Posts Tagged: FDA


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
2 days ago 17

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.
21 days ago 0

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
2 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
3 months ago 2

Government is to blame for the skyrocketing price of EpiPens, not patents

The problem is that the government is standing in the way of these competitive autoinjectors getting into the hands of the patients who need them. For example, …
By Brett Trout
3 months ago 23

Horizon Pharma sues Actavis, Lupin for Paragraph IV certifications on generic Pennsaid

Horizon Pharma filed an action for patent infringement against Actavis and Lupin Pharmaceuticals in response to the filing of Abbreviated New Drug Applications (ANDAs) by both defendants …
By Steve Brachmann
3 months ago 0

Swiss researchers make breakthrough in medical microrobot technology

ETHZ, one of the Swiss universities involved in the recent microbot breakthrough, received a patent in 2013 for a related technology. U.S. Patent No. 8405256, entitled Wireless Resonant …
By Steve Brachmann
4 months ago 0

Courts Answer Key Questions Over the Reach of the BPCIA

Two recent Federal Circuit opinions provide some answers to the issues presented by complaints alleging non-compliance with the BPCIA. In Amgen Inc. v. Sandoz Inc., the Federal …

Biologics Applicant Must Give Post-Approval Notice to Reference Product Sponsor

The Federal Circuit held that there was no statutory language that made section (8)(A) non-mandatory. Further, Amgen v. Sandoz disposed of Apotex’s argument that (8)(A) would …

FDA approval of Teflaro puts Allergan’s portfolio of anti-infectives into focus

Treatments for infectious diseases is one area where Allergan is looking to buoy its fortunes in the coming years. The first quarter of 2016 was a strong one …
By Steve Brachmann
6 months ago 0

IP Protection Critical for BioPharma Given Number, Cost and Complexity of Clinical Trials

Biopharmaceutical innovation is difficult, expensive, time-consuming, and risky. More so now than ever. A 2014 study by Tufts University’s Center for the Study of Drug Development calculated …
By Dr. Kristina Lybecker
6 months ago 9

Federal Circuit Affirms Doctrine of Equivalents Analysis Using Appropriate Hypothetical Claim

The Federal Circuit held that it is not the case that a patent must spell out a claim element’s function, way, and result, for the doctrine …

A look at treatments for hepatitis C, America’s top infectious disease killer

The FDA has been pretty active this year in approving new tests and treatments designed to help identify and eliminate the hepatitis C virus in patients. Swiss …
By Steve Brachmann
7 months ago 1

Clinical Trials and Tribulations: Why IP Protection is Critical to the Future of Biologic Medicine

Given the importance of intellectual property rights to economic growth and technological development, as well as the wider benefits of biopharmaceutical research, the provisions found in the …
By Dr. Kristina Lybecker
7 months ago 3

Acorda Therapeutics v. Mylan Pharmaceuticals May Not be the Last Word on Personal Jurisdiction in ANDA Cases

The Federal Circuit held that Mylan Pharmaceuticals, Inc. (“Mylan”), a generic drug manufacturer, was subject to specific personal jurisdiction in Delaware because Mylan had filed an abbreviated …