Posts Tagged: hatch-waxman
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 (…
USPTO Director Andrei Iancu Discusses Patentability of Algorithms, PTAB Proceedings at Senate Judiciary Committee
Sen. Harris followed up by asking whether algorithms were mathematical representations of laws of nature. “You’re getting right to the heart of the issue,” Iancu said. …
The Abuse of Orange Book Listings by Branded Pharmaceutical Companies
AbbVie’s maneuver worked like clockwork to induce regulatory gridlock, which prevented generic competition and kept the company’s profits high at public expense, for years. Fortunately, …
Celgene’s New Revlimid® Lawsuits Shows Shifting Tactics From Earlier Natco Case
Celgene faces a new gang of generics moving in on its blockbuster Revlimid®. Over the past year, a number of generics have filed ANDAs against Revlimid®, including …
Merck Process for Stabilizing Antibiotic Compound Invalid as Obvious
The District of Delaware found that one of two patents asserted by Merck was not invalid and infringed, and the other patent, while infringed, was invalid as …
