Posts Tagged: FDA


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 …
By Christopher Loh
5 months ago 0

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 …
By IPWatchdog
1 year ago 1

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 …
By Joseph Allen
1 year ago 5

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 …
By James Pooley
2 years ago 0

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 …
By Jacob Moore & Julie Meigs
2 years ago 0

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” …
By James Pooley
2 years ago 5

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 …
By IPWatchdog
2 years ago 0

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; …
By IPWatchdog
3 years ago 0

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 …
By Tulip Mahaseth
3 years ago 3

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 …
By Russell Slifer
3 years ago 2

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 …
By Theodore Chiacchio
3 years ago 1

Federal Circuit Affirms District Court’s Finding of Validity of Claims Directed to Aveed®

When relying on scientific guidelines to support an obviousness rationale, practitioners should offer evidence for why contradictory guidelines should be discounted. A claimed constituent is not “necessarily …