Posts Tagged: Food and Drug Administration


Mary Engle Pennington: The Mother of Modern Food Preservation

The preservation of food and beverage products for safe consumption despite extended shelf lives at grocery stores is a major global industry. Both consumers and companies have …
By Steve Brachmann
2 years ago 0

Distribution Agreement Considered a Commercial Offer and On-Sale Bar

The Federal Circuit reiterated that the on-sale bar does not exempt commercial agreements between a patentee and its supplier or distributor. It is the commercial character of …

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
3 years ago 2

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
3 years ago 1

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 …

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
4 years 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
4 years ago 18

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 Gene Quinn & Steve Brachmann
4 years 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
4 years 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
4 years 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
4 years ago 0

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
4 years 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 …

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
4 years ago 1