Posts Tagged: hatch-waxman
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The Federal Circuit issued a nonprecedential decision in Indivior Inc. v. Dr.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 …
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 …
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 …
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 …
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 …
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 …
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 …
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. …
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 …
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 …
Hatch-Waxman Litigation: 60 Percent Increase in ANDA Lawsuits from 2016 to 2017
In 2017, U.S. district courts saw a total of 417 patent infringement suits related to ANDA filings made by drugmakers with the U.S. Food and Drug Administration (…
