A patent applicant dissatisfied by an patent examiner's rejection of that applicant's claims in ex parte prosecution has recourse by appeal to the Patent Trial and Appeal Board (PTAB) under 35 U.S.C. § 134, and to the Federal...more
On April 29th, Ambassador Jamieson Greer, U.S. Trade Representative (USTR), issued the 2025 Special 301 Report. In a press release (being quite different in tone from many over the past decade), the USTR stated that "[o]ur...more
5/7/2025
/ China ,
Copyright Infringement ,
Enforcement Actions ,
Intellectual Property Protection ,
International Trade ,
Mexico ,
Pharmaceutical Industry ,
Popular ,
Trade Secrets ,
Trademarks ,
US Trade Policies
The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme). The issue...more
2/13/2025
/ Appeals ,
Hatch-Waxman ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Oral Argument ,
Patent Litigation ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Statutory Interpretation ,
USPTO
The Office of the U.S. Trade Representative (USTR) issued its "2024 Review of Notorious Markets for Counterfeiting and Piracy" on January 8th, directed to "prominent and illustrative examples of online and physical markets...more
1/16/2025
/ Centers for Disease Control and Prevention (CDC) ,
Counterfeiting ,
DEA ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Pharmaceutical Industry ,
Prescription Drugs ,
Trademark Infringement ,
USTR
Last month, at the Biotechnology Innovation Organization (BIO) Intellectual Property Counsels Committee (IPCC) conference in Washington, DC, the Honorable Judge Pauline Newman of the Federal Circuit gave a lunchtime address...more
In Natera Inc. v. NeoGenomics Laboratories, Inc. the Federal Circuit affirmed the District Court's grant of a preliminary injunction against NeoGenomics in patent infringement litigation involving Natera's U.S. Patent Nos....more
The Federal Circuit once again had an opportunity to opine on the extent of behavior by a generic drugmaker who opts to accept a "section viii carve-out" in its FDA approval (resulting in a so-called "skinny label) on...more
U.S. Senator Chris Coons (D-DE), along with Sen. Thom Tillis (R-NC), have been the motivating force for patent reform for almost a decade, primarily in their efforts to roll back legislative efforts and judicial decisions...more
In April, Ambassador Katherine Tai, U.S. Trade Representative (USTR), issued the 2024 Special 301 Report. In a press release, the USTR stated that "[m]any of the issues highlighted in the Special 301 Report demand...more
6/20/2024
/ Biden Administration ,
Counterfeit Drugs ,
Counterfeiting ,
Intellectual Property Protection ,
International Trade Commission (ITC) ,
Piracy ,
Section 301 ,
Trade Representatives ,
United States-Mexico-Canada Agreement (USMCA) ,
USTR ,
WTO
Last week the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings. This post concerns the decision in Medtronic, Inc....more
Although merely exemplifying the burden imposed on an appellant by the Federal Circuit's substantial evidence standard of review over decisions by the U.S. Patent and Trademark Office regarding the facts underlying legal...more
12/8/2023
/ Claim Construction ,
Entitlements ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Nonobvious ,
Obviousness ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
PTAB Precedential Opinion Panel (POP) ,
Trademark Litigation ,
Trademarks ,
USPTO
Proper construction of claim limitations reciting the chemical property of pH (which denotes the concentration of hydrogen ions in a solution as an indication of acidity) has arisen several times in district court and Federal...more
12/8/2023
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Claim Construction ,
Innovation Patent ,
Intellectual Property Protection ,
Inventions ,
Inventors ,
Mylan Pharmaceuticals ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
SCOTUS ,
Teva v Sandoz
It came as something of a shock in May, 2021 when the Biden administration voiced support for waiver of intellectual property protection mandated under the TRIPS agreement for COVID-19 vaccines (see "Biden Administration...more
11/9/2023
/ Biden Administration ,
China ,
Compulsory Licenses ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Enforcement ,
Healthcare ,
India ,
Intellectual Property Protection ,
International Trade Commission (ITC) ,
Popular ,
Research and Development ,
Tariff Act of 1930 ,
Therapeutic Services ,
Trademarks ,
TRIPS Agreement ,
Vaccinations ,
Waivers ,
WTO
The Federal Circuit reviewed the latest decision from the Patent Trial and Appeal Board (PTAB) in an inter partes review that claims 3-6 and 10 of U.S. Patent No. 6,548,019 are obvious, in Rembrandt Diagnostics LP v. Alere,...more
The Patent Trial and Appeal Board (PTAB) has benefited, particularly after enactment of the Leahy-Smith America Invents Act, from the deference to its factual findings mandated by the Supreme Court's interpretation in...more
In earlier times, the Federal Circuit, responding to efforts by the U.S. Patent and Trademark Office to reject patent applications directed to biotechnology-related inventions, held (In re Brana) that utility of such...more
The Federal Circuit provided a reminder last week that merely identifying an unappreciated consequence of a prior art method cannot confer non-obviousness on practice of methods that did not acknowledge that consequence, in...more
Through the vicissitudes of the continuing chaos of subject matter eligibility, Senators Coons and Tillis have been steadfast in attempting to provide a legislative solution. They chaired a series of Congressional hearings in...more
Through the vicissitudes of the continuing chaos of subject matter eligibility, Senators Coons and Tillis have been steadfast in attempting to provide a legislative solution. They chaired a series of Congressional hearings...more
The Federal Circuit's Special Committee released two documents relevant to their continuing assessment of Judge Pauline Newman's fitness for the bench today, neither of which can be considered comforting to the patent...more
In its recent review of a district court decision the Federal Circuit characterized as "a thorough opinion," the Federal Circuit affirmed invalidation for obviousness of four claims from four different Orange Book-listed...more
The Supreme Court's consideration of the standards for satisfying the enablement provisions of 35 U.S.C. § 112(a) has been occasioned for the first time in over a century by the Court's granting certiorari in Amgen v....more
5/12/2023
/ Amicus Briefs ,
Clear and Convincing Evidence ,
Enablement Inquiries ,
Intellectual Property Protection ,
Life Sciences ,
Patent Litigation ,
Patents ,
Reduction to Practice ,
Standard of Proof ,
Trade Secrets ,
USPTO
An appellant's burden on appeal is never easy but it is particularly difficult when the questions at issue are based on factual evidence. The appellate judiciary is loathe (generally) to second guess a district court judge...more
"This application claims priority to [properly identified earlier-filed application, the disclosure of which is expressly incorporated herein in its entirety" is a phrase commonly found in patents and patent applications as...more
Minerva and Hologic, competitors selling devices used for ablating uterine endometrial tissue, are notable for their dispute last year that gave the Supreme Court an opportunity to reassess an established patent law doctrine,...more