Posts Tagged: FDA


SCOTUS says OK to give notice of commercial marketing before FDA license under Biologics Price Competition and Innovation Act

42 U.S.C. § 262(l) of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) regulates “biosimilars,” biological products that are highly similar to FDA-approved biological products. Section 262(…

Mylan’s Preliminary Injunction Against Aurobindo Affirmed

The Eastern District of Texas granted a preliminary injunction against Aurobindo in favor of Mylan in the case of Mylan Institutional LLC v. Aurobindo Pharma Ltd. On …

Federal Circuit Clarifies On-Sale Bar Under America Invents Act

In Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., the Federal Circuit reversed the district court and held that Helsinn’s pre-AIA patent claims, “were subject …

Want to Revive the Economy? Restore the Patent System!

The old arguments that patents inhibit innovation, and non-exclusivity with compulsory licensing leads to a brave new world are now in vogue. We've stood at this fork …
By Joseph Allen
2 months ago 17

What happens when lifestyle drugs like Viagra and Cialis lose patent protections?

Each year, millions of men rely on pharmaceuticals like Viagra and Cialis for their erectile dysfunction (ED), but they may not be the only ones facing dysfunctionalities. …
By Angélique McCall
2 months ago 12

Federal Circuit limits breadth of claims based on definition in specification, prosecution history

On April 6, 2017, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in The Medicines Company v. Mylan, Inc. (2015-1113, 2015-1151, and 2015-1181) …
By John M. Rogitz
2 months ago 0

The FDA process, patents and market exclusivity

A patent is not the only path to exclusivity. In fact, the FDA characterizes patents and "exclusivity" separately. "Exclusivity" refers to exclusive marketing rights granted by the …
By Angélique McCall & Gene Quinn
3 months ago 1

Derivation requires showing conception and communication of idea from claimed invention, not an obvious variant

Mylan had to show by clear and convincing evidence that the idea for the ’445 patent claim was conceived by someone at the FDA and communicated to Mr. …

Amgen v. Regeneron: Will the permanent injunction against Regeneron’s new PCSK9-inhibitor hold up on appeal?

On January 5, 2017, the District of Delaware issued its long-awaited decision in the patent dispute pending between Amgen and Regeneron wherein the Court granted Amgen’s request for …
By Zachary Silbersher
5 months ago 1

Passage of the 21st Century Cures Act and its Potential Implications on Biodefense

With the Cures Act now signed into law, the incoming Trump administration has an opportunity to advance the broad-spectrum medical countermeasure goal set forth by the U.…
By Jim Joyce
6 months ago 3

Senate passes 21st Century Cures Act, President Obama expected to quickly sign bill into law

Earlier today, by a vote of 94 to 5, the United States Senate overwhelmingly passed the 21st Century Cures Act. Having passed in the House, the Cures Act now …
By Gene Quinn
7 months ago 6

21st Century Cures Act passed overwhelmingly by House, major health reform bill moves to Senate

The 21st Century Cures Act has broad bipartisan support having been passed in the U.S. House by an overwhelming 344-77 roll call vote. It also has …
By Steve Brachmann
7 months ago 18

Understanding the BPCIA Litigation Pathway to Avoid Expensive, Incurable Mistakes

Modeled after the Hatch-Waxman Act, the BPCIA seeks not only to encourage competition in the field of biologics but also to promote innovation by, among other things, …
By Chittam Thakore Ph.D.
7 months ago 1

FDA rules updated on patent information, paragraph IV certifications for ANDAs and 505(b)(2) applications

On Thursday, October 6th, the U.S. Food and Drug Administration (FDA) published a 79-page notice in the Federal Register regarding new rules surrounding Abbreviated New Drug …
By Steve Brachmann
8 months ago 0

Is Nome, Alaska ready for Paragraph 4 ANDA litigation? How about San Juan, Puerto Rico?

Nome, Alaska and San Juan, Puerto Rico are both home to a federal courthouse where, ostensibly, under the recent Acorda Therapeutics holding and subsequent court decisions, a …
By Jennifer Mauri
10 months ago 2