FDA recently doubled down on its approach of allowing new language in an ANDA label as the result of a section viii statement – a so-called “carve-in.” Section viii statements assert that an ANDA does not seek approval for...more
A trade secret owner must file a civil action under the Defend Trade Secrets Act (“DTSA”) within three years of when the alleged trade secret misappropriation “is discovered or by the exercise of reasonable diligence should...more
Two weeks ago we discussed Vanda Pharmaceuticals’ ambitious cert petition asking the Supreme Court to discontinue the “reasonable expectation of success” standard for patent obviousness that for decades has been a mainstay of...more
Among the most established standards in patent law is that obviousness requires a motivation to combine the prior art with “a reasonable expectation of success.” The Federal Circuit alone has employed the “reasonable...more
8 Puma Biotechnology is the latest victim of standing requirements in patent cases that continue to wreak havoc on plaintiffs’ ability to recover a full measure of damages. In Puma Biotechnology, Inc. v. AstraZeneca...more
3/27/2024
/ Article III ,
AstraZeneca ,
Biotechnology ,
Damages ,
Injury-in-Fact ,
Intellectual Property Litigation ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Royalties ,
Settlement Agreements
The America Invents Act ("AIA") bars a person from obtaining a patent when the “claimed invention” had been “on sale” more than one year before the filing date of the patent. 35 U.S.C. § 102(a)(1). Acesulfame potassium...more
The Federal Circuit's decision on claim construction, Barrday, Inc. v. Lincoln Fabrics, Inc., 2023-1903, 2023 WL 7871688 (Fed. Cir. Nov. 16, 2023), takes a dizzy dive into the age-old question of when a claim should be...more
The U.S. International Trade Commission (ITC) has broad power to issue exclusion orders blocking the importation of goods determined to have infringed or misappropriated complainants' IP rights. Moreover, the ITC’s in rem...more
FTC recently placed improper Orange Book patent listings squarely in its crosshairs. In its September 2023 policy statement, FTC announced that it would “scrutinize improper Orange Book listings” and “use its full legal...more
The Federal Circuit's claim construction gospel set forth in Phillips has been entrenched in the minds of patent litigators for nearly 20 years.1 The intrinsic evidence - the claims, specification, and prosecution history -...more
On August 22, 2023, the Federal Circuit affirmed an IPR Final Written Decision holding claims to deuterated derivatives of ruxolitinib unpatentable as obvious and rejected the patentee’s argument that a skilled artisan would...more
In the first decision to issue following the Supreme Court’s denial of certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, 22-37, Magistrate Judge Sherry R. Fallon of the United States District Court for the...more