Posts Tagged: hatch-waxman


Bipartisan Agreement That Drug Prices Are a Problem (and Patents are Complicated) Could Mean Changes for Pharma

During a hearing of the Senate Committee on the Judiciary on Tuesday titled, “Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition,” senators heard …
By Eileen McDermott
18 days ago 12

Filer of an ANDA Paragraph III Certification has Standing to Appeal from PTAB in IPR

The ‘650 patent covers a compound called fesoterodine, which is an antimuscarinic drug marketed as Toviaz® and used to treat urinary incontinence. Mylan Pharmaceuticals petitioned for IPR of …

CAFC Overturns Preliminary Injunction on Generic Suboxone Film Over Newman Dissent

The Federal Circuit issued a nonprecedential decision in Indivior Inc. v. Dr. Reddy’s Laboratories, S.A., which vacated a preliminary injunction handed out by the District …
By Steve Brachmann
6 months ago 1

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 …
By Gene Quinn & Steve Brachmann
6 months ago 23

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
8 months ago 3

Federal Circuit Reverses, Finds Opioid Addiction Treatment Patent Nonobvious

The Federal Circuit reversed the District of Delaware’s decision to invalidate Orexo’s opioid treatment patent as obvious because obviousness was not proved by clear and …

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
9 months ago 1

Expectation of Success – How Much is Reasonably Needed for Obviousness

How much is needed to reasonably prove obviousness? In UCB, the majority found UCB, Inc.’s asserted claim nonobvious under non-statutory double patenting.  The dissent, however, found …

Reflections on Drug Patents and the High Cost of Healthcare

The Hatch-Waxman Act and the Biologic Price Competition and Innovation Act are both forged from a noble ideal, grounded in a commitment to a robust and earnest …
By Arie Michelsohn
11 months ago 1

Why should we encourage generics to challenge pharma patents?

What was the federal government thinking when Hatch-Waxman originally passed. Why would Congress incentivize generic manufacturers to challenge the patents of pharmaceutical companies? It is the same …
By Gene Quinn
11 months ago 1

Senator Hatch files Amendment to Fix IPRs for Pharma, Save Hatch-Waxman

Late yesterday, Senator Orrin Hatch (R-UT), co-author of the Hatch-Waxman Act, filed an amendment in the Senate Judiciary Committee to address what many characterize as abusive inter …
By Gene Quinn
12 months ago 21

Patent Litigation Shows Shift Towards Delaware, Decrease in High-Volume Plaintiff Filings

Legal data analytics provider Lex Machina recently published a post featuring data points regarding the filing of patent infringement cases in the year following the U.S. …
By Steve Brachmann
12 months ago 2

Federal Circuit confirms validity of patent for UCB’s Vimpat®

Appellants were generic drug manufacturers who filed Abbreviated New Drug Applications ("ANDAs"), seeking approval for generic versions of Vimpat®. As a result, the Federal Circuit affirmed the …

China extends drug patent exclusivity to 25 years

Among members of the news media, patents have been a popular whipping boy when contemplating why Americans pay higher drug prices relative to the rest of the …
By Steve Brachmann
12 months ago 0

Vanda v. West-Ward: This Time, Dosage Adjustment Claims are Patent Eligible Subject Matter

The Federal Circuit’s decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, No. 2016-2707, addresses the complicated topic of patent eligibility in the pharmaceutical space. Much of …
By Stephanie Sivinski
1 year ago 18