Posts Tagged: FDA


Patent settlement between AbbVie and Amgen delays Humira generic until 2023

On Thursday, September 28th, a judge in the District of Delaware entered an order stipulating dismissal in a patent infringement case brought by North Chicago-based pharmaceutical firm …
By Steve Brachmann
17 days ago 0

Patent battle over generic Inomax leaves five Mallinckrodt patents invalid as naturally occurring phenomenon

A memorandum signed by Judge Sleet shows that Mallinckrodt’s patents were invalidated under the Section 101 patentability standard set by the U.S. Supreme Court in 2012’s …
By Steve Brachmann
1 month ago 4

IP Strategy is a Tricky Balancing Act for Pharmaceuticals

The 20 years of protection afforded by a patent is intended to promote innovation by allowing inventors a chance to recoup development costs and derive a profit from …
By Shai Jalfin
2 months ago 2

Restricting Patents on New Combinations and Uses of Medicines Makes No Sense

IP-skeptics charge that these inventions are little more than a way for pharmaceutical companies to cynically prolong patent life and maximize profits, without providing any meaningful innovation. …
By Philip Stevens & Jack Ellis
4 months ago 5

Supreme Court of Canada rules on Promise Doctrine in favor of Pharma Patent Owners

The Supreme Court of Canada issued a ruling in AstraZeneca Canada Inc. v. Apotex Inc., which gives patent owners a far greater ability to protect their intellectual …
By Steve Brachmann
4 months ago 1

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
6 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
6 months ago 19

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
6 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
7 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
9 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
10 months ago 3