide begin to move the rules in the right direction, more is needed before post-grant proceedings will be accepted as …
Federal Circuit Treatment of ‘Commercial Success’ in Hatch-Waxman Cases
In order to establish that the commercial success factor supports a non-obviousness finding, the patentee must establish that a connection (or nexus) exists between the novel aspects …
